Hearing Matters Podcast

Exploring OTC Hearing Aids with GAO's John Dicken: Affordability, Stigma, and Market Dynamics

July 31, 2024 Hearing Matters

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Unlock the latest insights into over-the-counter (OTC) hearing aids with our special guest, John Dicken, Director for Healthcare at the GAO. This episode promises to shine a light on the newly FDA-approved OTC hearing aids, featuring an in-depth discussion on their availability and the rising consumer interest. Discover the challenges in tracking OTC sales data and the potential for these devices to create new markets for those with mild to moderate hearing loss without diminishing the prescription hearing aid industry. We also debunk common myths about hearing loss and explore the nuanced differences between hearing and listening problems.

Click here to read and/or download the GAO's OTC Hearing Aid Report.

Explore the intriguing dynamics of affordability and stigma associated with hearing aids. Did you know that despite OTC options being priced from $200 to over $1,000, and prescription aids costing several thousand dollars, stigma significantly impacts people’s willingness to use them? We reference studies showing that even in countries where hearing aids are free, many still opt out. Our conversation highlights the crucial role of professional guidance in selecting hearing aids and how private practices can provide affordable solutions, ensuring a balanced approach between OTC accessibility and expert support in tackling hearing health issues.

Our discussion touches upon the importance of ongoing market evaluation, and how Medicare Advantage plans and the Department of Veterans Affairs are navigating these challenges. Tune in for John Dickens’ valuable expertise, particularly his insights on making OTC hearing aids a viable, cost-effective option.

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Dr. Douglas L. Beck:

Good afternoon. This is Dr. Douglas Beck. I am an audiologist with the Hearing Matters Podcast. And today's guest is John Dickens. And John works as Director for Healthcare for the Federal Government and General Accounting Office, the GAO. Today we're going to discuss the GAO Report to the Congressional Requester, which was published on May 7th, 2024, specifically titled, Over-the-Counter Hearing Aids:Information on the New Medical Device Category.

Dr. Douglas L. Beck:

So John, welcome to the podcast. Thank you so much for being here.

John Dicken:

Thank you. Appreciate the opportunity to talk to you today.

Dr. Douglas L. Beck:

Yeah, we're looking forward to it. John, before we get into the details of the report, would you please tell us a little bit about yourself? What is your exact position and title at the GAO and how long have you been there?

John Dicken:

Great, thank you. Yeah, I am one of the directors in the healthcare team with the US Government Accountability Office, or GAO. My area of responsibility covers issues related to public health and private markets, including private health insurance and public health issues, prescription drugs and devices. I've been at GAO for most of my career and in the federal government for about 35 years now.

Dr. Douglas L. Beck:

Oh my goodness. Okay. Well, what I'd like to do, tell me what you guys researched and what you found.

John Dicken:

Thank you. As a congressional agency, we were asked to look at the early experience once over-the-counter hearing aids were approved by FDA less than two years ago, and to see what the experience has been in terms of the availability of over-the-counter hearing aids, and any evidence as to what the effects have been in that less than two years since they've been made available.

Dr. Douglas L. Beck:

Generally speaking, the hearing aid market for decades now increases three to 5% annually, the quantity of hearing aids sold, and that's been very, very stable, very steady over the years. So I know from the reports I've read that hasn't been impacted. The prescription hearing aid market has stayed the same or grown 5, 6, 7% over the last two years. And so my question would be what do you know about OTC with regards to the quantity of OTC products that had been purchased or sold in this last two-year period?

John Dicken:

And I think what you indicated is consistent with what we also heard or saw. That there was not a lot of data at this release stage on the actual sales, but we did hear that there was both increase in consumer interest in looking into hearing aids, whether over-the-counter or otherwise. Some hearing professionals reported more inquiries regarding them. But not a lot of early evidence on what the actual volume is, that it has not yet shown a dramatic change. But is a new over-the-counter product available for certain individuals.

Dr. Douglas L. Beck:

Would GAO or the federal government actually have a number even in three, four or five years? And the reason I say that is because it seems to me that a lot of these products, if not 98% of these products, come from overseas, and they can come through Amazon, they can come through UPS. And I'm not saying anything negative about either of those, but my point is that that wouldn't be something that you'd be able to count because it comes in privately and it goes to the consumer privately. Do you have a way of knowing what those numbers are?

John Dicken:

Yeah. And again, just to distinguish kind of GAO as a congressional oversight agency, it would really be federal agencies like the Food and Drug Administration or FTC. But you're right that there is not kind of a mechanism for that consistent reporting. Their focus is making sure that establishments, whether domestically or internationally that are factoring hearing aids, whether over-the-counter, prescription are registered and that there is oversight of adverse events. But the actual reporting on sales and volume is not something that is consistently reported.

Dr. Douglas L. Beck:

And so I think one of my suspicions, and I could be totally wrong, but I think that because the interest was there two years ago, everybody was making a big fuss, and rightfully so, I have published in op-eds. So what I think has happened is that these are perhaps parallel universes that the prescription hearing aid market seems to be very stable and growing at its regular pace overall, the years that we've been looking at that and maybe there is a separate group of individuals who are going to seek and obtain OTC products, but I don't think one necessarily cannibalizes the other. That's totally my opinion. I don't have data to support that. Does that make sense to you? Do you think that that seems about what you've discovered?

John Dicken:

Certainly it seems very reasonable. I don't think we have hard evidence on that, but that seems consistent with what I've heard too. And that over-the-counter hearing aids are intended for individuals with mild to moderate hearing loss, which may provide those to a different population that have been seeking hearing professionals and long-term prescribed hearing aids.

Dr. Douglas L. Beck:

And I think probably from the 2024 demographics I've read, if we say that the vast majority of people with hearing and listening problems have mild to moderate sensorineural loss, all of us in the professional community know that mild is 26 to about 40 decibel pure tone average and moderate is 41 to 70. But patients don't know that and they often will underestimate or overestimate their hearing loss. And many people with listening disorders or subclinical hearing loss, also called supra-threshold listening disorders, many of those people who have difficulty will say, I have hearing problems. They have a listening problem. But to the patient, to the consumer, those two things could be identical. The metric they may use, I can't understand speech and noise, and they don't know why. And so they might seek an OTC product. And so it's really hard to have numbers on these things because we have very mixed group of participants when we talk about patients or consumers we had the categories that professionals use, normal, mild, moderate, severe and profound, and we have numbers that we attach to that. As soon as we talk about self-perceived mild to moderate, we really just don't know.

John Dicken:

That is a concern that we did hear as we talked to experts and stakeholders, that difficulty in assessing hearing loss for individuals. And so that's consistent with both literature and what we heard from healthcare professionals.

Dr. Douglas L. Beck:

Then we look at in page three of the report, and I know that you didn't create any of this and the folks on your team, but they're just reporting approximate levels of noise sources and sounds. They say motorcycles 95 dB. But that in isolation is so difficult because the question is, well, how far were you from it? If you're measuring it at the tailpipe, a meter from the tailpipe, you got a very loud sound. But if you're the driver wearing a helmet going down the road at 60 miles an hour, the opposite way of the sound, it's not 95 dB. Conversational speech in the chart, it says conversational speech is 60, but it doesn't recognize whether it's a dBHL scale, which is what we measure hearing loss in, or whether it's dBSPL, which is the more objective sound pressure level scale to say that average sound level in decibels without specifying HL or SPL. We just don't know.

Dr. Douglas L. Beck:

And the analogy for most people who are not hearing care professionals, we talk about temperature, we can say, wow, it's 35 degrees out. Is that cold or hot? Because 35 Celsius is pretty darn hot. It's about, I'm going to guess, 94 degrees or something like that. But 35 Fahrenheit is just three degrees above freezing. So we know we've got a lot of qualitative stuff throughout here. But nonetheless, your group did a pretty good job at going through this and trying to really understand what is the status. And if you were to summarize, what would you tell me? What did we learn by you guys looking at the data? What takeaways do you have?

John Dicken:

Yeah, I think some of the key points that we found were first looking at to what extent the federal government through FDA or FTC is monitoring the effect of the new available new category of over-the-counter hearing aids, letting Congress and other individuals know what the status is of that. It is still early to have more complete data or experience in less than two years on what the effects have been on hearing loss treatment broadly. But we did hear from stakeholders a number of issues, some of which you've raised today, looking at how the hearing aids are the costs, the availability, making sure that they're appropriate for the individuals that are-

Dr. Douglas L. Beck:

If I might interrupt for just a moment. Go back to cost for a moment. The range is tremendous on OTC products, right? You can probably buy some of these for $39. I don't recommend doing that. But they go up to perhaps $1,000 each for the better quality. What was the average and what was the range that you guys were dealing with?

John Dicken:

Yeah, I think we also saw a range of costs for both over-the-counter and prescribed hearing aids. The report talks about a common range of 200 to over $1,000 for over-the-counter. And then prescription hearing aids, as you know, could be $1,000 or several thousand dollars for that high-quality equipment.

Dr. Douglas L. Beck:

And the thing that I think is so interesting about the pricing, and I don't know the FDA's intent, I don't want to speak for them, but it seems to me overall that when they identified access and affordability as the key impediments, I think those are important, of course, but I think they missed the really big one. And I think the really big one that prevents people from acquiring and wearing hearing aids is actually hearing aid stigma. Even if you go to WebMD or you go to any resources '23, '24, and you just look up hearing aid stigma, you'll see it's alive and well. The stigma relates to many factors, but when people wear big old hearing aids behind their ear, they are thought to have a lower IQ. They are thought to look older, and they are thought to look more disabled.

Dr. Douglas L. Beck:

Now, none of that should be, and none of that is reality. Stigma is to me the biggest issue because there are reports in audiology, and I don't know that the FDA looked at this or that these were considerations they had prior to making their rule. So in 2017, maybe 2018, the American Academy of Otolaryngology--Head and Neck Surgery published in the flagship journal for the AAOHNS, a study by two of my friends, Dr. Mike Volante, who was at WashU at the time, and Dr. Aminah. And what happens in the study is they looked at the cost of acquiring hearing aids in the USA versus elsewhere the cost, getting it in the USA was always the highest of all countries, and they determined more or less, one-third of all people who were candidates for hearing aids acquired them.

Dr. Douglas L. Beck:

But then they looked at places where hearing aids were totally free, like the UK, the EU, New Zealand, Canada, Australia, places where the government provides hearing aids, and they found the uptake was only about 41 or 42%. And that's very interesting. They can get them for free and yet 6 out of 10 people didn't want them. And there are a couple other studies that show that same sort of thing. And I think that is not because of access or affordability, they're free and they're available. I think that's the hearing aid stigma, and I think that's the much more powerful thing.

Dr. Douglas L. Beck:

And what I would've preferred is if the FDA said, hey, listen, we know this is a big unmet need. We have a lot of people with hearing and listening problems. The new Global Burden of Disease study in hearing published in 2024, they show actually one out of every five Americans has hearing loss. And that's pretty startling because most of us thought it was only 38 to 40 million in the USA that would've hearing loss on an audiogram. But they're saying it's up to 70, 72 million people. My point is that if 6 out of 10 people who have access and have them for free don't acquire them, I don't think it's really about access and affordability.

Dr. Douglas L. Beck:

Now, again, that's not your department, you didn't make that decision. I know that. But I think it's curious because now that we have OTC and the better products are a little bit more expensive, that kind of overlaps with prescription hearing aids. Back in 2014, 2015 in The Hearing Review, published a paper, now this is almost 10 years ago, but what he said at that point was that probably 80% of private practice hearing healthcare offices in the USA could provide prescription hearing aids for less than $1,000 for two. They're not going to be the very best, but the patient would be able to go to the office, get a diagnosis, get a prescription, get a warranty that covers loss, theft, and damage for two or three years and walk out for a thousand bucks, maybe 1,500, something like that. And I think that that's still pretty much the case.

Dr. Douglas L. Beck:

I think most private practice offices can see a patient, test the patient, counsel the patient, and provide product for a couple of thousand dollars. And what I'm seeing now in the marketplace, and again, you're the expert on this, but it seems to me the marketplace for OTC two good hearing aids, the left and a right, you're probably starting at about 1,000 or $1,200 and going up to maybe 2,000 or 2,500. Is that a fair range? Is that consistent with what you found

John Dicken:

That certainly with the range of what we heard from people in the industry, yes.

Dr. Douglas L. Beck:

And my issue as a doctor of audiology is that for that same price, they could see a professional. And I do think that a lot of the stakeholders groups, they had some fascinating things to say on page six of your report, consumer preferences and professional concerns. Do you have that in front of you, John?

John Dicken:

Yes.

Dr. Douglas L. Beck:

Okay. So on the bottom one, the bottom point, one study of consumers found a strong preference for working with a healthcare professional. Now, that's not new. We've been saying that for years that given the choice of ferreting your own way through this healthcare problem, would you rather do it yourself or would you rather see somebody? And you guys found 84% [inaudible 00:14:28].

John Dicken:

Yeah, we're citing, we did a review of literature and that's citing a study that was published in the Journal of America and Medical Association last year. But yeah, that was one of the peer reviewed studies that we saw that highlight the importance of the issues that consumers, even in the availability of over the counter hearing aids, the importance of generally education and in many cases, complementary with working with hearing professionals and being able to identify the best treatment for them.

Dr. Douglas L. Beck:

And then you had another point. I mean, I was so impressed with this report. I thought this was spot on, I guess it's point two on page seven. Similarly, a study of pharmacists who may be responsible for advising OTC hearing aid patients in their communities, two thirds of the pharmacists who responded said they did not have the necessary knowledge to counsel patients on OTC. So what do you recommend for that situation? Because I can absolutely imagine somebody going into a Walgreens or a CVS or a Rite Aid or any of the excellent pharmacies around the US and say to the pharmacist, should I get this and what do we do in that situation? Is there any help for the pharmacist?

John Dicken:

Yeah, I think this just speaks to kind of the need from all sources, whether from audiologists and hearing care professionals, for pharmacists to have information for consumers that can be available through federal sources like FDA, which has some resources for consumers. And so FTC plays a role in assuring that marketing of products, including of over-the-counter and prescription hearing aids is consistent with what the requirements would be. And so I think all of this, whether it's for pharmacists or for individuals, speaks to the need for good and consistent information that can be made available and outreach, especially given interest that's been made with the new availability of over-the-counter hearing aids.

Dr. Douglas L. Beck:

I think your point is well taken. I'll tell you what, if the FDA were to call me and ask me, what do we do about this problem? You know what I would say is the easiest way to fix this would've been what many of us recommended in 2017, and that would be to recommend or mandate, whatever the FDA saw as appropriate, that prior to getting a device make services and professionals available to the patient. In other words, say you must get a hearing test by a state licensed professional. And then when they're reviewing the test with you and they're talking about rehabilitative philosophies and products, then once you know the type and degree of hearing loss you have, once you have reasonable expectations, now go out and buy your product. You might buy a prescription product from that provider or you might buy an OTC. We would've saved a lot of unnecessary frustration and mistakes because then the consumer is now educated.

Dr. Douglas L. Beck:

I think that the easiest solution to so many of the stakeholders' points and highlights would've been for FDA to recommend or mandate a hearing test by a state licensed hearing and care professional. Because that person would've looked in your ear, that person would've done your test, they would've explained the test, give you a copy of the test, tell you what type of hearing aid you might be looking for, and then let the patient buy it at OTC or buy it from that provider or another provider. But I think we're in this mess because I do think that the way that this unfolded leaves so much ambiguity and so much uncertainty.

Dr. Douglas L. Beck:

One of the points that you guys mentioned on page seven, difficulty assessing hearing loss, and the second bullet point under that says in a study of hearing healthcare professionals, almost 90% of survey respondents agreed with the statement that consumers are not able to accurately predict hearing loss. I know professionals say that, and I think that that is totally true, but did you see data to support that where patients might've thought that they had a mild loss, it turns out they had moderate or severe or vice versa?

John Dicken:

I think in addition to the study that we cited that you're referring to, we did cite other studies that talked about the issue of the difficulty that consumers may have on both ends. I think we saw a study on page seven that found that about 13% of consumers participating had underestimated their hearing loss, but on the other hand, about 5% had overestimated. So that is certainly something that's challenging for consumers to be able to do as self-assessment or through tests. Certainly FDA went through a five-year process and between the legislation that required them to develop an over-the-counter hearing aid category, but it does have labeling that would suggest when consumers could seek healthcare professionals for some of the issues where they may not be able to accurately assess their hearing or what the best treatment would be.

Dr. Douglas L. Beck:

I want to give you another one or two of the findings here because I think these are really important. On page seven under affordability, you talk about a study before the final rule went into effect, found that 17% of people with hearing loss cannot afford OTC if they cost more than $500, and I have to presume that means 500 a pair. Suze Orman, the financial guru who is brilliant, she says, most Americans, 6 out of 10 Americans don't have $500 for an emergency medical situation. But again, if we're spending $1,000 a pair, that's the upper end or middle to upper end of OTC, which puts it I think a little bit beyond, most Americans can afford, 6 out of 10. And maybe this will change over time. Maybe they will become less expensive and better products.

Dr. Douglas L. Beck:

And the FDA's primary charge was based on access and affordability issues. And I still think that OTC is beyond the price that most Americans can manage it. Again, going back to Suze Orman, 60% of Americans don't have $500. And if they don't have $500 for an emergency, I just don't think they're going to be putting it into hearing aids, particularly if they have a mild or moderate loss. I thought that the original idea, and this is just my own thought process, but I thought originally when we were talking about OTC five, six, seven years ago, that these products would be available for maybe 99 to $200, something like that. And I think many of us were surprised at how expensive OTC can be, and I know there are some products that are $1,000 each in the OTC range.

Dr. Douglas L. Beck:

So John, based on your study of this, I wonder, do you think that lowering the OTC price point retail would change the nature of the report?

John Dicken:

Well, I think that speaks to why it's important kind of in what we heard was that over time, as the cost and technology continues to develop, important to continue to evaluate what the effects of this have been, to make sure that a range of issues between effective treatment for hearing loss and particularly for the mild to moderate hearing loss is for adults that the over-the-counter hearing aids were intended for, that that is being met with products. And FDA's primary responsibility, while the legislation may have been intended to help affordability and availability, FDA's role is really to assure the safety and effectiveness of products. And so the out standard is to make sure that the products that are available are safe and effective. Other federal agencies like FTC want to make sure that they are marketed accurately and clearly. And so the market and the industry itself will continue to develop as technology changes, as different competition changes. And that's why it's important to continue evaluating as the availability over-the-counter hearing aids matures beyond the first early experience that we've seen to date.

Dr. Douglas L. Beck:

On page eight, your group says, with regard to marketing, three of the eight external stakeholder groups expressed concerns about marketing claims for OTC. So I think we're at an interesting point where we know that some of these products can be quite good, some can be quite expensive. I don't get the impression that people are clamoring towards OTC, but I'm not seeing a lot of data yet that really is consistent with access and affordability because I think they've come out quite a bit more expensive than we thought. And access I think is good. Access now, almost any retailer that has a pharmacy is dealing with this. So I think they've improved access. By the same token now it's 2024 and access is also just hold up your phone and put in hearing aids and you've got access too.

Dr. Douglas L. Beck:

I want to just cover a few more things, John, and you're being very generous with your time. These are kind of the footnotes to the work you did. Medicare Advantage plans may choose to cover prescription and OTC hearing aids as supplemental benefits. GAO previously reported 90% of MA, or Medicare Advantage, plans offered hearing aid coverage and about 82% offered at least OTC benefits. So that's kind of interesting. What are the typical benefits that you saw with OTC through the Medicare Advantage programs?

John Dicken:

Right. So our GAOs prior reported looked at the availability of what are known as supplemental benefits, that they may not be part of the Medicare Advantage core set of benefits, but that they can be offered as a supplemental benefit. And as you noted, we found that the vast majority of Medicare Advantage plans did make hearing aids available. What we also found though is that the Centers for Medicare and Services, which administers the Medicare program and oversees it, did not really have good data from Medicare Advantage plans on the extent to which those supplemental benefits including for hearing products are used. And we made several recommendations that they should clarify how Medicare Advantage plans should be reporting information on the use of supplemental benefits and making sure that that is accurately coded.

Dr. Douglas L. Beck:

The last point I want to bring up in the addendums, which is page eight here, where they talk about some of the references, they have a really interesting finding that I think most people would be unaware of, and this is in the GAOL report. And again, I was really pleased to see that they covered this in this much depth. The Department of Veterans Affairs procures hearing aids for its beneficiaries through national contracts with selected vendors.

Dr. Douglas L. Beck:

So I'll tell you that the background story on that is every year the major manufacturers of these products will bid more or less for what they will provide and what the cost will be and then the VA is able to pick and choose what they think is the best value. So that's fine. I have no issue with that. And the VA, we should say, is probably the number one supplier of hearing aids across the USA. The VA buys more hearing aids than anybody else does. According to agency officials February 2024, the Department of VA does not procure OTC hearing aids for its beneficiaries because the cost of prescription hearing aids through those contracts is less than the cost of the OTC hearing aid.

Dr. Douglas L. Beck:

That to me is a very bold statement. I was surprised to see that in the report. And I think it speaks to the probable speed bumps that all of us have to face as we move forward. That these are professional issues, professional products, but when they're purchased in very, very large quantities, the price goes down substantially. This is what we do in capitalism, it's supply and demand, and I have no issue with any of that. But I think it's pretty shocking for most people to realize that the VA is getting such incredible pricing that they don't see a need to go through OTC because they're already getting better products at a price. Can you talk to that point at all?

John Dicken:

You referred to what we found and showed. And I think more broadly we've looked at VA in terms of beyond hearing aids, but their process for purchasing prescription drugs and found similar things. That through their process with contracts, we actually compared the prices they were able to obtain for both brand name and generic prescription drugs to those obtained by Medicare and often found that VA could get prices that were half to two thirds lower than the Medicare prices for brand name drugs and generics. Much of that is a number of reasons for that, they are a direct delivery of purchasing and being able to make purchasing contracts through their system. And so that seems to also be borne out by their contracts for prescription hearing aids where they are able to negotiate lower prices than may be available for other producers and have focused on that rather than over the counter hearing aids.

Dr. Douglas L. Beck:

I wonder what would happen if FDA addressed that. And I know that's not your area. It's not my area. But if FDA were to say we have products that can be acquired for less money, and if we're talking about access and affordability, maybe using that VA purchasing power to buy these products, maybe that makes a lot more sense than trying to create a retail product that on its own can be used without professionals. I'll tell you, at the VA, they have excellent audiology and hearing aid dispensing professionals available to help diagnose and treat patients, and I think that makes a huge difference. And they're doing it for less money than OTC is what it sounds like. So I wonder if you think any of this is going to change. Are we just going to stay in this channel or do you think there's an opportunity for change here?

John Dicken:

Yeah, I hesitate to speculate. GAO's role is to look at the evidence. But certainly many of these are long-term challenges of how to have the most effective treatment for individuals, whether in this case for individuals that may be experiencing hearing loss, technology continues to change and this new category of over-the-counter hearing aids introduce a new dynamic that would be important to continue to track. FDA is the starting point of this, to assure that products that are marketed are safe and effective, but then it's decisions by the actual purchasers, whether that's VA or Medicare or Medicaid or private plans or individuals and their families that may be paying most of the costs because many, many plans, both federal and private insurance plans are not covering this. And so that dynamic will continue to evolve in future years. Why it's important to continue to monitor issues, I think just speaks to within the complexity of the US health care system, we have many of the best products that are available, but they can be available for some individuals at high cost, others that may be able get coverage and trying to address that wide range of issues of availability, quality and cost-

Dr. Douglas L. Beck:

That's a great [inaudible 00:30:05].

Dr. Douglas L. Beck:

John, I wonder if you can comment on this because what I found as a private practice audiology more than a decade ago is if I saw a patient and I was with them 35, 45 minutes and I billed them $200, $250, if they had Medicare, I'd get 38 bucks or 35 bucks. That was the end of it. So the Medicare patient got this great deal and somebody walking in who's uninsured had to pay the full price. I think you're seeing that with healthcare in the USA, that the programs are very different, and it's that when you have Medicare or Medicaid or private insurance, you're subject to a whole different set of cost guidelines. I can tell you that when I was in private practice, it was almost not worth billing for services because reimbursements were so low, but for people who were uninsured, they had to pay the bill. So the person without insurance is paying a lot more for services and products than the person with insurance, and we still have tens of millions of people who have no insurance whatsoever.

Dr. Douglas L. Beck:

So I wonder if you can comment on that because it seems the inequities in our insurance programs are highly problematic. What's the best way to acquire healthcare?

John Dicken:

I wish I had the answers to those problems. That's where I think your experience speaks to the challenges that face professionals as well as consumers in navigating an often complex range of options and availability based on their particular circumstances and location and health coverage.

Dr. Douglas L. Beck:

Yeah, these are big issues. Anyway, listen, it is a joy to speak with you, John. I'm so delighted you gave us the time you did. I want to again say that the GAO is the General Accounting Office and their US Government Accountability office report is called Over-the-Counter Hearing Aids:Information on the New Medical Device Category published by the GAO, May 7th, 2024. And you can just Google that and get a copy. It's pretty easy. And John, thank you so much for your time. I certainly appreciate your presence, your knowledge, and your ability to speak to these issues.

John Dicken:

Great, thank you. Really appreciate your interest and sharing your expertise. Thank you.

 

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