NANCY MACKLIN: Thank you, everyone, for joining us tonight for the presentation of Over-the-Counter
Hearing Aids: Rationale for Support. First I want to thank our captioner this evening,
Cindy Thompson of
Alternative Communication Services.
Thank you very much Cindy.
Tonight we have with us Stephanie Czuhajewski, who has more than two decades of nonprofit
leadership experience,
and is currently the Executive Director of the Academy of Doctors of Audiology also known
as the ADA.
We also have Dr. Alicia Spoor
who is the owner of Designer Audiology here in Maryland and she is the President-Elect
of Academy of Doctors of Audiology and also the legislative chair of the Maryland Academy
of Audiology. Welcome to both of you.
I'm very excited about this webinar tonight.
It is a hot issue right now and we're very glad that hearing loss is finally getting
some media attention and we're finally in a position to do something to help people with mild
to moderate hearing loss get some help so I'll go ahead and let you get started.
>> STEPHANIE CZUHAJEWSKI: Thank you, Nancy.
And thank you, attendees for joining us for this very important conversation.
ADA has actually been thinking about the topic of alternative hearing aid delivery models
for the past 40 years.
And part of the reason for that is because at the time that audiology started dispensing
hearing aids, audiologists were, themselves, an alternative model of hearing aid delivery.
So it's a very interesting dynamic.
ADA has been thinking about this more in earnest certainly over the past three years since
we had the opportunity to sponsor what was then the IOM or the Institute of Medicine
workshop on hearing loss and healthy aging which took place in January of 2014.
So there we heard so many compelling presentations about the gap between the number of people
who could be helped with a hearing aid and the number of people who actually get treatment.
So of course as many of you all know on the line tonight, the statistics are really staggering
and today literally hearing aid adoption rates stand at around 25%.
So hearing aids themselves have improved dramatically over the past several decades yet adoption
hasn't.
So why is that?
In my portion of our time together today, we'll discuss a little bit about the background
and then some of the information that's formed ADA's thinking about the issue of direct to
consumer or over-the-counter hearing aids, the problems and solutions around
affordable, accessible hearing care for adults and the role of those devices
in the hearing health care system.
So just a little bit of background on the history of ADA.
As I mentioned, there was a point where audiologists did not dispense hearing aids.
And really ADA was founded because there was a group of audiologists who were at the time
viewed as quite radical who decided they wanted to dispense hearing aids for profit.
So after a U.S. Supreme Court ruling in 1978 forbidding professional societies from having
codes of ethics that would restrain trade, ASHA actually rescinded ethical guidelines
that were in place at the time that wouldn't allow private audiology practices to dispense
hearing aids for profit So this really allowed the private practice
of audiology to flourish.
And practices grew in the 1980s.
So, too, did the profession in terms of it's qualifications and educational requirements.
In the late '80s it was determined that there really was a need for a clinical doctorate
degree to take audiology to the next level and really give audiologists the type of training
and clinical expertise that they needed to take care of patients in the future.
So with that was borne the AuD or doctor of audiology degree and ADA has always really
been on the bleeding edge in that we were one of the strongest components of bringing
a master's degree to a doctorate degree in a time when there was a lot of pushback around
that.
In the '70s we did something provocative in the '80s we did something provocative and
then in the 1990s the first AuD degree was conferred and by the mid 2000s it was the
entry degree for audiologists and training in private practice.
I don't know where -- there we go.
So we continue on this forward-thinking path.
In addition to talking about the Over-the-Counter Hearing Aid Act tonight we will touch a bit
on another piece of legislation working its way through Congress called the Audiology
Patient Choice Act.
So going back now from the workshop in 2014 that was held at the IOM, we know that in
2015, the President's Council of Advisors on Science and Technology or PCAST held some
sessions and formulated a report that was sent to the President of the United States
and also published and disseminated publicly.
And in that report were a number of recommendations that ADA carefully evaluated.
Someone told me once that it takes 20 years to become an overnight success.
As Nancy sort of referenced, that has certainly been the case with the well-deserved attention
that's been given to the importance of hearing loss recently.
So for the past 20 years there have been a lot of things going on.
And then really it's sort of come to a head over the last three years starting with the
IOM and then looking at the PCAST and some of their recommendations that came out.
So in looking at the four recommendations that they had, they included people from medicine,
technology, science, one of the folks who was heavily involved was Dr. Christine Cassel
who is with the National Quality Forum, Thomas Camber from older adults technology services,
Charlotte Yea from AARP and they even requested input from other professionals and experts
like Dr. Lin at Johns Hopkins.
So in looking at the recommendations themselves, one of them was that the FDA should designate
a distinct category of basic hearing aids, non-surgical air conduction hearing aids intended
to address bilateral, gradual, onset, mild to moderate age related hearing loss and adopt
distinct rules for those devices.
The second recommendation from PCAST was for FDA to withdraw its draft guidance on the
November 7, 2013 Personal Sound Amplification Products or PSAPs.
The third recommendation was for the Federal Trade Commission to look at the delivery of
hearing health care and make some determinations that were parallel with its Eyeglass Rule.
And require audiologists and the sensors who performed diagnostic hearing aid tests hearing
aid fittings to provide the customer with an audio gram and everything that goes with
it including the audio profile at no additional cost in a form that could be used by other
dispensers or hearing aid vendors.
And then similarly in efforts like the Contact Lens Rule to ask the FTC, again, to define
a process for patients to authorize hearing aid vendors instate and out of state to obtain
a copy of their hearing tests.
The results, everything that was around the results, including that audio profile so that
the testers would furnish those, again, at no additional cost.
So as we looked at those, we provided qualified support.
The ADA provided qualified support for all four recommendations.
And we did so for a number of reasons.
We feel that it is very important that we move the needle in terms of adoption rates.
We feel it's very important for competition to be increased in the hearing health care
space.
And we feel that this can be done in a responsible manner through the FDA and through the legislative
process.
So as we provided that qualified support, we did make every effort to ensure that the
audio logic care that's so important and successful for patient outcomes continues to be recognized
and continues to be implemented.
We requested that there be strong recommendations for example for patients to seek and obtain
an audiologic evaluation but we recognize that that pathway into the hearing health
care system is not going to be the chosen pathway for every consumer so we do not believe
that it should be required.
We also felt that the PCAST recommendations, they interchanged the term class and category
when discussing over-the-counter products.
We recommended that they only use the term category at that time.
We also wanted to make sure that the PSAPs would be appropriately labeled, if they would
be used as non-registered devices and encourage the development of PSAP standards.
We also believe that all companies and all manufacturers should be allowed to make truthful
claims about their products.
And we felt that the recommendations would allow that.
At the time we also put in an opposition to online diagnostic testing, although we're
very supportive of online screening.
It was felt at that time and still continues to be the case that a true diagnostic evaluation
can't be successfully achieved without having a good patient history, without having otoscopy
without having a lot of the things that an online test is not yet available -- or able
to do.
But we recognize that as these things -- as technology advances in that area, once that
is able to be achieved, we wouldn't oppose it in the future
So we looked at the PCAST recommendations in our subsequent position on those.
Moving into 2015, the NASEM committee is continuing to meet at the same time and subsequent to
that the Food and Drug Administration decided to hold a workshop on streamlining some of
the regulations that the FDA has imposed.
And they put a call out for comments and for participants in that workshop.
So ADA was represented there and discussed some of the barriers we thought were the -- the
biggest barriers to care at the time we discussed We pointed out that cost is an irrefutable
barrier it's not the only barrier but certainly is a barrier and one that's been discussed
by several governmental bodies over the last few years including Congress and administrative
agencies.
Many people are viewing a hearing aid purchase as the third biggest purchase that they might
have in their lifetime beyond a house and an automobile.
So it really is something that's substantial.
And I have to note here, too, that many audiologists also find cost as a barrier to providing the
care that they want to deliver to their patients.
So independent practices struggle in negotiating prices from hearing aid manufacturers and
many are moving towards unbundled delivery models that allow more transparency in that
regard.
Direct-to-consumers and OTC devices will undoubtedly lower the average selling price of hearing
aids.
And they will also expand competition and encourage a further movement by the audiology
community towards that unbundled piping model.
So additional major barriers that we identified to care during that meeting included unClear
Pathways to care for the consumer.
It's not always easy to identify the right provider, be it an audiologist, a hearing
aid dispenser or otolaryngologist and making sure you're getting all of the services you're
entitled to.
We know that HLAA has a fantastic resource that people can download from the HLAA Web
site that provides a checklist of what you can expect when going to an audiologist but
we know not every consumer can access that or find their way successfully into the hearing
health care system and also awareness is an incredible barrier at all levels.
So awareness by the consumer about the availability of products and services available to them
in the hearing health care space but also really the awareness among other health care
providers, including general practitioners about the importance of hearing health for
their patients, including a lot of the associated maladies, co-morbidities and the importance
really of getting treatment as soon as possible if hearing loss is suspected.
So as we continue the presentation to the FDA and in our subsequent comments, what we
were really seeking were two main requests from FDA.
The first of which was to eliminate the need for medical clearance for the purchase of
a hearing aid.
So as early as 1993, the FDA had already identified the requirement for a medical evaluation for
adults seeking to purchase hearing aids as something that was not working in the way
that it was intended.
There was widespread use of the waiver.
And there was just a lot of anecdotal evidence that people were not actually following the
regulation in the way that the FDA had intended when it was written in 1977.
We also know that roughly 90% of hearing loss is not medically -- is not medically treatable
so it makes sense for the person to come into the hearing health care system with an audio
logical evaluation and then be referred if it's identified by the audiologist that that
would be needed based on the red flag conditions that they can identify.
So we requested that.
And then secondly we requested that the FDA restructure regulations at that time to allow
for Class I medical device hearing aids to be sold direct-to-consumers.
We know that hearing aids have been sold over the Internet and through mail order for the
past 50 years.
This is nothing new.
What we were seeking is for there to be more standardized regulations in that regard and
more widespread access for the consumer to the OTC devices.
And in our view, again, this would allow the factual information to be presented.
It would allow for the consumer to have more opportunities to make an informed decision
about their hearing health care and more opportunities to determine where the device is purchased
from should they need a hearing aid.
We, again, wanted to have a requirement from FDA that the devices would have a strong recommendation
to obtain an audiologic evaluation, although again not a mandatory requirement for that
evaluation.
So working in parallel was the National Academies of Sciences, Engineering and Medicine who had
after the workshop in 2014 formed a committee to really take a more in-depth look at accessible
and affordable hearing health care for adults. Now, the committee included physicians, audiologists,
consumer advocates and other experts who met for about a year.
They had a series of workshops.
They had a number of presentations from a variety of different stakeholders.
And then they had what I can only imagine was a considerable amount of internal debate
before reaching consensus recommendations in June of 2016.
So they had 12 recommendations that came out of that And I think it really is important
that we think about those holistically.
So they wanted to improve population based information on hearing loss and hearing health
care.
Develop and promote measures to assess and improve quality of hearing health care services.
Remove the Food and Drug Administration's regulation for medical evaluation or waiver.
I think we can all start to see the pattern here in that thinking.
For recommendation No. 3.
Empower consumers and patients in their use of hearing health care.
Improve access to hearing health care for underserved and vulnerable populations.
Promote hearing health care in wellness and medical visits
Implement a new Food and Drug Administration device category for over-the-counter wearable
hearing devices.
Improve the compatibility and interoperability of hearing technologies with communication
systems and the transparency of hearing aid programing.
Improve the affordability of hearing health care.
Evaluate and implement innovative models of hearing health care to improve access, quality
and affordability.
Improve publicly available information on hearing health
And promote individual and employer, private sector, and community-based actions to support
and manage hearing health and effective communication.
ADA, as I understand it, is the only provider organization that came out in 100% support
and unqualified support of all 12 of those recommendations.
So when we -- we looked at it in a very holistic manner and not just looking at No. 3 and No.
9 and No. 8 and saying, well, we like those but not the others.
We feel like the committee really did its due diligence in terms of the type of research
and input that it was receiving.
We felt that it was a very independent body.
And that it came out with a -- the recommendations in earnest after really listening to all of
those stakeholders.
We did note with interest that the recommendations were consistent with some of the PCAST recommendations
and also with many of the presentations and thinking that were given at the FDA workshop,
particularly from consumers and then also through the ADA presentation, as well.
So subsequently, the National Academy had an additional meeting in December, which followed
on the heels of the initial OTC hearing aid bill introduction which happened very late
last fall.
And at that meeting, the FDA proactively stated that it does not intend to enforce that requirement
that individuals 18 years and older get the medical evaluation or sign the waiver prior
to purchasing hearing aids.
So ADA was very pleased about FDA's decision to seek enforcement of that.
And it's our understanding that they are taking steps to roll back the regulation itself.
But we do note that there are many states who also independently still require that
medical evaluation for the waiver and unless or until the OTC hearing aid act is passed,
you would have a very inconsistent model in terms of whether or not that would be required
from state to state to state.
So ADA believes that the national legislation, the Federal legislation, is needed in order
to ensure that that medical evaluation requirement is removed across the nation.
So that everything will be consistent.
So with that I hope I've provided a little bit of a background that sort of has been
forming ADA's thinking on this issue over the past several years And at least demonstrated
that we've had a consistent position across all of the different independent bodies and
then some of our comments.
So with that, at this time I would like to turn it over to Dr. Spoor who will actually
get into the legislation and the legislative initiatives themselves.
>> ALICIA SPOOR: Thank you.
So -- and thanks for attending and for HLAA for putting this together
So I want to start out with what I would call the most senior legislation that you're going
to see presented tonight and there's the Hearing Aid Assistance Tax Credit Act.
And full disclosure, I'm 36 years old.
I remember being in Graduate School when I was going to school in the district and I
think the tax credit had been introduced at that point in time.
So this is not a new concept to a lot of people.
But it is something that has been reintroduced and you can see the Senate Bill 48 that was
introduced very early in this Congressional session in 2017-2018 and basically what this
legislation says for anybody that's not aware of it that it would allow anyone who is purchasing
a hearing aid to take a tax credit up to $500 once every five years.
And the only stipulation so far is that the hearing aid needs to fall under the FDA's
Food, Drug and Cosmetic Act so there are a lot of unanswered questions which I'll come
back to in a minute and also if you take that statement one step further shows if you were
to buy two hearing aids, then you would have $1,000 tax credit.
In the prior legislation, there have been a $200,000 income eligibility cap for the
household.
So that rules out some of the people that might have a large income being able to take
advantage of this tax credit.
But some of the questions that have come up with this hearing aid tax credit bill since
the introduction of the over-the-counter hearing aid piece is what happens if you don't go
to a provider to obtain the hearing aids?
What happens if it's a PSAP which is equivalent to a hearing aid right now And they are not
being regulated, does that still fall under that category.
And there's a lot more questions that have been coming up.
With that being said, as Stephanie Czuhajewski just noted, we know that cost is a barrier
for many people.
It's not the only barrier.
But it is a barrier.
And you're going to see some of the evidence come out.
And there's lots of literature and studies that can show that, too, which I can reference
at the end but when cost is an issue this is one way to get around it and if cost were
truly not an issue then this piece of legislation wouldn't have the support it's having in Congress
over and over again.
So ADA has supported this as well as many other both hearing aid manufacturer groups
and provider groups.
And it's something that has been introduced for a long time.
But hasn't really gotten the momentum to move forward.
So this is really the brunt of why I think most of you are sitting on this webinar tonight,
which is the Over-the-Counter Hearing Aid Act of 2017.
And I do want to point out that this is technically the second time that it has been introduced
into Congress.
It was introduced at the very, very of the 2015-2016 Congressional hearing But as you'll
see it was reintroduced in both the Senate and in the House on March 21st of 2017.
So we're really going on about two months that this over-the-counter hearing aid bill
has been in Congress this time and it was introduced in December before so you're really
looking at a lot of information that's been out there for about the last six months.
And I do want to know, especially coming from the audiology standpoint and I think some
consumers which I cannot speak on behalf of, I can tell you my patient views about HLAA
-- but HLAA could probably give a better view on what the consumers are saying but there's
a lot of misinformation that's out there about this Over-the-Counter Hearing Aid Act.
So I would strongly encourage you, you can look these two bills up on Congress.gov and
they are very short bills.
They are only six pages.
They are essentially double spaced.
They have very small margins when you actually read them.
And I would highly encourage you to read it to see what is actually written in this legislation.
But basically the legislation is going to define what an over-the-counter hearing aid
can be.
And as many of you have heard, we have talked about mild and mild to moderate.
It provides regulations for the control of OTC hearing aid sales.
And so they are talking about safety and efficacy and outcomes that might be placed on this
type of device to be sold and it overrides the state licensure law which Ms. Czuhajewski
just referred to about the FDA guidance -- I'm sorry the state license law regarding the
medical evaluation and medical waiver for condition of sale.
And it also makes the FDA guidance from November of 2013 finalized to distinguish between hearing
aids and PSAPs.
So again, there's a lot of misinformation out there.
And especially with ADA as somebody who supports it, I want to note that there's a couple of
things that we see in this piece of legislation.
It does call out that there needs to be regulation.
So right now there are a lot of options available on the market direct-to-consumers you can
order via mail.
You can do catalog.
You can do Internet based sales.
And there are no regulations whatsoever.
So we don't see this as something that's going to open the floodgates.
It's really something that's going to put regulations so we have often termed it as
a reregulation hearing aids that are available direct-to-consumers.
So now with this you're going to see devices that have appropriate outcome limits, that
have appropriate labeling, that have appropriate standards, that have instruction manuals which
are already supposed to be there under the condition of sale for a hearing aid.
But aren't always being there.
And with this reregulation, there's actually a method that you can go back and actually
start to enforce some of these issues for companies that are or are not looking at it.
This would also allow the manufacturers of these devices to make truthful statements.
So again, Ms. Czuhajewski already referred to, there's a lot of things you can get out
there right now.
But you can kind of say whatever you want about these devices.
Some of them function the exact same way as a hearing aid.
They are just termed something different if they are sold over-the-counter or if they
are sold through a provider's office so you are going to see things that are actually
making truthful claims about what products can and cannot do.
And again, as I mentioned, the legislation as it's current written is written for mild
to moderate hearing loss.
And I know there's a lot of variations as to who agrees with mild.
Who agrees mild to moderate.
But in the case of ADA, we have agreed with mild to moderate.
And so pointing out kind of where we are in this situation, you've got the house bill
-- the House Bill this HR 1562 it's already been heard in the Energy and Commerce Committee
that happened on May 2nd it's very interesting to hear Dr. Schurr Dr. Powers and Dr. Lin
who were there speaking on behalf of physicians and Hearing Aid Association respectively and
it might be combined into the larger group of the MDUFA bill on the Senate side the legislation
was marked off on May 10th so you'll start to see that move forward a little bit more
in the next 24 hours, as well.
So as I mentioned, ADA does support this legislation.
It's consistent with everything that Ms. Czuhajewski has already said, it's consistent with the
PCAST recommendations.
It's consistent with our FDA presentation.
And it's consistent with the Institute of Medicine or the NASEM recommendations.
And so we have been supportive of that all along without a lot of qualifications and
of course ADA is supportive of the actual legislation, as well.
We also want to point out that you will see a lot of information that's available in peer
reviewed studies and research methodologies that talk about the use of non-treatment when
it comes to hearing loss may be greater than risk of self-treatment I think this is interesting
from an the audiological side in the fact that a lot of audiologists or hearing aid
dispensers or physicians who might be selling hearing aids have promoted there's a risk
of falls, there's a risk of quality of life decrease, there could be a risk of graduated
dementia and Alzheimer's and things like that when it comes to why you should actually obtain
hearing aids and go through this process.
But now that the option of obtaining hearing aids is out there, some of that information
has been kind of pushed under the rug in terms of why you should get something that might
be a little beneficial as opposed to not doing in the long run and as I mentioned before
the legislation does require the safety, the efficacy, the labeling and the reporting system
to be addressed.
None of that is written in this legislation.
That's all something that there are timelines put in place as to how long the FDA would
have to create those different types of regulations.
But they are not something that I can speak to because we are not -- they are not actually
being developed.
Within the legislation.
They are probably being looked at at FDA since the FDA mentioned they would be looking into
this at the NASEM meeting in December So the other thing that we want to point out
while you're on the phone call today is the Audiology Patient Choice Act of 2017 and this
is a House Bill that was introduced on May 2nd of this year.
So in this Congressional session, it has been introduced in the last two Congressional sessions,
as well.
Try saying that three times fast.
But this is -- this essentially does three things It's going to update the Title XVIII
of the Social Security Act which is essentially Medicare and it will allow any Medicare Part
B beneficiaries to have director access to an audiologist so as most of you may know
in order to see an audiologist at this point in time there's the requirement of a physician
order.
As well as a medical necessity in order for Medicare to actually reimburse for services.
So that would take off this extra burden of having patients obtain that physician order
before they actually come to the audiologist and go through the testing for medical necessity.
It would also reimburse the provider for any Medicare covered services that are allowed
under the state defined scope of practice so it's not any additional scope of practice
it's not any additional services within the Medicare system but currently if there's a
vestibular issue and you have poor balance you might see the audiologist for balance
testing but then you would have to go to a physical therapist to be covered under Medicare
for reimbursement for that type of treatment even though the audiologist is allowed to
administer that treatment under their state scope of practice.
They are just not able to be reimbursed so this is allowing for patients to have a one-stop
shop or a consistent place of service for both treatment and diagnostic coverage.
And then the third thing it would do is it would categorize audiologists as limited licensed
physicians and this would put us in the same taxonomy or category as other non-physician
providers before we jump off the deep end limited licensed physicians is not a term
that ADA or anybody else has come up with that's what Medicare happens to call these
non-MD providers so we're talking chiropractors, podiatrists, dentists, pharmacology is trying
to work towards this, as well.
So as I often tell people, Medicare can call me anything they want as long as they put
me in the category with all of those other non-medical doctor providers that are providing
the same type of care that I am and that would be the optometrists, the chiropractors, the
podiatrists and the dentists.
And being very upfront I love this piece of legislation because ADA has written it.
this is drafted by us and it is moving forward because of the ADA.
So obviously we do support it.
It would still allow patients to see a provider and purchase over-the-counter hearing aids
if that were something they would want to do.
It would allow patients to go direct to the over-the-counter model in terms of purchasing
hearing aids and then come to an audiologist if they wanted to do so.
It would just give them the accessibility of seeing a provider without extra barriers.
It is worth noting this does not say that Medicare should be covering the cost of hearing
aids.
That's a whole other finish to tackle This is really kind of looking at giving patients
access to professional care.
And to have Medicare cover some of the costs that they have already covered in other services.
But it does not specifically say anything related to hearing aids.
Right now hearing aids are excluded from the Medicare Part B system and we can talk more
into that but that's a whole other webinar, as well.
And again it doesn't add any new services to Medicare.
Just provides you, as a patient, the ability to see whomever you choose for the services
that you would like.
So with that, we wanted to make sure we provided an overview of but we wanted to allow ample
amounts of time for question and I'm sure, Nancy, you have quite a few coming in.
So I'm going to turn it back to you and we can move forward from there.
So thank you very much >> NANCY MACKLIN: Okay.
Perfect, thank you very much.
The first question comes from Dwaine Smelter he says please share your evidence for cost
being a real barrier.
When adoption rate is the same in countries where hearing aids are free.
>> STEPHANIE CZUHAJEWSKI: This is Stephanie, I'm happy to take that initially.
We would be glad to send you some of the studies that we have.
They actually demonstrate that cost is a significant barrier in the United States.
Where we have very low actually adoption rates versus what they are in other countries.
Certainly there's no country where adoption rates are approaching 100% or anywhere close.
But there are countries in Europe where adoption rates exceed 40% and cases where cost isn't
a barrier and even though over there they do have issues with access and very long wait
times from time to time, with their national health care systems and so forth, they still
are seeing adoption rates that are much higher than in the United States.
>> ALICIA SPOOR: And I'm going to piggyback -- sorry Nancy I'm going to piggyback off
of that too this is the actual NASEM summary report it is a book you can see that but Chapter
4 is dedicated to hearing technology.
And you can see a lot of their studies and research that they have obtained.
It starts on Page 196.
I have read it a couple of times.
But you can find some of the information and answers that you're asking for there, as well.
>> NANCY MACKLIN: Okay.
I was going to say I can attest to that because the financial assistance page of our Web site
is the one where people spend the most time and most frequently viewed.
And our phones and email are quite busy with people inquiring about how to afford hearing
aids.
We get between 3 and 8 every single day of the week and some days it's as high as 10
inquiries on that subject so it is a problem.
The next question comes from Brad if OTC hearing aids become available, what capabilities might
be provided by hearing aid manufacturers to hearing aid users to program their hearing
aids using hearing profile data provided by an audiologist?
Will that even be possible?
>> ALICIA SPOOR: I'm happy to start with that one especially being on the clinician side
and then Stephanie, you can jump in if you would like to.
But I can tell you that at this point in time, it's anybody's guess what might be out there.
There's a lot of speculation as to what these devices might be.
There's no rules or regulations or enforcements that's happening right now on devices that
are direct-to-consumers currently.
And so I think in terms of imagination, the sky is the limit.
But a lot of that is going to be yet to be seen.
Part of what I see as a provider is if you come in as a provider -- if you come in to
me as a provider this is my personal opinion I'm already providing you with your audiogram
and if you think you have a device you can program then all the more power to you if
there's that capability there are already devices now that let you fine tune and have
equalizers that are hearing aids from the hearing aid manufacturers that are currently
being provided.
Through and audiology or hearing aid dispenser or physician model.
And so I think you're going to see lots of things And that's kind of like asking what
new technology is there going to be in the next ten years?
Some of the things I think that are being developed we don't even know about yet because
it hasn't come to market and it's not regulated or it's not researched or hasn't been rolled
out so that's a roundabout answer to say I hope you have lots of ideas and lots of options.
>> NANCY MACKLIN: Stephanie, did you want to add anything to that?
>> STEPHANIE CZUHAJEWSKI: I think Alicia covered it beautifully.
I think the only thing that I would add is that really the sky is the limit in terms
of future technology.
We've been seeing things change so rapidly.
And as we think about direct-to-consumers opportunities in the future, I think we need
to move away from the sky is falling mentality to that sky is the limit mentality.
Because I think there are many opportunities to use telehealth and teleaudiology to couple
with what these technological advances will be in terms of phone applications and things
that we're going to be able to download.
I think in the future we're going to see a ubiquitous device really.
And I think a lot of your hearing aids are actually going to be software only.
If you have a good device, you're going to maybe even be able to switch up the kind of
hearing aid you have by virtue of just changing your software program.
>> NANCY MACKLIN: Exciting.
Exciting times for sure.
Vicki said what does it mean allow manufacturers to make truthful statements?
I think she might be pitching that one to you, Alicia.
>> ALICIA SPOOR: Yeah I'm happy to start with that one.
I think what you're referencing, and this is something I'm sure Stephanie will chime
in again, as well at the end, right now what that means is that you cannot sell a hearing
aid that's intended -- I'm sorry let me back up.
You cannot sell a device that's intended to treat hearing loss over the counter.
So what's happening is you're seeing a lot of devices that are four an enhancement of
hearing.
Or for those kind of hunter type of situations where you might want an increased sensitivity
of hearing or you might want better than normal hearing.
And so these are all advertising tricks that some of these devices are using.
And I'm not saying it's right or wrong.
But these are labeling things that PSAPs currently, personal sound amplification products cannot
say they are intended to treat hearing loss even though they may be used for that type
of situation or they could be technologically the same to a hearing aid that I as an audiologist
would sell in my practice but because it's not intended to treat hearing loss, you might
be able to purchase it through a mail order catalog.
But if it is intended to treat hearing loss and they make those advertisements, then you
are required at this point in time to come through that provider and provider being the
hearing aid dispenser, the audiologist or that physician.
>> STEPHANIE CZUHAJEWSKI: And this is Stephanie I'll just add so what the FDA looks at currently
and what they have counseled people through their drafts guidance and drafts PSAP guidance
which hasn't been finalized is that it's really about intended use.
So the technological components of the devices could be identical But because one device
is intended for use in the treatment of hearing loss, it either has to be deemed a hearing
aid and marketed and regulated appropriately, registered with the FDA appropriately.
Or it's not supposed to be marketed for the purpose of treating hearing loss, even though
by virtue of it's technological features, it may very well be able to do that.
So in a lot of ways the PSAP manufacturers and folks who are not currently making devices
that are FDA registered as hearing aids are doing things to sort of skirt that requirement
and really kind of getting right on to the edge of what legal -- what's legal or not
legal in terms of what they are saying about these devices.
From ADA's perspective, we would like the guidance to be perfectly clear so that the
playing field is level for all manufacturers, those of hearing aids and those of other devices
so everybody kind of has the same expectation and is held to the same standards.
And that way, in that regard, you feel that people can market their devices transparently
and truthfully.
And we believe that companies should be able to make truthful claims about their products
as is consistent with the First Amendment.
>> NANCY MACKLIN: Okay, the next question comes from Jeff, who will write the training
material for OTC sellers of the qualifications for OTC sellers?
>> STEPHANIE CZUHAJEWSKI: I think I can start.
And I can be corrected later.
I'll tell you that I'm not 100% true at the end who exactly will be sitting in a room
writing it.
I'll be right upfront with that.
But what the legislation calls for, the OTC hearing aid act is it calls for the FDA to
come up with the modification to the current regulations on the sale of a hearing aid.
So the FDA would be directed through the legislative process to make the regulations necessary
or to modify the existing regulations in order to account and allow for those OTC devices
to be sold safely and efficaciously.
Now, we know that when (inaudible) and Jeffrey Shuren (phonetic) tested at the House Energy
and Commerce Committee submeeting a couple of weeks ago, he made affirmative statements
and concluded that the FDA would be able to do that.
And to do so in a way that would be safe and effective to the consumer should the legislation
be passed.
>> NANCY MACKLIN: Okay.
The next question also from Jeff, does HLAA support the APCA?
And yes, we do.
But I think we might be behind on posting some information about that.
I know Barbara is on the webinar, and Barbara, if you have a microphone, I can have you answer
that.
If you want to provide more information.
I know I'm kind of putting you on the spot there.
And I'm not sure if she's -- she's on a microphone with a mic.
But you will be seeing more information about that, about our support of that.
Kathy writes age related hearing loss was the basis for PCAST and NASEM recommendations.
If someone has a medical history of chronic disease, trauma or ototoxic medications will
OTC not apply and cannot be sold and audiological management will be recommended first?
>> ALICIA SPOOR: Yeah, I'm happy to answer that question.
The answer at this point in time from how I understand it and this is from me reading
the legislation, is that, no, if you have any co-morbidity or pre-existing condition
that could be linked to hearing loss, there's nothing that would prevent you from buying
some type of OTC device.
That being said, I would highly recommend that you look at the energy and commerce hearing
that happened on May 2nd which that video is publicly available.
Because they did talk a lot about whether or not there would be medical conditions that
would preempt like a mild hearing loss versus a moderate hearing loss in terms of the treatment
that would be provided.
And because I am not a medical physician, I'm not going to answer that.
But Dr. Lin did go that route when he was asked that question So that's something that
I would look into, as well.
That being said, part of the good stuff that's coming out of this over-the-counter hearing
aid legislation and as we have tried to move forward, especially with the diabetes guide,
is that we need more awareness when it comes to hearing and hearing loss and hearing prevention.
And we need more awareness.
And we need more data.
And we need more data-based practices and best care and standards.
And everything that goes into these packages.
And I think that's one of the things that this is starting to show is where some of
these areas have fallen short and where some of these areas need more things.
And where some of this could be beneficial.
And that's not only good on the consumer side for people that are listening and also for
providers that are doing hearing and balanced health care but it's also good for those primary
care physicians and those internal medicine and family practice that are -- and gerontologists
that are kind of the gatekeepers at the moment of these people to help funnel them to where
they need to be when they do have those co-morbidities or co-diseases present.
>> STEPHANIE CZUHAJEWSKI: The only thing that I would add to that, I think Alicia -- Dr.
Spoor did a great job of covering that question is that the purchase of an OTC device and
the purchase of audiologic care or treatment by an audiologist is not mutually exclusive.
And this is something that we want to make sure that we continue to really put out there
into the universe is it's not going to be an either/or decision for many people.
We anticipate that the incorporation of OTC devices will actually bring more people into
the system as Dr. Spoor mentioned and with that they will be able to take these devices
and go into an audiologist or even better, start with the audiologist, get a fantastic
audiologic evaluation and get your Needs Assessment and get everything that's comprehensive on
the frontend and then if an OTC device is something that your audiologist recommends
that could work for you then great then go buy it and go back and get subsequent treatment
if that's what you want to do.
Or even better, we anticipate that many audiologists will actually sell these OTC devices right
in their practices and you'll be right there and able to purchase them on the spot and
then go back and get the care or treatment from an audiologist if that's what you choose
to do.
>> NANCY MACKLIN: Okay.
Do you know when it's likely that we will see these bills passed?
Like what's the timeline in the bills getting passed and actually seeing OTC devices on
the market do you think?
>> STEPHANIE CZUHAJEWSKI: So as we understand it, the way that the OTC bill is currently
attached to an FDA reauthorization bill in both the House and the Senate, the FDA reauthorization
bill by virtue of its deadline for renewal needs to be done by some time in September
as we understand it.
So we expect that if the OTC component and the OTC legislation stays attached to the
bigger bill, that it will pass along that timeline if it's successful.
That said, there's no guarantee that it would pass at that point.
If it does, I believe that the requirements to the FDA are a three-year timeline from
the time the bill passes until when a lot of these things would be implemented.
That said, the FDA on its own has the authority to do many of these things from a regulatory
standpoint without the mandate from the legislative body.
So as we understand it from their announcement in December, FDA is already looking at the
best approaches for implementation for OTC hearing aids as we mentioned they have already
voluntarily removed the requirement -- the enforcement of the requirement for the medical
evaluation and are looking at rescinding that regulation.
So we are really unsure about the legislative success for the bill.
But we're very hopeful that it could be passed before September.
And that with that the FDA is already working and could even be done in advance of that
three-year mandate >> NANCY MACKLIN: Great, Barbara Kelley is
online.
And can provide more information about HLAA's support of the Audiology Patient Choice Act
of 2017.
Go ahead, Barbara.
>> Hi, yes, we are definitely supporting that And we will have more information on that
on our Web site soon.
>> NANCY MACKLIN: Okay.
Do you have a timeline, Barbara, or when -- of when that will be posted?
>> No, I don't, we have written or letter of support and we're just about to submit
it to the Academy of Doctors of Audiology.
We were working on tweaking that.
>> NANCY MACKLIN: Okay.
Good.
All right.
I can see there's a lot of legislative activity going on in HLAA among our small staff but
we're doing the best we can.
(Chuckles).
>> NANCY MACKLIN: Okay.
I believe there was one more question here -- let me just scroll down
Will this presentation be available later?
Yes, absolutely.
It has been recorded and we'll post it usually it takes us about a week or so to get it posted
on our Web site along with the slides.
So definitely you'll be able to view it again and share it with your colleagues.
Walmart pharmacy departments in Texas are selling hearing aids now.
For about five years.
Do you think that's going to be the trend?
I know that CVS also has hearing centers in their stores.
What do you think about that?
>> ALICIA SPOOR: Yeah I'm happy to start that answer.
Yes, Walmart and Sam's Club has been selling hearing aids.
Costco has been selling hearing aids.
As Nancy just mentioned CVS especially around my office has been selling hearing aids But
I think there's a big difference to point out and right now all of that is still provider
sold devices and what we're looking at is something that will not necessarily -- it
should strongly recommend but nothing that necessarily requires that provider for that
sale.
So we're looking at different models.
So yes you might see more devices in big box stores, pharmacies, grocery stores, Radio
Shack, technology devices, things like that but the OTC legislation is looking at decoupling
the device from that provider.
>> NANCY MACKLIN: There's a question from Tricia what are consumers saying to you at
HLAA regarding this legislation?
Barbara, do you want to chime in on that, as well?
>> Oh, sure, I would be happy to.
Well, many of our members tend to have more severe to profound hearing losses with very
complicated fittings and they have enjoyed the good care of their audiologist and hearing
instrument specialists for many years So this over-the-counter category really wouldn't
apply to them.
But they understand that with the innovation in technology and opening up competition that
it would be good for hopefully bringing all of the costs of hearing aids down.
And some of them have said to me, you know, I wish I would have done something sooner
about my hearing loss.
And I might have if something like this were available And then of course we've heard from
other consumers who think this is a good idea because they can't afford hearing aids and
then of course as I'm seeing from the questions, there's some really good questions about PSAPs
and over-the-counter, and what over-the-counter will look like.
So I almost -- well, I know we won't be able to get to all of the questions so I'm almost
thinking we might need another webinar.
>> NANCY MACKLIN: I think so.
There are several more questions and unfortunately we are not going to be able to get to all
of them.
But one that really sticks out is from Priscilla she says as a physician what should I tell
my patients about the OTC devices?
Do you think to take that question, Alicia?
>> ALICIA SPOOR: Sure, I would be happy to start.
First and foremost thanks for being on the webinar because there are so many physicians
that I speak to on a regular basis that aren't interested in hearing about balanced health
care for their patients so thank you for being one of the select few and please lead your
colleagues along the way, as well, I think what you need to tell your patients is that
at this point in time start with the audiologic evaluation and then move forward from there
so this is OTC legislation is something that they could look into.
But it's not something that's going to happen overnight.
There are devices that are out there but because they are not the best regulated devices it's
not something that patients should go out and purchasing on their own right now the
model of care is still going through the audiologist I would think in terms of testified based
practices the best practices you would want your patients to have that baseline evaluation
before any type of treatment is there.
That being said I would strongly encourage them to be active and be looking at this and
be asking and be well prepared when they go see a provider so that they can say are there
low cost options, are there treatments that are available for me that maybe aren't hearing
aids but more assistive listening devices or hearing strategies and you have your elected
members to do what -- for you and your patients think are best that's why we elect them that's
what I would say to you as a physician and that's what I try to tell my physicians when
I meet with them.
Stephanie I don't know if you have anything to add from what you're seeing from our audiologists
as well.
>> STEPHANIE CZUHAJEWSKI: I think that's excellent advice, we are seeing that there are more
audiologists who are utilizing some of the PSAPs and other products within their practices.
So I think, again, if the patient starts -- seeks out an audiologist that offers some of those
types of alternatives and gets the evaluation and then know there would be some low costs
or alternative options for them.
>> NANCY MACKLIN: We hear quite often from people who say their physicians told them
it was just part of aging, just turn up the TV, and really nothing can be done.
So as long as you don't tell them that, that there is help available.
And we appreciate you being on the webinar tonight.
Thank you so much Alicia and Stephanie, unfortunately we are now at a time and I apologize that
we cannot get -- we are out of time and I apologize we can't get to all of the questions.
That makes me think we need to get on the calendar for a second webinar.
And maybe by the end of summer or fall, a second one would be timely and we'll be able
to give an update on what the legislation is doing at that point.
So thank you, all, for attending this evening and thank you Alicia and Stephanie so much.
This was very informative.
I appreciate it.
>> STEPHANIE CZUHAJEWSKI: Thank you, it's been a pleasure.
>> ALICIA SPOOR: Same for me, thank you very much
>> NANCY MACKLIN: All right, good night, everybody.
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