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Hi . We are going to get started. That could everyone get in their seats?
Good morning, if everyone could have a seat. We will get started. Welcome back for day
2 . As a break said yesterday we had an exciting first day and we are looking forward to an
equally exciting day two. We have three excellent panels of speakers coming up one on hearing
technologies, one on innovations and one on contemporary issues in hearing healthcare.
Later this afternoon and we will a final panel that will provide some reaction and stimulate
some discussion looking to the future. As I mentioned yesterday, the webcast will be
posted on the workshop website as well as -- as soon as possible at the conclusion of
today's workshop. You can look forward to that and the slides for those of you interested
those will also be posted. As well as coming attractions. So, before we get started, I
want to take a moment to thank all the IOM staff , Tracy Lustig, senior program officer
and all of her staff have done an outstanding job helping us organize this and pull off
the workshop. They all work in the background but without their efforts, this would never
come to fruition. Please join me in thanking them.
[applause]
I think this workshop has gone extremely smoothly and that does not happen by accident thanks
Tracy and all the staff. Okay. Carol? You will introduce the first panel? Brenda? Pardon
me. Thank you.
Good morning, everybody. I just would like to encourage you, if anybody here has never
experienced listening through a loop whether you have a hearing loss or not, whether you
have a hearing aid or not, there are phones you can use just to experience it. I think
you will be quite amazed. It is my pleasure to introduce the three panelists, Cindy, Eric
and Fiona, please come up. We have session five this morning on hearing technologies
and it is really a great lineup of speakers I think it will be very dynamic group. We
have Cynthia Compton-Conley who is going to be doing a technology overview. She is CEO
of Compton-Conley Consulting and we have Eric Mann from the US FDA who will talk about FDA
regulation and hearing aids and we have Fiona Miller from the University of Toronto who
will talk about technology assessment. Let's get started.
Good morning, everybody can you hear me okay? It is a pleasure to be here. I will take you
on a wild 25 minute ride through assistive technology a talk that normally takes two
hours so, don't blink. What I will cover is current and future technologies, talk a little
bit about applications, barriers to use and make suggestions for how to remove the barriers.
This next slide is my attempt to summarize all of the possible technologies we have at
our disposal now. If you look across the top you will see I have tried to apply them to
severity of hearing loss you will notice of the top there is a blue group, all the hearing
aids, cochlear implants, hybrids, etc. and the bottom group are hearing assistant technologies
also called assistive listening devices as well as alerting
devices. Most of the time people are trained to go to the blue group first as the heart
of hearing enhancements. I will not go into all of these technologies right now except
to say that we all know they have advanced over the years, there is very sick -- sophisticated
signal processing in all of the systems but they have one thing in common . The microphone
is worn on the head and as Terry eloquently talked about yesterday this means speech understanding
will be negatively influenced by room acoustics. If you look at the diagram you see there is
a synergistic effect among audibility, noise, reverberation. The target signal, whatever
it is you are trying to listen to whether it is speech or music could become too soft,
masks or covered up by the noise smeared by reverberation or any combination of the above.
Directional microphones, while we have a large body of evidence that shows they do improve
ability to understand speech and noise, in certain real world settings, they don't always
do that. He may function as if they are omnidirectional especially if you're seated beyond the critical
distance in the reverberation of the room.
They are not always a solution for face-to-face communication.In addition, hearing aids and
implants alone don't always work for media. For example if somebody wears implants or
hearing a and implants and they want to listen to media privately using an iPod they need
extra technology to do that. In addition these devices don't always work by themselves for
the telephone for example you can't always pick up certain cell phones and hold them
up to your hearing aid or you have a buzz you may need other technologies. Finally they
don't always morning people of convenience sounds, security sounds, different cues. There
are so many sounds in our environment today in the old days we listen to one ring town
now we may have 10 retells a refrigerator telling us when to buy cheese all types of
things we have to listen to. What I would like to point out is we have four receptive
communication needs.We need to engage in face-to-face communication, one-to-one, group, we need
to receive media on various platforms and we also have to engage in telecommunications
on various platforms. We all need to be alerted to various signals.
These four needs have to be met in various venues of a persons life.Home, work, volunteer
work, leisure activities -- this is why you have to do a needs assessment. You have to
have a grid in your mind of four needs, all venues because in each venue the tech knowledge
he could be the same, a little twist or totally different technology. For example I might
have a patient who has FM at home but can't use wireless technology at NSA and that happens
a lot in the DC area. What we have is the necessary partnership between personal hearing
instruments and hearing assistive technology this takes and improves communication modern
hearing instruments came provide an extended. I like to look at the technology types and
in four different ways you can classify according to four needs how they will be used, you can
classify them according to ownership so personal, public, portable, stationery, hardwired, wireless.
I will talk about technologies for face-to-face and media first. I will not go over the slide
because well Terry talked about it yesterday but this cash carry couple -- catch carry
couple is basically is assistive listening device you can compare it crudely to binoculars
for the years as binoculars take an image make it closer you can inspect it that is
what assistive listening devices do they reach out, grab the sound function like a 30 year
as Merck Ross would say, and bring it closer so you can here. If they don't cure the room
acoustics the overcome the room acoustics. You can have a hard wired or wirelessly between
the sound source and the listener.
I will just go through some of these technologies. Probably most of you have heard about the
ubiquitous pocket talk or how many have ever use the pocket talker? This is like a body
aid so you have a microphone, amplifier, and earphones so you can add an extra microphone
you lapel on a person you can have two people seated across the table or in a counseling
situation in a hospital, nursing home, etc. just put your phones on the person and talk
to the person rather than yelling at the maybe the person doesn't have amplification yet.
At the bottom of the slide you will see there is three methods of coupling. And this is
going to be reoccurring, I will make a point with this in a few slides but acoustic coupling
is using air phones on a naked here. Inductive coupling is using a neck loop or silhouette
inductor which sends electric magnetic energy into a circuit inside the implant called at
Telecoil, a wireless receiver. The third method is direct audio input where you plug a wire
into the bottom of the hearing aid or implants. One of the decisions that has to be made is
which coupling is best for the person. So, that is part of the needs assessment process.
As far as the wireless technologies are concerned I will talk about what I call the classic
to elegies , infrared, frequency modulation and hearing loops and also the more modern
wireless systems these are wireless hearing aids with what I call connectivity this is
the same as the classic system just a new twist on it so for example I would like to
call your attention to the top of the slide I divide these systems into two system this
is just my own way of doing it. There are systems that always need a stream or assistance
the only need a stream or or phone. Certain of the system still use a TV transmitter you
plug into the back of the TV or other sound source, and a battery-powered microphone you
can clip to espouse. These are Bluetooth they transmit to a gateway device called a stream
or , technically called a transceiver because it receives one form of energy changes it
to another. So in this particular product the changes it into a near field. Attic induction
signal received by a radio inside the wireless hearing aids.
The second type of system resound and star key right now don't need an intermediary device
at least for microphone and TV. You could take a Mike, go to a restaurant and talk to
the other person or plug a transmitter into the back of your TV walk into your living
room and hear stereo. People really like that option. These could also be used in the workplace,
you could use sometimes people use TV in the workplace for teleconferencing, you can also
put microphones around it , an office table, things get a little complicated if you are
trying to do ADA access and people have more than one brand of system because they are
not compatible with each other. I have been in situations where there is easy --
80 microphones on the table I'm exaggerating. You've heard of infrared at home you've heard
of TV ears, you can attach a TV transmitter to the back of your TV system you can also
use a transmitter in an office these are often used in places where security is a concern
because infrared won't leave the room. People use them in juvenile court for example.
Give the same methods of coupling and -- I changed my slides last night -- you can have
FM systems, another option, these are used in school systems but
adults also use them and probably -- one of the more versatile, classic systems. You also
have a battery-powered microphone all the way to the left people can wear so you can
have a conversation in a restaurant, car, at home, at work, at play. You also put a
transmitter on a table and one or more microphones or attach it to your TV sets. There is also
one additional option on the far right which is DAI , bit it is a BTE receivers of FM is
not worn on the body is plugged into the bottom of a hearing aid, implant or incorporated
into the case of the device. The last but not least is induction loop. A person can
buy an induction loop system for $300, plug it into the back of the TV, and has amplifier
a wire that goes around the room and just like the streamer system you can walk in and
start to hear, you can do that with the loop system as long as you have one thing, a Telecoil
inside your hearing aid or implant. You can move the table, chair, office, this room is
looped, the floor was taken up and the room is looped. There are two types of loops perimeter
and phase delay one is just a wire going around the room, if you're wearing a hearing aid
the Telecoil has to be mounted vertically. With a phased array it doesn't matter how
it is mounds that you always wanted vertical and I have been in situations where I have
given talks and watched people in the audience look at me like this or like this because
the Telecoil is not situated in the hearing aid properly. Or even more importantly, just
as important a, the Telecoil has not been programmed to be equal to the microphone circuit.
I once saw a man ripped the doc tape off a loop and put the loop on his shoulder so he
could hear better. I once saw a guy like down on the floor which made it difficult to speech
read. I have seen it all. I've been in the trenches. Let me also talk about FM infrared
and loop in terms of permanently installed systems for large areas. These can be mandated
under ADA or not. With these systems you have less coupling options. In this room we have
a system that uses a loop that they all have a mixer amplifier , we have a hardwired microphone
here, you might have wireless. If you want to play sound it is in the mixer and on the
output stage you have an FM transmitter. Under ADA, theaters, etc., are only required to
have two forms of coupling. Includes -- acoustic an inductive usually and neck with because
you can't expect them to have every single input board for every make and model of implant.
It would be insane. The same thing with infrared same coupling. If you want to access FM or
infrared, or loop, you have to have a Telecoil. Either in your hearing aid or implant or in
your streamer and some hearing aid companies have Telecoil's inside the streamer. If you
don't have that all the way to the right then you might supply and under the chin or neck
loop receiver with the Telecoil in it but that would only work if you don't have two
great of a hearing loss and if you have more of a flat loss not a slope configuration.
I will give you two scenarios the life of the consumer using large areas systems based
on 30 years of working with consumers as well as research by American Academy of audiology
and hearing loss Association work now being done by Juliet Sterkens and I've read a result
of how people react to be systems. If you're going into the theater that has an FM or infrared,
you will have a nice evening with your spouse or friend, you buy the ticket, ask for the
receiver, you have to hand over your drivers license and you have a pretty significant
loss and you want a receiver with a neck loop that they give you one with earphones. You
politely say no I really want one with thank you loop. The manager goes intake was out.
Believe me this happens I was hired by a special master to a court after and ADA lawsuit I
had the dress up in disguises and ask for them for three years as part of my job it
was fun I saw a lot of movies it was pretty fun.
[laughter]
So, it gets thank you loop you go into the theater the receiver is dead you are like
oh my God I have had at the manager gets a new battery now the receiver is intermittent
the volume control is 30 it sounds like graph and the manager says I don't know what to
tell you, we are in compliance following the law gives you your money back your ID back,
you are unhappy and you want to go home and reenact the scene in platoon you are so annoyed
or you go to the Kennedy Center, a loop system is installed according to standards your Telecoil
is installed by your audiologist , you buy the ticket you walk in you don't have to ask
permission to train when you flip the hearing aid to Telecoil or MTC you can hear your spouse
without having to yell and hear your own voice, you enjoy the show, feel happy and voila.
Infrared systems can be stereo and they can and some people can detect stereo over dyadic
signals we've done some studies the Gallaudet where people can tell the difference between
dichotomy and ionic but for ease of use, loops when hand -- win hands-down so until we find
something better don't make fun of him I see blogs about it and it really is annoying.
So I am telling everybody watching this webcast just think about it. It is great to work for
yourself. There is a new technology spread spectrum frequency hopping which is exciting
to meet these are portable system the same coupling options as FM that they have the
option for being used one-way or two-way communication. For ADA access it is great for one-to-one,
to her group, 100 people to her groups here is a situation where everybody is wearing
a transceiver all people can talk to each other and the mic is open so it's more of
a natural conversation so you can set it up -- I did one , one time with ERISA Spanish-speaking
tour guide speaking to a hard of hearing Spanish English interpreter group or hard of hearing
in normal hearing people who needed to talk back to the tour guide through the interpreter.
You can do things like that. You can -- I have set up the professors who are hearing
impaired and have to hear a whole group of students, I have done board meetings, you
can do medical school operating theaters, but you have to first assess the needs and
find out what kind of communication is going on so you can decide what type of microphone,
what type of receiver, do I need transceivers, what about lighting, seating, you need to
set up rules of communication. A mix of technology in training. You can't solve problems of just
technology.
You have to put need before technology. This is the take away from the Section I have been
talking about. It is a cacophony of coupling options. There are different systems. If this
is confusing to you imagine your mom trying to figure this out. So each person's system
has to be adjusted to achieve the best signal, Telecoil have to be programmed, and the system
is requiring receivers like FM or infrared , they require maintenance and large areas.
Again, you have to have a Telecoil to have access. I also want to talk about the third
need, telephone, I don't have a lot of times will breeze through this and hit the highlights
of this diagram shows the different ways you can couple to landline, VoIP and cell phones.
Let me talk about a few options. I like to provide binaural listening to people because
research has shown it does improve understanding except for certain people for example if you
look to the left you'll see several hardware technologies for cell phones, landline, VoIP
phones. You can plug in silhouette inductors, and go hardwired you can plug in a neck loop,
if somebody is using a Vista to two headset maybe they are a telemarketer with a hearing
loss, replace the headset with a neck loop. We have wireless Bluetooth technology and
also all the way to the right Plantronics makes the Bluetooth hub with a headset you
can put the headset away and just used several streamers because they will work with it.This
is just a snapshot of a whole host of technologies that can be used for telecommunications access
at home and at work. There is captioning now.We are watching live captioning but there is
landline captioning, smart phone apps, you can caption on your smart phone and use a
hands-free interface at the same time. Captioning can be used by itself or in addition to auditory
input. There is web-based captioning for teleconferencing . There is other text services we know about
e-mail, instant messaging . But there are automatic voicemail transcription services
normal hearing people use but hard of hearing people use so your voice mail is sent to you
via a text or e-mail. And Gallaudet has done some research on this. I put a link here so
you can read up about it. There are specialty devices. Anybody working in the medical profession
can use an amplified stethoscope, a visual stethoscope. I was happy to see this because
I remember when I was recommended a portable oscilloscope for a medical student. They actually
made them it was bulky but at least she was able to go through medical school. Last but
not least this always gets short shrift are alerting devices for home, office and public
areas. You look all the way to the left you see all the various sounds that can be -- that
can occur in a persons day from the time they wake up until the time they go to bed and
we also have various queuing sounds. There are alerting devices that will pick these
up using a microphone, direct connection, I recommend pressure mounts for severely hard
of hearing people, children, a mother who had Alzheimer's they wanted to
know in the middle of the night if she left her room. If she walked out of her room she
would step on a mat and the bed would shake so they could watch her.
The systems can be hard wired or wireless and you can use an auditory signal, enhanced
or visual, vibrant tactical or a combination. Owsley they are stand-alone systems, unit
trauma, one of -- Unitron is working to have Gateway devices you don't have to have a hearing
aid on to know things are happening but if they are on the gateway device will take the
signal from the alerting device and make a beat in your ear I know Apple has a conceptual
patent for a similar thing. They are thinking along those lines . I do want to take a couple
of minutes to talk about fire safety because this is a concern I know Terry mentioned yesterday.
I used to sit on the national fire protection Association committee for notification devices
and we were able to get new standards past four visual notification devices for the deaf.
There is a body of literature now, I have a link at the bottom, where you can find more
information but there is some pretty scary statistics individuals aged 65 and older have
more than twice the national death rate. Smoke detectors peak at 3100-hertz where people
have hearing loss and there's a 40-decibel difference in alerting to a signal from being
awake versus asleep. If you are in a deep sleep, on medication, sleep deprived him under
your pillow and your smoke detector is behind a closed door, you might not hear it. Also,
research I have done, shows people with hearing loss incorrectly assume they will be able
to hear a smoke detector.
If you ask them if they tested it they say yes I press the button I can hear well you
are awake not asleep what sleep stay are you in? This is a concern this needs to be recommended
more often then it is, because people don't have their hearing aids or implants on all
the time. I like to take time and talk about disruptive technology a couple companies leaping
into new areas. I included the slide because in my hotel you are allowed to ask for a Pat.
I have a goldfish in my room named killer . The Hotel Monaco in case you want to have
a pet but he kept me up last night splashing .
[laughter]
I had to move them into the bathroom and shut the door. Resound has a streamers system first
generation transceiver so Bluetooth enabled phone will send the transceiver and a proprietary
Bluetooth like signal will be sent to the Resound hearing aid but they have been working
with Apple and in the spring you will seen the new iPhone with Bluetooth 4.0 so you can
stream voice calls, podcast, Facetime, straight to the hearing aid. You might save yourself
well this is pretty good like the holy Grail. You don't have to carry a stream or around.
But the astute person would say wait a minute don't I still need a Telecoil in large areas?
And you do. Until we have something like Wi-Fi where it could take my cell phone to a theater
and people are working on this, and Wi-Fi goes to my phone and my phone goes to my hearing
aid or maybe goes directly, we still need to think about how people access these large
area systems. It might be a situation, depending on a person's need, they are using wireless
hearing aids but they still have a Telecoil in the hearing aid or streamer. Also I would
like to see the day where people could come to my house for the Super Bowl party, doesn't
matter what hearing aid they are wearing, what implants, maybe there is a chip built
into my hearing aid like a closed caption decoder chip, universal design anybody, any
make, any model of hearing enhancement devices would work and you don't have to hook it up.
Remember in the old days when we had to teach people how to hook up a caption decoder that
was when hair and shoulder pads were bad.
So, I also see the day where maybe we will have a Swiss Army knife device that will meet
four needs be a hearing protector, the self adjusting , I only have 30 seconds, there
is research being done at national acoustic laboratories and elsewhere on self fitting
hearing aids. That is something that might happen. Apple has a patent, Richard Einhorn
will talk later about smart phones being used as hardwire hearing advancement devices and
I just want to end by saying, we really need to look at what consumers really want, what
they need and how do we meet the needs. This is the million-dollar slide here.They want
full communication access for a lifetime. We need to employ a holistic needs assessment
process that carefully assesses residual hearing using best practices, speech and noise testing
and analyze individual needs. The four needs, in the venues. And use self-assessment inventories,
you have to look at health, situations, finances, there tech savviness and devise a customized
solution set of technology and training and verify it and validated and have a feedback
loop if it is not verified and not validated you won't recommend it. People make the mistake
of jumping into the technology before they analyze the need. Or, the analyze the need,
recommend the technology and don't program the Telecoil, for example. This needs to stop.
I don't have time to go over my challenges and solutions but you can read them in -- the
one thing I would say , I think we need a required sequence of didactic and clinical
work for audiologists and it needs to be standardized across programs and we need to be board certified
or better yet it needs to be a minimal requirement. There needs to be a minimal requirement. I
will stop now. Since this thing has been blinking for a while.
[applause]
Good morning everyone I am Eric Mann working at the FDA it is a pleasure to be here today
and to participate in this workshop on healthy aging in hearing loss. I have really enjoyed
the presentations to date thank you Cynthia for that very nice overview of current technology
. We are going to shift gears a little bit now and talk about FDA regulations of hearing
aids and the requirements. Hopefully, I will keep this at a very high level, I have to
keep it at a high level even I only have 15 minutes and I vow I will try to keep regulatory
speak to a minimum and try to keep this accessible to people. I will try to do the 30,000-foot
approach to regulations essentially. So, I will start off by doing an overview of device
regulations and how we use a risk-based approach in regulating medical devices and I will hone
in on hearing aids in particular and hearing aids are kind of the unique device there is
a handful of devices at FDA that actually have their own regulations apart from the
classification regulations intended to ensure safety and effectiveness and hearing aids
happen to be one of those.We have specific regulations regarding labeling and one for
conditions for sale and I will talk about those and the reason that we have those regulations.
So, just at the very -- 30,000 foot level within FDA would have an office of medical
products and tobacco. And within that office are four centers, there is the Center for
Drug Evaluation and Research, they regulate drugs, we have a center for Biologics, we
have a relatively recently created Center for Tobacco Products but I work in the center
for devices and radiological health. Of course, hearing aids and the regulation of auditory
devices are within that center. I would point out that the regulations for all of these
centers, particularly the first three are pretty much geared toward ensuring safety
and effectiveness although the specific regulations , cross centers do vary and today I will be
speaking from the CDRH or center for devices perspective. FDA derives its regulatory authority
to oversee safety and effectiveness of medical devices from the food, drug and cosmetic act.
We have a very clear definition as to what constitutes a medical device and have it listed
here in bullet form . Essentially any product intended to diagnose, cure, mitigate, treat
or prevent a disease/condition or, is intended to affect the structure or function of the
body and it does not achieve its intended use through chemical action or metabolism.
As you can imagine the last bullet , chemical action and metabolism is what separates devices
from Biologics and drugs. So a device should not act through chemical action or metabolism.
This is a very broad definition but it does draw a bright line between things that are
medical devices and those that aren't and I think it is particularly relevant to the
discussion we have had about PSAPs often onto the workshop so far so I want to highlight
that clearly a hearing aid is a product that is intended to treat or mitigate hearing loss
and is thus very clearly a medical device whereas a
personal sound application product, PSAP, to be used by normally hearing people under
certain listening conditions . The Walker game here for hunters being a good example.
That is not treating a condition or preventing or mitigating or treating a disease or condition
, that is normally hearing individuals, nor is it affecting the structure or function
of the body is providing amplified amplified sound to the auditory system.
We do have a distinction again between a hearing aid which treats hearing impaired consumers
of any degree, this includes mild hearing loss, moderate and severe. Any product intended
to mitigate or treat a hearing loss is considered a hearing aid in FDA's view whereas a PSAP
is for normal hearing individuals. There has been as a tangential point, we've had a guidance
document now try to make this clarification. We recently updated that guidance document
in draft form at least with some specific examples to clarify the types of claims that
would be more associated with hearing aids and PSAP 's. I want to emphasize this is not
a change in FDA policy or new FDA standard, this is merely us trying to clarify for manufacturers,
consumers, practitioners the distinction between a hearing aid and a personal sound amplification
product. I am sure we will have some questions and discussion about that later but I just
wanted to start with that. So this definition is wide, as stated, and the slide illustrates
the huge diversity of medical devices that FDA oversees. It includes everything from
something as simple as a time depressor or Band-Aid, on the left-hand side, all the way
through things like tanning beds and best implants down below here -- again these are
structure function type devices and that is how they meet the definition you would consider
a tanning bed necessarily treating a disease that it does affect the structure of the body
so it does meet the device definition . And then certainly at the other end of the spectrum
we have very sophisticated high risk type devices like neural stimulators, artificial
hearts , pacemakers and so forth. How does FDA approach the regulation of such a wide
variety of medical devices?
The answer is it is not a one-size-fits-all approach. Certainly, you wouldn't expect a
randomized controlled trials for a new tongue played coming on the market [laughter] well
maybe some people would but FDA does not on the other hand when you are developing a new
neurostimulator or artificial heart or heart valve, you would want a well-designed clinical
trial to establish safety and effectiveness. The answer as to how we regulate this why
Brady of devices is when the medical device amendments to the Food Drug & Cosmetic Act
were enacted back in 1976 it created a risk-based classification in which the regulatory requirements
were gauged to the risk posed by the device. So, we have three classes of devices. Class
one, considered low risk, class two of moderate risk and class three, high risk . So the regulatory
requirements are gauged according to the risk level. Class one we have regulatory
or general controls which are intended to ensure safety and effectiveness of the device
and I will go into more detail as to what that means exactly, general controls, but
these are basically the baseline level of regulatory requirements that apply across
all device types. When we move up a notch to the moderate risk level we fill general
controls in and of themselves are not sufficient to ensure safety and effectiveness of the
device so we fill additional special controls are needed special controls can be something
like a performance standard, ISO, ANSII or performance data the device would have to
meet like a guidance document the FDA has created that outlined certain points that
need to be addressed in a premarket submission or could even be something like a post- market
surveillance requirements like a registry or device tracking . Finally at the far end
of the spectrum on class three devices, high risk devices, general controls again are not
sufficient to ensure safety and effectiveness so we have the premarket approval process
.
You may be familiar with that, it is a very in depth premarket application including all
sorts of information on the manufacturing, preclinical studies and usually the centerpiece
of a PMA is a very well-designed clinical study, well-controlled study and there is
typically even an outline of a plan for a post- market study as well. So that is of
the high-end, class three devices. Again, we have a risk-based classification one size
does not fit all. So how do hearing related devices fit into this overall scheme of things?
I have kind of outline the specific hearing devices in where they fit in classifications.
Your typical air conduction hearing aid which we have talked a lot about during the workshop
here is a class one device so it is considered in essence a low risk device. Class two we
have things like bone anchored hearing aids, we have wireless air conduction hearing aids
I should point out it's not the risk of the wireless hearing aid is significantly different
than an air conduction hearing aid from a safety standpoint it is more in terms of regulatory
controls we need to ensure effectiveness because of wireless interference, issues, FDA felt
those were important enough that we do need special controls to ensure those devices will
be effective in those situations , and labeling in everything else that goes along with that.
In class three high risk type of auditory devices we have things like cochlear implants
as you might imagine we have certain implantable middle ear hearing devices the most recently
might be a total of five cell middle ear hearing device and things like auditory brainstorm
-- brainstem implants.We have complete spectrum of devices within hearing related technologies
. Getting back to the class one garden-variety air conduction hearing aid that is really
the focus of the workshop so this is where I will spend most of my time in terms of regulatory
controls we have in place for those technologies.
Again, they are class one devices and FDA has determined a general controls and of themselves
are sufficient to ensure safety and effectiveness of the air conduction hearing aid device type
. What are general controls? I have a list here on the slide in bulleted form first is
prohibition of adulterated or misbranded devices again kind of diluting this down to layman's
speak it essentially means the labeling for the device should be truthful, accurate and
not false or misleading. We have a quality system regulation
good Manufacturing practices are also one of the general controls as well. There are
baseline can -- requirements for manufacturers to register their facilities with the Ed TA
and to list the types of devices that they are marketing. There our various recordkeeping
requirements, some provisions regarding repair, replacement or refund but these are very rarely
-- very rarely come into play. When these were first enacted back in 1976, there was
a requirement for premarket notification also known as a 510(k) but as of the 1990s most
devices are exempt from the requirement for premarket notification as long as they comply
with the preceding general controls, the air conduction hearing a typically would not have
to have a premarket application to FDA. The exception would be if there is a fundamental
change in technology to the hearing aid or if the hearing aid is being indicated for
a new population. That would exceed the limitations of the exemption and would in fact require
a 510(k) most by 10 CADE biases are now exempt including most air conduction hearing aids.
-- most 510(k) devices are exempt -- in addition to the general controls, hearing aids are
a little unique in terms of having a specific regulation regarding their labeling and conditions
for cell. So we will talk a little bit about that right now. But I do want to emphasize
most air conduction hearing aids are not prescription devices that is the type of restriction that
we have for some devices prescription versus over-the-counter or nonprescription devices.
In general, most air conduction hearing aids are not prescription devices however they
are restricted by regulation with respect to labeling and with respect to conditions
for cell. We will talk about that a little bit more so here is the restriction regulation
regarding labeling and it is 21 CFR 420 , there is a requirement within this labeling regulation
for the manufacturer to develop a user instructional brochure. And it outlines the content of the
brochure within the regulation and in particular there has to be a very well-defined instructions
for use that includes a diagram with all of the different components of functionalities
of the hearing aid described . How to insert the battery or remove the battery, how to
maintain the hearing aid, conditions to avoid damaging the hearing aid those kinds of things
as well as the expectations that a hearing aid , air conduction hearing aid will not
restore normal hearing and to get the most out of a hearing aid this is only part of
a rehabilitation program that you may have optimally physician involvement as well to
fine tune the hearing aid.
These are in the user instructional brochure. There is a section called warning to hearing
aid dispensers and this outlines what we call the so-called red flag signs and symptoms.
These include things like draining from the ear, asymmetric hearing loss, that sort of
thing. These are flags that the hearing aid dispenser needs to actually go and refer to
a physician . In addition to that we also have an important notice for perspective hearing
aid users , it describes the whole conditions for cell process need for necessity of a medical
evaluation and also a technical performance data section as well is defined by this standard.
The other regulation is the conditions for cell revelations essentially requires medical
evaluation by a licensed physician within six months of dispensing hearing a there is
a provision available for a waiver, users greater than 18 years of age as long as the
patient signs a statement acknowledging is not in their best help adjust the dispenser
may not encourage the waiver and the dispenser should afford them an opportunity to read
the user instructional brochure as well. And their recordkeeping requirements. These are
at the conditions for cell just to emphasize the reason for that both of these regulations
of the outcome of an interdepartmental task force back in the mid- 1970s some Senate hearings
which we are looking into the sub optimal diagnosis and treatment of hearing disorders
prior to dispensing a hearing aid. So, essentially again
the medical evaluation requirement we describe is not based on a safety issue with the hearing
aid it is more about wreck nice thing medically and surgically treatable causes of hearing
loss and providing optimal health care for patients.
And that is pretty much it I just want to point out that we do have some very good researchers
-- research online available if you are interested in . And my contact information as well. Thank
you.
[applause]
Thanks very much for the opportunity to speak with you today, I am coming from Toronto Kaunda
I am a health health services researcher I work from one of Ontario's health assessment
groups that generates evidence relevant to this so I think I am speaking -- I hope I
am speaking -- one of the key workshop objectives which is to think about innovative hearing
technologies and their role in here at the -- healthy aging and experience the us and
how technology assessment is an important tool, both a barrier and the drug industry
commonly talks about health technology assessment test the fourth hurdle. After getting through
a Phase I clinical trial. A Phase II clinical trial, a phase two been a Phase III 1 trial
and the health technology assessment will be a fourth hurdle. It is also a very, very
important facilitator. Both with respect to use. I will go into this in some detail it
is really a field of applied policy analysis developed and designed to support decisions
about payment. For help tech elegies. When I use that term and talk about drugs, devices,
diagnostics, and a range of procedures and agencies vary in their scope but they will
also look at public health interventions such as health promotion, different ways of organizing
healthcare as well as high-tech and low-tech technology. It is an evidence informed and
value laden enterprise that as I say plays an important and growing role in determining
what kinds of technologies and services will be available for patients within healthcare
systems and is increasingly being thought about an organized to support technology development
to acknowledge its role within innovation systems. And to think about how it can more
to play function with respect to development. But may take up these two issues.
Before I do that I feel I have to address a couple of assumptions here where perhaps
you're thinking you are from Canada a single-payer system everything you are talking about has
got nothing to do with what we are dealing with here. Let me start with that one which
is one of Canada's premier health economist,
Bob Evans, a favorite quote from him in modern healthcare systems people pay for the care
of other people not for their own. Which is to say that for the most part we behave
as users of healthcare in a very different way than we behave as users of most of the
other services we get access to whether it be plane tickets or toothpaste or any number
of things. Healthcare is primarily financed through payments -- primarily not financed,
sorry, through payments by the users for the episode of care that they use. It is primarily
financed in fact through collective payment mechanisms, insurance systems, public or private
and again the US is no exception to this.
In fact if you look at the data , on this, one way of thinking about this question of
who is paying for the direct consumption of your healthcare is to ask what proportion
of the total spend is coming out of people's pockets in the way you pay for your plane
tickets or your toothpaste. In fact across countries there is a general trend to a reduction
in out-of-pocket expenditures including in the states, this is in 2013 data or 2014 but
the US has for a number of years been less than Canada actually as a percentage of the
total spend coming out of people's pockets. In this country, as well as in single-payer
systems like Canada's healthcare system and other European countries and most of the industrialized
countries for it is a public taxpayer-funded or Social Security state mandated system of
course you are moving somewhat towards that. The vast majority of your healthcare is provided
collectively. We pay for each other's care. Not so much for our own. The other point you
would be thinking is okay, that is great but we are talking about primarily, hearing aids
and other hearing related technologies. Of course the coverage of hearing aids is quite
variable there is partial subsidy in my own province there is two of Canada's biggest
provinces to provide some substantial coverage of technologies and of course the medical
service, healthcare services that help in screening and provision of care and obviously
it is more developed in Europe and very limited I understand in the US. However I think part
of the point of the workshop is very much to focus on healthy aging. This is about it
health policy conversation a very important conversation in which all countries have to
engage in to ask about how we support healthy aging and as some of my colleagues in Toronto
argue small things matter. In big healthcare systems.If we are talking about healthy aging
it is not the hip and knee so much or cardiovascular or heart surgery but it is in fact support
for living at home.Supportive care for transportation, meals, personal support, these are the types
of small things but actually enable people to age healthy and arguably hearing aides
are one of those technologies and services what are the small things that matter. This
is, many of you will be familiar with, as we look at healthcare systems it is not so
much aging that is the pseudo- me that will overwhelm us, it is the extent to which people
age in chronic and debilitating conditions versus healthy. And this is the triangle is
very important because what it suggests is the vast majority of the population, 70% to
80% have sustained supported through self-care supportive care low levels of small things
that help people to age healthily and go up the triangle you need much more expensive
much more intensive interventions until you get to level three which is where all the
money is going when really in healthcare systems so the point is I think an important part
of the conversation is where is hearing technology hearing support technology is it an important
part of supporting healthy aging and downward substitution lower-cost technologies to avoid
sooner investment in higher cost technologies so I hope I have come into the technology
assessment is relevant let me know talk about it.
Let me try to explain how it influences use. Now first of all HTA is an American invention
one of many American innovations , the term was first used in the U.S. Congress in the
late 60s the Office of Technology Assessment developed in 1972 no longer exists unfortunately
but really started this organized, multidisciplinary field of policy analysis to say how do we
support decision-making.The Agency for Healthcare Research and Quality in the US is still an
important supporter and conductor of health technology assessment it is international,
continues to grow the international network has 57 member agencies and 32 countries. And
that exist because , I follow appropriately on the previous speaker, it exists and has
been developed as the newly approved does not always mean new and improved. And what
regulators look for in determining market access is really some fairly, from our perspective,
pretty basic and fundamental stuff. Is it safe to have on the market? At least for specific
class of patients? Does it work at all? Does it in theory do what it claims to do? From
the perspective of collective payment, our insurance systems, we are asking more rigorous
-- the fourth hurdle -- the higher bar we are saying , is it safe or at least as good
as alternatives in the real world? Is it worthwhile , not a question so much often asked here
but in many countries, is it worthwhile to invest? It is a different body of evidence
and evidence -based and value laden. It is this nest -- next stage bringing to decision
to bear in value making its role is -- why was developed, right exists, why it is growing
but still is not an incredibly established mechanism in a way that the regulatory authorities
are. Regulatory authorities exist in all jurisdictions they have a clear role in determining market
ask -- market access, it varies in the US FDA and in Europe where I am not sure if you
have discussed this but regulatory requirements for market access for medical devices are
much reduced although there is some effort to up the ante there.
But, HTA despite its importance is a more recent development and in some healthcare
systems it is fairly detached from coverage, providing guidance but not actually deciding.
And other healthcare systems it is very directly informing the coverage. Some of you will have
heard of the national Institute for health and clinical excellence in the UK, which as
a national agency reviews technology, says it is a go and they must be covered, must
be provided and in Ontario, our agencies work more like that across provinces. Canada doesn't
have a single healthcare system, we have 13 depending on who you count, 14 that all provinces
and territories have their own system within each, HTA often has a fairly close link, direct
link to the decision to buy. And sometimes there is more complex, more embedded in decision-making
so there is a movement in Canada and some European countries to locate health technology
assessment within a regional health authority or hospital where they are actually say not
just in principle it will be good to have that within this years budget this is what
we will invest in. It is an even more fraught, it is a variable world. But nevertheless there
is variations on a menu of the evidence that needs to be looked at and
the first and most important and the one that determines most of the decision-making though
not all about whether or not to invest in health technology is clinical evidence. This
is the basic evidence a regulatory authority would ask for, safety and efficacy but it
is also an emphasis on real-world effectiveness so why -- while market access typically says
with a very carefully selected group of patients does your technology yield an outcome, from
the HTA perspective we want to know whether the usual group of patients in more real-world
conditions actually achieve that outcome. Moreover in the regulatory context the question
is often does it work against nothing? Whereas in the HTA context it is a comparative effectiveness
because there is typically not nothing going on at the moment before this new technology
hits the market. So, we want to know how it compares to the existing best case scenario
or at least another technology or package of services being used. We want to know how
it compares. Is a better? So, that is what AHRQ , Agency for Healthcare Research and
Quality in the US supports through its evidence centers, it's HTA, focus on clinical -- clinical
evidence of US there has been tremendous resistance to going next step which is common , certainly
in Canada, the UK, most of Europe, which is to explicitly tackle the economic evidence
question. If we are all paying for each other's Healthcare Services the question isn't just
whether in principle this is beneficial, but whether we want to invest in this given the
limited pool of resources that we have. Under the assumption that if you bring in these
five new technologies the cost X, something has to give so we want some assessment of
what we call the opportunity cost. What are we for going in order to invest? There is
many, many different approaches to this in places like Canada, Australia, the UK, it
is very much a cost utility with a standard focus on quality adjusted life year and all
the evidence that goes around that. Sometimes it is more, as in Germany, more in France,
more about specifying what price you would pay to get the value you want. So, that is
the basic -- basis for this technology are we getting improvement in my for quality-of-life.
That for the cost per unit of improved quality of life, that is the sort of value for money
question for the next is the budget impact because it may be fabulous value for money
but it is still so wildly expensive for so many people it can be invested in. Nonetheless
this is a big art of HTA.
-- what happened to my presentation -- press the wrong button. Finally HTA is a fraught
and complex exercise evidence informed and value laden. To say the nickel evidence is
-- benefits exceed the burden, there is a value judgment there to say it is worth investing
in, is clearly a value judgment. This increased effort and interest in getting very explicit
about what value judgments are bringing to bear and whether value assessments are appropriate.
And part that is about patient preferences because it is not always the case that the
clinical evidence is looking at a target that really matters to patients. You can have the
best quality evidence on outcome A but, outcome B is the thing that really matters. If you're
looking at comparative effectiveness how do we balance our desire for high quality evidence
against our value commitment to serving patients which is what this is ultimately about. That
is a very important thing is juggling around patient preferences and expectations and experiences.
The other is health equity that the value for money decision doesn't tend to ask whether
or not this is distributed fairly across the population; it is just a unit of quality improvement.
But, maybe we need to think about this unit differently if it is supporting healthy aging
and if it is supporting some acute, intervention elsewhere or end-of-life for example.Finally,
there is the larger question of how these agencies conduct themselves and that is a
sort of accountability for reasonableness is a common phrase. Transparency what they
are doing, clarity and the reasons they are using, consistency in the application of the
reasons and forum for repeal and review which there seems to be revisions -- my own focus
of work is there in trying to ensure that this, as I say, evidence -based the value
laden exercise meets expectations of the communities it seeks to serve.
So, that is HTA as it has existed, continues to exist and that's amounts of work internationally
and local groups that continues to push the envelope and increase its influence in deciding
what we will provide for each other within healthcare systems. But increasingly HTA is
being asked to think about its role in the technology innovation system. We did a terrific
talk about the technologies that exist and coming what is the role of something like
HTA in trying to encourage that? What kind of technologies do we need to address users
needs. What is its role there. And I think this is an image from the UK, innovation health
and wealth which is a really nicely lots of interesting work in many many countries focusing
on this but think about innovation in health as a question of health but also wealth what
is the role of healthcare systems in HTA. Obviously, innovation, policy, increased attention
with organizations like the national Academy, not just the push side let's fund new research,
which HTA has very little to do with but the demand side, how in fact from the perspective
of buying innovations does that demand drive the innovation system. How does demand give
the right signals to those who seek to produce. How does it pull the innovation towards consumers
how do we organize demand. And there is increased attention to that within healthcare systems
that they are drivers of growth or not as the case may be.
There is a couple -- I will talk about three, what I characterize as experiments in health
technology assessment happening in various places around the world as we think about
the role of HTA, not just as a sort of bar, meet this standard and we will provide -- we
will pay for this, providing for our population but also to recognize that bar, that barrier
is a way of influencing and pulling innovations towards ultimate users. The first experiment
is for health technology assessment to pay more attention to the whole adoption question
because to pay for something is obviously an issue but doesn't mean it will be used,
doesn't mean it will be appropriately used doesn't mean you have altered the way providers
pay in making the service or technology available to consumers. How do you think about that?
So obviously in places like the UK there has been a move to bring the adoption question
in alongside the assessment question particularly for medical technologies to have an analysis
of both , whether in theory we would want this new technology alongside how we would
get it used. If it is good enough to pay for then you are trying to get used equitably
and broadly across the appropriate population. Really focusing on that. Also in Ontario,
my own jurisdiction, we are behind the UK in this I think that working more actively
on implementation.
It is a very recent report. The second experiment is around harmonization. Health technology
assessment and the evidence expectations but it has, how they harmonize or not with other
evidence expectations so there is two parts of this. One is to say look, the regulators
they are out there saying we need this evidence. And it is fairly low as you know when it comes
to hearing aids. Or properly low but it is not a huge evidence requirement that that
is what they're asking for. There are other ways to harmonize or align with HTA's want,
the evidence they ask for, with evidence regulators ask for would that be easier for developers
if they knew it is not the fourth hurdle but part of the first, second and third hurdle?
I think there's all sorts of challenges there but it is an active area of exploration. In
Europe for example and certainly internationally there has been much discussion about that.
The other is in many ways the fact that each HTA agency unlike the regulators who say market
access to the US that is the decision they make or in health Canada -- HTA says we will
pay for this within Ontario's healthcare system or or within this hospital or within the Blue
Cross Blue Shield system or within the VA system or -- obviously the insurers follow
each other and tend -- there tends to be if somebody says yes with CMS is yes then others
will too. There is a consistency across agencies in the evidence they seek. There is lots of
good and bad reasons for that so lots of interest in that, there's an interesting initiative
, Green Park collaborative between industry and HTA agencies to work through at least
one disease area and say what would be the evidence that HTA evidence would be looking
for. The third experiment is what people are calling early health technology assessment.
So, HTA comes after, typically, revelatory review. So, you have all sorts of industries
particularly small and medium-size companies who are thinking regulators, they recognize
that they know that that is well-known and they are developing their product with an
expectation they will be this level of regulatory review they have no idea of the influence
of health technology assessment bodies who have another set of expirations about what
evidence is to be generated part of the solution might be to bring the health technology assessment
enterprise earlier as sort of decision support for industry, fail fast, fail early, no sooner
if it is going to sell. But also, as I was discussing earlier, to think about the intelligence
that health technology assessment brings together as a sophisticated customer, ways of making
decisions for pools of people and bringing the intelligence that knowledge about what
we will pay for, for each other, or think is appropriate to give to each other early
in the decision, design and development phase. In Ontario we have a machine -- interesting
initiative our group is heavily involved with trying to be a single portal for evidence
review and evidence generation earlier in the design and development phase. And that
means that we are working with large multinational enterprises but also small, medium-sized enterprises
that have really no idea in the design and development phase ultimately within the show
to make, to prove in our case in Ontario's health care system we will pay for and in
Ontario this initiative has actually now brought to the attention of our technology assessment
group that decides on what medical technologies specific to look at we have never before looked
at technologies developed by small and medium-size enterprise in sort of 15 years of operation
but in the last two years with MaRS-EXCITE there is no multiple technologies from the
sector now going to be looked at for payment within Ontario's system which is probably
one way to think about Ontario's health care system it is one of the largest HMOs in North
America, that is kind of what it is. 'S. So, is where we are. So, in closing, HTA has a
growing and increasingly demanding role to support evidence to evaluate decisions and
more actively engage its role in innovation systems and I think it can play an important
role in analyzing the merits of our collective investments in hearing loss technology and
the downward substitution to support healthy aging and as a guide and incentive for the
further development of technological innovations that are going to support us moving forward.
Thanks very much.
[applause]
Now it is time for questions please come to the microphone and tell us who you are addressing
your question two. Thank you.
Hi my question is for Cynthia. You had a very interesting last slide which you did not get
to cover, your ideas on open platform and how that might be useful for pursuing research
and development . Could you say a little bit more about that?
Basically what I was speaking to is developing, especially for wireless technologies instead
of each company having a proprietary transmission and reception system have it the same. So,
you can mix and match products.
Okay.And then, Eric, could you kind of address that approach as well. How would that fit
into the FDA regulatory framework if somebody had a flexible tool like that, able to wire
up themselves, to create the transceiver from what ever input signal they wanted to, to
an output signal?
The issue is a little cloudy on the FDA regulatory standpoint because we don't have a specific
classification regulation for assistive listening devices. And, in general though, in terms
of new technologies within the 510(k) the Sith that follows in or is similar
to an air conduction hearing aid or related to that sort of thing it could basically as
long as there is not a fundamental change in technology or a new indication for use
in new population there wouldn't necessarily be the requirement for a premarket notification
to FDA as long as the general controls I went over our compliant with.
Eric, what would it take for a PSAP to be elevated to a class one device?
The word PSAP I think was generated , created within the guidance document that we created
back in 2009 and it was specifically meant to define a group of products that were not
intended to treat hearing impaired consumers. So, as such it essentially is not within FDA's
regulatory jurisdiction it is a consumer electronic products . Any time it would start to make
claims in terms of treating hearing impaired individuals then it kind of crosses the line
and becomes -- meets the definition of a medical device and we would essentially be classified
as inherited from can I ask a follow-up? The PSAP manufacturers would take this step to
say we want to market this to the hearing-impaired we have to go through channels to make it
a class one medical device?
That is one route, the other is when FDA does become aware of the device being marketed
clearly to the hearing impaired consumers this can take a variety of forms, there may
be enforcement action in terms of you marketing this device, you may not be explicitly calling
yourself a hearing aid but you are listing types of hearing loss saying low-cost alternative
to a hearing aid and small print we are not a hearing aid -- those kinds of situations
are potentially compliant related issues which FDA would say, you appear to be marketing
a device to hearing-impaired consumers we believe you are a hearing aid the way your
marketing your self you need to change or labeling or meet general controls for a hearing
aid.
Thank you.
This is mainly for Eric, the role as cochair is provocateur in many ways the following
on Barbara's comments, the reason PSAP comes up over and over again if the issue of access
to classic examples that come to mind clinical practice and research a 67 -year-old man and
Ajit professor from community college essentially on a fixed income he has a moderate hearing
loss and he has $500, that is all he has so, we tried various maybe -- there is always
hurdles so he finally has no access to any type of care another example is someone in
my research protocols who is a 72 -year-old lady who is disabled, she lives essentially
an independent senior living housing they can get around and she knows she has a hearing
problem and while going forward there's clear solutions in many ways healthcare workers
can do counseling education in many ways but finally what the issue is, access to some
type of rudimentary device. I bring this up because I think in the field of audiology
and acoustic sciences there is the pursuit of perfection we want the absolute best. He
appeared a lot today ideally what we want for ourselves but it brings the analogy back
to the idea if you want to get somewhere, ideally you want your tricked out car what
ever but sometimes it's just a scooter. And I think fundamentally the way we approach
hearing healthcare is you either have everything or nothing. And I think that is why PSAPs,
a lot because you can't afford a hearing aid you can't get back and forth but maybe a PSAP
at least and I think 37 years ago when the 1977 task force was convened by the FDA there
were real issues with PSAPs , personal amplifiers back then with issues of safety and efficacy.
But I think increasingly with technology literally in the last five years, that the gap between
what can be called quote unquote a PSAP in a hearing aid is increasingly narrowing to
nothing that is how you market and label it.And I think that -- I don't have a good solution
Eric I appreciate your comments on this it is a different mindset for the FDA to think
about this but fundamentally where I come from from and epidemiology our public health
specialist is I find my issues with access and that is why brought up the idea of the
over-the-counter hearing aid when I say over-the-counter I should clarify what I fundamentally mean
is some type of device which is limited in its output in terms of compression and output
from a safety point to be I don't think it is an issue, from and efficacy point of view
I would always argue something like that is better than nothing quite simply. Except right
now there is no access for a patient who has a hearing -- pretty much two thirds of all
of us will have as we age to get access to such a device my question is what we do from
a regulatory point of view to make access to such devices possible.
Thank you very much for putting that question. I think we all appreciate the need for access
to amplification as the population ages and I am glad we are having the discussion. From
a revelatory stamp out we don't make the distinction between a starter hearing aid and a more advanced
-- regulations define hearing aid as a wearable instrument intended for hearing-impaired individuals
so we don't slice and dice and say this group for starter hearing aids is not subject to
regulations and the other is. That being said I do understand that there may be some barriers
created by the regulations regarding conditions for sale I don't think the labeling regulation
has been a huge issue for anybody but conditions for sale certainly has been a hotly debated
provision over the years. I would point out however that the regulations as they exist
are not incompatible with the direct consumer marketing model. And this has actually been
done and is being done as long as the labeling requirements are met, as long as there are
-- there is a signed waiver and we've been very liberal in terms of interpreting this
as long as there is electronic signature, as long as a patient has the opportunity to
review the user instructional brochure as long as the record-keeping requirements are
complied with you can manufacture , can directly market to a consumer over the Internet via
e-mail and so forth. There is still a burden in terms of getting that waiver; it is not
, from the FDA perspective, not in the patient's best health interest to do that but, in the
preamble to the original regulation it was acknowledged that some people have religious
beliefs, some people have personal beliefs that would prevent them or would make them
less likely to a medical evaluation and the regulations accordingly have a waiver. Unlike
the case for some of our European colleagues as I heard yesterday a sound like there was
more of a -- the ENT physician is the gatekeeper essentially and some countries you have to
see that in the vigil before you're able to roll out those medically treatable houses
of hearing loss so I would just point out that the system as it exists is not perfectly
recognized there are a large number of people who are opting out for waivers at this point
and you could debate whether or not there signing the waiver is some benefit to the
patient in terms of actively informing them if a waiver is done well in terms of actively
informing them there are conditions potentially that could be treatable surgically or medically
that they may be missing if they often forgo that and they get the hearing aid, they're
not getting better perhaps a getting worse I should be at -- should see a physician as
a part of that, counseling process it is a compensated issue we are willing to listen
to different perspectives on this, there certainly is a process, a cumbersome want to change
regulations but it exists so as our understanding of this area increases over time and there
is an interest or certainly a citizens petition route to propose alternative ways of relating
hearing aids.
Antic Gilmore Hall hearing loss Association of America. Very good panel and appreciate
starting out the day with this kind of conversation and dialogue. I have a question and a follow-up
are eyeglasses and contact lenses regulated by the FDA and if so is the process by which
those accommodations were made for opticians, optometrists and ophthalmologists relative
to prescription and distribution and eyeglasses and lenses, a process we could learn from
as we grapple with this whole PSAP hearing a process?
Thank you that question does come up quite a bit in terms of the analogy of eyeglasses
which are certainly available over-the-counter and hearing aids. I'm not familiar with the
ins and outs of -- historically how that decision was arrived at. I think part of the difference
between the situation of the pair of reading glasses and over-the-counter hearing aid without
a medical evaluation and waiver, has some degree to do with the degree of an individual
to appropriately self diagnose their condition and to appropriately select whether the eyeglasses
are an appropriate solution for their particular health situation. So I think most of us recognize
that eyeglasses are a very simple technology they are magnifying glasses. I think most
of us realize when you turn 40 years old as I didn't hold in the newspaper more like this,
there is not a lot of conditions , speaking to my ophthalmology colleagues, that manifested
that way, that respond to reading glasses and I think the feeling is is relatively self
diagnosable condition for consumers. Hearing loss on the other hand is a bit different
in terms of you can have a hearing loss from many causes from something as simple as a
cerumen impaction which does present a safety concern with the hearing a brown think anyone
thinks that is a particularly good approach to dealing with that particular condition
and then at the other end of the spectrum you have more concerning things, tumors, fusions
related to tumors all those kinds of things which admittedly are rare but they are present
and they would potentially be detected by a medical evaluation. Compounding that is
the fact many of those conditions which are medically and surgically treatable would in
fact improved with a hearing aid so it is not like a failure of a hearing aid would
trigger the person to necessarily go and be evaluated for the condition. I think these
are concerns that were taken into consideration when developing those regulations. Admittedly
I was not around when I happen but this is my reading of the preamble of the regulations
and some of my thoughts.
I appreciate that. And appreciate your comments I guess what I am trying to get at, this is
essentially a complicated issue for consumers and providers is there something we can learn
from the process about how those decisions were made in sort of a new way of thinking
about this versus hanging on to the weight regulations have been developed and implemented
today? I'm trying to help everyone think about this in a new way from a process point of
you not from just a narrow regulatory point of view.
I appreciate that I have to admit I don't know a lot about the process that was used
in that eyeglasses issue but in general, when we contemplate changing regulations, particularly
one that has been in place for so many years that was implemented in response to an interdepartmental
task force that I mentioned, Senate hearings and so forth, I think it is incumbent on us
as a regulatory agency to come as much as possible, based those kinds of changes the
modifications on science -based grounds. It will be that those -- the science has changed
since 1977 and if that is the case we have the petition process we have advisory panels
we get your clinical input on and we are certainly willing to do so.
Okay, this is for all of you if you have any ideas. There is a statistic which is more
or less that the average time of average age at first time hearing aid use is about 70.
The audiology clinic I am working with now in a geriatric hospital , the average age
of their audiology patients is over 85. There is a high cooccurrence with clinically significant
cognitive loss. Eric mentioned special populations could put a different lens on some of the
considerations -- I don't know what you meant by special populations -- Cynthia talked about
appreciating the context of the individual I think Fiona also may have some thoughts
about the different sectors of the population, aging population possibly having different
needs if we think about people who have hearing loss but also cognitive loss which will affect
how the use of technology, with the use of technology for whether they are using the
hearing aid thinking it will deal with their memory issues or a memory device thinking
-- the functionality of these devices gets overlapped , older people can't understand
the instructions in the pressure , so do we need to worry about aging and the comorbidities
with other impairments as we embark on actually trying to figure out what to do with that
generation, that age group?
>>[Captioners Transitioning]
He came in with his son who was 60, they came in with his wife and he was married for 60
years, he referred to her as his bride. I get a little emotional, was that my dad?
You could not hear, he have a lot of brainstem injury due to strokes, hearing aids were not
an option from that she needed microphone technology. I had to think outside of the
box? Was illegal to put an FM system and earphones? I put the earphones on and he was sitting
in a wheelchair. He has visual problems. Captioning was not an option for him.
He had not talked to his family in five years. He was very quiet and I put the headphones
on, he perked up. I asked him what he had for breakfast? His wife and son was in shock.
His wife was in her late 70s, I gave her instructions on how to use the FM, he lived five years
longer and had a great life.
It was a challenge to think of all it -- all of the different factors to make this work.
I found out about the lifestyle. People like to sit in the living room watching TV. I added
an extra microphone, she had control of the remote because she had said mute the TV before
she spoke to him. She like that. [ Laughter ] met those of the --
Those of the people you run into everyone's in a were I'll and that is an issue, I do
not know if I answer the question?
We need to figure about more of this, as opposed to what we are saying, this is what we have
to. It is too much to adapt given the other special needs and you get nothing. Extreme
case of you get nothing. You cannot do the complex speaking -- thinking that you just
described.
What can I take? How can I adapt? I once had a deaf student who wanted to be a cameraman
before they have the systems were you can do the captioning between him and his direct
your. -- Director. I a work with a company directing a two way system, I had to get a
list and learned what it is like to be a cameraman and what words are used? We had to find vocabulary
that he could eat -- understand. And he got a job with CSPAN and worked for three years.
I would like to offer and A -- bats answer. When I flagged and talk about substitution
and the US are paying for the bulk of the health care, to say they will pay for the
healthcare as we age whether we age well, or badly. Comorbidity may pile up as they
will, in ways that are accelerated. One of the questions IIS, -- I will ask, which came
first? What accelerated what? Downward substitution for healthcare systems, ensures public or
private to be recognizing the need to invest, is to substitute and lower tax support of
care. That is my response to that, you are likely the system is not doing well. Here
and back home as well as they need to do. In addressing supported if -- oftentimes it
things are seen as consumer items. They are not providing a very important thing to keep
people healthy at home and in their homes and living in their communities. Canada is
clearing the snow. Or picking up the groceries, this is not healthcare investment in traditional
terms. When you talk about healthy aging it is an investment, that keeps them healthy,
longer and in their homes. And reduces upward substitution, a fall and a crisis and expensive
long-term care. Or care in a rehab hospital. My response about the policy challenge that
I think you're engaged in a talk about importance of investment in these kinds of supported
technologies to support healthy aging and key people at the support of care state as
long as possible.
I would add from a regulatory standpoint, you were asking this or not? The new populations
and so forth, if a manufacturer went to market a hearing aid as devised to slow or stop -- [ Laughter
] -- progression of cognitive impairment. That certainly would be a new indication potentially
intended use for the device. Probably not even be within the hearing aid category anymore,
we have mechanisms doing with that. It would be need to be supported by clinical dated
-- data as well.
We have time for one more question and then a break.
Unintended consequences and I did not have the answer on this. Right now this is current
data, introduce a wireless device for international markets US, Canada, Europe, Australia and
New Zealand, regulatory testing causes over $100,000. You add FDA teased -- testing and
so forth, we are talking about $150,000, $200,000, laptops, regulatory fees, certification and
etc.
All of those have reasons for existing, but the question is, are we where we want to be?
And intended way killing innovation ensuring that companies will not put as many products
on the market, group Rob next -- group products were more buttocks would better serve the
population? Because of the regulatory costs?
I think this is a classic empowering question, the higher -- what you say industry has to
pass the hurdle to get things onto the market. That means the small mom-and-pop shop will
not be successful. The question is, do we want their mom and pop shops to be successful
at the end of the day if what that requires is the on the market are things that pass
no meaningful regulatory hurdle? The higher burden for the HDA if we invest in this for
a population which is what the healthcare insurance pools do. I argued you are right
it creates the consequence it is the higher the regulatory burden, the higher the standard
needs to be and the bigger the industry and company needs to be to meet the need for them
this sells its products at the prices, and you cannot have the low were -- smaller companies
will Knox is the. Pharmaceuticals have gone to that clearly, they are not mom-and-pop
pharmaceutical companies. As there were at the turn of the 20 best 20th-century. Medi-Tech
we see a growth of multi-national med tech center in response to the regulatory requirement.
Many if not all, consumers would wants.
If I could throw in another,, there is a chilling effect to a company's willingness to explore
something they do not know the market. Someone has an idea nobody knows if they will buy
it or not, you have to think long and hard before you explore that.
Okay listen thank you very much. We had some stimulating discussions this morning.
Applause.
We have to have everybody back here no later than 10:55 AM promptly. >> [ Session is on
a break until 10:55am EST ] >> We would like to get started, please take your seats. >> Please
take your seats.
Thank you.
[ Laughter ] >> We are ready to start the next speaker, it is truly a pleasure for me
to introduce a friend and fellow advocate. Richard Einhorn, He was hit with sudden hearing
loss, he has been able to bring his lifetime and knowledge of audio technology to find
better ways to hear. He will take you on a ride and give you all of the insights that
he has about how sound can really -- they can sound good even if they have hearing loss.
Here is BTE team -- here is Richard Einhorn Thank you. I want to think Frank Lin for inviting
me to the conference and Tracy and everybody at the Institute of medicine. It is an honor
to be here. I will show you a little bit of how I use consumer -- hearing technology at
least from my perspective. I have a couple ideas and how -- where I think things are
going?
I spent my entire life trying to hear better. Sound has been the primary way I orient myself
to the world. Now well -- I live with serious hearing loss my quest has taken on special
urgency. Hearing that are is essential for my excellent physical were being, something
that I do not know from studies that now simply as part of who I am. My background I am recording
engineer, former record producer and composer. I have a letter -- lots of professional experience
with sound equipment at the highest caliber and work in many difficult acoustic environments
long before I had hearing loss. This is the recording I produce with Yo-Yo Ma on -- and
this is Boice's of light performed all over the world and this will be performed in Washington
February 22. I hope everybody can, has over 200 performers and quite a show.
I am known as a hearing loss advocate, this is from the New York Times a advocating for
LOOPS I will not talk about this today. However I written about in major media published articles
about my poster hearing loss and in medical medicine that is things here and abroad. I
have serious hearing loss, basically I am deaf in the right ear and 60 DVU loss in my
left ear. Terrible thing to live with this condition it affects my life in sept -- except
composing which is primarily an active imagination. I need this mishearing to compose and I have
this much. So I'm good to go.
Without good technology I am functionally deaf. Normally I have a bunch of examples
that have plagued with my lost sounds like and this time because of the straight I have
my right ear is death but not quite deaf. Unusable hearing I have lost in my left eye
can simulate the sound of what my right ear sounds like, I thought this may be it interesting
to you here. This is something that I have not found too much literature about that describes
the physical effect. When severe it is really very unsettling. This is a recording that
I made up myself reading words, this is the way it sounds my left ear with amplification.
>> How can I possibly admit such infirmity in the one cents which should have been more
perfect in me than others. A sense which I what possessed and highs perfected. >> That
is a recording of what it sounds like normally in my left ear and to you. This is an example
of what the exact same sound file sounds like when heard from my right ear. >> [ buzz - muffled
]
Unbearable. Now sounds below 50 SPL. It is unbearable typically unaware earplug and this
year and I've had panic attacks which I never had before I had this. Hearing loss is a very
serious dangerous and disabling condition. It is not very well understood by many of
us. I did not understand anything about it until it happened to me.
Forgive me for playing that so loud. The other examples are not so loud. [ Laughter ]
I want to talk about hearing loss technology I use, there are no cures. The questions for
hearing loss technology are twofold, one of the Ms., Given damage hearing how well does
the technology let somebody here? How good is it. The second question, how easy and comfortable
is it to use?
Those of the questions about hearing loss technology . You can described them as questions
about acoustics, and ergonomics. I will focus today on wearable and portable devices to
hear better in noise. Because LOOPS require infrastructure to where.
-- wea -- wear.
Everybody knows these and they are really have terrific ergonomics. You will just stick
it in your ear and you are done basically, I am oversimplifying -- when you try to do
it when you do a demonstration you cannot do this exact way. The ergonomics are extremely
good. The technology and science is very impressive. I will start to antagonize people and forgive
me because I love you all.
The truth is many users including myself are less than satisfied with performance of hearing
aids in noisy situations. The reason for that, is because inadequate acoustic technique that
is using the hearing aid a lot of groovy things that go on technology inside of the hearing
aid, essentially the main issue is, the microphone placed on or in the ear is too far away to
pick up clean signals for me to be able to extract speech from noise. We can talk about
this forever and it believe people have spoken about this earlier in the conference.
Let me give you an example, audio example of what that means? I hold a microphone right
next to my ear where the hearing aid is where a friend of mine talks in a nosy -- noisy
café. Not only does my friends boys get louder, it also gets clearer as the ratio between
the background noise and my friends speech changes in favor of my friend.
I have the directional microphone pointed out you. Talk a little bit and I will move
it from your local which is where a hearing aid tries to hear gradually over to your mouth.
[ Indiscernible-low volume ] >> They started to take me to doctors and clinics. It took
about one year to really -- realize that I had hearing loss in both of my years. -- ears.
You will get the idea. What you want is a microphone as close as possible. Typically
people have stated well, if you use directional microphone that will help. Not eat -- not
enough. Improvement is not enough for people with severe a hearing loss. People said we
can clean up additional -- signal processes, you can not. This runs and 8-8 battery, -- this
runs in a tiny battery. It is impressive, I use professional signal processing software,
that runs on a MacBook Pro and I cannot do this.
There may be an algorithm that can do it, in general no. You need to get a microphone
that is close. You can with supplemental hearing technology. Which assisted listening devices
ALDs, these are common kinds of the one on the left is simple it is a microphone and
amplifier and the one on the right is more elaborate I have it here which is a transmitter
which has a microphone in it. And a receiver that receives. You can take this and give
it to somebody or put it somewhere, you will where this around your neck -- wear this around
your neck. Somebody can hold this and talk to you .
You are supposed to get this into the hearing aid, audiologists recommend this, using a
gadget called a net loop -- neck loop. You will plug this, where this around your neck,
put your hearing aid and the telecoil and you can hear what is in the microphone.
This is not a robust system, the main issue the Tcoil is susceptible to a hum. Let me
just play for you what the hum sounds like. You cannot hear through this.
There is no way you can use a neck loop with this thing. A hearing aid companies are aware
of this, they created integrated systems you will see here. This is a microphone that connects
wirelessly. Goes to a streamer that looks similar to the one I am wearing. This connects
with a different wireless technology to the hearing aid. This is near field technology.
There are many good things about the system it will work there are issues connected with
it.
The main issue is, it is expensive and the second issue it is proprietary. I have the
system and I do not like the microphone with all due respect to the people who made this.
I want to use another manufacturer microphone because I am locked into that hearing aid
and that streamer, I cannot use another microphone. From a consumer standpoint the typical term
is absolutely outrageous.
[ Laughter ].
In addition to this, all ailed these -- ALDs share a common problem you carry around a
bunch of stuff. [ Laughter ] nobody wants to do this.
While acoustically ALDs really do solve the problem and they were, they are essentially
a Goldberg trap. There are two wireless technologies in here, this is another technical term, a
royal mess . Can we figure out another way to do this?
By accident or by thoughts I stumbled across something that may point to the future. By
presentation here is transitional one between what was spoken about in terms of technology
and innovations that come next. That is, smart phones -- if you think about that for a second,
absolutely very powerful computers. Have a microphone, amplifier and output that you
can get sound out of. In fact for some of them the iPhone the sound quality is just
below professional quality.
They said -- they have microphones, amplifiers, DSP which is does -- *** Mitchell -- Bill
sound processing.
-- digital sound Processing. The next step is to see whether or not I can rig this thing
-- let me get this off . rig If I can this thing for hearing loss. In fact you can. The
first thing that you do, you get yourself a really good pair of earphones from that
go into the ear. You have a hearing aid like this one and you are good to go, you have
a very high quality hearing assistance device.
It is like Gallaudet with a telescope, very few do not have the next question, can I try
this? Yes you can. Very few people have tried this including people with severe hearing
loss have told me this system works. They are starting to be pure reviewer's of the
technology and it will tell you what I have told you already. Spirit --
To refine the system you put a directional microphone on. Think about this for a second,
a smart phone rigged for hearing set -- hearing assistance suggest a new approach. In which
you simply do not have any of this stuff, simply put the smart phone on the table like
this. It has a microphone built in, signal processing good enough to do directionality
and a much more processing that you can get out of a hearing aid. It is wireless from
here into the hearing aid, no streamer, there is no job . Easy to imagine something like
this, improved acoustic technique, ergonomics. Is this a dream? I thought it was three years
ago when I urged realize it can be done. I was in CES the first made for iPhone hearing
aid has been released.
Okay? There are issues, you do not want a made for iPhone hearing aid, but a smart phone.
The smart phone becomes the hub of a transparent assisted listening system. People will speak
about wireless standards and other technology later, I have been given the red lamp. I will
summarize and say as I see hearing loss is a medical problem. Hearing better is acoustical
and ergonomics problem. Hearing technology is not adequate it is not just the problems
in a total holistic waiver new approach to hearing assistance which is based on smart
phones could dramatically improve the ability of millions of people to hear. Thank you very
much.
[ Applause ] >> I have to pack up here, please forgive me.
Unfortunately when you lost your hearing, we have somebody in the community who really
does understand sound. That is going to have some real results for all of this. By the
way, the voices of light is a wonderful [ Indiscernible ] I encourage you to try to get tickets to
see this. It is amazing.
Thank you Richard Einhorn.
I will ask Karen Cruickshanks to come up.
We have heard inspiring examples for the need of innovation. This conference is a wonderful
opportunity to bring together all of the different it is. In the program we plan the next session
on driving innovation will carry the theme forward and bring people in outside the hearing
loss community and have lessons for us from broader audience, with the speakers make their
way to the table? All three of you. The first will be David Green his talk is lessons and
innovation come to us from sound world solutions. >> The staff and speak in -- the second speaker
is Stephen Berger. The last speaker is Valerie Fletcher. Talking about building design and
how we can get new ideas of how to improve the acoustic environment. So David Green,
please come to the podium. Thank you. >> How do I advance this?
Which button? >> Thank you. The red button?
Okay.
I will be talking about businesses that use technology, price and quality to change competitive
landscape in favor of the consumer. I will John upon my experience working in I care,
-- eye care I develop many major eye care programs in the world -- [ Coughing ] -- to
make them self financing from user fees but still serving lower income people.
I will talk about how we have had effect on the ecosystem in eye care? Affordable technology
combined with cost-effective and efficient service delivery. The business model be social
enterprise business model that has the right controlling governance to ensure fidelity
to social mission. Which in all cases has to do with accessibility, and affordability
. I will talk about eye how we apply the lessons in care to hearing.
I will go over and give you the punchline at the beginning of the talk . They very is
lessons that we are now applying to making hearing affordable and accessible have to
do with creating a business model that is self financing for all economic. They are
self financing from patient fees and not dependent upon any insurance reimbursement system. Where
there is tiered pricing, revenues are used across subsidize care for those who cannot
afford to pay below cost .
Creating business models that utilize choice to use production capacity and pricing and
margin to serve low economic strata.
The major point is that, price is used to change the competitive landscape in favor
of the consumer. How to use the new price point with good quality and good outreach
to underserved populations to change how other providers whether they are product manufacturers
or service delivery models how do we get them to also make their pricing affordable? We
do that through competition. And price sensitive markets.
How do we have the right controlling governance in a business to ensure fidelity to this social
mission of affordability and accessibility? Also how do we add in reducing time between
all the different moments when you see the client, the tech something wrong, provide
treatment? I call it the David Green lot of progress in -- proximity and time how do you
reduce the time? Spirit I ash I will talk about the ecosystem approach how you reduce
cost and margin throughout the whole system to arrive at affordability. A lot of that
is really removing what I call, non-thought you added margin,
-- Non-value added margin. And ensuring fidelity to the major business model.
Eye Care affects 285 million people who are visually impaired, of these 39 million are
blind in both eyes. Cataracts are the main cause of blindness. Providing comprehensive
eye care services with the emphasis on cataracts since that is the main cause of blindness
in the world . I have helped 300 programs become self financing doing about 1 million
surgeries per year.
Perhaps the best-known one is Aravind Eye hospital which 50% its services
for free or below cost, the remainder page well above cost and that margin is what is
user crossed subsidize. With the best with this in 2012 they made a 33% margin, for every
dollar that they spent they made $1.33 back. We spread this model around the world in eye
care.
This is a video. We were in South India, we did this eye camp and the community organizers
the patients -- can you turn down the volume of this? Thank you.
18 from Aravind test the vision, a doctor examines the patients and those needing cataract
surgery get patient counseling. And taking immediately for surgery. Those needing be
faxing get their eyeglasses or immediately after they get their prescription.
We do about 150,000 surgeries per year. A big part of this is patient counseling, and
we take them immediately to the hospital he -- Aravind is well-known. If we have the eye
On Sunday they have the surgery on Monday and they will go home on Tuesday. There is
a comprehensive set up to do high-volume surgeries.
Surgeries are more complex than the fitting of hearing aids in terms of sterile environments
and all of the different jobs that you have to have.
So that I want to give you -- can you for this somehow?
This will show you how Aravind has served and helped many programs become self financing
and adopt the model of sustainability with total access where free is really the lowest
price. Another group I worked with is in China.
[ Coughing ]
The eye system does about 40,000 surgeries per year and 32% are free or below cost. With
the cross subsidization model, here is one in Egypt. In 2009 dated over 10,000 surgeries,
and 43% of the cataract surgery was done for free. The surgery was at 25% of the market
rate.
The eye hospital I developed in Nepal. They did 47,000 surgeries, and still made a profit
of over $200,000, charging a price of $33 to the majority of the patients.
Here is a group that I work with in Gremmen I hospital -- eye hospital. This is in Bangladesh.
These is one of the 10 poorest countries in the world, at least 30% of the surgeries are
done for free with sustainability. Here is one and quad him all of. The whole idea is
to really convey to you that in eye care which has high degree of complexity, we figure it
out how to make this self financing from user fees we use the margin to cross subsidize
and survivors.
Here is another one in Indiana. It is up to 117,000 surgeries. Okay a? Here is one in
San Francisco we tell what we learned in all the different countries and apply it -- how
to deliver eye care to the uninsured, not documented, dual eligibility and Medicaid
in a way that removes barriers to access and this environment.
This will give you and that example is of the analysis. We compared Aravind labor cost
per surgery with Vancouver. Figure it out that will cost $460 in Vancouver cost $2.19
in Aravind. If you live Vancouver prices for the Dyadic -- Aravind staff which is $80 their
shows a level of efficiency that has been achieved at the West would do well to emulate.
The other major area that I -- adjusting the ecosystem, developing a portable product.
A lot of this is an parallel to what we're doing in sound world solutions for making
hearing affordable.
In 1992 I set up manufacturing to make intraocular lenses, Aurolab has 10% of the market share
they sell about 2 million per year and the lowest price is $1.75. This is for a CE Mark
certified lens. We also make suture and pharmaceuticals. It is of all about the shape of the business
model that chooses to price the products for affordability. They have effective changing
of competitive landscape. The lens cells at average price of $3.50 we have a 40% margin
on all of the products.
How you sculpt the business model not only the cost but the margin. Here are some pictures
of Aurolab manufacturing, it is state-of-the-art. It is the same you would find anywhere in
an -- in the world. . We make about 60 pharmaceuticals. Here is one of the main points of the talk,
that is, changing the competitive landscape with pricing as the lover. When Aurolab was
going in 1992 making the lenses, prevailing global price including in India was $300 per
lens. We came to market with a $10 land
All of the other competitors popped up around us, Indian companies that got our price down
to less than two dollars per lens. The surgical volume in 10 years went from 800,000 The surgical
volume in 10 years went from 800,002 $6 million -- 800,000 to 600 million -- 6 million
There was another example of a very large company where we beat them out on a contract
for suture with the government of India, $1 million contract no they were upset and pseudo-squinty
we did not to fill the requirements. They sued us and lost and they won on appeal but
we took it to the Indian Supreme Court and we ultimately won the case. In the meantime
they actually reduced the price from $240 down to $23. Again an example how to use these
forces of price competition in favor of the consumer., --
How we sculpt not only cost but margins to result in affordability? And we made 1 million
lenses in 2007 we had revenue off of the lenses of about $5 million. The biggest competitor
in a major sold -- in Asia sold $7 million. If we will supply Aurolab vice seven -- this
is an example of how we sculpt the business model to not only cost but margin and how
we create the distribution to results in affordability to the end-user. Completely different margin
model to the needs of low income people.
Now I will switch to the hearing. As you know that the WHO statistics say $278 million have
disabling laws and 340 million people have mild or moderate loss, only 7 million hearing
aids are soldier, 10% go to the developing world.
These numbers have not changed. And so we created -- there is the market need. I will
get into the sound world solutions now to make a disclosure, I do own shares in the
company just so that you know that.
People in both developing and developed markets all really need the same thing they need clarity
and amplification and in a real-world Varma, lower price hearing solution, user access,
simpler process for buying and fitting the process we like to simplify this further to
have real-time adjustment of the device. Easier to use especially with regard to batteries.
So this is my disclosure. What we have come up with is technology I am actually wearing
this in both ears I look kind of goofy -- this is a blue tooth enabled hearing aid and sound
amplify our -- amplifier. You can adjust this on the device or download an application to
a smart phone or computer whether android or iPhone, Mac or PC.
Adjusts the device using Bluetooth technology butt we are a hide of Apple and others to
deliver the functionality to the market. I hope create sound world solutions. [ Indiscernible
] was the chief technologist. He was frustrated at not being able to serve a broader segment
of the market. >>. In this case we took what was already out there in the consumer electronics
and creative the product with our own software -- own algorithms. As you mentioned, earlier
on I try to create a solution which traditional hearing aids, actually I got Aurolab up and
running producing the hearing aids. As failed for a variety of reasons, the main reason,
we underestimated the cost and complexity for the fitting for the emerging markets.
You need trained audiologist, sound room, computer, cables that go from the box to the
hearing device, etc. those by themselves cost $100, there is cost and complexity that we
underestimated this project failed. When I met up Mr. our most -- Stravous we created
a new product -- let me see. This is not advancing?
Creating a technology that was originally targeted to the great unmet need in the emerging
markets. Re-created -- we created a technology platform that enables fitting directly on
the device or through a variety of competing technologies that has directionality and noise
control for telephone and application -- amplification notes. It has a microphone, -- this is a Bluetooth
headset that you can use with a cell phone or streaming, we are releasing this as a personal
amplifier with limited output and hearing aid with maximum output of 130 DB with 70
DB of gain. Spirit we are the first to have these smart phone application controlling
the device without intermediary or -- devices. It is a 16 channel with a 24-bit resolution.
The chip in this device is from the Bluetooth chip industry. The company we buy this from
cells 1 billion of these per year, we do not have all development cost that hearing aid
companies have for developing proprietary chip. We use a robust chip that has more processing
power that any hearing aid chip. It has all of the features that you would see in advance
hearing aids with signal processing which you can see here, all of the features.
The other thing that we did it again for the emerging markets this is taking into account
the David Greenlaw, we created a mold system created out of proprietary it's real which
does not vibrate. You can program it for severe hearing loss where you do not have the feedback
sound. You do not have to make a customized mold. We also have a rechargeable battery.
For the behind the year version, 16 hour battery. We have a strategy for the emerging market,
to work with pre-existing program, enterprises and eye care programs, initial distribution
is through eye care programs I helped develop that serves the same demographics. The cataract
patients. We have a training program that trains the technicians to be fitting this
product and helping them develop a whole business model and pricing system around that.
This will give you an idea of the comparison of the product. Where we hope to make it affordable
and available with minimal time used for fitting. Okay so in the US -- we are looking to spread
this product to underserved communities through federally qualified healthcare center present
American Indian clinics, Spanish-speaking clinics and organizations, County health department
etc. reducing the cost and pricing focus on making the product affordable and accessible
word is really about fee for service. Rather than being a part of any insurance reimbursement
system. You want to make this affordable to the pocket of the client.
These are some screenshots of the consumer version. To finish up on the point, it is
not about reducing cost really about changing the entire business model, the ecosystem to
results in an affordable product. Using technology and looking at new and different channels
for how this product gets out to people to provide assistance in ways way or we hope
our price points, accessibility, will change how the rest of the providers behave. So that
hearing can be more accessible and affordable. Thank you very much.
[ Applause ]
The next speaker is Stephen Berger from TEM consulting. >> That is a great presentation
to follow I want to talk about standards and spending a lot of time in my career developing
standards for this audience that involved in that [ Indiscernible ] beginning in 1996
on compatibility between mobile phones and hearing aid's.
A lot of this is lessons learned out of the activity. I have five major areas I want to
touch on. I wandered into this like most people, I realized standards are a tool. And variety
of tools that serve different purposes. They can be multiparty contracts, vehicles for
knowledge transfer, specifications to ensure interoperability, we will discover different
kinds of interoperability. There are a vehicle for facility -- facilitating conformity which
all the records reprocess are intended to do. Those things that make sure products and
services meet specifications in reality, diplomate with real users in the field. They can be
a tool for technology planning. Letting one industry segment signal to another one, where
they are going and how they can stay linked up? >> So standards is multiparty contracts.
The point I am making is, is an is are a tool and actually there is a collection of tools,
we do well to understand which tool that we need the job that we are trying to do. And
what is the system into which we are trying to provide a solution?
With the's -- C 63.19 to solve a problem of interference and make sure that the T-Coil
and the microphone work between the phones. This started in 1996 we are in the fourth
revision, the standard is mandated by the FCC and recognized by FDA. In general we have
been successful. We did not get this perfect out of the box, we are on version four and
talking about what we need to do in version 5. In both industries technology changes are
has been some of that.
Can senses is almost impossible and cost is not aligned as one of the lessons we have
learned, it is worth thinking about. It is not unusual that if one industry which is
pay a little bit more someone else will get a benefit. How are you going to make that
happen? It is not easy.
Solution for C 63.19 was the application for the Coase fear him. This was the behind the
scenes, at the beginning of the process it would be fair to say that the phone industry
and hearing industry which are very different culturally, different in size a lot of things.
Were both finger-pointing it is your fault hearing industry we were here first you came
along and cause a problem. From the for -- phone side we cannot function without transmitting
the RF. What is a brilliant move, one of the phone companies [ Indiscernible ] to a hearing
aid chip manufacture and show them how to make a RF immune ship. That differences their
chip from others on the market, all the manufacture had to do had to buy the RF chip and the subsidiary
to the RF interference approved by 100 or more. Speaker they can -- they can differentiate
their work at, market and we have a consensus on we can finish the standard.
There was a lot of knowledge transfer. I have seen this and other standards. We had acoustics
experts explain to phone designers what was going on the kind of presentations we have
heard here in this conference, this was new information. In the early days of the meetings
a lot of letting one body of experts present to the other and understand each other's landscaping
of to find consensus solutions.
RF was moved to the hearing aid chip vendors and manufacturers. Specialized testing expertise
was communicate it to commercial test lab so that companies can take the products and
get them tested. Looking today, what do we need in the future?
This is parallel to's -- to some of the things I see, the audiogram is not enough to raise
the volume. There are issues of signal quality, those need to change the technology we are
using. I see signs of that as we go to war it digital technology new artifacts that find
their way into the acoustic stream that are problematic and all testing is not catching
this. Ensure for -- and RF we have the [ Indiscernible ] coming into use which deals with the complexity
in the RF signals. We will need something equivalent to the audio quality.
One of the innovative things we did in the fourth version of the standard, before we
recorded RF aced on -- based on the raw amplitude in the newest version, reregulate the phones
based on amount of interference that create in the hearing aid, they can have as much
RF as they walk. As long -- as they want as long as it does not create interference. A
factor of 100-1000. How it goes into the audio band. That was something that we did, I am
very pleased it is a topic and go into the future.
We need standards on acoustic and biologic stayaway zones. There are certain types of
modulations that go down and can be a biologic signature either audio interference, or misunderstood
as -- let's say a heartbeat. Or lack of a heartbeat.
RF designers went from architects -- they do not know the consequences of their decisions
in the way form as to what may result in interference that make cause problems with medical devices
or hearing aid stucco they need to know this. They can move the streams if you catch them
at the right place when the debate technology planning.
Interoperability. Critical purpose that standards can wave. We -- can play. We are working on
these in the area of coexistence, if your equipment and my government are close together
we do not mess each other up. We may want to go to the next level of where -- equipment
is not the same that we mean the same things. That mine is a 4 and yours is a 5 meaning
the same thing. There are standards like this. We go to the deep root level units from different
manufacturers work with each other for core functions or different functions. That is
really complex, you will start to while you bring people together you start to do interesting
things about the stifling of innovation. You want everyone to be the same.
Everybody can hell of into the power -- anybody can plug into the power plug, this works out
without effective feedback system, you really have to understand the system. If you do a
wonderful standard but the lab do not test properly, you will not get the outcome that
you want. If you do not have a way to get feedback out of the actual market experience,
and adjust without the interpretation were people misunderstand the standard. You will
not get the outcome that you desire.
That leads into conformity management. Every regulator works in this field, international
standards on this. Standards are not an end of themselves a tool that goes into a larger
process such as testing in the laboratory, then going into quality management systems.
Hopefully to make sure the products and services meet requirements in reality.
Other mechanisms are necessary to ensure technical requirements lead to the route outcomes. -- Right
outcomes. One of the things I do as a hobby is lab assessment for accreditation. It is
interesting when you have a new version of the standard. You go in and ask a lab manager,
how do you tell the difference between a good outcome and bad outcome?
They cannot tell you the answer. How do you know that you can screen out the bad ones?
That is part of Desch -- those to look the standard know exactly what they had in mind
it is the translation function the lattices is commensurate at the labs understand so
that excellent products get through and good products get through but those that are below
par get returned for further work.
Standards can facilitate market forces. When consumers do not know how to identify excellent
products they cannot make informed choices. I will go into some recent data it I'm scratching
my head about.
For a series of reasons, I got looking out how many Wi-Fi devices in this case, Wi-Fi
equipped laptops support dual bands. Operating in the 2.4 and the 5.0 GHz from in 2009 dual
band dropped to 20%. Now as you will see any minute, this is the picture of if you go and
make measurements -- I made measurements in the back and this is true in this room right
now, those who check your e-mail or whatever. 80% of you are crowded into three channels
in the 2.4 band, even though there are 21 channels available in the 5 GHz. That is trying
to -- Bacher right now in this room by the measurements I made yesterday. What sense
does this make?
We create traffic congestion, why do we do this? Here is the FCC Creek will see -- frequency
allocation, there are three overlapping channels, four and the 2.4, 80% of the traffic is he.
-- We can only operate here, all of the other spectrum landscape is available. Let me ask
you, how many of you know that your operating either the 2.4 or the 5.0 GHz band?
I have one hand. I can raise my hand I suppose [ Laughter ].
What is really -- interesting -- I have been making -- I actually have a reason to do this
for some research I am working on. I have yet to find any device operating in the channels
in the middle section and four of these in the lower band that require dynamic frequency
selection transmitting the control. The FCC allows all of the channels, and no one is
using them. Why is that? How many people even know that they could be using them but they
are not?
So here is some data that I recently took at different places some gates I was actually
-- last week the data in this room is pretty similar. But you can see, we've got about
25 channels available. For reasons -- 40-60% of the traffic is crowded into one channel.
What happens to the interference and problems? It will turn out, the same thing happens with
RF choices. What we really have to worry about then, in terms of what we are doing, any product
developer a choice and the only logical option for price, simplicity of designs, a lot of
reasons is to go to YouTube, Wi-Fi, -- Bluetooth and Wi-Fi. The device we heard about a few
minutes ago, is not optimize for this community. If the reliability level, the service levels
are different, you will have a mismatch and potentially unintended consequences.
So -- it is really important to understand what are the dynamics? I've come to love the
word ontology? The relation shown links between separate areas that guide is to act in certain
ways and creepy group dynamic perhaps we put into place as we do not want to be.
Over and over again what we see is, when a company does not a hard-core RF of a does
RF they get what they think is experts them a grabbing a module, put it into the product,
and it is a wireless product. You're in there with all of the other devices, chancellors
are you are a single band, -- chances are you are in a single band, in the most crowded
place, you have done this for very good business reasons. Is that really the service level
and reliability level that we want to be at?
Technology and planning . When to start to look at those things, you will come to a different
sort of Desch you know Desch how do we keep people in sync -- moving to the fourth generation.
I can tell you we have had the availability of the standard has been one of the few meeting
point for the industry talk about, what does that mean and what is a change and what do
we need to be sensitive to on the hearing aid side? So we stay synced up?
Technology requires different metrics . If you look at the history of audio standards,
there is a new audio standard for virtually every time we moved to a different technology.
This is true intellect of the Desch is in of A -- the
Their audio quality standards, we moved to for this there was a difference sets, voice
over IP there is another. We have to change the metrics because -- the mechanisms change,
the failure changes, we find out things are getting to the test should not be. Weekend
hear but it is passing the test, we have to figure out what is wrong? Get a new test for
the new technology become you see this progression. One of the reasons standards needs to look
forward and keep us current on those things we revenue about that before we get a lot
of product out in the field. Rather than after.
One of the most difficult challenge is how to end the life of what technology and move
to a better solution. That is really tough. I have no idea how to do this, we cannot just
keep and -- and and the, it is not sustainable in the long run. People to move to a new and
better solution. Will not leaving people isolated and orphaned with had been the previous solution.
It is something that we need to map out. Regulations end up being anti-innovative and that is not
where we want to be.
So onto ontology. There is real interesting work in this area, the task is to map and
then manage the complex ontology. I would argue that most of what we are talking about,
understanding the ontology that we are working out? What are the dynamics, relationships,
managed to get to a better future?
It is vital to the intended and unintended consequences. My question earlier this morning,
-- I highlight when he to understand types of innovation? Previous speaker brought up
disruptive innovation. Sustaining innovations are fairly easy. When someone will come up
as the previous speaker did was something that is really a different way of approaching
things.
That tends to be disruptive, standards and regulations tend to block disruptive innovation.
I do not think socially we want to do that. But it takes a lot of careful thinking to
make sure that we do not. >> So conclusion stands can serve a variety purpose is to support
understand the role and why you choose one you are choosing standards are not a fantasy.
They do not stop -- solve all the problems, their great with the right tool with the job,
they are lousy when they are mismatched for a feel-good exercise. When standards are part
of the conformity management system the other parts of the system must be a place or you
will not get what you want. Standards and regulations suppress innovation particularly
disruptive innovation. Is Desch it is a fact of -- it is a fact of life, it is a standard
of the regulation to minimize that and be a standard of what we difficult one of the
outcomes I think is to really focus on the outcomes and be very slow to dictate methods.
Sometimes we have to dictate the methods and we want to be sold to do that.
We should be alert when there are maybe Desch different outcomes for different groups. A
comment that hit my ears with this conference come to a different conclusion when we had
one conference for mild hearing loss and the other for water or profound hearing loss?
Stutters can document multiparty consensus and when they do that well, they can really
be powerful.
A challenge can be to move from one consensus from the past to one that is right for the
future. I thank you for your time.
[ Applause ]
[ Captioners Transitioning ] >> Concerning the theme the next speaker is Valerie Fletcher.
>>
Test >> Tracy Lustig
Telecoil Our next speaker is Valerie Fletcher from the Institute for Human Centered Design.
Thank you. I am happy to be here. One of the best experiences I've had was in the same
room talking about -- aging about 1.5 years ago. I have faith in this room and in this
organization. Also, I work across the spectrum of human ability, but this is a area of keen
interest to me. Like both of my parents -- they have severe hearing loss. My mother has died.
My father was alive and struggling. He is legally blind and severely hard of hearing.
My husband , as I heard yesterday, has grumpy old man disease with significant hearing loss
in his right here, but he claims it is not a problem because there is nothing much he
wishes to hear. [laughter] I'm going to go through a way of thinking about these issues.
I am delighted you are feeling that this is a time of change. A time when the conversations
have been going on for decades. He might be moving into a place in which action is now
possible. Just a thumbnail about who we are and how I ended up here -- we been around
for a long time -- since 1978. We are headquartered in Boston although we work with colleagues
all over the world. My team is scattered across the US. Our only physical spaces in Boston.
Nonprofit dedicated to enhancing the experience of people of all ages and abilities with excellent
in design. [indiscernible] does not cut it with us. We think this is important to the
experience as function. >> One thing I have heard is that many of the terms that we use
-- many ideas that drive us -- our ideas that we share with people here. One of the ideas
that we talk about a lot is that design is powerfully and were frowned and influences
everyone, often in a negative way. We are looking for an outcome that enhances a sense
of confidence and comfort and control in everyone.
The other thing that is a big idea that draws everything that we do and God knows this crowd
knows it -- and one ability is ordinary, not special.
It affects most of us for part of our lives. We do a variety of things -- we do a great
deal of design and consulting but we also do technical assistance on the substrate of
laws and guidance. For the nation and for the region we do a great deal of education
and training. Our current plan is to focus a great deal on Africa. In our research we
analyze data testing prototypes and we find features to the user expert lab. We have over
200 people that work with us on a regular basis. They are paid for this work with a
wide range of physical, sensory, and brain-based issues many with the compilation of those
issues.
We invest a great deal of attention in outreach to multicultural backgrounds so that our user
experts do represent our cultural spectrum. We try to get at US averages on that.
First, a note on accessibility. It has been referenced a couple of times. Cynthia's presentation
this morning was the most lucid ascription of technology in the state of the art that
I have heard anywhere. I am going to nail her later today. We must have her assistance.
We are building a new web resource for the nation for the national endowment for the
arts, national endowment for humanities and Institute for Museum and Library services
on accessibility and universal design. The weakest part test to do with technology for
hearing loss. Please don't leave without my having a chance to talk to you.
Effective communication -- hardly a new idea. This is a new idea first codified in the rehabilitation
act of 73. The regulations on that date back to 78. This is not a new idea. Yet, it is
still profoundly confusing. The idea that requirements intend to support a quality of
experience across the spectrum of sensory ability -- whatever information is written
or spoken is as clear as understandable to people with disabilities as it is for people
who do not have disabilities. Still a mystery in many cases on issues of hearing.
Far more sophisticated today on site issues. This is partly driven by the extraordinary
energy of our digital universe. This has change everything. Everybody is playing on the volume
of participation and a sense of priority has leapt into a very different realm. The 21st
century case for inclusive design -- why this matters now -- I am constantly struggling
with the reality that we have watched and embraced environmental sustainability in the
design world that is undeniable. It took a long time to happen, but it absolutely happened.
We are *** that inclusive design is an inherent core concept of social sustainability.
Part of the challenges that we are trying to convince people that good news also requires
action. So, we actually live on an average of 30 years longer than 100 years ago. We
survive thing that no one imagined would ever be possible. There were conditions -- congenital
in particular when I was a child and you were a child. They were considered a death sentence
before adulthood. People are now living an average lifespan. This does not mean that
there is no action that follows that. One of the things that is important to me is to
remind people of some of the issues that ought to characterize the pairing of environmental
sustainability and social sustainability with the notion of human diversity. Respect for
diversity, respect for interdependence. I've heard talk about interdependence -- Dr. Miller's
presentation this morning was a marvelous reminder about healthcare and interdependence
we Americans loath to think about.
Data driven -- the notion of evidence -- harping on that over and over what we talk about these
things -- we must have research. In the long view -- the investment we make today has implications
for decades to come. In many sectors of design. Global aging -- obviously, the number one
catalyst for this notion of universal or inclusive design. Constantly reminding people -- 10,000
baby boomers -- many of us in this room turned 65 everyday. We keep doing that until 2031.
That anyone can a nor that is astonishing. Yet, we do. I work globally and I have to
tell you that the United States is an outlier. I don't know if share -- Cher could stand
up, but this is the standard to which we Americans aspire. I love this quote -- we have an aging
society and adolescent culture.
Sometimes I feel hopeful that we are moving from that come up but not very hopeful. [laughter]
The second catalyst is actually the phenomenon of disability. Certainly, we know a lot more
about disability that we did even five years ago. Certainly 10 years ago.
One in seven people on the planet have a disability. 80% of them live in the developing world.
I'm delighted that the developing world has come into the room with a little more force
today. >> This is a reminder about regions for functional limitation. We still have along
with Europe the best data on functional limitation in the world. The reality is that we have
large chunks of the world -- we don't count a lot of sensory data. We don't count optional
losses that are sensory. -- Functional losses that are sensory. We surely don't count the
ones that are brain-based. Good God. Find me a number in Asia about brain-based functional
mutation. Let alone in Africa. It is difficult. We aren't always talking about the same thing.
Just as a reminder, we talk about hearing loss, join the club. We are talking about
the ordinariness of optional limitation and disability -- functional limitation and disability
-- that is not apparent that is the norm today. Wheelchair users that are still in many people's
mind the order line between his ability and not is a small number of people. We have reached
3.6 million people using field mobility. When all of us the people risk it over, we are
looking at 4.3. Not apparent conditions are the norm. It came up yesterday about emergency
management. A reminder -- we are always looking at the word disability as if there was a consensus.
That is absurd. The firm disability is mostly about carving a narrow door -- not too many
people get through it. That is the purpose most of the time. We have over 60 definitions
of disability in the US federal government alone. But we are seeing a shift away from
special needs and satellite to suggest that if we are seeing a shift away from special
needs at FEMA, we are seeing a shift.
FEMA -- this is 2010 guidance on planning for integration of functional needs supports
services in general population shelters. This came out of a strong critique to stop looking
at special needs which it come to total about 52% of the population. Not special anymore.
Reframing the role of design -- why am I here? Probably because I guess I hope to convince
you that this is a triple that all of us need to think about. -- A pool that all of us need
to think about.
I do not parse these terms as different from one another. Universal design -- inclusive
to dine -- one of the most common term in the UK -- these are a framework for thinking
differently -- were designed a place, things, information, communication, policy, focusing
on the user. This is a shift to the user and human diversity. Human centered design of
everything -- clearly what we have embraced in our organization. This notion of principles
of Universal design -- we talked a lot about value and evidence. This is the value statement
of the principles of Universal design. I have to say that they were generated by five US
realizations -- white folks with advanced Greece in 1997. All Americans. It has served
the world well, but I do worry -- my organizations was one of them -- our Indian colleagues have
a layer that is now -- they accept this and have their own layer that deals with their
own values and needs.
Global policies -- but we talk about taking this on, we need to think about taking it
on globally. It is not good enough to think about this only as Americans. In the world
health organization we have heard a lot of references to this -- The Way, Joe in my book
gave us an enormous gift with the ICF for all of his problems in the things that don't
work well -- the basic message that functional limitation is a mainstream universal experience
is undeniable. They it relies mental and physical reasons. An enormous challenge that they met.
For me, defining disability is a contextual variable and the most important thing. Functional
limitation is a pervasive act of our lives. It becomes disabling at the intersection of
the environment -- the personal environment. As is all familiar but I -- unpacking it is
not always familiar. Physical you medication information policy and social environments.
The WHO recommended inclusive design as the most promising framework for identifying the
facilitators that would minimize disability and support independence in old community
to Gratian. We are really talking about an aspiration for driving in a world in which
we cannot afford -- given the value of functional limitation -- anything less.
I trust that you are familiar with a year later -- the plan of action on aging -- priority
direction 3 -- ensuring, enabling and supporting environments put on the same ideas. I hope
some of you might be familiar with the third policy which is the UN convention on human
rights of people with disabilities. It was 2006. I keep hoping that we haven't had it
for as long as we have because we have made scant progress. Are people familiar with this
? This is a supplement to the international treaty on human rights. We had women and children
and now people with disabilities. Pay attention. You may find that the U.S. Senate once again
decides not to ratify this treaty. We are unusual in the world 158 nations have signed
it and 100 -- 137 have ratified it. But we are not among them. This is on the floor of
accessibility -- a shared global commitment and promotes the idea of inclusive design.
A few examples from a to environments -- the healthcare world is one in which we absolutely
need to be thinking about human diversity and not just tailoring assistive technology.
You may know this example -- the notion that we continue to have miserable little medication
bottles indistinguishable from one another and impossible to read in many homes of older
people. There may be two or three sets of these with different names that are commonly
forgotten because it is confusing to understand them. This is a very clever idea in which
you can actually colorcode the band so that mom gets the green and dad gets the yellow.
Imagine a system in which it actually stands up and does not roll on the floor. A variety
of ways to think about an ordinary product that makes people feel in control of an ordinary
act of their lives.
Unfortunately, my father takes 11 drugs every day. He does not have this. He is legally
blind and struggles with 11 gold tubes with white caps, none of which you can read. This
is an ordinary universal design idea. I haven't seen it anywhere but in Singapore. I do a
lot of work there. As some of you may know, they are hell bent are being the first of
everything they touch. Universal design is one of the things. They found it late, but
they are zealots in pursuing it. This is an older hospital and they decided to clean up
their act by thinking about the user experience of their patients. While they were designing
a brand-new hospital to replace it. In every room at every shift staff names and photos
of the staff are changed. This indicates who is on shift. What is their name and what do
they do for you? This happens to be the nurses on the shift and imagine if you could have
some hope of knowing the name of the person that is taking care of you? Remembering that
from shift to shift because you had a cheat sheet.
This is something that I have watched with a couple of family members and colleagues
who had severe experiences with cancer. This is a tablet which actually does something
that is difficult to do. Ask awkward questions of people who are profoundly ill. This is
a very quick 88 question survey which is done alone by the individual in the waiting room.
There are a lot of things in the course of cancer treatment that are embarrassing to
talk about. Embarrassing to answer questions. They take a long time. This gives an instant
communication to your oncologist before they see you. You can report things that are not
working well. You can do that privately and without having to articulate awkward situations
or hear someone ask you those questions and not respond. Work -- you do not look like
a crowd of folks that are seeking to retire tomorrow. You look like people who are enthused
with the work that you do and you are likely to work for a long time. We are in a majority.
This is the fastest growing age group in the workforce. This will continue at least until
2020. Baby boomers don't choose to retire partly because they can't and partly because
they don't wish to. This is fairly old data -- we paid for it so I have it. Unfortunately
I don't want to pay for it again. If the five and over -- key sectors. Public administration.
We are over 30% in the federal government in almost every state at this point.
In the workplace, one of the things that is difficult to do is sustained a priority on
investing in acoustics because it gets value engineered out. Before the construction. It
happens to us on almost every project. It is the first thing cut. What it will cost
you to have a good acoustical environment.
It is not just acoustics. One of the things that is critically important is being able
to see people speaking. A colleague across town -- people know counsel [last name indiscernible]
-- he is an extraordinary fellow who is& And that is done serious work in this. This is
mostly about people that are speaking with their hands. American sign language. You need
room to speak with your hands. It is the first time that people have come up with guidance
for the importance of visual connection to speech. That guidance is available to download.
This is the first residence hall that incorporates his guidance in new construction. Again, across
town.
Culture -- the web project is one of many things we are doing. This is a reminder that
everybody doesn't think the way that we do about some of the technology that can make
such a difference. You may know that In London are looped. You may know that the underground
information stations are looped. Essentially all of the museums are looped. This is one
of the places where some of our favorite music is recorded. All of this is looped. I thought
20 people to London in September. One was a man who is hard of hearing and has low vision.
He said he heard a concert in equality it ever heard in his life. This was eight St.
Martin in the Fields. This is a new technique coming out of Japan. If you have ever seen
the kabuki theater, don't think that they know what is going on. They don't much more
than we do about what is going on. The captioning may be marketed to people that are hard of
hearing, but it is actually for the Japanese to understand what is going on.
[laughter] This is an amusing thing -- this is in manufacturing now -- on the market.
A fire alarm which uses sent -- scent. A woman developed this and the alarm goes off and
the smell permeates your environment and causes you to weep and wake up. It is quite effective.
You don't have to that whether you're Telecoil is turned on.
People know this book -- design versus disability. Bob brick. I don't agree with all of Graham's
ideas but mainstream design could inspire, provoke, and to radically change how we think
about design for disability. This is one of the examples -- the cover that he uses -- super
cool eyeglasses. Inside is an example of an attractive, interesting, Jewel like hearing
aid. This is something that we referenced yesterday. A solar a that is been around for
ever invented in 1992 in Botswana. I am sure that Mr. Green knows about thing that are
more sophisticated. It is interesting that something like this does does not depend on
electricity has been around for so long.
This is a small gift -- those that have been thinking about what it costs us to struggle
to hear -- I don't know if you heard about this -- the author is an economist -- I believe
from Princeton and a psychologist. They suggest that scarcity of any number of things -- money,
time, attention, challenge, or bandwidth -- I am throwing it out as a way to have some shorthand
to think about bandwidth as a part of the problem we're dealing with. It isn't open-ended.
We have a limited amount of bandwidth. How much of our mental capacity is available at
any given time. The last point -- this is a publication of hours from 2012. My colleague
who is a professor of architecture in Belgium -- focusing on all of these ideas. Basically,
we are focusing in design on a radical shift from the person to the environment. Universal
refers to human diversity in a radical approach. But, design appeals for solutions founded
on empirical investigation and what my friend says is that we have an enormous research
agenda. The idea of facilitating environments is still a value and an idea more than it
is something that has the evidence-based -- evidence base behind it to act on. I would suggest
that if anybody is interested in thinking about moving on that research agenda, I would
love to talk. Thank you very much.
[Applause]
I would like to thank our speakers for these talks about how we might change our ways of
thinking about how to address the challenges of our changing world and improve our listening
and auditory experiences. I ask the questioners to make their way to the microphones. >> I
am Matt Quinn from FCC. Prior to this I was at missed -- NIST working on health IT. One
thing that we found was that often thoughts about human centered designed for an add on
later. Thus, never really truly were incorporated.
How do we change that perception that the difference between a hearing aid that someone
loves or a hearing device that someone loves or electronic health record that someone loves
or a mobile health application that somebody loves and one that house all the function
that they might need that they discard and don't use or they go constantly back-and-forth
to the audiologist -- this is the human factor of it. >>
[indiscernible] You mail a problem that is an intractable problem. I think part of what
we're dealing with is an attitudinal problem. The idea that this has the potential of a
pervasive value to a large portion of the population is a tour we have been unwilling
to go through. We have attitudes about aging and disability. We have identified a comfort
level. We aren't old until we are at least 80 at this point. Our systems change a lot
for a lower age range than that. We also believe that somehow the notion that this was an investment
for all of us -- and that we all had a stake in it is very tough for us to act on. To live
with. Africa great deal in Japan and the Japanese have a different attitude. They are getting
into the research and development phase at the very first conceptual conversations. They
are doing it because they feel they have a stake in figuring out how to maximize independence
as long as possible. They also feel like they have an obligation as a culture in an aging
society to make a difference in that way. We are struggling there. I think the attitudinal
challenges of thing that is the toughest. This is to get people to appreciate it. It
is still perceived as special and over here and not central to the ordinary product.
Until they needed.
Yes.
One follow-up -- you talked about the challenge of disruptive types of technologies and approaches.
One of them that I would like to highlight is some of the work that Greg Vanderheiden
at Wisconsin is doing. Something called the global public inclusive infrastructure -- GPII.
There is the idea -- is that of having a one-off product that fits everybody, that you have
an personalization from the clouds. Storing your personal preferences. Other things in
the cloud. Every time you touch or sign into something, it automatically personalizes this.
How we go from a market place today where you sell individual implements or regulate
individual implements one that is different for every person, potentially, I think will
be a challenge. Any thoughts on how we make this transition? Or if this is an approach
that is out there today in the marketplace?
Anyone who is a global player is so sick of the incredible complexity of life. If you
don't it to that point -- it has become not just a dream, but something that we have to
tackle. >> On the Greg Vanderheiden issue is one thing he has done is try to contribute
to the idea that we need to share data and make this argument across the board. Aging
and ability and culture. He has a website called raising the cap floor which is another
good resource.
Thank you.
If I could add a comment -- I think it is critical for those that get heavily involved
whether it be health records or hearing aid compatibility, to be continually alert to
who is not in the room and reach out. I got into a conversation with my personal position
that I've had for 25 years -- a wonderful doctor. He commented on from his viewpoint
that the new standards are not useful to him as a Dr. But he and his partners with their
scribbled notes communicate what they really need to tell each other. Whether he is right
or wrong, that is a voice that needs to be in the room. I can tell you that my doctor
doesn't believe in the room. From personal observations, I think there needs to be some
outreach. >> So, who is not here? Who needs to be here? Taking the effort to talk to them.
I am with you.
Noreen Gibbons with high health innovations. Stephen, I agree with your comments. Regulations
designed to protect us can also prevent a lot of innovation. At the same time I would
like to ask David and Stephen and Eric if he is still here -- a little bit about the
devices that we saw from Sound World -- I am assuming in the US they are marketed as
PSAP. As you all know, there is an issue with the FDA allowing a self assessment tool like
a hearing test on those devices. To be tied to the purchase of a hearing aid. I would
like to hear some comment about that if I could. >> [indiscernible] I will have one
of my colleagues respond to that question.
We are not making a hearing assessment -- we are just trying to figure out how to figure
out the easier listening preference. We don't really indicate anything there that we are
taking a test. The fact is that we give the people tools that after they do some assessment
to actually equalize it. So, it is an equalizer more than anything else. People have access
to the controls. This is so they can adjust to what they are wearing the device. In different
environments.
What we were overly concerned about is to limit the opposite of the device so that when
the device is sold as a personal amplifier we do not allow an output of more than 160.
This is to make sure that even if people make an error in adjustments that they are not
going to damage themselves. We think that we are much more conservative. Many of these
phones that people are wearing out there -- the output really goes completely uncontrolled.
[indiscernible - multiple speakers] I would like to add a comment. We originally designed
this product for emerging markets for resource poor environments. We had to come up with
solutions to serve those rockets that presently do not exist. So, if you think of the availability
of hearing aids and audiological assessment in the emerging world, it is very tiny. So,
we had to come up with business models and technology to serve those is this models to
convert the great unmet need and demand for better hearing. So, we actually took the help
of a design firm -- IDO -- to test out some of the assumptions about nonmedical technicians
and their ability to use our system to fit our device. That helped us in our design process.
We did that research in India. Each step of the way we were focus, really, on addressing
the great unmet need in emerging markets and how we use quality and price and accessibility
and ease of use to convert the need into demand.
Just as a follow-up, we tend to think of people in other countries which is wonderful. I am
glad we are thinking of them as well. There are a fair number of Americans -- the Hi Health
program will show you this any time. We would be happy to talk about that. There is an access
problem in what some people might call flyover countries. We don't all live in big cities.
We don't all have audiologists around the corner. I applaud you for recognizing that
need. The assessment part of it is an issue. I thought that the [indiscernible] that I
mentioned earlier with Frank about how the devices were being set up -- what sorts of,
if any, prescriptive a formal it was used. My apologies. I thought it was based on some
assessment.
It is not based on any sort of assessment to the decides -- device, then?
Yes, we use a [indiscernible] presentation of tones that we asked people to respond to
hear the tone. It is an intelligent system. We are testing different frequencies depending
on the person's response to the sounds of the here and we continuously monitor the environment
just to know that the accuracy of the measurement is good enough because of it is in a noisy
environment and the persons threshold is very close to the environment, then we tell them
to go to a quiet room. But, this is really an issue of starting this. We are not trying
to make a clinical evaluation.
Besides, we all know that with hearing aids, this is just a starting point on how to actually
adjust the response of the device.
We are just starting. We are iterating to address a huge problem. In fact, I was thinking
today that we should change the name of our product to the Cognition Enhancer. When I
set out developing eye care with all of my partners, we did not know where it would lead.
We didn't know the transformative effect that affordable intraocular lenses or sutures affect
would be on the market. Keep in mind that everything we are doing is an experiment.
It is about serving people. Serving the constituency of those that have difficulty hearing. We
don't know -- as I look back with eye, we had to navigate quite a few regulatory and
professional landmines which we were able to do. This was to increase the affordability
and availability of eye care and in this case people getting their site back due to find
is due to cataracts. This is the same venture we will embark upon with hearing. We hope
to shake things up. We hope that hearing aid companies and audiology will join us in really
shaping different market forces that serve a much greater number of people because I
think as Dr. Linn and others have said, good hearing has an effect on your cognition. They
are certainly related -- which comes first it is hard to know but I think is an important
arena and I am sure that there is going to be a lot of difficulties and five and misunderstanding,
but I think that we all have to think -- what is an ethical, legal way to be approaching
this problem? Even if we are not always in agreement about the different approaches.
Also, there is an issue of what is normal. We tend to think that if a person who has
a hearing loss -- more than 50 dB is not normal. Normal for a 65 or 74-year-old -- it could
be 40 or 50 dB hearing loss and it is normal. As we age we have deterioration of many fossils
of our body. Giving people access the ability to check adjust the advice to whatever their
needs are and eventually this would make them two things -- one, it will make them a war
and give them access to something that they can try. Click, they will realize that they
probably need much more than that. It is an excellent device and that is what we intend
to use it for in this market at this point. To make people aware like the reading glasses
-- aware of how much they need -- if they need more application and how much they are
missing by not having amplification. In special areas where they needed.
In closing, I want to say thank you. As a clinical audiologist for more years than I
will admit, it is an incredible need out there. Innovation and hearing healthcare is definitely,
as we heard, a lot of opportunities to meet people where they are. That doesn't mean geographically
necessarily. But, it is a big challenge for us. There is a lot of opportunity. Thank you
again.
Next question.
One element of design we have not talked about today -- some of the special issues that older
people have in using these devices. Cindy talked about the pocket talk. For some 80-year-old,
that is about the level that we are talking about. Someone, for example, using cell phones
as a hearing device for someone in their 80s. It is not happening. We have to design very
simple technologies. Something they can put on. From my experience with older people,
they are intimidated by cell phones. We have pictures of my mother's cell phone and the
remote control for your TV set. This may surprise you, but my mother often mixes up the remote
control with the TV with her cell phone. This is the level we have to think about. We haven't
had this discussion today. We need to ink about hearing devices -- think about hearing
devices at the older Asian population can use. If they can't operate it, they will not
use it. It will not work. We are talking about hearing aids. Frankly, we are also talking
about cochlear implant processors. I have worked with these with many older people . When
it is on and set up properly they get tremendous benefit. Sometimes they can't operate the
controls. They don't have the manual dexterity. There are too many buttons. A plea to everyone
-- please put this into the mix as we think about it. We are not talking about 60-year-olds
that are used to using computers. We are talking about older people who often don't have that.
None of us have wrought that up in the past two days. We need to think about that.
Wrapup comments?
A personal comment -- my wife --
I meant from the speakers --
If I could speak to the consumers -- this is legitimate. One of the reasons for creating
-- building the capacity to offer real people to test ideas and products and prototypes
is because the designers and the industry have found it difficult to find humans across
the spectrum of ability including older people that are quite fragile. There is no substitute
for actually doing testing with real people. Understanding the plethora of issues that
can be impediments that you commence. It happens day after day. -- That you miss.
In the sighted world, how many divine -- design world decided that they would test one person
that had low vision. What does that tell you? Not a thing. There has to be an understanding
that users need to be involved in the process. I think that just has to be something that
is insisted upon in every possible way in whatever process where we can influence how
people think about these things. The idea that humans are difficult to find with functional
limitations is a tragic confusion.
I apologize about the remaining questions --'s we do not have time. Thank you very much
for your participation.
[Applause]
Thank you. Lunch is on the third floor. The stairs of the elevator will get you there.
For any speakers from yesterday that didn't get a lunch ticket, please see me. We will
reconvene at 1:45 promptly. >> [This event is taking a lunch break and will reconvene
at 1:45 Eastern Time. Captioner standng by] >> >>
[Captioners transitioning]
We are going to get started again. Our ranks are thinning a bit. We are coming into the
home stretch with what has been a really provocative two days and I think a very important two
days for people with hearing loss. A normal partner of the aging process and I think we
are all leaving with new perspectives on services and products we provide I am Carole Rogin,
president of the hearing industry Association and also should claim that I am Nikolai Besgard's
sister we also have some other manufacturers from here in the US as well as components,
manufacturers and battery manufacturers. So, we are delighted to be part of this initiative
I will be taking back lots of key messages from our discussions and I hope all of you
are going to do the same. So, we are moving onto challenges and all of the speakers were
asked and have complied with the redundant -- with the request that they identify a few
key elements for research and study in the future. Our esteemed panel here today which
is almost outstripped all the chairs we had up here are some of the people who really
will be able to make those ideas and initiatives happen and are already working on some of
them. Howard Hoffman, is the Director of epidemiology and statistics at NIDCD and he is a guy as
we said so many times yesterday who can actually count stuff so we can measure it and see our
success. We are counting on you, Howard. Our next speaker will be Dr. Robert Burkhard a
professor and chair of the department of rehabilitation sciences at the University of Buffalo. I thought
I knew what he was going to speak about, he has been stacking up some comments throughout
the today's he has warned us about so who knows. And, we will finish the session with
a truly esteemed panel of audiologists, talking about an important initiative at NIDCD our
speakers are Dr. Amy Donahue who is deputy Director of the division of scientific programs
at NIDCD, Dr. Judy Dubno who is a professor in the Department of otolaryngology, head
and neck surgery and the medical University of South Carolina, my apologies there, and
Dr. Lucille Beck, the chief consultant for rehabilitation prosthetics as well as the
chief of the audiology and speech language pathology services at the US Department of
Veterans Affairs. Howard?
I'm all set thank you. I am going to rent your introduce you to healthy people. You
heard about that yesterday . We have an almost identical slide actually and we will do it
fairly quickly because my presentation is a little bit different qualitatively from
the ones that follow. But, I wanted to -- in fact this was useful for me to go back and
look into the history of healthy people and this first slide lets you know that it is
not -- it is run by the federal government but it is really meant to be much more than
a federal program. It was crafted, sustained really is a natural -- national initiatives
and there is a lot of outreach that goes along with this which doesn't involve my activity
so much, but there are a lot of people involved and you will see that soon. One of the central
concepts are the objectives are quantified and the ideal is to obtain measures across
the decade. This started out with just three areas back in 1994 the objectives. A group
probably to 20 or so of the year 2000. The year 2010 objectives, there were 20 chapters
each with multiple objectives and now by 2020 there are 42 topic areas. Each with innumerable
objectives.Obviously I can't cover this; the difference between 2020 and 2010 is that vision
and hearing were just one chapter in the past but now we have hearing and we've expanded
it to include the other missionaries of the Institute.
This can be the bane of my existence, everything done in Healthy People has to pass to this
committee. I can't change a single word on a single objective without war or less unanimous
support by all of these people who sit and meet every month and go over all the fine
details. It is incredible. But, what it guarantees is quality and uniformity and it works. It
has worked. The NIH appears to have two representatives, Martine that was for 2010 and she is an alternate
and for MCS a key player there is one person and the Director of all of this run out of
the office of disease prevention and health promotion is Carter Blakey, deputy Director
and her boss whomever it is at that time. How do we track objectives for helping people?
We need data and we learned this the hard way. The first in 2010 we came up with a questionnaire
for the health interview survey. It went into the field and you have $1 million to pay for
this well no we hadn't been told we have to have $1 million to pay for it so those object
this, that survey was yanked. We came back in 2002 with a much shorter survey we couldn't
afford to pay for but that reduce a lot of the questions we could address. One difference
between vision and hearing, this conference frequently talks about both, is that for it
division objectives everything is based on report data which is what the health interview
survey is all about. You can see here the history of the NIDCD supported parts of the
health interview survey. It has been expanding and it is expanding in part to address questions
in healthy people.
Examples of what we can learn from health interview surveys, I don't know of any other
way to learn this, is ideology or some attempt at ideology and of course we all know, we
think, but now we know from what people say is that aging is primary among all adults
what is the cause of your hearing loss, of course a lot is present at birth a lot maybe
noise induced but this is what people say and this was in 2002. For us, we wanted exam
-based measures at least in part and that meant that we had to fund, and we were continuing
to fund, health examination surveys included hearing and NHANES. Before I joined the Institute,
NHANES 3 was well underway continuing when I first joined and there was a question in
1994 we would it ever come back into existence because they stopped it. Now it is a continuous
survey, it should never have stopped but in fact, in 2013 and 2042 we have hearing yet
we are doing [indiscernible] we had to choose. The surveys are much smaller, I put the sample
sizes here, and we do only certain selected years at a time so this does limit the data
we have to put in for healthy people. But what can we learn from the combination of
health interview survey and NHANES obviously we can learn about hearing loss both from
threshold measurements, the impairment side and from reports of hard of hearing and other
questions. We learned a lot about tinnitus , we learn how recently they have had their
hearing tested, we learn we can ask questions about use of hearing detection and hearing
aids and of course these two surveys have a lot of information about comorbidity and
they were designed back when I first ran the government we would not have known how to
analyze such a complex sample survey but that methodology has cut up so we really have -- caught
up so we really have great tools.
The new 2020 hearing other sensory or communication disorders for short, air nose throat, voice
speech and language, consists of objectives within all of these areas. Probably the most
objectives are within hearing, that is the only one I will focus on today and I will
only tell you about a few of them. And here is a slide you saw I think with Meg, the only
difference is, I have broken out the sub objectives we actually have been tracking. This objective
three in 2020, increase the proportion of persons with hearing impairment who have ever
used a hearing aid or assistive listening devices or cochlear implants, because of the
NHANES structure we test from 20-69 so we had to have one objective for that age range.
Later when we were able to implement hearing testing in adults over age 70, we added 3.3,
but the same goal, but it is split out by age. And in between we were doing cochlear
implants for people of all ages. The other thing to point out I think from the slide
is, this is not something we had much to do with the targets are really softball 10% they
are not meant to be unreachable targets they are meant to be something that could be achieved.That
is something that originally we had a lot of latitude working on our individual committees
but more or less is now a uniform decision, 10% is what you are supposed to do for the
decade. The next question, increase the proportion of persons who have had a hearing exam on
schedule . You can see the baseline is sometime before 2010 and the target is for 2020. Again,
we have this age split.
This is typical, complicated, but a typical diagram or graph that comes out of this Healthy
People approach.We look separately within the two
age groups at gender, and we look within and arbitrarily we choose this to look within
age specific categories hearing examinations in the past five years is just coming from
the health interview survey and you can see that more men in the under 70 age range then
women were having hearing exams. In that age range more men report hearing loss so in a
way it goes together and you can see that with age there is still some difference between
males and females but 80 -year-old have more than the -- and the 70- 79 -year-old have
more hearing exams than the other this is naturally what you would expect but you need
to show it. Data collection for healthy people is rigid in the sense that these are the categories.
Race, ethnicity. They change for 2020 but this is for 2010. The categories for education
and income had to at least include these, you might get finer detail if you wanted and
of course gender and geographic location and disability status. There are now more categories
come of interesting thing to learn is that none of this is cross tabular in that we look
at income by gender by education, it is not multivariate, these are just cross tabs. These
are the data we have collected on use of hearing aids and you can see the top, the 70 plus
and 20-69. There is a gradual tendency to increase, at least in 70 plus, new cochlear
implant surgeries we are particularly pleased to have this and I think to point out for
children under age six, preschool children, this 15,000 -- 1500 per 10,000 is around 15%
15%, not higher, 15% and that is for pure tone loss estimated greater than or equal
to seven DDB period level, peer tone average I put this slide in, it may spark discussion
later some of the goals we established of course, took off. One of them is for newborn
hearing screening with considerable progress there. Finally, a discussion -- healthy people
program as difficult as it may be an exasperating at times it does provide a natural focus and
it is very important to have hearing health and other communication disorders side-by-side
with heart disease, diabetes and all the other things that are there. The goals must be national
in scope but are also meant to be useful for state and local . Objective, quantifiable
and ascertained periodically. If you can't collect the data in terms of helping people
the other thing is we have seen a clear example of success newborn hearing screening and those
with more moderate gradual improvement perhaps for the use of hearing needs for people 70
and older and I will be one of the topics we will discuss.
There's a lot of background literature now, now on why Healthy People was created and
how it has been sustained and finally, for 2020 this is -- and 2010 the sampling of all
the people that had a hand in this. No some like Meg may want to know more about it and
be involved and that is always an issue because there are so many people involved but my struggle
at the Institute is to come up with the data for the progress reports . Thank you.
[applause]
Civic I keep hearing this thing is simple but I see problems I am bobber card, here
are my disclosures I have been a member or chair of all of these committees, they would
be mortified to say I represent them I represent my opinion here today and nobody else. I think
we can all agree that the patient protection and affordable care act has been an contentious
and the rollout has been smooth.
[laughter]
But, part of the reason we are here and out of the reason I am trying to say what the
audiology partition and various organizations are doing is it is a lot of folks in healthcare
are concerned about the changes coming and despite a bill about this thick, there are
very few details and I think we have to look into our Crystal ball and see what is going
to happen but we have to prepare and I would like to spend the next 10 minutes or so talking
about what we are doing as a profession. The first change is going from a fee-for-service
to value -based care system that is really very critical. I have a quote here from Porter
that says , basically we are talking about value -based purchasing and value isn't about
more care about better outcomes. And how many of you after having an endoscopy will go back
for a free second one later that week? Honestly that is sometimes what we want. We have this
idea that more care is better care and that is in true actually better diagnosticians
should need fewer test then a poor diagnostician and a good rehab person should need fewer
episodes of treatment. Fee-for-service encourages increased utilization
and that probably rewards the dishonest and incompetent at least at times. We have to
go away from this and get away from the assumption that more services are better outcomes so
we really truly have to get into the game of how do we optimize value in healthcare.
And basically the value is the quality of outcomes divided by the cost. I am having
no trouble with this, Howard .
[laughter]
Let's talk about bundling and follow-up and bundling. Bundling for CPT codes has been
going on for a while. We do a CPT procedure and we can bill for a variety of individual
services, audiology me, acoustic in mittens or whatever and there are single codes just
for doing threshold estimation, maybe speech recognition but when we do test us, more than
about 50% of the time together there is a bundle code and we charge for that. Here is
something that will surprise you we get paid for less and the bundle code that individual
codes so because again we are trying to save money because one sixth of our gross national
product in the US is paid in healthcare and we can't afford that anymore and we can't
afford the growth and so this bundling of services for CPT codes is probably going to
continue and at the highest level might end up paying for an episode of care. So a patient
comes in with a particular disorder based on ICD-10 codes and we pay X amount for that
based on some severity estimate. Now let's talk about and bundling of hearing aids. A
lot of patients come in and say why is hearing aids so expensive? Well it is a some what
expensive and there are a lot of reasons for that but you're also paying for services I
don't know why people are embarrassed about that I don't know the last time you went to
have a knee replacement and you brought the joint in from, online you bought in the joint
imparted in said would you implant this for free . I don't think that happens so why are
we so bloody embarrassed to say we are charging for our professional services? If you want
-- setting a hearing aid is not easy I don't think the audiogram is a very good measure
of functional outcome and so we need to do a variety of tests, we have them coming in
with problems, we have to do a lot of work in order to have them have a good outcome.
So, we charge for those services but the patient might think they are just getting a hearing
aid.So that is bundled. And getting you a hearing aid you provide those services but
apparently they don't count them for anything. I don't think that argues for the value of
care we provide so, now we have online hearing aid sales. We've heard about this, it is starting,
it is going to happen. And you sit there and the patient comes in and it cost them much
less to buy the hearing aid online than it did for the hearing aid you are offering.
There could be a difference in quality, the services you are providing, so you decide
you are a family practice physician living in the Midwest in rural America you decide
nobody else is providing healthcare I am going to bison hearing test equipment and provide
the test myself. Fair enough I actually don't mind that, if you charge one patient for that
assessment, and another patient you don't charge, you are actually in trouble because
you can't provide at least for Medicare patients free services for some but not for all. You
have to either not charge anybody, which I don't think is saying much about the value
of the service or you have to charge everyone. Also, if you don't charge for those services
and all you do is sell them a hearing aid let's say you make $500 on the site under
what the cost of what you are doing and your time, then you have a patient who buys the
hearing aid online, they come in and say, can you provide all of the services here.
And for free because that is what you provided everybody else. You might have to provide
those services for free. For those patients who bought their hearing aid online. Again,
I think it is important we value the services we provide that we charge in the Medicare
won't pay for because it is not medically necessary, we charge anyway. They can pay
privately.
We have talked about value here at the beginning how does one code for outcomes because values
are at about look at all the services we provided it is about quality of care and outcome. How
do we code for outcome.One thing we have to do is code for the disorder and that is why
ICD codes come in. ICD can be traced back to the per Morty, public health anybody analogy.
It was the natural classification of [indiscernible] I think of Monty Python and the holy Grail
when I think about that but now it is international classification of disease. And there is a
clinical modification. ICD-9 has 18,000 codes while ICD-10 is almost [indiscernible] now
you actually can code for noise induced hearing loss due to a dolphin encounter. [indiscernible]
other contact with dolphin, there are dolphin bites, bird bites, so we have a level of specificity.
I don't like the weight hearing is coded in ICD-10 I know a lot of people don't, we still
need to do work that we can get at a level of detail we couldn't before which is a good
thing. I think somebody mentioned the international classification of functioning disability and
health earlier in the day and I think we at the very least could code for a level of severity
with an ICA code from 0 , no problem to four, complete problem. Here is the ICF brief core
sets, there is a longer one so ICF has these four areas, body structure which might be
most I can -- most akin to lesion testing that we code in ICD but also includes body
functions known as attention, memory functions which might be memory functions which might
be dementia associated dizziness, tinnitus but also get that environmental factors and
activities and participation. These are important. Hearing loss has technology with it that we've
heard about that could be over here or over here. It affects family relationships. Our
education, access to health services. ICF is a much broader framework to talk about
the consequences of hearing loss. Thank you again, on the quality side of things, the
physician quality reporting system, peak URS was designed by CMS to improve the quality
of care by providing care metrics for the services you provide, they are linked to CPT
and ICD-9, soon 10 codes and it started out as voluntary just voluntary reporting for
Medicare part B the service but the patient protection and affordable care act, Obama
care, includes a transition from incentive for participation to penalty to nonparticipation.
We only have a few codes for audiology remember we are reimbursed only for diagnosis of diagnostic
quality estimates are a little harder then rehab. So why should anybody be involved for
PQRS? The reason is money. Happiness does not buy you money in healthcare. And so, to
avoid the 2% penalty in 2014, folks have to report on at least 50% of qualifying patients
for three measures and receive half a percent in incentive you need to report on 50% of
qualifying patients 49 measures or as many as are available. How many measures does audiology
have available?
Right now, one measure is all. That is just audiology and making a medical referral for
dizziness. We can also use smoking cessation, counseling, blood pressure, falls prevention,
we've had some arguments over a few others within community. And am currently the audiology
quality Consortium which consists of 10 quality organizations shown below is working on six
measures for future use and we are part way through the process. Speech and noise for
cochlear implant referral, functional communication ability, tinnitus screening and evaluation,
ototoxic baseline measurement monitoring, this tubular
testing and I will not go into detail but they are moving forward. So we are developing
those measures but it will take us a while to get to the nine measures we want so we
have been talking about how a hearing loss is really important and we should provide
hearing loss services especially to elders. Yet if we go
and look at the Obamacare exchanges and Medicaid programs on the list here of essential health
benefits, does anybody see audio logic or hearing services directly? We have talked
about rehab and facilitative services and devices so it might be in their and prevention
and wellness might be our screening. Nowhere in there does it say we need the services.
If they are not specified specifically as an essential health benefit of seems most
likely accountable care organizations are going to include them. So we need to make
our services essential. What do we need? We need evidence that what we do makes a significant
difference in outcomes. So as a profession between audiology and otolaryngology we don't
play well together. There is plenty of evidence that audiologists are capable to diagnose
hearing conditions associated with significant mobility -- morbidity and mortality, and yet
AA oh HNS opposes direct access for audiology. Even though AAA has supported direct access
in recent years, the American Academy of audiology, to me at least it seems unlikely that will
pass the short-term. So AAA likes direct access to the American speech and hearing Association
currently pushing the comprehensive Medicare coverage for audiology services that is, we
can be reimbursed for treatment also while the Academy of doctors of audiology is campaigning
for limited licensed physician status, direct access and expanded audiology benefits under
Medicare. My personal opinion, do we care about the consumer? If we do I think elders
if we want them to live independently, longer and to reduce medical noncompliance because
those elders do not understand what the position of telling them and to affect their quality
of life I think we should support legislation that mandates Medicare cover the cost of hearing
aids and allow audiologists to be reimbursed for their rehabilitative services.
We also recently have been engaging in some interprofessional activity as a profession.
IPE is a hot topic, it has been for a decade plus. Mostly in the recent past, medicine,
nursing, pharmacy and some public health have been the central focus of IPE. Speech and
hearing OT and PT are starting to jump into that game now however right now there is no
clear evidence that interprofessional education leads to increased value in healthcare especially
in hearing services. So to end , and stand on the soapbox about research areas, the audiogram
is not a good functional measure of hearing. We have to start investigating hearing related
disabilities using a hearing handicap scale and/or speech in noise measures. We need to
move great from a disease based scale and hearing loss to a functional -based scale
to get at levels of severity hearing loss, quality-of-life and as well as quality of
care metrics. We have no good site of lesion testing for various causes of sensorineural
hearing lost , I think we need better test and that should be supported. I think there
are strengths and limitations to correlational research. A correlation between hearing loss
and dementia does not mean treating hearing loss will reduce the incidence of dementia,
I appreciate preliminary data available on this but we really need data that suggest
there is value in adult hearing screenings. And that there is a relationship, a causative
relationship between hearing loss and dementia. Medicare is broken and needs to be fixed.
Our evaluation system for codes, are the best -- at best flawed and at worst bias. We need
funded pilot projects to investigate the value of direct access for audiologists and what
happens the quality of care when audiologists are reimbursed by Medicare to provide rehabilitative
services. Thank you.
[applause]
They are the folks that helped me.
Okay, I am the last speaker for the day I am Amy Donahue from indie ICD one of the institutes
of the NIH and we support research that hopefully will provide some of the evidence we have
talked about that we need today. I'm going to report on a working group on accessible
and affordable hearing health care for adults with mild to moderate hearing loss. Judy Dubno
and Lucille Beck served as cochairs on this working group with me. In today's presentation
I am going to talk a good part of the time about the working group background and rationale
, especially accessibility, affordability, changes in technology in delivery systems
and highlight some of the professional attentions I'm going to provide some of the working group
research recommendations , tell you about some currently funded projects and highlight
some challenges and opportunities. Hearing loss as a public health concern we have talked
about this for the last two days I will not say much about this. Other than to say that
about 20% of those with hearing loss who could benefit from intervention, seek it. Many live
with their hearing loss for many years before they do so and for many and varied reasons
the needs of the majority of the individuals with hearing loss are not being met.
This research working group happened in 2009 and we looked at the hearing healthcare system
as a whole. With a public health perspective and this was a new research area for NIDCD.
The overarching goal was to increase the number of individuals receiving quality hearing healthcare.
To better understand the current hearing healthcare system, to identify gaps including
low-cost hearing aids and to identify innovations and opportunities for the future. The purpose
of the working group was to develop a research agenda leading to increased accessibility
and affordability. The research recommendations were be aimed at delivering better hearing
healthcare access and outcomes that are effective, affordable and deliverable to those who need
them. That are implementable and sustainable in clinical and community settings beyond
the research environment. And that complement and supplement, not replace, current paradigms.
The focus was not on research related to complex technological advancements for hearing aids
and cochlear implant; adults with severe to profound loss or children.These are areas
NIDCD has a very robust research portfolio in. This working group really focused on accessibility
and affordability. It also did not include public education. Why mild to moderate? Let
me just say about the working group was for adults of all ages with mild to moderate hearing
loss it was not specific to older Americans. But, mild to moderate hearing loss represents
the hearing status of many older Americans.They are least likely to have had a hearing screening
assessment, they are least likely to have used a hearing aid for one of many reasons
yet they are likely to benefit from amplification and early intervention may lead to better
outcomes.
Any of these individuals are still active in the workforce and many will transition
to severe hearing loss meaning -- meeting and requiring more complex interventions and
services in later years. Access is as important as affordability. In screening there are no
readily accessible low-cost ways for US adults to get hearing screening .For assessment we
have multiple entry points with competing interests and of course with devices, obtaining
a device to reach additional delivery models is a multi- visit process , direct to consumer
which heretofore has been the primary source of low-cost AIDS, are available through the
Internet, or magazine newspapers which can be consumer beware. And I would say the Internet
availability doesn't necessarily make devices accessible if you look at income and age use,
and we need better alternatives. Under affordability we have talked about this many times in different
ways over the last two days. We know this includes devices and services, out-of-pocket
cost of one hearing aid is approximately $1800, 70% required two ways they last approximately
five years so you start your replacement cost over again every time you need a new pair
of hearing aids. If you look at US household income, 35% of the household have an income
of less than $35,000 a year. And the median household income in America is $50,000 year.
So, if you look at those two factors and you ask yourself what is affordable, there are
likely different price points for different segments of the population. There our limited
scientific data on the specific cost of the specific impact of cost on adoption rates
, most of the data we have are from US industry surveys of non- adopters, cost is cited as
a primary reason and of those most in need which are those with the greatest degrees
of hearing loss, 66% said they were likely to get a hearing aid if there was 100 percent
coverage and 47% said they were likely to get a hearing aid if the price did not exceed
$500.
Beyond the purchase of all home or a car we know hearing aid services -- hearing aids
and services can be the third most expensive purchase for many Americans with hearing loss
over time. Hearing aid value which is the benefit relative to cost is a factor in return
and non- use rates and quality hearing healthcare is assumed to be the most advanced technology
thereby reducing access to those who can least afford it. Peer is not coverage, as mentioned
by Medicare, there is no coverage or limited coverage by most insurance plans
instead we have a reliance on Lions clubs and motor banks and this really is not an
acceptable public health solution. We need better alternatives if we really feel these
are necessary healthcare devices. There is a spectrum of socioeconomic capacities in
this country and the NIH mission includes closing the gaps in health disparities. Requiring
hearing healthcare may be especially challenging for the working poor and it is important we
remain conscious of the underserved in economically less advantage. Let's talk now for a minute
about changes in technology delivery systems. These have
been talked about. Many people have gone before me so they have laid the groundwork. New and
emerging technologies, we know now that hearing aid fitting is being automated and routinely
conducted on PCs. Is allows all kinds of possibilities for remote fitting, consumer programming,
hearing aids, the component costs are minimal, open canal fittings make them for less burdensome
and we've also heard about the smart phone entry into healthcare. There are rapid developments
there. NHS prairie areas and M health used in the smart phone as the mobile platform
they are eclipsing hearing aid functionality they've provided a wireless think I also would
say that even though ownership rates are rising, age and income variables influence ownership
rates so that is something to be sensitive to. Service delivery paradigms.We have seen
very rapid changes in that also.
The traditional delivery paradigm was you would go to an audiologist for in ENT or hearing
a specialist and they would have various devices. The new paradigms include storefront hearing
aid sales, Internet sales, telemedicine and since the working group occurred in 2009 we
have seen the entry of insurers into the delivery paradigm, direct patient. We are seeing a
corporatization of hearing healthcare where the manufacturer is becoming the provider
and of course we have M health and convenient Claire -- care Linux these will require changes
in the demographics and training. So how do we get to where we are? Dr. Mann talked about
the regulations adopted in 1977 prior to 1979 audiologist did not sell
hearing aids for profits it was against the code of ethics.Since that time hearing aids
have become an important revenue source from hearing healthcare professionals. We have
heard already about some of the professional tensions among hearing healthcare providers.
Where does that come from? It comes from a lot of different things. From disagreement
over the gatekeeper status , comes from differing education and credentialing requirements , it
comes from competition for the patient base revenue , a comes from unique belief systems
each group believes they provide the best services and of course we have heard some
of the debate on FDA read -- regulations. It's been noted already there's a lack of
agreement on legislative strategies for hearing healthcare. The professional organizations
have not uniformly supported reimbursement of hearing aids by Medicare and I would say
this really is a surprise to many citizens out there so if I was going to do my editorial
comment like Bob did, I would note that a united voice for Medicare coverage of both
hearing aids and services would send a very strong message about the value and importance
of hearing to help. As it is the agreement is limited among organizations to legislation
that supports a hearing aid tax credit. Which is $500 per device once every five years.
This has not passed but this is currently what is out there.
All of that in mind, and that was a very abbreviated version of the background for the working
group, what is the charge for the research recommendations? So the charge was that they
were to be aimed at technologies are delivery strategies that are effective, accessible
and affordable to those who want and need them. They are to take advantage of the current
and evolving technologies and healthcare delivery models, to consider innovative and creative
solutions with potential for implementation, this should reflect the current demographics
and varying socioeconomic capacities of this country and they should be practical and feasible
undertakings for the near future so, you want research. From a list of more than 70 recommendations
and there were a lot of recommendations, the working group members selected their highest
priority in terms of importance and feasibility. They were organized into 10 different areas
for the interest of time I will give you a couple of examples from these but you can
just read that for yourself to get a sense for how we have separated them. These are
the research recommendations now. One of the overarching research recommendations was we
better need to document the benefits of hearing healthcare beyond hearing, speech and noise.
We need to understand the benefits of hearing healthcare for general health, economic health,
lifestyle, well-being and family. We better need to understand the hearing healthcare
system variables, and we also need to understand the patients and their variables including
the unique needs and concerns across a patient's lifespan. This includes value, socioeconomic
status, attitudes, stigma, culture. For screen we need to evaluate the barriers to hearing
screening, to determine the best screening methods, sensitivity specificity, follow-up
rates and we need to develop accessible screening paradigms using emerging technologies considering
the target populations.
For assessment we need to determine the quality and accuracy of audio on the tree in different
healthcare settings using different means of delivery using in person, the Internet,
determine the necessary components of assessment batteries to guide the fitting of hearing
aids and other interventions as evidenced by impact on outcome. Beyond auditory, including
cognitive and psychosocial. Under here in a technologies, we need to identify the technology
variables that influence penetration and utilization rates. We need to identify the minimal technologies
that will achieve success and we need to compare various technologies for various populations
. Low-cost, one-size-fits-all versus high-cost. For the patient variables, we need to identify
patient variables that predict success we need to know the factors that influence need
and motivation I would need to better understand the characteristics of those that will benefit
from hearing aids or other interventions we need to develop better outcome measures as
standards of outcome measures to discuss hearing healthcare knowing how and when to measure
those outcomes as needed. And for aftercare needs for various service delivery models
we need to better understand the information, patient education necessary and the effect
that will have a benefit and outcomesoutcomes. Under delivery systems we need to utilize
innovative healthcare delivery systems and models for hearing healthcare and we need
to modify our current models, both the system and provider, to increase access and affordability.
And workforce and training of hearing healthcare providers for all of these changes. Different
models, we need to know the skills, the abilities of professionals and others providing
human health care whether they are in a traditional or nontraditional study. Finally under medical
evaluation and regulatory issues of course there was a lot of discussion on FDA. FDA
also served on this panel, I want to say . Do FDA regulations provide protection for patients
or do they create a barrier for access delaying necessary intervention. There were several
specific areas of evidence needed including the ability of consumers to detect treatable
hearing loss. Following the working group NIDCD widely distributed the working group
, on the website. We published an open access editorial which has all of the research recommendations
and references. We also published an article in ASHA's newsletter for a different audience
public from 2009 the present NIDCD has been encouraging research initiatives for grant
applications trying to engage a larger research community in these efforts. Five used both
traditional and unique NIH funding you can his arms. This is a listing of some of -- we
call them funding opportunity announcement that we have had to encourage grant of locations
to help us go after these questions and receive answers. We've had one, for research in hearing
healthcare which is very broad and covered almost the entire gamut of research recommendations.
That had support for phased research grants that allow an exploratory developmental pilot
phase, we've had funding announcements for grant applications dealing specifically with
determining outcome measures, for small business innovative research grants designed to lead
to commercialization of new technologies, we also crossed into health services research.
Without a follow-up working group on that, we have a program announcement out on that
and I would also say that many NIDCD staff have been involved in these activities both
program develop reviewers to review grant applications but the truth is this is a village
all of these cause for grant applications only matter if
scientists and the community believe questions are important and they are willing to take
their time and energy to submit grant applications and go through the peer review process and
receive NIH funding.
Very quickly I will give you a listing of some titles of a few of the grants that
have been funded so you can get a feel for the types of research that we currently are
funding that are directly related to this particular call for grants. The first one
is comparing the effectiveness of basic and premium level hearing aids. We don't really
have data about full feature versus low feature hearing aids. Minimal technologies for hearing
aid success in elderly adults. We have a clinical trial looking at the efficacy of a low-cost
hearing aid and a comparison of service delivery models. Best practices versus an over-the-counter
simulation.We have an application looking at whether consumers and audiologists can
detect your disease prior to hearing aid use trying to acquire evidence relevant to the
FDA required medical evaluation. We have a grant looking at disparities in access on
the US-Mexico border we heard about yesterday, the next two, user centered control of the
hearing aid signal processing and improving amplification outcomes in noise by self-directed
hearing aid, basically using smartphones and allow the user to make a adjustment and noise
in fitting to see if they have better outcomes. These next three -- next four are are dealing
with screening for hearing loss. Each is slightly different one is in a primary care setting,
the principal investigator on that, one is using a community-based centrist , one is
using a telephone screening test and one is using a mobile platform. Which one is going
after a different audience in a different environment? What are the challenges and opportunities?
As I said, you have to have a cadre of researchers who are interested in these questions and
believe in the importance of these questions and grant applications. We have a limited
pool of clinician researchers in the audiology otolaryngology world. We also have had heretofore
really limited interest in hearing loss research among other relevant professions. Gerontology,
primary care, family medicine, outcomes, health services, we have also had limited community
participation and research. This is research conducted in communities outside an academic
Medical Center in partnership with researchers. This workshop is a real opportunity to encourage
engagement of the larger research community in this endeavor. These research recommendations
remain timely and important, they require an interaction and collaboration among many
different players and multidisciplinary teams are needed. The reality is, it is challenging
to build during tight funding times but we have been able to do so. Hearing healthcare
research is a priority research area at NIDCD. Our Senate report language for 2013 appropriations
says, the committee strongly urges NIDCD to report research grants that could lead to
less expensive hearing aids, so such aids can become accessible and affordable to more
people. There is strong support for hearing healthcare research from NIDCD leadership,
staff and advisory Council. You can see slowly but surely, our grants portfolio is growing
and we hope to see this continue to grow over the next couple of years. I want to thank
the IOM planning committee for having us on the agenda, I want to acknowledge Judy and
Lou for all of their efforts and now I am done. Thank you.
[applause]
I would challenge any other health condition to have as clear a roadmap to research as
NIDCD has provided us. We have about 10 minutes for questions for the panel. If you would
come up and state your name and affiliation and the individual to whom you are directing
the question.
I am Juliette Sterken audiologist I am in private practice in Oshkosh Wisconsin. I think
that any solution that we are going to come up with, I have said this many times before,
is with my patients what I would've called low-tech technology, basic technology, with
a client who either uses wireless technology in the home for TV or a hearing loop or seat
loop, a church that is looped, at house of worship, a loop in the community place where
they meet for events or lectures will greatly satisfy the needs of clients. And makes my
patients very happy. I have experience in doing this and I think that any new technology
at the moment has to offer a Telecoil in the device so the client can access these hearing
loop systems in places where we know hearing aids fail. Hearing aids fail to deliver in
public places and my clients come in saying I want to hear so it's maybe more a statement
than a question but certainly I think the Telecoil is something that needs to be researched.
Comments from anyone on the panel?
I would just say that even though the workshop sounded hearing aid center, we tried as often
as we could to include other technologies to ensure the questions are related to multiple
technologies to give benefit and improve outcomes not just hearing aids.
I think think in Amy's talk there was a statement that there is an assumption that the most
expensive technology is always the best technology. I think I had -- that has been mentioned several
times here and that is an issue we try to deal with in the research recommendations
to do comparative effectiveness research and really answer the question about what is the
appropriate technology for a particular patient and we have heard a lot about needs assessment
and that is clearly needed.
Just to follow-up I have clients who walk through the house with a neck loop and system
to hear television five hours a day, six hours a day so for a lots of our clients just a
television solution will greatly enhance their quality of life. No doubt about it.
Thank you, Juliet.
David Bergeron, hearing partnership. I would like to express my gratitude and how happy
I am that the NIDCD has prioritized funding for community health worker research in the
hearing healthcare system. We talked a lot about this yesterday but I want to share one
statistic I think will help -underscore the opportunity.Several years ago, I can provide
a reference, I forget what agency did a census of how many community health workers , working
in the United States. Under scores of different job titles about 120,000 -- 120,000 but not
in hearing health. I think there is a big opportunity here. It is hard to imagine there
could be so many people involved in this way throughout the healthcare system and they
are not delivering high-value. Productivity. I think it is a big opportunity and I am very
grateful to NIDCD for recognizing it. Thanks.
I think we had an interesting presentation on that yesterday. Thank you.
Mary Hart commission with deaf, deaf blind and hard of hearing. We are a non- cabinet
state agency that advocates for and with people that are deaf, deaf blind and we do public
policy and are very interested and excited to be here. I also want to reinforce actually
in Minnesota we have deaf community health workers and one of the leaders of the movement
who provides committee health worker services in American sign language, we were able to
get to Robert wood Johnson award for community health leader. There is that innovative work
going on it has really made a difference in healthcare delivery in our state. I just wanted
to follow-up using evidence -based research to influence public policy and Mr. Hoffman
you were talking about the 2020 health initiative and sharing that data. I have to quickly go
online to look in Minnesota and we are not tracking that. We have priorities set in injury,
violence, cancer, heart disease, arthritis, stroke, oral health and obesity and those
are the priorities for 2020. How does that filter down? I have the national Board on
there but if Minnesota doesn't recognize age related hearing loss not being a public health
priority, curious?
Unfortunately I can answer that it is made available widely in the regional form, it
may be, I am speculating, that we just reached a little bit beyond what people were able
to absorb. There are 42 topic areas and you saw the number labeled brand-new and each
one was very complicated. Actually what we hope is 2030, maybe we can do that. We also
made it a little more complicated that we included other things besides adhering which
we thought were very important. Tinnitus which had not been included before but certainly
one of the clues we had was to be able to include things about vestibular dizziness
issues which I did not talk about. The issue was really with the gerontology group it turns
out they were [indiscernible] we were very can't -- cover
has been can imagine why wouldn't be included but obviously isn't.
Keep it on the agenda will you?
I just want to echo the need for the community-based research partnerships but one of the struggles
we have run into it is one thing to do comparability research on the equipment where I think it
has more of a controlled environment. When you move your research into a clinical setting
now what we ran into is major barriers not only between the time elements in the clinics
and the difficulties they have even if they want to participate in some of the research
when they are ending up in many of the changes that are going on in the healthcare field
now but also the barriers we have one we really want to do efficacy based kinds of things
we want to say it is not unreal, you want to do it in the real world, have a look real
so this will work in a normal setting because what you end up with is running into barriers
with HIPAA and barriers with CHR requirements and so forth. And so if you can't get access
or do something that is feasible and you don't have the money to have your own research staff
in a setting it really does create issues around making your research as effective,
or to work as well as you can to get the cooperation. I don't know how support for some of those
issues or how we can work around some of those issues so we can do some of the comparability
research and people will listen to the data.
Thank you that's a very good point and I will just begin the discussion with the use of
practice -based research networks which is becoming more and more of a direction, things
are going and I think the people on my right and left can speak more about it. Perhaps
Amy can talk about [indiscernible] and you can talk about what is going on in the VA
VA.
Correct. The practice -based networks basically this, for those who don't know that term,
it is where you have a group of practitioners that come together, they agree to participate
in research, they try to use similar processes for IRB, etc. to streamline the research process.
You may have a pool of them that agree to participate and different studies, different
practices will participate in different studies depending on the patient population what is
being studied. We have one called creating health excellence through research which is
at Duke clinical research Institute and it is otolaryngology private practice. We also
have a research grant that we just funded under this successful portal being done with
a primary care practice -based setting in Michigan. Some of them are out there trying
to piggyback on one that currently exist they are expensive to support and infrastructure
support is what you are talking about, is important but very expensive so it is one
of the struggles all of the research community has and NIH has, as a whole, to provide an
infrastructure making it easy for those who want to do research efficiently and quickly
so it doesn't become a burden.
Lou may want to --
I think the VA is an agency which faces very much the issues you are talking about in terms
of how do we actually deliver care and how to we study that. There is a research community
call the health services research community that is very -- a lot of funding devoted to
the community in the VA and probably many of the health services researchers known
throughout the country have been funded in the VA. We have a very strong infrastructure
and support network that looks at exactly what you are saying and that is the context
of service delivery. I think that is a lot of the reason where we will do these wonderful
evaluations in the labs and clinics and we see these amazing outcomes, really
real improvements and you move it out to the general health services delivery area and
you see failures. It is really the context within the service and I think the discussion
we have had the past two days with the confusion there is right now in this country about where
do you go to get services and what is your point of entry, where you start and what is
the flow is an area that really needs a lot of attention as we think about that. The other
important thing about health services research is you are trained differently your learn
to ask questions a different way, more survey data, you do quality improvement research
so your statistics, even the kind of statistics you use and the way you inform a service delivery
system is very, very different and also tends to be more interdisciplinary. We talk about
muscle -- multidisciplinary and interdisciplinary . We talked the past couple days about how
we are trying to move particularly for chronic conditions, we are trying to move to a patient
centered care or patient medical home environment which is of course it started in the UK, May
have started elsewhere but that was a chronic disease model. Let's get the right providers
and it is not the physicians, it is physician, the nurse,
the social worker, the community service workers, it is the model of a team working in an interdisciplinary
fashion because the goal is the patient goal. Not the audiology goal, not the EENT goal,
not the primary care goal. I think that is the culture shift or paradigm shift you are
trying to do when you get services into a clinic.
>>[Captioners Transitioning]
These join me and thanking the Trevor panel.
[ Applause ]
Some speaker left a hearing aid battery up here on the podium. It is the size of mine.
[ Laughter ] >> We are moving into the next panel so if you can please take your seats
and the speakers please,.
-- come up. >> All right we are going to get started.
I am Jennifer men -- Jim Furman one of the reasons I was excited that I think the issue
of hearing loss and all and -- in older adults may be reaching a tipping point. This the
time whether that is true. We are very much indebted to Institute of Medicine and all
of the partners for convening. In about one hour and 30 min. the IOM will come to an and.
The question for us, having come together and heard the German this information. What
are we going to do about it?
Is there a way that those of us in the room believe there is enough of issue and opportunity
and a will to get things done.
As we do this we will here -- heard this discussion as a public health issue, as a health issue
affecting medical issues, affecting older adults. An issue affecting consumers. So we
are probably having three outstanding experts. Virginia database -- Regina Davis, James Pacala,
and Charolotte Yeh.
Representing the big boys, the big organizations from those three fields. But we will try something
because this an official IOM session, the goal of this session really for all of this
-- I will pose this to the three presenters. There are lots of things we have talked about,
lots of priorities, if you can do was in -- 1,2 or 3, what is the most important thing for
collective action? Collectively that we may do?
After we hear from the speakers, you all will get the opportunity as well, to tell us quickly
of all of the things that we could do, what is the most important thing that we can do
to gather that will not get done otherwise? Excel right the process of communication,
one of the challenges of communication is one pertinent talk -- we will bar a technique
from occupy Wall Street. [ Laughter ] . That is twinkling, if somebody says something that
you agree with, you get to twinkle. [ Laughter ]. If you like get a little bit go like this,
a lot, like that. If you have concerns you go like this. Spirit -- you can do this when
the speakers are talking, -- the idea you talk about universal design and communication.
We used to have a fancy dialogue things. -- Dialogue things. -- Dial up things.
How do you feel about twinkling? [ Laughter ]. Regina Davis.
It is a pleasure to be here, I was not able to attend yesterday session, some of the comments
may be redundant. I want to tell you about the American public health association, oldest
and largest organization of public health professionals in the world been around for
140 years. We service umbrella organization for public health professions that represented
every sector of society. We protect the health of all Americans from serious and preventable
health threats, also seek to ensure there is access to universal services. With that
the issue of hearing loss is no different in terms of the issues that we have identified
as very important.
Public health implications of hearing loss go beyond the immediate threat to the individual,
hearing loss is think two things like isolation, -- to things like isolation, depression, leading
to other public health and safety issues. It is important that we address them at the
primary levels. Unfortunately, we know that Americans are seeking treatment and interventions
of the time when it is too late or not able to communicate. Also this is not just a US
issue, we see this worldwide. With that we have several scientifically-based policies,
on the books, from which we not only guide our work but official stance on particular
issues.
Specifically a PHA -- APHA. I will talk about these and will come back during the discussion.
Specifically advocate for early and cost-effective screening programs for at-risk populations.
Careful evaluation and treatment, public education about conditions, warning signs and importance
of each seeking treatment. -- And the importance of seeking treatment. All so the awareness
can lead to opportunities to employee measures such as hearing protections, opportunity to
educate individuals about taking the precautions now. When we think about not just these particular
populations but younger populations.
Through the headphones on all the other things that they expose themselves to, these will
continue to be issues. These are things that we are constantly advocating for not just
for this operation and for others, as a public health is a community based approach, you
-- use the various settings for the populations. In addition to the primary care physician
office and a cute care settings. Also making use of places of worship, community based
programs, retirement communities amongst others. We also say that the the things we continue
to do as we have a broad advocacy platform, continue to promote the need for research
to address things such as whether -- whether a particular stance on where we should begin
screening for asymptomatic individuals? Know that this affects a broad base of individuals
and using that to identify partners that can be involved in this.
I will stop there and I will come back to the conversation is that -- as a composition
continues.
-- As the conversation to continues.
And want to be thinking the IOM for asking me to speak. I want to briefly introduce myself
but are start by saying I am not and expert on hearing loss. What I am a primary care
physician and a geriatrician. I oversee a large family medicine department in the country,
University of Minnesota. We have four primary declare -- care clinics and underserved areas.
We are one of the players in training primary care workforce.
I have done American -- work with the American geriatric Society, an organization of about
6000 older adults health care workers. I can give you my perspective as a geriatrician
from my standpoint . The main point I want to me, it has been made over and over again,
the different ways of attacking the problem of hearing loss. There have been two made
ways, one from the healthcare standpoint that would be from medicine and public health.
The other one is from a tech or environmental standpoint . Those two fundamental ways of
approaching the problem we need to come together. That is the main point I want to make.
I will get backed -- back to that at the end of my comments. I am a doctor, I will speak
a little bit about own personal challenges and observations from approaching the problem
from a medical standpoint. Let me describe to you some of the hurdles that I see at least
from a medical standpoint of trying to approach this problem in a primary care setting.
I will tell you about the setting of my own personal practice and self many Annapolis
underserved community, busy clinic, we are training residents, training mental health
workers and pharmacist at the same clinic. Family medicine department in an era of poor
compensation. For primary care sources we struggle to remain viable, the average age
of my patients in the clinic is about 85. And they are frail . On average I usually
through the course of one half-day I will use three different interpreters, and I do
not speak any of the other languages.
It is a challenging setting to deliver care. Giving the setting, I see at least six hurdles
and I will briefly describe all six six hurdles and I will briefly describe all 62 the approach
of appropriate approach to care for hearing loss, the first is structural. This is something
that Dr. Burkhart touchable, we have a system in medicine where everything is off -- predicated
on the visit, on my seeing the patient. Nothing can go on when I do not see the patient, it
has to happen when I see the patient, compensation and so forth. That is a bad way to set up
ethical care because of course was the stuff that happens to patients is when they do not
see me.
The second is the era of evidence-based medicine, this is unintended consequence, we have gone
at some times at least two extremes, that we go sometimes two extremes, we demand that
something works. Many things we do in medicine there is no evidence. There is no evidence
if I put my stethoscope on Charlotte chest that as evidence that something is going on.
We do this, right? Patients expect that. We get handcuffed into the evidence-based medicine
and the funding that ties in, it hampers the ability to forward important endeavors.
The next one is a problem I called the tearing the of a cute. That was coined by Todd Bodenheimer
at UCSF. When you try to get evidence-based proper prevention and chronic disease management,
featuring EFD acute they have a need any spend all their time doing that the problem. There
is no time everything has to happen in the visit. Nothing outside of data visit. Tyranny
of the acute. There two more tearing these, tyranny, which is the chronic illness. When
I started in family medicine and I took care patients with diabetes . The check up involve
looking at a few numbers that the patient wrote down and adjusted the dosage of the
insulin and regular insulin and I was finished. If I see somebody with diabetes there are
15 things that have to happen. They are good. Not bad. Provide better care.
It is a lot to do, when I see somebody who has diabetes, they have acute need and I just
the need and deal with the diabetes, oh yes -- maybe I should check them for hearing loss
too? I cannot deliver to do all of those things. The last one is the tearing a -- tyranny of
prevention and health maintenance. There is a lot of stuff to do. Duke in 20,000 -- 2003,
look at all of the different preventive activities that somebody had to do and standardized it
to a standard family medicine practice. 7.4 hours per day if you did everything that you
are supposed to be doing with your patients. Would be spent on prevention and health maintenance.
Obviously back -- that is an awful burden.
The annual off dust wellness -- the annual wellness visit, let me tell you follow me
around, there is a lot to be done and one of these. It is not easy to accomplish. I
do not speak out against this, it is a challenge when all of the other tearing a -- tyranny
goes on to accomplish this in one visit. The last burden, hearing loss is neglected in
medical education and training. Inset -- residency you mention heart failure you have a warm
fuzzy. I know about this, if somebody mentioned incontinence or a fall, or self-neglect, any
of the geriatric syndromes. Or hearing loss, driving problems, you wring your hands little
bit and fuss and stare at your toes. Let's talk about the heart failure. That is another
burden that we need to approach in education and training.
I came up with solutions. My first comment is that doctors and medical approach alone
given all of the tearing a -- Tierney I talked about will not solve the problem.
Not everybody is Tom Powers. He gave a nice presentation yesterday but he is the exception.
Not is everybody is clued in as he is. We cannot clone Tom and expect medicine to take
care of it. Have to change the equation. I suggest three ways of changing the equation.
Big-ticket items that I do not think you have any problem with.
We need to advocate for better health policy to remove the barriers that need to be removed
to facilitate that are care for hearing -- better care for hearing loss. The structure barrios
-- barriers care is provided an organized around medical visits. We need to get away
from the Andy ACA and patient center homes and ACO are moving in that direction. We have
a long way to go. We need to remove the financial barriers, primarily the financial burden of
hearing assistive technologies and hearing aids.
That is number 1.
Number 2 is awareness. We need to education -- educate the population and the workforce.
The health and aging foundation you can find this and, health and aging.org designed as
a research for patients and caregivers. Aging and health 8-see -- A-Z webpage that you can
use. There is a site to ask what you can ask your care provider? There is a whole set of
pages for caregivers. At the AGS website. There are sections for the caregivers on hearing
nice -- hearing loss and communication techniques.
Number 3, we need action and research, better research, how to partner medicine, public
health and technology to come together to really create a better environment and ways
of looking at this problem. More research and funded people at Dr. Frank Lin and Albert
and other folks who are looking into the problem for a variety of different perspectives. We
delineated very well research gaps . Finally we need research and implementation. The kind
of things that [ Indiscernible ] are doing and lots of other folks. We implement these
things to provide help for older adults. Thank you very much for your attention.
I will turn this over to Charlotte., Dutch --
I want to piggyback on what my panelists have said and share my thoughts. I want to be clear
even though I am a physician for the will ARP -- AARP, I were would have percent -- I
wear 100% of the has of the consumer. I have listened carefully yesterday and today. After
hearing such a phenomenal presentation and thank you to all of you who have put this
together. It is a great learning experience for me. When I sit back and I think about
the take away from this. I am looking at it through the lens of chief medical officer
of AARP we service 37 million members in this country.
We have products and services that we offer to the 50+ that come close to $1 billion per
year. My job very small is improve the experience of the care for the 50+. A small job. The
second rule that I have I am an emergency physician when I hear about the alerts -- my
life is centered about preparedness. Wayne you work in the ER department you see what
happens to the failure of communication. And miscommunication, and the challenges of the
physician of trying to communicate in a busy loud noisy ER department the kind of instructions
for care and follow-up care.
It is very personal because my father who spent 15 years with progressing hearing loss
the classic hearing loss, could not or did not think he needed anything. And finally
he got his hearing aides and all of a sudden, he was not shuffling, he was walking with
confidence. He was not bent over, he was animated, telling jokes he was not quiet, he was part
of the family and he was telling jokes, laughing and enjoying his children and grandchildren
and away I have not seen since I was a child. As you can tell, a lot of really personal
thoughts and passion that this vision of what we can do with hearing and hearing loss can
bring. Spirit what --
When I think about this I have three messages underneath. I major take away for all of us
involved with the you the audiologist, patient, public health, researcher etc. we have to
change the conversation. We need to change the conversation because it is about consumer
and consumer engagement. The rest of health care is already pursuing consumer engagement,
motivation etc. it is time for the hearing community to also face this. What we really
want to do is change the conversation not only about what hearing loss is and means
to the average consumer? What we demand of the industry and research? We can get the
change that we are asking for. Script when I taught --
When I talk about change in the conversation there are three components. Change the conversation
about the heart and mind of the consumer, the person. The second one, talk about it
as a continuum not a on/off switch. The third is affordability not just money, but time
effort and convenience.
Hearts and minds. Consumer retail does this well, who wants the new fancy shoe, a better
car? Because retail knows how to grab the hearts and minds. If we want to follow that
and have the hearing test and understand the importance of the hearing, we cannot talk
about it as a hearing loss. It is more about what you gain from social interaction? Family
connections? Productivity at work? It is about gaining not a loss, it is lifestyle and how
you can live better. Not a standalone disability, it is integral to everything that we do every
single day.
That is what I hear is how important hearing is to that component, why do I think we have
not talked -- tap into the optimism? We did a study one of the things we have as the AARP
is the supplemental health plan. Can we do a study and take a look at quality of life
issues, not just health but quality of life? Hearing loss has a greater impact of the quality
of life than diabetes, heart disease, coronary artery, hypertension or any other medical
condition. Like you say, medical students we do not talk about the quality of life.
What is fascinating, we have all of the airwaves that are covered with diabetes, obesity, 30%
of the population. 2/thirds have hearing loss.
AARP in conjunction with the American speech and language and hearing association did a
survey in 2011 of 50+ population to get some attitudes about hearing and hearing loss.
What was fascinating is 85% -- said that hearing was very important to the quality of life.
76% said it is personally important to me in my life. 68% well over 50%, we are not
paying attention to hearing loss has an important health care concern.
You have a population who wants to talk about it and we are not capturing it. 43% said they
had a hearing test. 88% in the last five years had a vision test, 71% had a flu shot, but
58% more people have had colonoscopy that hearing tests. What is wrong with the prevention?
The other interesting thing, we hear a lot about a stigma. People do not want to have
a hearing aid, it is time to blow this away, in the survey it shows 64% said that they
do not think that hearing loss -- hearing aids that you are getting old . 66% said it
really did not matter they disagree. 71% did not worry about whether other people saw them
with a hearing aid. The paradigm shifting and we need to be there.
What would make them get a few hearing test? 68% would say it was hurting the relationship
with my family. 59% said if it is a burden on my family if I were to become a burden.
AARP research, to most -- the top three things on people's minds, care about connectivity,
relationship with others, when you are 100 years old that is what matters the most . The
second is not being a burden on your family, the third is the brain fitness and stimulation
to the brain. It seems to me you are a -- in a wonderful opportunity, that efficient we
want to have a good life and time for what is next in our life and what is possible?
The hearing committee is in a wonderful place to be this begin to say it is not about laws
about gain.
That is the first message we have to change and get upbeat. Not a negative thing.
The second piece, continue him we all -- we talk about hearing loss or do not. Hearing
aid or not. I think what I heard and what resonated with me, it is all so a continuum
of acceptance. Should we be talking about where you are on the stage of acceptance?
And the products and capabilities and how do we help people adjust and move through
the continue him? -- Continue him? -- We talk about hearing as a lifestyle and across the
spectrum of actual hearing loss but where you are in your life, stage of life and activities
that you do. About behavior change, motivational, patient activation, readiness to change, those
are things we talk about in healthcare we should talk about them and hearing loss as
well . And the last category is changing the composition. It is covers, reimbursement,
it gets paid for by others.
I want to say it is not just about money, also resonates for me. Respect for the time
and convenience of the consumer. If you have to go back multiple times for readjustments,
what do we do with the technology to make it easier see can do it from home? By father
once he got his hearing aid, he went through adjustments, for several weeks, it was two
hours to get the audiologist and he lives in a major metropolitan city in Pittsburgh.
The time, convenience, the conversation, helping you make this self adjusting? Self-care and
so forth to make it easier. The other form of affordability is that not just time, and
money, also the effort of hearing. Are heard loud and clear when there is lots of noise
how you cannot have a conversation.
What can we do to reduce the effort? Improve the time management? And the dollars? If we
can get the research to do this, we can do the health policy changes to do this, I think
we can bring in the consumers to help move the industry. What I would buy to say, this
is the baby boomer generation, they are coming. I thought was also really interesting, the
AARP, 70% of people who said they have excellent hearing, 50+ an older, also thought they were
younger than her stated age. Can you talk about a motivator for the baby boomers? We
are the ones that brought civil rights, put a man I need mood, rock 'n roll, we brought
Woodstock. If this is not a generation that can bring about the change, I do not know
what else is? I think that we can do it.
[ Applause ] >> So what I would like to ask you, we have heard this now, we will come
out of the conference and hopefully, we'll get together and do something. If you could
wave a magic wand or set the agenda and say, if we were to do one thing to gather -- as
a group. What would it be?
If you can do two things, what would it be?, -- come up, Maybe I will start to get the
ball rolling. We really have to tie this issue to the things that really matter, I think
Charlotte talked about one that matters to people which is fundamentally the quality
of their lives . In a compelling way, I think that will matter to policy may best makers,
it is contribution. The extent that people with hearing loss are really not working or
working fewer years or less on average not volunteering, helping in the family. That
to me has a higher probability of being persuasive case, one of my wishes would be that we really
try to look at figure out if we can make the connection and the way that I think would
attract policymakers.
My second one, if 40% of people over the age of 65 and 70% over 85 we need to direct this
through a universal design. There is no point in saying, everybody in the room has a hearing
problem, we have to have a loop in technology here we have to realize if you talk about
population, senior centers, retirement community, the majority of people having the issue we
need to do things like we have done on close captioning for TV we need to address this
as a -- take a vantage of the public universal design solution. I went to a animated cartoon
and I swear I could read the lips of the cartoon characters. Somebody figured out how to do
that through technology.
What are your ideas? We want to hear from as many as possible in the next 20 min.
I could wave my magic wand. My name is Wen Chen. We support research in the public communication
related to healthy aging in older adults, within my program we have a portfolio on audiology
and support research through hearing loss. A lot of heat -- issues we have been discussing
in the last two days, after hearing a lot of the issues been discussed, one thing that
resonates with me through my experience. We could do better in terms of communication.
The message to the general older adult community. Especially related to hearing loss and what
kinds of devices and hearing aids that would be helpful for them. It is really astounded
to see many choices that are available, but not clear to me which ones are really good
for were kind of older adults and hearing loss. I wonder if those of the things that
we can get better clarification on? And also there is some terminology that could be confusing
to people who are not audiologists or hearing experts. For XM -- for example telecoil, if
we put this in terms of noise cancellation device, that may be helpful. Almost everybody
are heard in terms of complaining about the hearing loss, in the older adult population,
I cannot here in -- hear in noisy environments. Does a hearing eight help me?
Hearing aid help me?
There are devices available, the terms of the devices are not very clear. Or intuitive.
Those are things they should ask for, certainly as a research funding agency, we are more
than willing to partner with other relevant organizations in the area of research. Spirit
--
Collective action around communication, changing conversations, awareness of the problem and
solution.
I know within NIA we have the office of public communication, I will go back home and work
with, how to enhance this area of communication. I am open to hear all of the recommendations
from we are part of the sponsors for the workshop. We are very interested in hearing the outcomes
of the workshop at the end. I want to bring up the awareness from the topic and want to
make that clear to everybody.
We want you try to get as many people and ideas out as possible.
James Appleby. Picking up on those comments, the two areas I suggest we collectively try
to get after. One comes down to the research base. Generating the research necessary to
demonstrate this intervention has value not only improving health outcomes and perhaps
turning around some trajectory of some patients lives from also getting out the impact to
what you were saying about the economic benefit of the activity in terms of how it changes
with the older adults, they engage in the impact down the line. And getting -- back
to the stigma. I really want to believe the data from the AARP. So much flies in the face
of what we see day in and day out. It encourages me that perhaps we can make efforts to try
to as you say -- change the conversation or reframe the conversation. To get smokers to
rethink about being around for Mike grandchildren so let's think about the -- per has to can
look at the reframing process and figure out how to change the conversation . So indeed
people are not afraid to talk about this and willing to engage and tried to -- taking proactive
change -- steps around their own issues of hearing loss.
Reframing the conversations that may be very relevant for this issue.
I support thought -- fats. -- that. Can I live successfully with hearing loss and stay
young and sexy and relevant and stay in the workforce? Is the message all of us coming
out of the conference should start talking about in terms of reframing the conversation.
The fact there are many ways to live successfully with hearing loss including all of the technology
options that we talked about. Coming together around these things would be really helpful.
I guess my first which -- wish, hearing healthcare would be essential health benefit. The secondary
one would be -- for the FDA to push a little harder in the honesty and advertisement only
district of innovation that I know of noise reduction and in the hearing aid is creative
micro strategies put we are inundated with the improvements and noise ratio in artificial
environments that do not really help the patient.
Thank you.
The major issue the first major issue that is helpful to come out of the conference is
something that you talked about. Affordability issue. That requires basically one of the
things that is important -- requires some sort of dramatic change to the FDA rules.
FDA rules unfortunately there is a tremendous amount of players involved in this. There
is a way to change the rules so it works out for a win-win for consumers and companies.
Hearing aid companies, manufacturers and everything else, it will be difficult, but that I would
like to see, some sort of other kind of meeting which would focus specifically on the rules.
Empowering all of the companies and players to be able to make affordable solutions. The
second thing that I think would be helpful, with a striking and as a conversation I had
with Dr. Frank Lin privately, all of the hearing loss despite the fact everybody that we know
has been impacted negatively by hearing loss because even if we John have it ourselves
we have relatives, it is not high up on the agenda. Looking at this, we have to -- we
have a marketing problem. More sophisticated way of looking at this, somehow or another,
another thing that should come out of the conference, a way of raising the profile of
how serious this condition is? How essential it is to our lives works in the notion of
quality of life also any larger notion.
Thank you.
I would like to see us reframe the focus of the hearing healthcare delivery system with
the patient at the center of the audiological assessment. Audiologist have to remember that
people are coming to them because they have difficulties in certain areas. They must leave
your office was solutions. If a person on the readiness continue them, -- they may not
be ready for a $6000 hearing aid they may only having problems with the television or
telephone, give them a deep ice . To be paid you need a personal sound amplifier? Working
with the policy people to work this into -- we have to make sure audiologist listen to the
patient, patient comes in for a solution and leaves with a solution.
My feeling is a little bit like what Richard said. Engaging the hearing population as well
as the hearing loss population. They need to understand this is not a universal problem
but close to it. Part of that I think is making hearing aid's as I said in my talk yesterday,
as affordable and adequate is and effective as wearing glasses. This massive technology
that we deal with, needs to come down to make something that will allow us to hear and go
out and be normal people in the world like everybody else. Just like wearing glasses.
It is also complicated, a lot of us feel like we have an unusual and embarrassing condition
that we need to keep to ourselves.
My name is Stephen Barnett . I am a family physician. At the University of Rochester.
Two things I did not hear clearly during the two days I would like to be a part of the
conversation. The first I think that very Chiswick asked this question, now that I have
hearing loss what else should I be concerned about? There are cross-sectional studies that
suggest socialism, do we change this careening? Lower risk for certain things? I do not hear
a lot about, surveillance that is more meaningful for making decisions from the standard HHS
question on the hearing loss is not helpful, the NIDCD questions have more meaningful information.
The one piece I have not seen it, since 1991, the duration and whether it is a cognitive
load issue? Or duration was stress issue? Opportunity to adjust box knowing how long
someone has had the hearing loss, will help us understand the data. So surveillance and
broader look at healthy aging.
I have to preface this by saying, I've been married to a wonderful man for 25 years, does
not wear his hearing aides as often as he should. My colleague in the audience for a
laugh if he hears the story again because he saw this clearly one day. A couple of weeks
ago my husband and I were watching television and an ad came on talking about asthma. The
woman is sitting in the couch in the living room, if you've seen this, twinkle? She talks
about how her asthma does not affect her life.
Okay does not have that much of an impact. All of a sudden they show her husband walking
into the room, he makes a comment about, don't you remember the trip we had to stop and go
to the ER? Each of her children walk into the room, mom this scares me when you cannot
breathe? Her boss is shown, Charlotte you missed a couple of meetings last month all
of a sudden these other characters come into, you have to be careful not to be punitive.
When you send the message, my husband turned to me and said, wow. That is what you tell
me about my hearing loss.
It was the moment -- yes this is what I've been trying to tell you, you misunderstood,
you talk about miscommunication and lost hearing, your 18-year-old son, that is not a good thing
sometimes. Misinterpretation of the conversation. Somehow getting the message it is not just
you that is affected when you have hearing loss, your committee is defective. If we can
have somehow -- unbiased message on this, it would be very helpful. Speed up --
If my wife for her she would volunteer.
I thank you for the wise recommendation for universal re--- universal design. I am Valerie
Fletcher. I have heard of more of vignettes of success in the last two days than ever
before. In many cases they are about collaborative efforts with the patient and clinician, and
people who understand technology. They are great story, very great stories. The one organization
that carried 100 stories or 200 stories of very distinct individual profiles and what
works, go a long way towards eradicating the assumption that nothing works very well.
I echo what other people have said. We think about educational approach which I think is
critical to inform and make people aware, we have to build into that we know hearing
loss is across the life spectrum. And a true focus on prevention and looking at the strong
values to the noise in the environment now. Environments are built to be noisier. That
is a critical problem in general. I also will -- also think we need awareness to be built
into critical types of things, we talk about universal design, there are many ways we can
build facilities that are hearing friendly. We do not intend to do that unless you take
into account maybe putting induction loop when you build it. You do not worrying about
that after the facts, people in architecture do not get this in terms of information. Work
force, I think we need to look at interprofessional kinds of activities and changing the roles
and responsible these and what -- who could do what's in the best way?
I am trying to get through everybody.
I am Alicia, being a healthcare professional who works for some of Dr. Lynn's colleagues,
the long-term goals will be long-term goals I would like to put a plug in for a short-term
recommendation . I feel we are on the same page in what we want to do for helping people
and doing the best that we can and getting to the end state the we need to communicate
with the general practitioners more so they know what they are asking for. I should ask
my patient, are you smoking? If are you should see your doctor because you should stop. Having
a quick sentence or a plug to say, how was your hearing? That the patient goes well -- at
least you can say, here is a name or website or something that you can do about it. >> It
may not be a reliable test.
I would like to come back to this theme of the workshop which is hearing loss and healthy
aging. My one British we succeed in creating a disconnect between chronologic aging and
biologic aging. There has been a fundamental assumption here, the biology will go wrong
and we will do something about it. I am disappointed we have not spent more time I what we can
do to slow of the biologic aging. Preferably and centrally, we touched upon this a little
bit, what do we do about the noise exposure for example? What do we do about that if people
just slowly turned up the television, training their brain to listen to louder and louder
talking? If we sort of sit in the room and read as "or, sitting in the room listening
to a audio book maybe 20-30% the speed of normal conversation. You do that for the next
10 years what are you doing to train your brain much more? There is a lot more that
we can do to affect the biology of what is happening. And not just a shoe in that is
going wrong. My one wish is disconnect between chronologic aging and biologic aging.
Is this clock accurate? We will take the last -- and then we will turn this over.
A couple of things, one is I understand from the AARP that most baby boomers want to stay
in their homes as they grow older. You cannot stay safe in your home if you do not address
hearing loss, the message has to get out, and helps the health care, wishes of the person
and helps the wishes of the family. Is a strong message we need to send. Secondly I totally
agree with Richard, the FDA regulations are out of date, not in touch with what is going
on in the world today. Not what tech or with society, we need to get a group together and
hit the issue head-on very strongly. And thirdly, I would like the hearing aid manufacturers
to spend more time taking sure that hearing aids work in noise and not selling us a lot
of extra equipment to overcome the fact they do not hear in the noise environments.
I would like to have more clarity on the association between hearing loss and broader outcomes
like some of the psychosocial functional and physical -- there is a lot of great research
showing associations. If we have more information on mechanisms and cause and effect, it will
go along ways. As a physician is able to counsel the patients on their hearing loss, as a public
health professional, evocation for better funding and services for these people. The
second thing I would like to see, but are outcomes, data on the solutions that we have
talked about over the last couple of days. I faint -- think that will go a ways telling
patients what will work for them and advocating on a broader scale. Last thing, I think it
is important to discover or find out who the at-risk population is so we can focus on these
people.
Howard Hoffman. I want to answer partially Dr. Barnett's question. I did not mean to
leave the impression we only collect it or from NISH. We ask in the cross-sectional survey
how long they have had hearing loss? As part of the answer. Really what would like to have
would be longitudinal data, there are some surveys that can accomplish this. Karen is
smiling because she has been doing this for the last two decades.
[ Indiscernible comment or question-not within range of microphone ]
That is very informative data. Difficult to do on a national level, we are trying with
children, department of education in first or second grade. Testing the hearing, this
is never been done in the US, we are trying for the children, there are some adult studies,
and some panel surveys that maintain the panel year after year. That could be very helpful.
Of course we know the benefits of clinical trial, if it can be done. It is a big if,
and being done appropriately.
Diane with high health innovation. Awareness is a big passion of mine, I'm speaking for
years on the topic getting the message out. When Charlotte just spoke a few minutes ago,
she really was talking about turning the positive. I love that because I tend to think -- in
the positive light. What message how are we being perceived as we are giving the message?
As we educating and raise the level of awareness? You want to motivate and make people feel
good, we want to get the message out as far as what are the solutions and how can they
access the proper care? The messaging is really important. Also we learned over the past couple
of days and have known this, there are many people that need hearing testing, I look to
see and hope that more primary care physicians, we'll go ahead and start testing. Testing
the patients, and finally this is probably my biggest hope, we see all of the new delivery
models, access, affordability and learning the details of what affordability means, not
just the cost. We can all work together in harmony, we know there is not just one solution
for all of the patients that need help. >> I'm glad that Sergio was over there. Bill Likins
and. -- Linkenson. At this stage of my life I am revisiting a worthy manufacturer. I am
a local audiologist. I would like to say that I think in the 21 years I have been 15 patients,
running a medical center and hearing aid programs and doing research and teaching students.
This is the most proud moment I had been in audiology when you look around and what makes
us special, the huge diversity that is in this room. From medicine, primary care, clinical
practice, private and public, industry manufacturers etc. devices. All of that is what the common
denominator between all of this -- is why we do what we do. The one thing that everyone
has in common in this room, is the why we choose to got up out of bed in the morning
and do what we do? The what is what defines us. I will hope that you walk out of the room
and we do not fall back into breaking apart and being German by the what, and being driven
by the what .
-- And being driven by the what.
I think I can set down at the last two, I want to share the idea of -- of the identification
of the hearing loss. It is difficult for me to believe in primary care offices, it is
okay you can write a prescription for all of this stuff, I want you to have a colonoscopy
and everything else, I understand time is important for people who see a lot of patients
today. In our institution University of Miami, we inputted with the new EMR system, when
we look at age factor, certain flag show up. All of the primary care they say how was your
hearing? It is okay -- how is your hearing? They have a slide screener, if they fail they
automatically put that into the referral base. It will flag for the audiology. Those patients
are seen or identified, we would like to see this go throughout, as fortis dental care
for everyone -- as far as standard care for everyone. Up to the age of 50 you are supposed
to have certain test on. I think we should do that for the hearing -- this affects our
lives, Charlotte thank you you are 100% correct. Everything negative that hearing done, but
now we turn it into a positive, we are going to identify the laws. Help them -- identify
the loss, help them and turn everything originally negative and affected their lives in a negative
way, and improve its. -- It. The last comment around the FDA, look at the outdated measurements
for implants candidacy. I have two people who sit there on the highest tower and scream
out, hearing aids did not work for me. The implant did. It is not fall under the regular
CI the are now the most happiest people in the world. We need to look at what we are
doing out there.
Let me just say one last comment before I turn this over to the cochair. We have come
together and we do have a shared chance of urgency there is A issue and problem that
matters. We have identified real areas of work in terms of changing the conversation
and awareness. More research, training, education of the professional, policy and. Torii issues.
New technology both for individual and universal design levels. One thing that I know, the
reason this conference happened because we had leadership but we had backbone support.
The IOM organize and put together the meeting and made this possible. If any collection
of action will move, if we're going to move together we will have to solve for the issue
of whose data job is it to provide backbone support the collective impacts? I believe
there is opportunity for collective impact and the things we are talking about can better
do together than on our own. There is a whole to solve for but who do we have to solve for
the support?
A round of applause.
[ Applause ], --
So I will have some very brief finishing comments because it hasn't been -- has been a wonderful
two days. I think the planning -- thank the planning committee.
[ Applause ]
I want to come back briefly in the last one-2 min. to the last slide. They get a and -- again
there are pressures that will change things and this is where we all know we will get
eventually to this point. We want to leave a workshop like this with the tangibles in
mind. What is the plan going forward? We had some brilliant ideas over the last couple
of days. The one reason why I know this workshop has already been a success, but a number of
agencies and organizations that have been here. Are jotted down a list which I find
is stunning.
You can go on and on and on. This is the first time in the history essentially we had a meeting
like this where we have had this many F's -- this many stakeholders in the table. The
conversation has begun, we are much closer to catalyzing the change that much faster.
I will finish up and thank you all for being here.
[ Applause ] >> [ Event Concluded ]