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Dr. David Akbari – Raising the Bar Across Hearing Technology

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Dr. David Akbari

Dr. David Akbari is an award-winning audiologist and public policy advocate, specializing in evidence-based best practices. He is the Senior Medical Science and Clinical Affairs Liaison for Intricon Corporation, where he has worked for over a decade.

Dr. Akbari’s ideas have been published in the Star Tribune, MedCity News, The Hearing Review, Hearing Health & Technology Matters, and The Wall Street Journal. He also serves on the Editorial Advisory Board for The Hearing Review and the Academy of Doctors of Audiology Task Force on OTC Hearing Aids.

Here’s a glimpse of what you’ll learn: 

  • Dr. David Akbari’s background in music synthesis
  • What does Intricon do and how do they create hearing technology?
  • Raising the standards for hearing aids
  • The difficulties of enforcing standards across manufacturers
  • Where OTC hearing aids are heading in the future
  • The difference between providing technology and providing care
  • Treating comorbidities before correlations are officially proven
  • Should patient satisfaction be the greatest priority?

In this episode…

Over-the-counter hearing aids introduce a unique problem to the world of audiology. A complex issue such as hearing care is being given over to the general public, changing the subject from purely medical to financial as well. This raises questions for manufacturers and hearing professionals on how to best take care of patients.

Dr. David Akbari has transitioned his career toward upholding better standards for hearing technology. He is on several committees and boards dedicated to best practices so patients won’t be left in the dark. Now you can learn how these changes will change the audiological landscape.

Dr. Mark Syms is joined by Dr. David Akbari, the Senior Medical Science and Clinical Affairs Liaison for Intricon Corporation, on this episode of the ListenUp! Podcast to discuss better standards for hearing technology. They talk about Dr. Akbari’s background in music and audiology treatment, what Intricon is doing to improve OTC hearing aids, treating comorbidities, and working with manufacturers.

Resources mentioned in this episode

Sponsor for this episode…

This episode is brought to you by the Arizona Hearing Center.

The Arizona Hearing Center is a cutting-edge hearing care facility providing comprehensive, family-focused care. Approximately 36 million Americans suffer from some sort of hearing loss, more than half of whom are younger than the age of 65. That’s why the team at the Arizona Hearing Center is focused on providing the highest-quality care using innovative technologies and inclusive treatment plans. 

As the Founder of the Arizona Hearing Center, Dr. Mark Syms is passionate about helping patients effectively treat their hearing loss so that they can stay connected with their family and friends and remain independent. He knows first-hand how hearing loss can impact social connection and effective communication. By relying on three core values—empathy, education, and excellence—Dr. Syms and his team of hearing loss experts are transforming the lives of patients. 

So what are you waiting for? Stop missing out on the conversation and start improving your quality of life today!  

To learn more about the Arizona Hearing Center, visit https://www.azhear.com/ or call us at 602-307-9919. We don’t sell hearing aids—we treat your hearing loss.

Episode Transcript

Intro 0:04  

Welcome to the ListenUp! Podcast where we explore hearing loss communication connections and hello

Dr. Mark Syms  0:17  

Hey everybody Dr. Mark Syms here, I’m the host of the ListenUp! Podcast where I feature top leaders in healthcare. This episode is brought to you by Listen Up Hearing Center, I help patients to effectively treat their hearing loss so that they can remain better connected with their family and remain independent. The reason I’m so passionate about hearing loss is because I lost my brother Robbie twice, first to hearing loss from radiation to his brain tumor. And then again when he passed away, I only care for years and the e and t. I performed over 10,000 ear surgeries in my career taking care of many more patients with hearing loss. I’m the founder of Listen Up Hearing Center. I’m also an author of the book of the same name Listen Up!: A Physician’s Guide to Effectively Treating Your Hearing Loss if you want to learn more about that go to listenuphearing.com. That’s listenuphearing.com. Today I have a great, interesting guest. It’s Dr. David Akbari. He attended the Berklee College of Music and then obtained his Ed degree from University of Minnesota. He’s a key opinion leader and advocate for evidence based practices. He’s the chairman of the workgroup formulated for hearing aid prescription standards, he’ll give us the alphabet soup and the numbers that are correlated with that. He serves on the editorial advisory board for the hearing review, as well as the Academy of Doctors of Audiology Task Force. And over the counter hearing aids. He’s also the currently the head of audiology at Intercom. And we’ll talk about that more. David, thank you so much for your time coming on to listen up. This is great to have you as a guest.

Dr. David Akbari  1:39  

It’s great to be with you.

Dr. Mark Syms  1:41  

So just you know, obviously I get it. But when you went to Berklee College of Music, what did you study at Berklee?

Dr. David Akbari  1:50  

Oh, that’s a great question. So when I went to Berklee, you know, like many people that go there, they tend to think, Boy, you know, I want to be a rockstar, I want to be somebody that really makes a living in music. But yeah, I suppose, I suppose. But what really attracted me at Berklee was the curriculum involving music synthesis was the degree program I did at the time, which, you know, synthesis is the idea of making something from nothing. And what really got me into acoustics and sort of vibration as a physical phenomenon was this idea of mathematical models of sound, and how you could not only make different sounds in the environment, either mimicking natural sounds or creating totally new sounds. But we also really explored in the curriculum, how do you make alternative controllers for musical performance? So for example, what kind of a gesture make something feel musical, the idea of like, faded-in vibrato, or something like that, where it’s absolutely artificial, but it makes you feel like it’s real. It’s a real human performing that gesture.

Dr. Mark Syms  2:53  

What is faded-in vibrato? For the

Dr. David Akbari  2:54  

so it sounds like this. Ah, sounds like you start flat and then it goes on, you start to add in vibrato and five violin players do this vocalist use it, it’s just generally considered a musical technique. So if you’re creating a synthesizer from nothing, being able to add that in is something that sort of gives you those chops of making something musical.

Dr. Mark Syms  3:15  

Yeah, it’s interesting. I mean, just aside, I was at a wedding this past weekend, and there was a guy playing music at a hotel, he was staying. And he basically you could tell he was recording each part tracked the playing live, he would record one track for about 30 seconds, then the next track for 30 seconds. And then by the time he warmed up the song for about two and a half minutes, he had 45 tracks playing simultaneously, plus his live track on vocals. So I that might be a simplistic, but it sounds like that type of technique you’re talking about.

Dr. David Akbari  3:47  

Amazing. Yeah. I mean, the stuff I worked on was much more boring than that, you know, I was writing software for other people to make music essentially, at the time. And I was actually living in Hollywood, California, when I kind of decided to go back to graduate school and was like, you know, I can really help people with this knowledge, instead of use it to enrich myself.

Dr. Mark Syms  4:03  

Well, hopefully both, hopefully, both. And so that actually leads into so you decided to pursue an AUD degree, correct? Yes, sir. And so was that out of that concept of hearing? Or is that the genesis of it? Yeah.

Dr. David Akbari  4:18  

You know, what was really interesting at the time is that the compositions I was making including you really a turning point for me was the year 2007. I was commissioned by the then head of curation at the Carnegie Hall in New York City, and they was working with a guy named Michael Rhodes and he commissioned me to do some sort of soundscape kind of classical computer music for performance in the young composers series. And you know, I was working on that kind of stuff. And I thought, you know, I’m cultivating such a deep understanding of the phenomenon surrounding vibration as a physical phenomenon, you know, vibration as it exists in the universe. But what if I could enhance my knowledge by understanding how that affects the human body? Like, how do we understand hearing? And that led me to study of hearing science, the clinical applications of hearing loss? Like how do people when they lose their hearing? What happens? You know, so things like, you know, the widening of the cochlear filters, or the physiological tuning curves and things like that, and all those great hearing science concepts, I had no knowledge of that at the time, but I knew I wanted to learn it. You know, that makes sense. Like, you don’t know what you know. And until, you know, a little bit and then you realize, wow, I have so much yet to know.

Dr. Mark Syms  5:26  

Yeah, and psycho acoustics, as well — absolutely.

Dr. David Akbari  5:30  

I mean, they talk about that in music. You’re right. I mean, they talk about psychosis all the time, but it’s sort of poorly defined to be honest with you. Yeah,

Dr. Mark Syms  5:37  

I mean, that’s actually fair enough, right. It’s kind of a big bucket that different people put different stuff into, I actually think it’s an underappreciated part of hearing by one of the most underappreciated parts of hearing. Oh, definitely. So so that later you get your AUD degree, and then where do you go?

Dr. David Akbari  5:53  

So, you know, as I was doing the AUD degree, I sort of was distinct from a lot of my peers who wanted to sort of just go into hospitals and work in clinical practice, I really early on wanted to be in the industry, because it really was a good fit for me synthesizing what I learned about sound, the science of sound and everything. And also, you know, what I could do in terms of product development. I mean, that’s really what the kind of stuff I was doing at the time was writing software for other musicians to use to create, you know, like Hollywood films, for example. And I thought, well, you know, I have all these great ideas about directionality and speech in noise, or even music and noise, like sound source separation kinds of ideas. And like, Wouldn’t it be amazing if I could implement that on a very low power body worn device, such as a hearing aid? And that’s kind of what led me to seeking out a company who would allow me to pursue that passion. And that’s where I found Intricon Corporation.

Dr. Mark Syms  6:53  

All right. Well, as you’re saying in the warm up, it’s a very interesting name, but it’s not totally descriptive. In other words, you know, so what do you do for Intricon? And what does Intricon do? Yeah,

Dr. David Akbari  7:07  

Okay, so maybe I start with what Intricon does. So Intricon is a medical device manufacturer. Unlike a lot of medical device manufacturers related to hearing aids, they don’t just make hearing aids. So hearing health is one of the key parts of the business. But they also make diabetes monitoring devices for a company called Medtronic. Intricon also makes surgical navigation and electromagnetic tip location sensors to assist in certain types of surgery, as well as what’s called the chocolate balloon catheter, which is a type of catheter that’s drug coated in is allowed to be used for certain therapies and interventions in that way. And so hearing health is just part of the product portfolio. And what I’ve done at Intricon is I’ve been there over 10 years now. And for the first I want to say nine or so years, I was in an R&D capacity, the research and development. And my brain just really loves that stuff. I just love research and development. But since there’s been all this brouhaha about OTC or over the counter hearing aids, it’s over the last couple of years, I’ve actually transitioned into a regulatory role. So that’s what I’m doing today is I’m working more on the regulatory side to ensure compliance worldwide for testing the hearing aids and the standards. And that’s kind of what you know, sort of fell in my lap was the, you know, being the chairman of this working group on doing the standards for prescription hearing aids, as well as being a sincere advocate for getting the policy prescription right on OTC hearing aids.

Dr. Mark Syms  8:37  

So forgive me, David, go ahead. And please give the formal I mean, I was kind of making light because it’s a quite a committee name. But go ahead, if you would give the formal name of the committee that you’re working on standards for prescriptive hearing aids.

Dr. David Akbari  8:52  

Oh, sure. Okay. So it is a committee the formal name is ANSI/ASA, which stands for American National Standards Institute, and the Acoustical Society of America. And it’s, it’s a group called S3, which is bioacoustics, working group 48. So it fits into a broader scheme with the S series. So like, there’s S1, S2, but S3 really is bioacoustics. There’s actually a subgroup called animal bioacoustics, which I’m not involved in. But the bioacoustics group is the bucket with which we’re under. And it comprises quite a large and diverse thought leadership group among the industry. In fact, we just had our meeting last week in Seattle, peripheral to the triple eight show. And I think there was 42 people from 18 countries that were joining and they were all there really to help the American policy prescription, both in terms of you know, where we need to go in terms of the standards and the measurements, but also in terms of actually sussing out the details. So for example, a lot of these people had concerns about certain aspects of the OTC hearing aid final rule. Others wanted to discuss the technical details of doing good testing. And keeping in mind that the tests that a lot of clinicians use to determine whether a hearing aids good or not, is what’s called ANSI S322. And it’s those two CC coupler tests for QC are for quality control. And that’s a really flagship standard, a really important standard for prescription hearing aids, as you mentioned.

Dr. Mark Syms  10:30  

And so what’s the overall charge of the committee? Like what, when, when the committee or if it, you know, comes to fruition in terms of its first standards? What area of clinical practice, you know, getting kind of where the rubber meets the road? Will that kind of apply to or cover?

Dr. David Akbari  10:47  

Yeah, it’s a really interesting question, it actually will affect every single hearing aid that’s sold in the United States period. So for example, with the OTC hearing aids, there’s another standard called NC CTA, which is this Consumer Technology Association. And their standard is 2051. And it’s historically been considered, sort of, quote, unquote, PSAP standard, personal sound amplification product standard, but it’s been repurposed by the FDA to be used for the OTC hearing aid rule. And the reason for that is it’s got criterion referenced values in there. So for example, it says you can’t have a hearing aid more than 120 dB SPL, which is that pico SPL 90, if you look at the standard, it actually references, NCS 322. All throughout. So what’s interesting is that there are two different purposes is the CTA is meant for a criterion referenced value. And the S322 does not include performance criterion, because it’s meant for the manufacturers to set their own. And typically what happens is they’ll do a statistical distribution, and figure out min max nominal kinds of things there. So to answer your question, it affects every single hearing either sold in United States.

Dr. Mark Syms  11:57  

Okay, and so how does it affect it? In other words, so to the common person, like, okay, so you got these standards? What does like so you give the standards, the manufacturers, but what does that affect? Or how does that affect them?

Dr. David Akbari  12:08  

Oh, sure. So it does a few different things. So the first thing it does is it creates a method that’s reproducible, to test a hearing aid period, just to test it like, so there’s all sorts of informants

Dr. Mark Syms  12:19  

Or to test its integrity?

Dr. David Akbari  12:24  

Both. So if you think about the words, and the word we’d like to use is quality control, because it does both like the performance aspects, how does it perform? What’s the gain? What’s the output? And the integrity? Is something wrong with it? You know, you know, it’s a way to assess if a part’s dead, and it’s actually a common test that clinicians will use when they order a hearing aid for a patient to see — is it working, coming out of the factory? Or is it defective? That’s a really common use of it. So it’s intended to be a test method that’s reproducible. And manufacturers are allowed to set their own tolerance. That’s kind of the key thing with S322. And key and this distinct feature of the OTC rule/

Dr. Mark Syms  13:03  

You mean determine whether what percentage of their manufactured hearing aids need to meet it to consider them within standards, or?

Dr. David Akbari  13:09  

That’s one aspect and then the other is on any individual measurement? What is the pass-fail criteria?

Dr. Mark Syms  13:14  

More likely this hearing aid in particular passes or fail? So exactly. That’s why it’s quality control. So it’s these are manufacturing standards, in terms of what how often can it not meet those standards? And what are those standards that they should meet? But they set them themselves in terms of what percentage they have to meet? Is that correct?

Dr. David Akbari  13:33  

That’s right. And typically, that’s the result of what we call an operational qualification or OQ test. And you basically you manufacture 30, hearing aids or something, you test them all, and you plot a distribution, and the you sort of call the tails, the min and max, and then the median is the nominal or similar. I mean, other manufacturers have different ways of doing it.

Dr. Mark Syms  13:51  

But this is an interesting concept. So what would cause so you know, I mean, honestly, from let’s say, from a consumer electronic point of view, we pretty much expect each iPhone to do the same thing. Right? And on occasion, maybe there’s a short in one or something from a management but by and large, you know, an iPhone is an iPhone is an iPhone, right? So from a hearing aid point of view, what was the two variability within 30 different hearing aids being manufactured? This is what I mean, I don’t know enough about the manufacturing process. So it’s kind of an interesting question.

Dr. David Akbari  14:26  

It’s a very interesting question. And the answer to the question is, when you’re designing and manufacturing hearing aids, oftentimes what you’ll do is you’ll outsource certain specific components, like the receiver, for example, which counterintuitively does not receive sounds but produces those sounds. What I tell patients is the speaker that’s right, and the idea is if you run the processor, it’s receiving a signal from the processor that’s right and it’s functioning as a speaker. What happens is if you buy those components from another supplier, there is inherent variability in the component itself. And so when you’re combining different components, you’re sort of adding those sources of variability together. And so when you have the final finished product, you might have a little variability from the receiver, little variability from the microphone. And those tiny amounts of variability add up in the manufacturing process. It could be something like two, three dB or more across a spread, and it’s enough to say, Oh, my goodness, you know, somebody could hear that or it’s a difference. And typically, it’s a well-controlled manufacturing situation, because they’ll open them up. And they’ll figure out well, what is it so this measure correlate, for example, you know, total harmonic distortion might correlate to resonance phenomenon, the instrument, you’ll have the it’s really tiny, and it’s kind of rattling around, and you got to figure out it, you know, maybe you need to isolate it, or there’s it relates to the design, as well as the component selection.

Dr. Mark Syms  15:46  

And so correct me if I’m wrong, there aren’t a lot. So the speaker microphone side or microphone and receiver side, there aren’t a lot like by and large, there are a couple of manufacturers of both. Is that correct? That’s right. Yep. There’s not a huge amount of them as many microphone manufacturers are there out there?

Dr. David Akbari  16:04  

Oh, my goodness, I couldn’t tell you offhand. I mean, I gotta believe there’s less than 10? For sure. I mean, I’m aware of like the big ones like Knowles and Sony on and in those, there’s perhaps several more.

Dr. Mark Syms  16:16  

And then how about on the receiver side? There are only a couple of those about the same?

Dr. David Akbari  16:19  

Yeah. You know, it just depends. I mean, the technology hasn’t really changed that much. You know, it’s these little membranes that vibrate. You’ve got MEMS microphones and other things that are more encapsulated, more rigid surface kinds of things for small embodiments, with their power supplies and so on. But to your point, yeah, there’s, there’s not many, I think the biggest differentiator is a lot of the big manufacturers are molding their own rigs and making their own receiver units and so on nowadays, you know, but that’s not as typical as we might think.

Dr. Mark Syms  16:47  

And so interestingly, because you know, when you think about the brains are the DSP that by and large, should have, that’s like, kind of the iPhone equivalent, right? You would, but the same output, it’s actually the parts that the manufacturer puts on their chip, that actually determines the performance. variability in performance, I should say. Sure, sure. Oh, that’s, that’s really fascinating. And so the, the workgroup is to give the standards that then the manufacturers assume that manufacturers have a seat at the table as well, in terms of giving input for

Dr. David Akbari  17:22  

this, exactly the manufacturers do, as well as the FDA. They sit on their representatives from the world. So there’s people from you know, I want to use the example of Germany without naming names, you know, the guy that runs the major test house over there, in order to sell products into Germany. I mean, you’ve got to go through his test.

Dr. Mark Syms  17:41  

Environment, right.

Dr. David Akbari  17:44  

Yep, exactly. And, you know, there’s — everybody’s got a seat at the table. And I would, you know, add to your listening audience, it’s free to join. There’s no requirement other than that you’re willing to participate. And it’s very formal. I mean, it’s conducted in a very formal way such that there’s a gavel procedure, and, you know, we gavel resolutions and, you know, call the orders on. Okay.

Dr. Mark Syms  18:05  

And so the other thing that you mentioned that you’re so involved in, is, you know, you were on a maybe still are the Academy of Doctors of Audiology Task Force and over over the counter hearing aid. So that’s on the other side, between prescriptive and over-the-counter, correct?

Dr. David Akbari  18:20  

Yeah, it’s actually mostly focused — at the time, was focused on the over-the-counter stuffing directly. The idea being that they wanted to provide inputs to the FDA, as part of the comment period to get the best possible outcome for the independent audiologists are those who are seeking autonomy of practice. Right.

Dr. Mark Syms  18:40  

Okay, and so that that I assume, to some extent, that’s come to a culmination right. In other words, the rules are out. And then if there’s a revision, it would go and try to help with a revision, is that correct?

Dr. David Akbari  18:50  

Yeah, that’s right. It’s a really great group. And it was separated in terms of like technical aspects versus like the public policy and licensure aspects and so on. And, you know, kudos to the ADA for really recognizing the need to go about forming the taskforce and then issuing the comments and opinions to help shape the public policy outcomes.

Dr. Mark Syms  19:09  

Yeah. So now just kind of stepping back. I mean, because it sounds like you’re really involved in a lot of this just through the nature of your positions. Looking at it from kind of a higher elevation, what do you think’s happened? And so we’re into OTCs. You know, there were some people who would have told you it was like the equivalent of Y2K, but you know, we were going to have all these crashes of all these systems, and in the end, the world just kind of went on. So you know, kind of what’s your take on where things are with all of that right now?

Dr. David Akbari  19:39  

Yeah, that’s such a great question. And I really appreciate you asking that. You know, my take on it is that there was a lot of time, talent and treasure and the debate over OTC spent on the issue of output and gain. And really, you know, when you’re going through the process of getting these OTC products on the market, they look at output gain, they say, Well, that’s good. rate, but tell us about the wireless performance coexistence and radiated immunity and tell us what you’re labeling. So it really doesn’t ultimately have a lot to do with outputting gain. And so what I think has happened in the work of the standards group has kind of confirmed this is that they’re, the FDA had a really tough job, let’s be honest, and kudos to them for doing what they did. But on the one hand, they’ve got the congressional mandate, which is that you have to come up with these set of performance criteria that are going to influence public policy. On the other hand, they’ve got the industry saying, whoa, whoa, whoa, this is going to totally disrupt our business models, it’s going to cannibalize our existing consumer base, which is the providers. And it’s going to cause devastation. So we can’t allow this. And so what’s happened is, as a result of all that, in the antsy, CT 2051 standard, there’s a couple of measurements that people are concerned about. And I think it’s worth going into the detail on that. Yeah, so the the first is this distinction that’s been added for input versus output distortion. So recall that for the public policy debate, there was a huge amount, like I said, of time, talent, treasure dedicated to output and gain. And the FDA decided they wanted to put a limit on output, they chose 117, peak oil spill 90 as that maximum limit in the two CC coupler. And they chose not to have a gain look, by the rules. Well, what actually happens is, if you look at the test for input control distortion, you actually have to produce an output static output a 70 dB, and you have to produce, you have to sort of take the hearing aid way down to get that output. Well, the problem is you’re into the noise floor. And if you couple that, with the 5% maximum performance criterion, it becomes an implicit gain limitation. And this is something that I’m preparing, you know, to sort of gently or friendly remind the FDA, you know, that they chose not to enforce a game rule. But yet there is one, arguably in the final rule that they need to address. The other one is that people don’t realize this, but the OTC hearing aids are actually currently held to a much higher standard than the prescription hearing aids, because they actually have a defined set of performance criteria and where manufacturers just get to say what the prescription is. So what’s happened as a macro result of all this is that we, you know, there was many predictions, I myself have been on several programs making macroeconomic predictions about how this will increase access and affordability in a macro economic sense by providing more competition, which has a downward effect on price. But what’s happening is, I think, tactically, right now, a lot of people are struggling to get through the 510 K process because of some of the ambiguity around some of these standard measures. So you’re not seeing as many of like the sell fittings and the innovation that you might have expected to see as quickly as we might want to see it. But what I can say is that after what DC has come about the policy prescription, which was access, meaning people who can’t have access to a calibrated equipment, or who live in rural areas, and also the affordability, where you know, it’s a little bit less cost than they might have with a provider with a bundled model. Those are actually emerging today. I mean, you’re seeing products like the Lexy lumen, powered by Bose, you see, you know, a couple of the other ones, like the new Hearos IQ buds are out there as an OTC product. There’s several more, I expect, there’ll be many, many more as time goes on, and as the public policy increases, but I think, overall, that’s what’s happening is you’re not seeing as much as you might want to see, although I think the goals of the policy prescription are starting to manifest.

Dr. Mark Syms  23:34  

Yeah, it’s interesting, because my take is, access is an issue, but it’s really CIC the MS awareness, I think, you know, this will make people much more aware that there is technology that can help them rehabilitate their treat their hearing loss, and it’s kind of an entree product, right? And so sure, and then you realize, well, some of them will realize, well, if I can get a correctly adjusted prescriptive product, I’ve got a much more likely chance of being satisfied with my ability to hear and communicate. And so that’s kind of where I see it going.

Dr. David Akbari  24:04  

Well, and that’s such an important point too, Mark, that you’ve got this potential where everybody thinks of OTC as this be all end all, but you just hit the nail on the head, I really think it’s about providing this effective on ramp to ongoing care that sometimes we use the term hypercare that you can get access to your care, your condition may change and that you have you have those resources to help you and that it also folds into some sort of an oral rehabilitation program. Things that people aren’t billing for, necessarily today aren’t really a source of funding, but absolutely affect the public policy and public health outcomes, which is really what this is all about.

Dr. Mark Syms  24:39  

Right? Right. But on a macroscopic level, obviously right and so it’s like anything, some people you know, want a bespoke totally custom product and some don’t. And so having I’m not sure they’re the same people that that you’re competing for, but it certainly should hopefully give a better name to rehabilitating your hearing loss with you hearing technology, be it OTC or prescriptive?

Dr. David Akbari  25:03  

Definitely Well, and that’s what I like to tell people is that, you know, much like in the 1970s, when it was seen as potentially unethical for the same person to test the hearing and then dispense the hearing instruments, that now we’re in a similar historic moment insofar as the providers are able to decouple themselves from the provision of the care, as opposed to being device salespeople. I think

Dr. Mark Syms  25:25  

that’s it. I mean, I think that some of that paradigmatic application, that paradigm is that people are self imposing, right. In other words, you know, there is a kind of belief that if you dispense hearing aids, you sell Alright, sure, I believe when you dispense hearing aids, you treat people’s hearing loss. And so, you know, it’s the difference just becomes the room enumerative environment, right. In other words, you know, if your primary care doctor prescribes to you, high blood pressure medicine, that renumerated model is different, but it’s still somebody in quote, selling you a type of treatment. That’s a great point. Right? And so, you know, you know, it’s that counseling and getting people you know, because in some ways, you could look at it as a difference, right, like, so we can all go to Home Depot, and we can all buy buckets of paint, and we can all self-applicate. So that might be, etc. Some people might choose to hire a painter who goes and picks the pain out and applies it for you. And that’s hiring a painter. And so there’s, there’s really a different model in terms of getting what you want to get done, how you want to get down on what the price point is, and getting it done. I would posit to you even though I’ve painted a decent amount of my life, a professional painter is going to do a better job than I am.

Dr. David Akbari  26:43  

And I think that’s absolutely right. And that’s such a great metaphor as well. And I think that’s really applicable to OTC which is why it’s so important to encourage people to have that on ramp to the prescription hearing aids as they need them as well as to that on ramp to the oral rehabilitation piece.

Dr. Mark Syms  26:57  

Right? I mean, I guess it depends what you mean by on ramp, right? So I’m not sure whether or not you know, so people who paint to come and paint your home, they don’t tell you, Well, let me help you go get the paint at Home Depot, they just say, you can go get the paint at Home Depot have at it. And if you want my services come my way. So that that’ll be an interesting thing. Because I know, some people who do prescriptive hearing aids are kind of doing OTCs as well. Um, it’ll be interesting to see if that really makes sense as a differentiator.

Dr. David Akbari  27:26  

Yeah, and I suppose that’s what I sort of mean by the on ramp is this idea that, you know, you say you get your feet wet, or you dip your toes in with OTC and you decide for whatever reason, it’s not right. But you don’t want to give up on hearing aids altogether, you’d like to try something different. And that’s when you say, well, maybe I need the person to paint my house, because I’m sure just not getting the quarters, right, or, you know, whatever.

Dr. Mark Syms  27:44  

Yeah, I mean, my big concern, though, is people who have poor performance with OTCs, and use that as a justification to never treat their hearing loss. And so that’s kind of that’ll be an interesting thing to see how that, you know, cooks out, or how that all pans out?

Dr. David Akbari  28:01  

Yeah, definitely. What my hope is, is that there’s enough product options available at a variety of different price points, that they can kind of see where their risk tolerance is, as a function of price, for benefit. So the idea being that, like, if people don’t perceive the benefit, well, maybe just having a tiny bit of benefit for a small price is better than having more benefit for more price. And we’ll see you’re right, if this is something that’s going to be born out in the market.

Dr. Mark Syms  28:25  

Yeah, that’ll be interesting, though. I mean, I guess it depends what you consider success, right? And so by example, it is not considered in medicine. If I give you an anti-high blood pressure medicine and, and your blood pressure is now 160, over 90, that would not be considered success. And so I wonder if the concept is you hear less bad, I’m not sure we should actually consider that success, especially if there’s an associated risk of dementia, you actually should get to whatever the best rehabilitative option is possible if we’re trying to decrease the impact of dementia.

Dr. David Akbari  29:03  

It’s such a good point. Yeah. Because the idea is like, if we’re trying to influence the public policy, that public health outcomes mean, that’s where you want to focus. So for sure, you’d wanted to find that first. And I think where the FDA is kind of trying to put the table stakes are like the access piece alone, you know, in sort of peripherally affordability. But what we’re seeing is actually a lot of these ot C’s are not that much cheaper than doing the prescription route. So people are asking that question, why not just go to the provider?

Dr. Mark Syms  29:27  

Right now? Well, I mean, I think right. So I mean, it’s actually kind of interesting. In another division of the FDA, there’s certain like, so there are very safe and efficacious high blood pressure medicines that have been around since the 50s. But interestingly, they are not over the counter. Right. Some of that has to do with the disease process, right as compared to perhaps allergies where they are over the counter. And so, you know, what is the health criteria and so if you’re trying to mitigate risk of comorbidities of hearing loss US, and you actually need to have ensure that the hearing loss is treated. And so suboptimal treatment where you know, you hear less bad is kind of an interesting, I actually think it’s a quagmire from a public policy and implementation point of view, right? Less bad hearing is really what we aspire to?

Dr. David Akbari  30:16  

That’s right. Well, you’ve got, you’re gonna have people with a variety of the disease conditions as well. Certain people, for example, might say, Well, I have tinnitus, that’s debilitating. And yeah, I got some hearing loss too. But I just really care about the tinnitus. And so they’re hearing less bad in that sense. They’re really not treating the hearing loss per se, but they’re doing what they’re choosing kind of the a la carte for their symptom. And I agree with you, I think there’s there’s some work that could be done in the public policy side, to help encourage people to get those best practice public policy outcomes,

Dr. Mark Syms  30:42  

I think that evidence of the comorbidities has to evolve to right, you know, sure, compelling evidence, not that it’s not but more compelling, which is kind of interesting. You know, if you look at medicine, so high blood pressure is a great example. Medicine started treating hypertension or high blood pressure in the 1950s. And the evidence showing that decreasing the high blood pressure mitigated, the risk of heart attack came out in the early 1970s. And so there are many things we do in medicine before we actually have the outcome data to demonstrate that. So it’s kind of I don’t know what the thresholds would be in terms of the power of the study to show the morbidity, morbidity, secondary to hearing loss. So it’ll be fascinating in the next five to ten years.

Dr. David Akbari  31:25  

It’s really fascinating. I think, to your point, you know, even the example you gave about dementia and hearing loss as they’re related to each other, you know, even the literature on that even this year is coming much more strong were at the end of last year, people were really questioning that even you know, in the, you know, in the side of getting products cleared for the market, and you know, they look at claims and so on.

Dr. Mark Syms  31:44  

Why they’re questioning it, because perhaps it’s commonsensical, but you might not have the study that demonstrates it, right. Sure. Absolutely. You’ve known that problem for decades. It’s just now somebody is, you know, putting the chops to the data to demonstrate it. Yeah. So I mean, what is the particular cause cognitive load versus a social isolation is probably a little bit of both. But you know, in the end, you’d be hard pressed to argue somebody with hearing loss, getting their hearing loss treated appropriately, is a good thing. So you’re not going to do harm to them.

Dr. David Akbari  32:18  

Yeah. Yeah, that’s right. And I think that’s one of the things that maybe was a little bit overblown, in the lead up to the OTC final rule was this perception that there’s going to be tons of harm that’s given to society writ large, as a result of over the counter hearing aids. And I think perhaps it could happen. But I think it’s more likely to be the example you gave where people are just tolerating bad fittings, as opposed to people are blowing their eardrums out with intent, excessive sound pressure level,

Dr. Mark Syms  32:45  

Right. But I would argue to you, for fittings in OTCs, and poor fittings and prescriptive hearing aids are a widespread that I can’t say for OTCs. But in prescriptive hearing aids is a huge problem in and of itself.

Dr. David Akbari  32:59  

Well, and to your point, I mean, if it’s a problem in prescription hearing aids, the OTC is a lot of them are just going to follow that same approach just going to change the labeling intended use. So perhaps it’s all sorts, it’s likely to be a problem there as well.

Dr. Mark Syms  33:10  

Well, I mean, ideally, not everybody has factory settings, right?

Dr. David Akbari  33:14  

Yeah. Yeah, that’s about right. Well, and you know, the FDA, I can say to the audience here that they are very serious when they review this stuff. I mean, they are willing to challenge not only the outcome measures of your clinical data, but also the response skill and the validation of your your, your harvested patient response outcome instrument, you know, so let’s say you did, as you said, How do you like your hearing aid fitting on a scale of one to five, you better be ready to validate and prove that you have statistical evidence to show that your instrument is valid and generalizable? I mean, so they’re, they’re not just going to let stuff get get through on this.

Dr. Mark Syms  33:48  

That’s an interesting model, though. Why is patient satisfaction a measure of outcome?

Dr. David Akbari  33:55  

It’s a good question, perhaps where the sales end goal is.

Dr. Mark Syms  33:59  

So what’s the patient satisfaction of being normotensive? Right? So if your blood pressure is 120, over 80? What’s the satisfaction level? I mean, actually, people tolerate side effects from the medicines to get there, right. So it’s really mitigation of risk, right? So you want to be normotensive to decrease your risk of heart attack and stroke. And so if you want to be mitigating your risk of dementia, for instance, you need to be prescriptive, right. And so it’s kind of an interesting concept. I don’t get perceptual patient perception as a criteria for treatment of disease. But that’s a bigger conversation. So it’s a kind of an interesting paradigmatic approach.

Dr. David Akbari  34:35  

It’s a really important conversation too, because I think a lot of the data that’s coming out is at least to some extent, using patient perceptual data, exactly your point to reinforce the mitigation the disease process, which may be inappropriate, as you look to

Dr. Mark Syms  34:47  

and that’s a social approach. In other words, a social awareness approach to hearing loss, which to me, I mean, I’ve had people with significant hearing loss as you look at me and say they don’t have one. Yes, your perception and we know that surveys don’t correlate with audiogram. Right? In other words, so social perception of your hearing loss doesn’t correlate with your actual audiogram. So it’s kind of a fascinating concept to be kind of like asking somebody to high blood pressure. Do you feel like your blood pressure is high? Oh, yeah, you do? Okay, well, then let’s give you a pill, you don’t feel like it’s high. Okay, let’s not. But interestingly, we do do an audiogram, which is an objective measure of hearing loss. And so I think one of the problems is, we are all stuck in a social perception, concept of hearing loss other than an actual prescriptive prescription, like you have a hearing loss, you need to treat it. Whether or not you perceive it doesn’t matter. That’s really interesting. Yeah. It’ll be interesting to see where that all goes. So Well, this has been a great conversation. David, I asked everybody, what’s your I mean, especially you, you went to Berklee did all this stuff you’ve been around. So what is your favorite sound?

Dr. David Akbari  35:46  

My favorite sound? Oh, my goodness, I have a very specific answer for that. Right. So you know, in my spare time, and you know, as a result of studying, you know, all kinds of music and being a musician for many years, one of the things I just love to do is to I call it blending cultural influences. So it’s like, you know, mixing records, like turntables, and whatever, you know, you might do a digitally, but this is my favorite sound is when you’ve got two separate pieces of program material, and you combine them to make something new. I just, I love that. And it kind of speaks to this whole presence. Have you ever heard when people say classical music makes you smarter? Or you smell flowers? Maybe? So like, actually deconstructing? That was something I was really interested in years past. And we’re finding or what we found in the, the neurophysiological correlates, are they if you can produce a slow moving sound, and then have different rates of modulation layered on and it gives you that same effect in classical music just

Dr. Mark Syms  36:43  

naturally does that but right, it’s part of its intrinsic to classical music. Yeah. And

Dr. David Akbari  36:47  

so for me, that’s my favorite sound is combining like two different, you know, songs or sounds or

Dr. Mark Syms  36:53  

mix, Master. You’re mixing music. Yeah, it’s like

Dr. David Akbari  36:56  

real time arranging. It’s almost like what I tell you.

Dr. Mark Syms  37:00  

Well, which is kind of what some DJs do. Yeah, exactly. That’s right.

Dr. David Akbari  37:02  

Yeah. And, you know, if I’m being honest, I this was something I like to do when I’m not working is

Dr. Mark Syms  37:08  

the whole, you know, that’s been a big part of rap music. Right is sure. Makes sense. So that’s kind of, that’s great. Well, this has been great. If people want to get a hold of you. How would they get a hold of you?

Dr. David Akbari  37:20  

Yeah, so probably my socials are the best way to do that. You know, I’m on LinkedIn. And that’s probably the best one for professional interactions, just send me a message, or you can contact me through there. I don’t really use a lot of the other ones, like Twitter or anything. But I do use LinkedIn. So maybe that’s the best one.

Dr. Mark Syms  37:37  

Again, everybody. This is Dr. David Akbari, you know, he’s doing working on the standards for prescriptive hearing aids, the NC standards, and he’s also the head of audiology at Intricon. And so if you want to reach out have any questions for him, you know, he’s been generous with his time with us, and I’m sure he’ll answer connect with you, David, this has been a really great discussion and really appreciate your input and look forward to seeing what you do. You know, with the standards, I’ve been on standards committees. It’s a, it’s a long process, but it’s usually worth the outcome at the end, but it’s a wonderful thing that you’re doing and the other work that you’re doing is excellent. 

Dr. David Akbari  38:14  

Well, thank you, Dr. Syms, and it’s just so great to be with you. 

Dr. Mark Syms  38:17  

Alright, thanks for coming on. And this has been great.

Outro  38:22  

Thanks for tuning in to the ListenUp! Podcast. We’ll see you again next time and be sure to click subscribe to get updates on future episodes.

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