Comparing Self Fit Hearing Aids to Professionally Fit Devices: Exploring Intricon’s Clinical Trial Results

self fit hearing aids clinical trial intricon
July 7, 2022

The ecosystem of hearing care service delivery continues to evolve as technology enables patients to self-fit their amplification intervention.

In this episode, David Akbari, AuD, Senior Medical Science, Clinical and Regulatory Affairs Liaison at Intricon Corporation shares the research methods and outcomes of Intricon’s self-fitting amplification technology called Sentibo. In particular, Dr. Akbari shares the nuances of how the Sentibo device uses a proprietary algorithm that is not based on traditional hearing prescriptive models, and yet provides optimized audibility and sound quality to the end user.

Full Episode Transcript

Amyn Amlani 0:10
We’re all aware of the technology advances in hearing aids. Now the hearing care market is seeking to expand its ecosystem of service delivery options in this space. Here with me today on this week in hearing is Dr. David Akbari senior medical science, clinical and Regulatory Affairs liaison at IntriCon micromedical technology. Welcome, David. And would you kindly share your background with our viewership?

David Akbari 0:35
Hello, Amyn, it’s great to be with you. So my background is I’m an audiologist. And I got the AuD and MA degrees at the University of Minnesota Twin Cities. But my background in this really started at Berklee College of Music where I did my undergrad with a specific focus on music synthesis. So I looked a lot at software development, and more specifically haptic interfaces for musical expression, which was something that at the time, I had no idea it would lead me to audiology, but here I am.

Amyn Amlani 1:04
Oh, that’s really, really cool. So Intricon Corporation, we’ve heard this name several times with some of the products in interfaces that you all have had with product development. Can you tell us a little bit about the company?

David Akbari 1:19
Sure. So Intricon, corporation’s really been making many, many high quality regulated medical devices for 45 years. So the company started in 1977. And Intercon really focuses a lot on the medical side, with continuous glucose monitors, interventional catheters, electromagnetic tip location, and surgical navigation, all sorts of micro- micro electronics assemblies, but Intricon itself started as a hearing aid company making components trimmers at that time, these days, of course, hearing aids have advanced a lot. And so Intricon has also advanced with the addition of ultra low power wireless technologies in hearing aids, digital signal processing. And generally Intericon is a joint development manufacturing company for body worn medical devices. So it’s not just a hearing aid company, and actually was named Minneapolis St. Paul Business Journal 2022 manufacturer of the year.

Amyn Amlani 2:12
Oh, congratulations. That’s really, really cool. So almost a one stop shop. You know, it’s kind of the best buy, if you will for for these, these kinds of micro electronic tools. Sure. Okay, so let’s start out before we dive into this, this this really cool study, that was the results were released. Let’s talk a little bit about the state of the industry. And we know that the penetration rate isn’t where we want it to be. And we know that that’s caused by various aspects. And so we’ve had all these advances in technology, and we have all these legislative reforms that are now leading to accessibility and service delivery. So let’s talk a little bit about this and then move into this self fitting components that you all have released.

David Akbari 3:00
Sure So you know, with regard to low penetration rates caused by various aspects, at the biggest level of this, really, it’s about access, and affordability. And so the United States is a very big place. And so when we think about audiology, you tend to think about a very medical environment with calibrated equipment, skilled, licensed professionals, it’s really a white coat type of experience. But many people in the United States live in areas that are quite remote, and they don’t have access to that type of calibrated equipment, professional skill sets, or any of those tools. So former CEO and board director Mark Gorder, really saw a trend early on and commissioned a lot of research to look at why there were problems with penetration caused by various aspects, including in the mid part of the last decade in the mid 2010s, we were at the first new entrant into the NHS and 35 years, which is a socialized health care system. And what I found really interesting working on that myself was that even in the UK model, the penetration rates aren’t what people would perhaps want them to be. And if you really peel back the onion in terms of consumer satisfaction, one trend that emerged, at least in my view, was that the number one reason people want hearing aids is also the number one reason they’re dissatisfied, which is hearing in background noise. So it’s not necessarily one thing. It’s it’s a combination of things because it’s the product a little bit. We’re trying to make everything louder, to be able to hear in background noise, you’re making the noise louder to but it’s also about our whole paradigm with this. And so I think there are some opportunities and I’m not saying that the paradigm itself doesn’t work. It works fantastic. But I think it’s it’s sort of this this Pareto principle where you do the tremendous amount of work and the sort of the last percentage points. And so for this particular aspect and market segment, the low penetration rates really can boil down to and I think the best words to use are access and affordability and they can mean a variety of different things.

Amyn Amlani 4:58
Yeah. 100% Then you talked about the white coat piece and the accessibility. And that’s now allowing the profession in the industry to move into this, do it yourself this direct to consumer model. And so you know, as we’re moving into this, there’s again an improvement in technology in that area. And then there’s also an advancement in the service delivery of these things. And so you guys have a self fitting product that’s available that you have you studied just recently. Let’s dive into that a little bit.

David Akbari 5:32
Sure. So the product itself is called Sentibo and the name Sentibo itself is Latin. And it means ‘to understand’ rather than just to hear, and actually Sentibo today is not for sale in the United States, we’re still in the process of going through that regulatory approval. But it is commercially available today in Germany. So it’s sold in Europe. And it’s really was based the concept is based on the idea of like tinnitus, retraining therapy or something where you’ve got this excitation and relaxation idea. And in the German model, it is actually something that’s offered in the audiologist office. So as much as we’re looking at it, it’s potential in the United States, for this future not yet defined OTC that in fact, actually in Germany, today, it’s been more used commercially, with within the audiologist practice and cheekily, it’s kind of the the spouse of the person coming in for hearing tests. They’re the ones who are curious, and they want to try it and sort of think of a kiosk in Germany, and then they’re standing there sort of poking buttons and messing around because they’re curious about their hearing. And you can kind of see the, that little seed or that sprout start to emerge that once people get a taste, they’re going to be more likely to pursue hearing as a holistic life goal.

Amyn Amlani 6:48
Yeah, it’s, and that’s interesting. So so this product that is dispensed in, in the in the German market, you know, is it? Does it have an interface? Does it have a smartphone interface? Or is it just a device that’s worn on the year? Can you can you describe it a little bit more maybe?

David Akbari 7:08
Yeah, sure. So it does use as I understand any combination of the iOS platforms in Germany, so you have iPads, iPhones, iPod Touch, it just generally works on iOS. But if you think about it, it’s mostly just a vehicle. It’s a common ecosystem, that’s fairly standardized. And it’s used in that way. Certainly, you could make it something that you drive from the hearing aid itself, but in this particular area, when we start talking about improvements in the technology, really that human factors engineering piece ends up being a big part of it.

Amyn Amlani 7:41
Yeah, 100%. And you’ll be looking at the literature, we’ve had some mixed results, where in some studies, you know, the participants have been successful with these tools, and in others that they haven’t. Can you talk a little bit about that? And how that relates to your product and the study that you all designed?

David Akbari 7:56
Sure, sure. So there have been a lot of articles that have looked at self fitting the efficacy and of course, safety. just to preface these remarks, the study that we did, really was done with the explicit intent of supporting the regulatory filing. So you know, a lot of these are really intended to advance the academic understanding of where we’re at as a profession as a field. And so you do see a lot of those articles like, I think Larry Humes and colleagues did did a nice article where they looked at audiology best practices versus a ‘consumer decides’ versus a placebo paradigm. And what you find there is kind of that the consumer decides was was comparable, you can’t really make claims about either group. But it wasn’t horribly bad. It wasn’t so bad about it. Everybody knows about the prominent ones in the industry. So I won’t necessarily name those. But one of the key outcomes of some of that research is this idea of a dimension reduced controller, this idea that in order to maximize the haptic interface, or the interface with the human being, is that it’s all about the simplicity. But it embeds this level of complexity. So when we say dimension reduced controller, imagine having just one scroll wheel that controls a plurality of compression, band equalization, output, limiting, and so on and so forth, you’re able to customize your experience with simplicity, almost not unlike the Apple single push button that does so many different things, fingerprint sensor, you press it in the double press, press, and hold, and so on and so forth. There’s all these different haptic interactions you can have. And so one of the research when they’re looking at that a lot of it’s focused on hearing attributes, or the what’s actually produced at the ear canal, but arguably, in this particular area, the haptic interface is as important or more important in terms of user acceptance and the accuracy, sensitivity and specificity of these results.

Amyn Amlani 9:44
Yeah, no, 100%. And I would also add to that there’s, there’s a health literacy piece that goes with this too. In other words, if you don’t give the right labeling or the right instructions, then you might come up with a different outcome than what was intended for that particular component.

David Akbari 10:00
Absolutely. And perhaps that’s one of the biggest potential outcomes of the OTC legislation, no matter what ends up in the final rule is that it gets people thinking about their hearing, as an act of sense is something that stays with them in their whole lives. And something that they can work to actually improve. I mean, think of the idea of hearing, or awareness of sounds versus listening, like active listening and focused attention. So you have things like selective auditory attention, and other executive function type things that relate to auditory cognition. And we’re just sort of at the precipice of that wealth of literature now, where people are starting to think about this, but when you when you talk about health literacy and labeling, people just able to get a taste is going to really improve the public awareness of what we do as audiologists and allied professions.

Amyn Amlani 10:47
So as we’re talking about health literacy and labeling, I think this is an area that has a prime opportunity for emerging research in our in our area. And I think we will start to see some of this information, come to the forefront and really help not only the provider, but also the patient when it comes to this affordability, accessibility. And then hopefully, with the adoption of these, these are tools that are going to be available for people who are struggling to hear in these different environments. So I think that’s going to be really, really important and critical. So there was a press release that was came out about a week or so ago. And you all had collaborated with another third party in done a study? And can we talk a little bit about what that study was and some of the methodologies and maybe some of the findings from that?

David Akbari 11:44
Sure, absolutely. So we did commission, as I mentioned, the self fitting study. So what we wanted to do was validate labeling human factors, attributes, as well as a potential software option that we intend to submit for regulatory approval. So this regulatory clearance, excuse me. And so the issue with this right now is that we’re before we’ve actually achieved that regulatory clearance milestone, so I’ll talk generally about it to the extent it can. And so we did collaborate with contract clinical research organization called Amptify labs. And that’s it’s a separate entity among that that business group, but they are seasoned professional audiologists, really great to work with, I have no limit to the good things I’ll say about working with them. And they’ve really identified the need to service this particular segment that they know manufacturers are going to have to go through this rigorous evaluation, perhaps in the future. But what we did in terms of our study was the main focus at the highest level was we wanted to show non inferiority. That was the key outcome is the design that we did, really focused on comparing outcomes of two different fitting approaches. So our as in Intricon’s professional fit approach with the proposed Sentibo self fit approach. And so itself, you know, backing up a little bit with Sentibo, it’s based on a psycho acoustic audibility model. And so a lot of the debate around OTC and about hearing aids really focuses on the national acoustics, laboratories, nonlinear revision 2 (NAL-NL2) fitting rationale. And it’s a great fitting rationale, it’s been used, you know, since 2011, or whatever. And people use it. It’s kind of an industry standard for audiologists. But we wanted to challenge that a little bit in this market segment and really look at some of the key differences. In so probably the biggest key difference in the audibility model is that we’re using the sort of concept of equal loudness contours. And so what that means that some people call them Fletcher Munson curves, others have referred to them as Robinson and Dadson curves, researchers in the 30s and 50s, who have looked at this, now we call it ISO226. So it is standardized. And, you know, for reference, this ISO 226 standard, the 40 phon level, is the basis for A-weighting when we start to look at filter attenuation characteristics. So there’s precedent a little bit to look at phon levels as it relates to psycho acoustics and perception. What we were interested in is looking at how this could be affected by hearing loss when you give people the control themselves. The other key piece to this is it’s based on the science of the bark scale. So it’s sort of this musical organization, logarithmic organization, as opposed to frequency inherits when we look at the processing in the algorithm. But the design of the study was we wanted to do this to show non inferiority of satisfaction and fitting process outcomes. In a multicenter prospective, interventional, randomized, single blind, parallel group design. So that’s what we did. So we didn’t do a crossover. We did a parallel groups design. It was randomized, single blind, and that’s because even though we’re studying this today, we are operating under the current regulatory framework, you know, so OTC does not exist yet. And it will not exist until the final rule is issued. So we do have to kind of be cognizant of that. Ideally, we’d like do double blind, of course, to have a stronger study, but, and then of course, it was randomized. And then we did an intervention, both for the professional fitting, as well as the self fitting. And so one of the key attributes that we’re looking at, in addition to the findings about the self fitting and what goes into the ear canal, is also really, we spent a lot of time and effort looking at the usability and human factors piece of this. So unboxing, is the labeling understandable, is it effective. And I think to the extent that in OTC, everybody’s relying on labeling as a key control point, you’re gonna see a lot of emphasis put on that going forward, I think, is where, you know, labeling and validation of the consumer experience as they get the product. And the other piece is you know, when you look at OTC hearing aids, really, it’s not about just selling a product on a peg. It’s a whole process. And that’s what we’re kind of trying to look at here. In terms of how we set up the studies, we wanted to kind of set it up to look at an ecosystem of care. More so than just here’s the product and how did you do?

Amyn Amlani 16:04
Yeah, that’s really cool. Excuse me, that’s really, really interesting. And so you talk about this a little bit, backtrack just a little bit, you talk about the psycho acoustic model, and how it differs from the NAL acoustic model. Can you just for our audience, who may not know what those differences are between those two, just give us a short summary of why they’re different?

David Akbari 16:27
Yeah, sure. So the idea with NAL NL2 is that you use the results of a diagnostic hearing test. So when you have the audiogram, you measure the audiogram, you have the softest sound that you’re able to hear you get in each ear specific degree type and configuration of hearing loss, you’ve got bone conduction thresholds, you’ve got air conduction thresholds, and you just put those into the NAL-NL2 algorithm, and it gives you prescribed output, which we call our prescription. And so that’s it’s essentially think if you think about it, we’re trying to manage the loudness growth in the impaired year, whether that’s essentially we’re hearing loss or conductive or mixed hearing loss. The difference with Sentibo is that we’re not claiming at all that this is any type of hearing test, really, that we’re trying to say, if you, for example, are listening to beeps. And then ultimately, when you wear hearing aids, you’re trying to listen to sounds in the world. That’s kind of an abstraction, if you think about it is that we’re putting these results to tones very specific tones into an algorithm. And then we’re predicting we’re essentially we’re guessing, in other words, we’re making a good guess, don’t get me wrong, it’s an educated guess. But ultimately, it is a guess, because we simply don’t possess the ears of the person we’re trying to treat. And so since he was a little bit different, because we give the onus back to the person. And so the audibility model is really based on the concept of multiple environment listening utility. So how can you take this product, and listen to it in a number of different environments, in order to maximize your own satisfaction, and it’s a little bit different, because, for example, we’re not making a diagnostic assessment We’re Not making This is not a hearing test. We’re also focused really on the end goal. So imagine a world where you simply go go up to yourself fitting solution, you put your hearing aids on, much like you would put on glasses that you’d find at the supermarket, and then you just you edition, it, you evaluate it in that sense. And that’s more where we’re approaching this as opposed to this NL2 model, which, you know, ends up being back into from making decisions about surgery, or a very medical focused form of Audiology.

Amyn Amlani 18:31
Yeah, and that’s interesting. So in order to do this, it sounds like you would have to have some presets, you would have to have certain differences in your electroacoustics, just like you would with eyeglasses, right? You’ve got your one point and your one point fives and your twos, you would have those presets and people could put these devices on and then and then listen to that. Am I understanding that correctly?

David Akbari 18:53
Yeah, that’s one way to do it. That is one way to do it. There are a variety of different ways to do it. And if you look at the proposed FDA regulation, they talked about tools, tests and software. And this is kind of an example of that quantity. And if you notice how they parse it, it’s all three together, it’s tools tested software, it’s not tools, and then they enumerate it tests and then right, it’s all three. And so that is an example. And it’s in fact, an example the FDA has used when they’ve described this. There are a number of ways that this could manifest itself, but certainly that’s a great way to characterize it.

Amyn Amlani 19:23
Okay, great, great. Yeah, just to get for clarity for individuals. And so you you have this Sentibo device, did you compare it to another device?

David Akbari 19:33
No. So we just compared it to our individual devices, because you know, when you start adding the variability of different components, in different fitting methodologies and differentials, but keep in mind, when you put something into NAL-NL2, there’s all kinds of specific implementation details that manifest themselves when you actually go into the hearing aid level. So the different components that you select that are in the hearing aid, the plastics that are used, the propensity for resonance phenomenon exists in the hearing aid that results in auditory feedback, for example. So these are things that complicate it. But certainly that could be an area of interest in future research.

Amyn Amlani 20:08
Oh, that’s interesting. So you took you took your product, and you found that the self programming, on average came up with more improved satisfaction, you had sound quality improvements. Can you talk a little bit about that? That’s from the press release.

David Akbari 20:29
Yeah, sure. So I think, when we looked at the satisfaction endpoint, so just to talk about the study design a little bit, that the primary endpoints that we looked at, were we were looking actually, for non inferiority, that’s what we set out to do is to show that it’s not worse than the sell fitting is not worse than our Pro Fit on the same device, because you’re trying to kind of control for all those variables that could that could add variability. And what we actually found was, that mean satisfaction for the primary endpoints for self fit was greater than the Pro Fit, and actually, there was less variability. And so my explanation for that is that when you give the person that control in their hands, and they’re able to decide what sounds right for them, in that environment, they’re able to hone in on something that’s they’re reasonably agreeable to, is my explanation for that

Amyn Amlani 21:18
That’s interesting, you know, if you think about today’s technology, right, so take a smartphone, and you’re in an environment where you’re listening through your headphones, it’s no different than you going in and changing maybe the filter setting on your on your music, or taking your headphones in, on my phone, and maybe I’m a little more of an audiophile, I have a little filter setting, I can go in and change it to reduce the lows and maybe increase the highs, so that if I’m streaming a call or something, I’m not getting the upward spread of masking. So is that kind of the tone that we’re talking about here?

David Akbari 21:57
Absolutely. And it’s like, really comes back to this idea of a dimension reduced controller, if you think about the example you gave, think of what would a tone control mean? Right? Is it a bandpass filter that you’re adjusting the cutoff frequency? Is it you’re making a filter wider or smaller with with Q, which is the inverse proportion of bandwidth, and so on, and so forth. I mean, it’s a great way to look at this.

Amyn Amlani 22:20
Yeah. As we were talking about the health literacy, you know, one of my frustrations when I was a clinician, was we never knew what the device was actually doing. And I’m hoping as we’re talking about health literacy in these patients, now we’re getting these tools, that we’re going to be able to say that this is a tone control. And if you do this, this is going to be the outcome. And so do you foresee potentially, and again, we do know that that might potentially be some of the health literacy that could come out?

David Akbari 22:49
Absolutely. In fact, to the extent that people are given an impetus to be interested in what their hearing aids are doing, or their technology’s doing, it really positions audiologists as leading advocates for this because imagine offering a service where in your clinic, you can have people come in, and they’re just interested in learning more. And it’s a fee for service type thing that you know, what’s stopping you from measuring Real Ear on this, for example, and being able to explain how it’s working or to help them hone in on things that they could need help with. So I think what’s going to happen, ideally, coming out of all this, both research and public policy is that people will have an increased level of health literacy such that once they get a taste, it’ll spur some curiosity for them.

Amyn Amlani 23:34
Well, you know, David, one of the things that I’ve argued for, and you just brought this up, was how did this benefit the provider? And I think as people start to think about what’s coming next, they’re going to have to change the service delivery model. And it’s going to vary depending on Social Determinants of Health and things that are available in the environments and what have you. And for some individuals that are going to need that extra help. And if there’s a way to set up and I’m going to use Apple as an example, you know, where you go in and you’ve got the the folks that are at the counter, and you’re able then to ask a question, and they’re able to walk you through the the the usage of that particular tool, but in this case, because your healthcare provider you could potentially charge for it. That is a service delivery model that could potentially assist the healthcare provider as we move into this into this new marketplace. Would you agree with that?

David Akbari 24:32
Absolutely. In fact, one of the things I like to describe about this is if you think about the history, you look at the latter part of the last century, some people actually saw hearing aids, the act of dispensing hearing aids as unethical, that we were sort of diagnostic technicians as audiologist and it to some extent it was unethical to also dispense the hearing aids. I believe that we’re in a similar historic moment at this time. With the advent of OTC hearing aids and consumers really taking the onus on themselves. Now, if you think about the current model where we use, it’s unfortunate, but it’s the reality that people, when they come into your clinic, they sort of sometimes will have the sense that, well, you’re broken, we need to fix you, there’s something wrong with you, you know, your hearing is broken, and so on and so forth. Whereas one of the things we’re finding in some of this research we’re looking at, is that if you give the power back to them, and you say, well, instead of that you’re broken, how about this could help you, here’s a tool that can help. And then they’re able to use it as much or as little as they want, it gives them a taste, and they’re more likely to be agreeable to what we’ve already established over many years as audiology service delivery. If you think about it, this could represent a tremendous opportunity for Audiology as a profession and really elevate audiologists to a true as we are already a true doctoring profession, but even solidify that even more, you think about something like a dentist where the dental hygienist comes in and does cleans your teeth, and then the doctor will come in and look at your X rays, and so on. I mean, this could be the type of thing you see analogous to OTC hearing aids, where you have someone who’s like a blue shirt as a reference to a Best Buy service professional or an audiology assistant, or what have you, who’s doing some of the non licensed professional work, and then you come in as that expert provider, and really demonstrate the value of your service beyond just the device. So it’s an opportunity for audiologists to really decouple ourselves in the value that we provide to the public from just being a salesperson of a device. And that’s tremendously powerful. In my view.

Amyn Amlani 26:32
No 100%, I agree with you, you know, and I, we heard it here first. So David, I’m gonna give you credit for this, you know, meeting patients where they are and empowering them is the key to the future of folks adopting this technology and bettering themselves through the help of the service provider. I think that is a very, very powerful message to send to our viewership. And as part of our future, as we, you know, evolve as a doctoring profession. I think that’s, that’s a well, well said statement. But to give you credit for that, my friend.

David Akbari 27:06
Well, thank you for that.

Amyn Amlani 27:09
So are there any other things that you can share about the study? Or should we move on to you know, what’s coming next?

David Akbari 27:17
Yeah, well, I mean, about the study itself, you know, some people had asked about our power level, and so on and number. That’s right. We did exceed. So in other words, in order to demonstrate the non inferiority hypothesis that we sought to prove, we assumed equal outcomes in both groups self fit and Pro Fit. And we really wanted a 90% desired power level under one sided test with a point 0 five, Alpha 95% confidence in other words. And so what that meant is based on the the effect size we were expecting, and the resolution of our questionnaires, it meant that we needed about 80 people, and we ended up with 92. So we did exceed that that 90% power level in this particular sampling distribution. And also, you know, we were talking about dependent variables or some of the outcome measures we use. So we did, we measured subjects satisfaction, which were we asked them about sound quality, as well as the fitting process. We also measured the the APHAB as a secondary outcome, which was the abbreviated profile of hearing aid benefit, pretty standard outcome measure. We also use this the speech spatial inequalities index, which is the SSQ 12. With just 12 Questions about speech, spatial inequality. So can you hear the dog and it’s a one to 10 point scale. And, of course, what we also want it to do to really focus on high quality, safe operation of these devices as we we measured the results as they would be at the level of the eardrum. So what kind of a sound pressure level were we presenting to people and was it safe, and we were able to show I think, the absolute peak outcome output in the use case that we presented it in other words, we were measuring a maximum power output on the Real Ear system, I think, was 101.3, or something like that. It was, you know, so there’s a considerable debate around that maximum output, whatever, and whatever that lands on, we’re hoping that you can just drive a truck through that tolerance from an Intricon perspective. And that’s the thing that’s the point I want to make about this is that these will not be cheap hearing aids that end up as OTC products, I think people have this perception that there are these predatory companies out there who are going to want to just seize the opportunity of OTC hearing aids. And I don’t think that’s the case at all. I think these are going to be the most premium features, it’s going to be high technology, it’s going to be stuff that you’re going to see premium features in this segment because as you have self perceived mild to moderate hearing loss, those are the people that are going to have much higher expectations of the fidelity of the product, and things like that. So I think a simple way to put this is there’s a magnificent diversity in the United States of people. You know, we come in all different shapes and sizes and colors and preferences. Why would we not expect our Hearing aids which become part of us to be the same.

Amyn Amlani 30:02
Another profound statement, David, that was that’s absolutely true. You know, and I’ve never thought of it in that way. But that is absolutely correct. If you have a mild to moderate hearing loss, your your hearing sensitivity is better. So your expectations should obviously be higher. So 100% That’s, that’s, it’s been fascinating so far. So, David, for the impaired user, we have all of these advantages for them. And these tools that are starting to be created. Do you really and I know you’ve touched on this a little bit, but I’m going to expand on it. Do you really feel like we’re going to increase that market penetration rate that we said was low when we first started this conversation?

David Akbari 30:50
Yeah, so the market penetration rate is low. And the way I see this is if the legislation isn’t opened enough, if there’s not enough opportunity to unleash the spirit of American innovation for this, you probably won’t see those improvements. Now I’m optimistic. And it’s really been Intricon’s position that the final OTC rule should be issued without delay, and should be substantively similar to what was in the proposed rule, which would allow companies to provide high quality, highly regulated medical devices that could serve as currently the and or underserved people. And if you think about it, if you look at the aggregate statistics and data and intercoms commissioned research about this, just in summary, if you had all the audiology programs, who are graduating AuDs, in the whole country, in every single one of those students was dispensing hearing aids full time, which we know is not true, that just doesn’t happen. For whatever reason, you still wouldn’t even come close to meeting the needs in the aggregate sense of honor underserved Americans. And so what that means is this is and this is coming from the NASEM and PCAST reports. And so I think, as long as there’s an open enough format, in other words, this OTC hearing aids are not overly restrictive, you will see improvements in that penetration, because it’s going to be predicated on the ecosystem of care. In other words, it’s not just a product on a peg, it’s a whole process, you know, things like 24 hour care and support, things that help us as audiologists focus on what we do the best. And then, you know, they say double down on your strengths and outsource your weaknesses. It’s kind of a way to look at this. And I think as long as that spirit of American innovation can be unleashed, not overly burdened with the regulations, you will see this market segment flourish. And you’ll see a lot of people have tremendous quality improvements in their lives. You know, I think it’s, for example, one of the false premises I’ve heard lately is, is people assume that OTC hearing aid users will pick OTC hearing aids over the audiologist. Actually, what we’re seeing is that they’re picking OTC over nothing. And that’s one of the problems with this particular market segment is that, as we know, people tend not to seek services for hearing loss, when things start to really affect their function, they start to you know, you start to get this garden variety sloping, high frequency sensorineural hearing loss, and it starts to affect the speech frequencies, then they get the help, whereas OTC hearing aids, as we’ve long known from the pediatric world, early detection and intervention is key. So when we can get people interested in this, we can get the health literacy, we can improve the outcomes. And that’s really what this is about. This is not about selling hearing aids. It’s about improving the public health outcomes, reducing the social isolation that people feel, and just really benefiting the quality of lives in addition to positioning audiologists, as leaders in this space.

Amyn Amlani 33:39
David, it has been fabulous having this conversation with you. Have I forgotten anything? In this in this dialogue,

David Akbari 33:48
you haven’t forgotten anything. But I might add to this that, you know, with the sense that OTC hearing aids are having all this new regulations, I think there’s going to be also an increased focus on the prescription hearing aid side as well. So that’s another exciting thing coming out of this and in my current role as Chairman of ANSI ASA, S3 working group 48, which is controls one of the standards authors one of the standards. ANSI S3 22, which is the standard for quality control 2cc coupler in the testbox. I think you’re going to start to see more focus on that stuff as well and I think audiologists whether they’re for or against OTC hearing aids, I think you’re going to still see no matter what happens with OTC, an increased focus on medical audiology, which should make many audiologists excited, and I think it’s a good outcome eventually for this health literacy improvement we expect as a downstream effect of OTC hearing aids.

Amyn Amlani 34:42
The future should look right for our profession. You have been a wealth of information, David, and I hope to get you back on here. Once maybe the OTC bill has passed in have a conversation about what that’s going to look like down the road So thanks again for your time, forgive my voice. And I look forward to seeing you again, David.

David Akbari 35:06
It was great to be with you. Thank you

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About the Panel

David Akbari, AuD, is Senior Medical Science, Clinical and Regulatory Affairs Liaison at Intricon Corporation. Dr. Akbari’s primary research interests in audiology include auditory neuroscience, language development, physical acoustics, development of fitting rationales used in amplification, and interacting with the ANSI and IEC committees to develop standard measures for hearing aid evaluation. Dr. Akbari is the chairperson of the ANSI/ASA S3 Working Group 48, in which he has been actively involved since 2013. He earned his AuD in audiology and Master’s degree in speech-language-hearing sciences at the University of Minnesota, Twin Cities. Dr. Akbari’s education and experience in music – he is magna cum laude from Berklee College of Music with a degree in Music Synthesis – adds to the broad and deep perspective he provides on the topic of hearing health.


Amyn M. Amlani, PhD, is President of Otolithic, LLC, a consulting firm that provides competitive market analysis and support strategy, economic and financial assessments, segment targeting strategies and tactics, professional development, and consumer insights. Dr. Amlani has been in hearing care for 25+ years, with extensive professional experience in the independent and medical audiology practice channels, as an academic and scholar, and in industry. Dr. Amlani also serves as section editor of Hearing Economics for Hearing Health Technology Matters (HHTM).


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