Amyn Amlani 0:11
On August 17 2022, the Food and Drug Administration released its final rule establishing the regulatory category for over the counter hearing aids. Here with me today is Dr. David Akbari to discuss the tenants of the final rule ruling. David, welcome back to this week in hearing.
David Akbari 0:30
It’s great to be with you.
Amyn Amlani 0:32
So David, before we dive into this finalized OTC framework for our audience, would you mind again, just introducing yourself?
David Akbari 0:41
Sure. So my name is David Akbari, and I’m a senior medical science clinical and Regulatory Affairs liaison at Intricon Corporation, and my background in a lot of this stuff. Beyond my education and experiences, I’ve been involved in what is now called OTC hearing aids for probably about seven years since 2015- 2016 or so, at the earliest stages of some of what we previously called direct to consumer. And I’ve worked on many of the products that people probably recognize in the market. So I’m sort of in a situation where I’m qualified to talk about this.
Amyn Amlani 1:16
Well, and David, you also served on some ANSI standard committees as well, right?
David Akbari 1:22
Yes, that’s right. So the standard for prescription hearing aids. So that’s called the ANSI ASA S322, which is the standard for measurement of quality control on hearing aids, I happen to be the current chairperson for that working group, which is the ANSI ASA S3 working group 48.
Amyn Amlani 1:41
Okay, so So you’re, you’re quite well versed in the conversation that’s going to take place today. But before we dive into that, we got to go back a little bit just so that we can get everybody up to speed. So, OTC, the legislation, as you pointed out, has been around for about seven years. And what prompted the early stages before this final ruling, if you could just walk us through that, please?
David Akbari 2:05
Sure. So in Obama’s – former President Obama’s second term, he commissioned some research from the President’s Council of Advisors in science and technology, and the National Academies of Science, Engineering and medicine. And they each issued reports, discussing sort of the market, the addressable market capacity needs, and the current landscape of audiology and the service delivery models. And essentially, what they found is that there’s low adoption from accessibility and affordability issues in hearing aids more generally. And that was at the 2015 -2016 audiology provision at that time. And what they saw was, which I think is really important is that even if you had every single audiologist out there, dispensing hearing aids full time, you would still never even come close to the capacity need that would happen. And it’s sort of become part of the baby boomer generation, there’s this big wave of people coming of age to be about, you know, 65 to 67, sort of retirement age, who are really in need of the services. But then if you cross reference that with a number of audiologists and hearing dispensers actually to you never even come close. And so it really is it prompted the need for radical reimagining of what we could do as far as servicing the need of un underserved Americans.
Amyn Amlani 3:26
Yeah, and so we have these these the PCAST, the NASEM report that then led to this FDA Reauthorization Act, which then the government said okay, we’re going to now establish this thing called OTC hearing aids. So what is OTC hearing aids just in a general sense?
David Akbari 3:47
Yeah, so the FDA Reauthorization Act of 2017, sometimes called Fodera define the need for creating a category of OTC hearing aids. An OTC of course stands for over the counter. And so you might think of it as analogous to a prescription drug that now becomes over the counter something like an NSAID pain reliever or something, where the idea is you’re able to sell a hearing aid previously available only through a prescription over the counter without the involvement of a licensed professional. And what they did in the Fedora is they define the need for OTC but they didn’t specify the detail. They sort of kicked that can down the road and directed the FDA to do that. Yeah, so the reason that this is really important is because it gives an important on ramp for best practices, audiology care, in my opinion. So you have something where much like in the world of physicians, like the best practice dictates that you don’t just give somebody opiates for pain treatment that you actually have to have follow up care and aftercare as part of a holistic treatment method. I really see OTC hearing aids as similar to that insofar as it’s not really just about The device, you know, people oftentimes think about it like that, where it’s just you’re selling a product on a peg. And realistically, in this to get the need of FDARA correctly addressed in my view, it really will depend on the on ramp and the availability of what sometimes it’s called the ecosystem of care. So follow up care, treatment support, service delivery. And of course, more than audiologists are able to do that. You know, we talked about Best Buy with their blue shirt service professionals, not licensed professionals. But in my opinion, audiologists are absolutely the most qualified and best able to service the needs of people who are experimenting with OTC hearing aids. And I really see audiologists as the best premium option for people to go from the purchase and experience of OTC hearing aids to that best practices audiology treatment care. And in my opinion, it’ll lead to more independence, more autonomy for Audiology, and it really will help grow the profession in terms of being a doctoring profession. So I see OTC as a huge opportunity, not just for the consumer, but also for the provider.
Amyn Amlani 6:08
Yeah. And just to add on to your point here, you know, the next component I think that’s really going to have to be developed is health literacy. We’ll talk a little bit about how health literacy will help us expand the involvement of other individuals through the help of the audiologist to meet the needs of the larger growing population.
David Akbari 6:31
Yeah, so health literacy is going to be a really important auxiliary effect of the OTC final rule. What and what’s really interesting about it is, you know, many of the comments if you read the final rule, we’re talking about the need for the FDA to create literature to create some sort of a common way to interpret hearing aids. But actually, what the FDA said is, well, we’re going to require this specific things in the labeling. And then consumers will have to themselves decide and comparison shop. So in other words, that indirectly says that the consumers have to onboard all of this mental information, they are going to have to start to learn about what is hearing loss, and how is my experience map to the potential treatment pathways. And it’s a really interesting way to go about improving the health literacy outcome there, of course, will be a learning curve to that. But it’s really an opportunity, in my opinion, as well for audiologists to promote and disseminate high quality educational information that really addresses that health literacy need. And my opinion, there’s no better suited profession than audiology to lead that.
Amyn Amlani 7:31
No, and I 100% agree with you. I think it’s going to be critical. And I think it’s, as you pointed out a huge opportunity. And, you know, it’s going to take a little time, but the future is here
David Akbari 7:45
Amyn Amlani 7:47
Yeah. So, David, as we’re diving into this, this legislative framework, right, we should probably preempt the audience to know that there’s a consumer side to this. And there’s a prescriptive side. And we’ll talk about the consumer side first. So I’m gonna turn it over to you. And if you’ll just dive into the OTC category, what it means for consumers. And, you know, we can start diving a little bit into the weeds here about, you know, what it means for the product, and then we’ll eventually talk about some of the service delivery options that are available as well.
David Akbari 8:21
Sure, so there’s definitely a lot to unpack here as far as what it means, as we just refer to health literacy. How do we get those numbers and what does that really mean? And that’s where you get into the standards themselves. So there are two really important standards that the FDA calls out in terms of the electro acoustic performance of hearing aids. One of them is accredited by ANSI, and it’s promulgated by the Consumer Technology Association, and it’s called ANSI CTA2051, which is a standard that is what we might call criterion referenced as opposed to norm reference, insofar as that there are specific performance criteria you have to meet in order to claim compliance with that standard. The other one is very familiar, I think to a lot of audiologists manufacturers out there, which is accredited by ANSI, and it’s promulgated by the Acoustical Society of America. And it’s called S 322. And it’s different in scope and intent. So the standards are both different in scope and intent. And so unlike ANSI CTA 2051, and ASA s 322 is actually a measure for quality control the hearing aid. And what that means is that the manufacturer sets the limit of the Pass- Fail criterion. And there are simply tolerances that come from that defined in the standard. So in the technical parlance, what we say in the manufacturing side, is it sometimes it’s called an operational qualification. In other words, you build a bunch of hearing aids, and then you measure a statistical distribution and set your tolerance limits from actual measured parts, if you will. And so that’s how you start. It’s sort of a reactive way to define tolerance limits. Around the performance of hearing aids where ANSI CTA’s different is they just state straight up, you have to meet no greater than 5% input or output distortion in the specific circumstances. And it’s actually a very hard standard to meet. In my opinion, it’s harder to claim compliance with ANSI CTA 2051 In some ways than it is ANSI ASA s 322. Precisely because there’s there’s no flexibility in terms of what you’re allowed to. To get away with as far as your measurement, you have to meet those requirements to claim compliance.
Amyn Amlani 10:33
And I think that’s an important point to make is, you know, the thought is, is that some of these OTC devices will be clunky as they come onto the market. But that’s been preempted through these various standards in saying that we’re going to be really, really strict in what comes onto the market, because our number one goal is consumer protection. Yeah,
David Akbari 10:53
it’s a really interesting point. And perhaps one of the most interesting things that came out of the OTC legislation is the idea of latency. So you know, previously people were thinking, Oh, well, does that mean latency to the wireless streaming, or maybe the phone use case or whatever, it’s really latency of the internal hearing aid processor. And what that really means is within the context of the OTC category, in my opinion, what’s going to make that difficult isn’t they say it’s 15 milliseconds, one five 15 milliseconds. What’s interesting about that is when you do what’s called Full Duplex audio, in other words, you’re getting audio in and you’re producing audio out, at the same time, on a computer, that processing delay, is tends to be pretty long when you like, imagine having an iPhone app, for example, and you call it a hearing aid, you are allowed to do that, of course, through the final rule, but you have to meet these very strict performance standards. And it’s unlikely, in my opinion, with current generation iPhone or Android technology that you could actually meet that I don’t think you would be able to meet that unless you had like a custom kernel or something. In other words, a layer between the hardware and the operating system. That’s, that’s custom and very low latency in order to do that. And the reason for that is, are things like the temporal fine structure continuance, we might call it, where it’s the psychoacoustic idea that you have, when do you start to perceive two sounds and time as different events. So for example, that 50 milliseconds, if you have like, say, two transient signals that are within 50 milliseconds of each other or less, it tends to sound like more like a resonant comb filter. Whereas when you start to get in my end, usually what I used, and I learned this in the music industry, but 24 milliseconds, is for the kind of the worst case scenario, when you start to perceive things as two events. So it’s like dat dat, you know, like, you start to hear it as like a transient signal that starts to kind of clearly become to events. But some people are very sensitive at that. I mean, some people have detection thresholds that are much lower. But you know, 15 milliseconds for internal hearing aid processing, is actually quite good in terms of being able to analyze interpret, synthesizing the environment. I mean, that’s very, very fast. As far as a hearing it goes, and it does limit the potential for sort of cheap things to end up on the market, because it’s a very strict standard is ASNI CTA 2051 and that’s just one example.
Amyn Amlani 13:14
Yeah, and I’ll just add this, you know, if we think about a communication, right, you always are looking at the talker, if I’m the listener, and you would have the McGurk effect, in that the person’s mouth would be moving, and the signal will be coming in a little bit later on. So to bring it back to kind of a speech perception or, you know, back to your graduate level courses, it’s there to ensure that the communication process is a continuum. And it’s not two different things where the individual is now struggling to understand what’s going on in that in that in that framework.
David Akbari 13:51
Sure. And you mentioned McGurk. I mean, it’s also, you know, from the speech science pedagogy, like the voice onset time, things like that, the formant processing and so on. I mean, it’s if you’re able to process that such a fine temporal resolution, you’re gonna have better outcomes, because it directly relates to speech perception. But what’s interesting is the ANSI CTA standard, also, in their declaration is supposed to accommodate more than speech. It’s supposed to be music and all these other things. And so that’s a really interesting effect. And it’s very new, in my opinion for Audiology to start thinking more holistically, beyond sort of the Speech Stimuli that there’s a ton of pedagogy around.
Amyn Amlani 14:25
Yeah. So now let’s turn our attention to distortion, right? We know that distortion is a big factor, because it introduces noise, right? And signal to noise ratio is one of the biggest issues that our listeners face. So there’s a there’s a there’s a component to this new framework. Can you talk a little bit about that?
David Akbari 14:45
Yeah. So what’s really interesting about the distortion stuff is in ANSI CTA 2051 they require both input and output distortion. So what’s really interesting about that is if you consider the device having a scalable dynamic range coming out bit, what they require, just in summary is you have to present 100 dB SPL into the hearing aid. And you have to measure no greater than 5% total harmonic distortion, which is actually a really hard test. In fact, a lot of audiology equipment doesn’t even go that loud. If you think of that, and I won’t name names, but the contemporary examples, it’s a little different than ANSI s 322. And so far, it’s a little bit harder, because you’re measuring both on the input and the output, and you have a hard criteria of 5% Max, whereas for ANSI ASA, s 322, for example, it’s whatever the manufacturer says plus 3%. So if you said, as a manufacturer, you permit 5%, you actually can measure up to 8% in the clinic and your test box and still be within the spec. So it’s a pretty strict standard. As far as everything goes with distortion, really specifically, I think this one because there are many types of distortion is focused on harmonic distortion with the idea that it’s referencing sound quality.
Amyn Amlani 15:58
Yeah, yeah. So again, the stringency is still there. And then the other thing that I found really, really interesting in the in the new ruling, that is not necessarily on prescriptive devices is volume control, these new devices are required to have some sort of a volume control. Can you talk a little bit about that?
David Akbari 16:14
Yeah, sure. It’s, it’s really interesting, because it seems the FDA responded to a comment. They said, Well, we think a volume control should be required on everything. And, and previously, if we remember from the proposed rule, they sort of had this difference in intent. If you had a volume control, you could do one thing, if you didn’t you do another. Well, now they change. And the final rule is, is everybody’s going to have volume control. What I found interesting is in your viewership, here, our viewership, we look at comment 87 from the final rule. And essentially what it says is that does not have to be a physical volume control, which, when we start to talk about generally, the OTC rule, allowing more innovation in this space, the FDA sort of agrees with that, and they’re saying that it could be a remote control or a mobile device. And their intent is to allow design flexibility for manufacturers to develop and market smaller hearing aids. So the idea is, as the FDA points out that there are potentially dexterity issues, and cosmetic issues with the idea of reaching up and adjusting something, they feel it’d be more discreet, to have options and flexibility in the space, even though they’re requiring a user adjustable volume control. So couldn’t be an application not necessarily physical, but the requirement is that it has to be user adjustable.
Amyn Amlani 17:25
Yeah, yeah, I find all this absolutely fascinating. And then, you know, we’ve got the device than the device has a pre market component to it as well for the over the counter. And so can you talk a little bit about the difference between self fitting and customization, which is on page 19 of the final ruling?
David Akbari 17:46
Yeah, sure. So it’s really interesting that FDA sort of came up with this idea, you know, and it starts with the idea, well, what is even a fitting- like what is fitting at all? And so you know, because a lot of people when they hear the word, they think physical fit, they don’t, they’re not thinking about audio fit, like we tend to in the industry. But the FDA very clearly defines self fitting and customization as distinct. So customization is the broad term. And self fitting is the more specific so it’s the idea of like, a rhombus squares, a rhombus, but not all rhombi are squares kind of idea. So like, so fitting with the customization process. But not all our fitting is a customization process that instills in the device frequency dependent settings for this specific user. So that’s the FDA definition in this. And so what they’re saying is not are also fitting as customizable, is customization. But not all customization is self fitting is kind of the piece. So what they say, quote, self fitting process instills frequency dependent settings through the user interacting with the device or an accessory to the device. So that’s what they call it. And they give some really interesting examples. So they say, for example, if you have presets, so if you have like they use the number three actually give the number three presets, typically not self fitting, it has to be more than that, in their view. So the FDA is language is that it has to allow the user to cause frequency dependent changes based on the user’s preference in order to be self fitting. So that is more than just selecting from a limited set of presets in order to be considered self fitting. So customization need not until self fitting, though self fitting is a kind of customization.
Amyn Amlani 19:30
Okay, yeah. Okay, I got it, I got it. And then there’s a labeling piece that goes with this as well. And there are some some some components here that have to do with education and risk and benefit. Can you talk a little bit about those?
David Akbari 19:46
Yeah. So what’s interesting is that the FDA, from the proposed rule to the final rule, did change the labeling a little bit. So they made it their intent was to make it a little bit easier for a lay user to understand. And I think it’s a really important point. To make, because if you think about other OTC type things, and I think people made this argument in reviewing the proposals, essentially, how do you prevent a person from ingesting a whole bottle of NSAID pain relievers that they bought OTC? Well, the answer is labeling. So we’re sort of relying on labeling as a key control point. And so in the case of the OTC hearing aids, they sort of come up with this operative statement. And then they ask, Well, how do you know if you have this? So this hearing aid is is for adults with signs of mild to moderate hearing loss? How do you know if you have this? And keep in mind that this is intended to be self identified? People – So this is a perceived mild to moderate, they didn’t budge on that. So there’s no audio metric objective criterion. So you have to kind of answer yes or no to the questions. You have trouble hearing speech in noisy places, you find it hard to follow speech in groups, you have trouble hearing on the phone, and so on, and so forth, there’s a few of them. And so that’s actually required to be on the label. And it’s a it’s a key control point. Because with regard to the labeling in this pre market idea, there are a bunch of special controls, you have to meet usability engineering being one of them. So what that means is they have to categorize the risk profile, in terms of what you have on the package and labeling. And then you have to actually validate it, you actually have to sit people down, have unboxed this thing, and observe them and see if they can actually do it. And the labeling is kind of a key piece to that. Because it’s not just what’s on the box, but also what’s in the user manual, as far as indications for use risks and warnings, others aspects of the device like components that might be in its smartphone compatibility, and so on.
Amyn Amlani 21:33
Yeah, and then there’s also the the the manufacturers email, and their address has to be on there. And if I remember, right, there’s also the issue of the ear tip insertion deaths. Can you talk a little bit about that?
David Akbari 21:50
Yeah, so the the ear tip insertion depth is a really interesting topic, because previously, they kind of said, I think it was anything after the second Bend has to be like sort of proximal to the second band, or it’s like closer to the outside of the body. I think that was really interesting. But they changed that in the final rule to be a fixed depth of 10 millimeters, which I think is pretty good, it’s actually still a little bit deep, in my opinion. But what that’ll do is it’ll allow potentially innovation in this space, specifically with things like ITEs or in the ear products or completely in the canal products in the canal products, things that you can kind of grow the the physical fit profile of the device itself. But that 10 millimeters is interesting, because not everybody’s going to have 10 millimeters of usable ear canal, potentially, you know, like, say you had skin cancer or something and they carve out the mastoid bone, there are certain medical indications that have nothing to do with hearing that could compromise that. Of course, you might argue that those aren’t OTC candidates. But the idea is that they’ve changed from a relative measurement to a fixed measurement, which I think is a good thing overall. But it really kind of forces you to think about it. Because now do you have to validate, you know, the insertion depth of the product. I mean, perhaps you do. It’s one of those things, we have to kind of note that and perhaps in the labeling, you also have to be careful with how you say, to put it on and what you do. So for example, if there’s a detachable tip, probably need to document the pull test results, you know, like there’s a physical test to make sure that enough force is applied such that’ll leave the tips in place, you’re not losing stuff in the ear canal. So it’s an interesting thing that they’ve done.
Amyn Amlani 23:27
Yeah, and again, just to reiterate what we started, we started out talking about at the beginning here, the idea that these clunky devices will be on the market is not necessarily true. They’ve been very, very prescriptive in defining what these devices are going to be, and to ensure that the quality is there for the protection of that consumer who’s going to be purchasing these without the assistance of a licensed professional.
David Akbari 23:52
You mentioned the manufacturer, email and mailing address as a way to communicate with them. What another interesting thing is with regard to labeling is they do actually require in the final rule that manufacturers provide summaries of clinical data or trials that have been completed directly to the consumer, which is really interesting, because to the extent that for example, you validate the ear tap depth insertion, or you’ve looked at a self feeding or whatever to to validate the efficacy, you are actually required, according to the provisions in the final rule to communicate that to some extent in the labeling and consumer literature, which, as we discussed earlier, could have a net benefit to the health literacy piece.
Amyn Amlani 24:31
Yeah, yeah, that’s really interesting. So David, before these, these products can come to market, there’s a requirement called a 510k. And I’m not sure everybody understands what that is. Can you enlighten us on that, please?
David Akbari 24:47
Sure. So people use the term 510k as sort of a colloquialism or a noun, but what it refers to is it’s talking about the Food, Drug and Cosmetic Act and It specifically as section 510K from the fd&c act. So what it talks about are a variety of special controls. When you have a product that you want to legally market, there are things you have to go through in order to do that. And so what’s really interesting is not only the 510 K requirement itself, but how it interacts with other manufacturers that have products already on the market that they want to include, as an OTC product. And so the FDA enumerates, several special controls are what they’re called. So for example, the OTC category itself, you might consider general controls. So there are things you have to meet their standards you have to meet, but there are also special controls, and the FDA enumerated them as electromagnetic compatibility, that you do have to evaluate the sufficiency of clinical data in the case of cell fitting, usability engineering, so validating the labeling people can unbox and put the the stuff on here. And these are all related to standards as well. I mean, usability has a variety of standards you have to do, you have to look at verification and validation. So what that means is verification is did you make the product right? Validation is did you make the right product. So it’s very much into the FDA parlance. And you also have to do hazard analysis. So all of this is to say that people might think that this will open the door to a glut of poor quality products. My contention would be that that’s not exactly true that these special controls will ensure that there’s at least a minimum efficacious standard that’s being followed, for all OTC hearing aids, even if they don’t have the self fitting piece.
Amyn Amlani 26:39
And David, just for the audience’s knowledge, how long does this process usually take? It’s not a week? I mean, I’m assuming it takes several months in order for this process to take place.
David Akbari 26:51
I mean, yes. So when you look at what’s required in terms of generating a 510 K, I mean, there’s a lot to it. I mean, you have to make a lot of documents and requirements. And perhaps people who are watching this program have seen like the decision summaries from some of those products that have come out on the market, that’s just a small snippet of what’s in the 510K, you have to provide detailed test reports on every single category and aspect of the device. And what the FDA is trying to do through the 510k program is make a determination of substantial equivalence. So in other words, that you have to say, is the product that we’re intending to market, we select a predicate, is it substantially equivalent to that predicate or not? So and what that means is, you know, do you get similar outcomes? Or it’s, it’s really nebulous, like, you have to define that. And that’s where people are designing clinical trials, and they’re doing a lot of research on this, in order to get 510k marketing clearance. It’s, it’s a pretty robust process. And, you know, to your question about how long is it going to take, I mean, a lot of companies have teams of people, large teams, in various different disciplines. I mean, it takes months to do this kind of thing. And I mean, this is many, many people’s full time job just to do this constituent components of the 510k. So it’s quite something actually to go about this.
Amyn Amlani 28:06
Yeah, again, just to reiterate, again, these products are not are not just being thrown out on the market. There’s, there’s, there’s a basis behind them. And there’s research that has to prove their worth for consumer safety. So David, now let’s, let’s turn our attention a little bit to scope. So we’ve talked a little bit about quality control, we’ve talked about the pre market components, and now we’ve got scope. So can you fit these on anybody?
David Akbari 28:32
So the question is that you asked that the answer is no, you cannot fit these on anybody. So it’s specifically meant for adults who are age 18 and older. So when when you look at the redefinition of the prescription category, it’s really those people who are moderately severe or greater, or children, they are not OTC candidates, it’s really just adults, greater than or equal to 18 years of age was self perceived mild to moderate hearing loss. And that’s a really key point that there were a lot of comments contending, you know, what is self perceived? Should there be some sort of an audiologic objective criteria and FDA seem to stand quite firm on that and say, Nope, it has to be self identified, self perceived, mild to moderate. So you asked the person, do you have mild to moderate hearing loss? They say yes. If they say no, well, they’re not a candidate, right? But if they say yes, then they’re a candidate. And it differs from both piece apps in the prescriptive category, which are really important outcomes of all this. Because what’s really interesting in the final rule is that PSAPs are not devices in according to the final rule, they are not considered device. So the FDA clarifies that they’re for normal hearing individuals for situational listening, and so perhaps implication is like signal to noise ratio improvement, but clearly not devices and their intended uses for normal hearing people. Likewise, the prescriptive category is meant for people whose either confirmed audiologic criteria are moderately severe or greater or Are they simply are not self perceived mild to moderate hearing loss, they would consider themselves greater than that. And so what’s really interesting is that the FDA, in fact, did refuse to define categorical criteria for the degree of hearing loss.
Amyn Amlani 30:12
Yeah, and I think that’s an important point. We’re gonna jump into that in just a minute here. You know, I think the other piece that’s really, really interesting here is the fact that for the OTC devices, the FDA is recommending that a provider does not have to be involved in that process. And so how does that work? I mean, is that a risk? What are we looking at here?
David Akbari 30:40
Yeah, so in a sense, that sort of like, and I know, there have been interviews lately, where people have said, you know, this could help 90% of people or whatever, well, I would kind of step take a step back and look at analogous to like a physician’s best practice. So if you look at the general practice model for physician, they’ll say, generally, it’s not the best practice to just give somebody a drug and send them on their way that there has to be this follow up care. This aftercare in addition to the the medication that they’re providing OTC hearing aids perhaps are similar in that sense that, yes, you will allow people to get these products in their hands, so there’ll be able to buy them at pharmacies and drugstores and whatever, it’s not necessary to see a licensed professional, but in my opinion, these devices will only be effective with the involvement of a licensed professional, or at least some sort of a hybrid care model or ecosystem of care. You know, maybe it’s not a licensed professional, but maybe a licensed professional has come up with a best practices scheme that they’ve trained others on, for example, audiology assistants or something like that. So they’ve been very clear, it’s not required to have a licensed professional. And in fact, at the state level, the FDA has declared their intent that anything that frustrates or interferes with the intent of the OTC rule they won’t allow. So you’re not allowed to say you have to have a license to dispense OTC hearing aids, you can volunteer that you can say I have a licensed professional. And I also sell OTC hearing aids, you are allowed to do that. But you’re not allowed to have a requirement for a license in order to sell OTC hearing aids. So I think it’s really less in my opinion about selling the device. And it’s more about this on ramp to audiology best practices as part of a care approach. And you might liken it to prescription drugs where the OTC device will really be effective when paired with audiology best practices. Without that you might see marginal benefit, which could fulfill the intent of the OTC final rule. But certainly it won’t be as good as it could be.
Amyn Amlani 32:35
Yeah, yeah. I 100% agree with you. And we’ll talk a little bit more about perspectives here in just a minute. You know, two other pieces here. Quickly, there was some discussion about output and gain, you know, between the the proposal and what actually came out? Can you enlighten us on that?
David Akbari 32:56
Yeah, so there was a lot of debate about output and gain. And, you know, briefly in the proposed rule, they had a provision where it was I think, 115 dB SPL, and that was peak ospl 90 really important distinction, because what that means is, it means the maximum output of the hearing aid as measured in a 2cc coupler, with a 90 dB pure tone sweep. So, it was not a complex signal, for example, where you’ve got upward spread of masking in the product, we tend to call it upward spread of distortion. It’s sort of analogous to that biological phenomena, maybe a little bit cheeky, but they said as if it was 115 dB SPL, peak OSPL 90 If it did not have input control, compression and volume control, and then they would allow you to go to 120 dB SPL, if you had both. Well, in the final rule, they’ve decided, well, we’re going to require volume control on everybody. So that’s different. But what they’ve done is they kind of kept this idea that there was a classification difference that if you had something that was totally linear, you could go up to 111, in the final rule, and they referenced sort of this NIOSH 98 criterion, and then they will allow, of course, to go to 117 if the circuits capable of input controlled compression, and what that means is that on the basis of audio input alone, the compressor can activate and modify loudness, growth, loudness being the perceptual correlate of intensity in the hearing itself. And so the reasoning that the FDA gave was that they called it a 3 dB exchange rule. So that’s where they got from 120 to 117. In other words, their reasoning in the proposed rule was that you would get, you know, 30 seconds or whatever to self identify if there was a hazardous situation and be able to remove the hearing aid by reducing that maximum output by 3dB the FDA believes that doubles the non hazardous exposure time that a user can have, but they declined to have a gain requirement. So their idea was that they were going to define the ceiling As safety, in other words, the total peak output of the hearing aid, they’re going to call that safety. So when you have your peak OSPL 90 and a coupler, hearing aid can’t get louder than that. Now, realistically, hearing aids are not going to perform at that level for extended periods unless you’re already in a hazardous situation without the hearing aid. I mean, that’s just a reality. Because what the idea was, as FDA points out is this, it speaks to the idea of headroom that you have some amount of residual output in the hearing aid that you’re not using. But that you can accommodate for peaks in the signal. So it would allow you to have you know, more something that in the device represents the biological sense of hearing more closely, because that’s what we’re doing with the medical device. We’re with the hearing aid medical devices, we’re managing loudness growth in the impaired ear. And so it allows you to kind of represent that a little bit better. But what they said is for the gain requirement, they weren’t going to require that because they want to allow people to have more audibility, or more gain for low level inputs. And we know kind of from the market track data, that that’s a really important indicator for first time user acceptance of hearing aid is audibility for low level inputs, specifically. So it’s interesting that they chose to do that. That’s what they did. And that’s going to be now the what we have to do in the final rule.
Amyn Amlani 36:20
Yeah, and I found that this this particular piece really, really important too, because sound quality is the most important attribute for listener use. audibility is certainly important. Don’t get me wrong, but the sound quality is the most important piece. And if it doesn’t sound good people are less likely to use their devices, which is what the market track survey as you pointed out, references so I think that’s a really important piece. And then David, there’s the whole distribution piece where OTC device, OTC hearing aids do not have a preemption, nor does it provide exemptions for state or local requirements. And then consumer protections are not preempted. What does that mean?
David Akbari 37:05
Well, you know, this is potentially a little bit of a contentious issue coming out of the final rule that what they’ve done is they’ve reclassified all hearing aids, because what they did is they removed this 21 Code of Federal Regulations 801.420. And they repealed 801.421. And they’re going to replace that with the 801.422. So what that means is, they removed one of the regulations that was going to provide that preemption. And so what that does is it sort of becomes a situation at the state level where previously unenforceable rules could now be enforced. And so what it allows states to do, for example, is to create what they believe are consumer protections around OTC hearing aids. But the FDA was very clear in the final rule that the states are not going to be allowed to do things that frustrate the intent of the OTC regulations. So for example, states could not make a requirement to be licensed to do OTC dispensing. But it does set up a really interesting circumstance where every state is going to kind of have to figure this out. And what I I’m very optimistic about this, because we have great professional organizations in our field. And I would look to them and their leadership, for guidance as we proceed down this new and Uncharted path in order to engineer the best outcome for both consumers and providers.
Amyn Amlani 38:33
Yeah, and I think it’ll be interesting as these these states develop and enforce these particular requirements at the at the state level. And we’ll have to have a discussion about that as they start to roll those things out. Because some states are in Sunset laws now, and some states will be there in a short period of time. So we’ll have to get you back on David as those things to start to evolve. The last thing that I have here with respect to the legislative framework, is this thing called prescriptive category that we talked about where the licensed professional gets now to participate in a more traditional way, if you will. Can you talk a little bit about that?
David Akbari 39:15
Yeah, so that kind of dovetails from the previous point we were making, because it sort of sets up a situation at every state level, in terms of defining what’s a prescription, what’s a dispenser, you know, so it’s going to really take the cooperation and involvement of all three parties licensed dispensers, audiologists as dispensers of hearing aids, and of course, physicians as people who prescribe things. So it’s gonna really set up some interesting resolutions in the months ahead. I’m optimistic that audiologists will continue to be recognized as leaders in this field, but it just says it does set up a little bit of a potential conflict there, that I’m optimistic the professional organizations can help us navigate. Yeah,
Amyn Amlani 39:58
yeah, I 100% agree with that. And then the second part under this prescriptive category, if you’ll just highlight this a little bit, is we talked about the quality control under the OTC categories. What is now the prescriptive quality control component? Yeah, so
David Akbari 40:15
that’s a really interesting question. And the answer to that is it comes back to the bread and butter ANSI ASA s322. So it’s, it kind of gets back to what sometimes it’s called GMP or good manufacturing practices, it’s really going to set up a focus. You know, we kind of said that last time I was on the program about a focus on the prescriptive side, and it’s really gonna get into the electro acoustic performance criteria. Right now. And I think that’s an interesting point that the FDA made is they’re actually referencing very specific versions of the standards. So on the prescription side, there, they are pointing to the ANSI ASA s322, 2014 revision, which was reaffirmed in 2020. We’re currently working on the standards group on a new revision of that with a key outcome goal to be harmonizing with our European colleagues. So on the prescription side, you might look at manufacturers and typically the idea is you want to test a part once and be able to sell it worldwide. So on the standards development side, it’s a harmonization is a really important goal. And so what’s really interesting is that on the European side, they’ve actually, they’re deprecating IEC 60118, part 7, and they’re putting all those electroacoustic tests in IEC 60118, part 0, so they’ve kind of rearranged things. And so there is a little bit of a project that we’ll need to do on the standard side as we get to a new revision of ANSI ASA s322, where we incorporate a lot of those new measures that our European colleagues have developed and verified. And I’m really excited about that, because it adds a lot of new things about wireless testing, things like companion microphone, signal to noise ratio, there will be new ways to test that. And we’re always looking at new standards, you know, there are new ways to standardize things. So for example, a colleague of mine named Randy Wagner, who’s over at the NIST, he’s he’s leading a subcommittee on the development of feedback canceling. So it’s like a standard for the detection presence or absence of feedback in a hearing aid. And what’s really interesting about that, as you can imagine situations where a lot of manufacturers have very different ways to go about implementing their algorithms. But somehow in the standards methods, we have to find a way to find common ground. And what’s interesting about that is, as users enter the OTC space, it’s inevitable that at least some perhaps many will end up in the prescription space. And so we want to make sure that as there’s a high quality requirement on the OTC side, that we maintain that on the prescription side as well. So in theory, one of the net outcomes of this OTC rules, you’ll actually get higher quality prescription hearing aids as
Amyn Amlani 42:59
well. I think that’s a really important point that you just made. And then the last thing I have here, David, under the prescriptive category is distribution. So the preemption was rescinded. What does that mean?
David Akbari 43:13
Yeah, so it kind of gets into this idea of interstate commerce. So the further prescription category because they removed 801.420, it now kind of gets into the state level requirement. So it ends up being something where it’s controlled, more or less at the state licensure level through that credential. So the preemption In other words, the federal preemption was rescinded. Because the FDA is sort of saying, well, we want to just wash our hands of this. And the states are going to kind of have to figure that out. So in terms of the distribution, that’s what we’re kind of talking about, with who’s allowed to dispense and in what conditions. So for example, in the final rule, they pointed out Rhode Island, I think it’s like New York and Rhode Island or something, have requirements for a physician waiver. And I would encourage people to read Karl Strom’s piece on Hearing Tracker, where he talks about the history, you know, because then we don’t have to get into the timeline here, but it goes all the way back to 1977. So there are these old laws that are kind of now resurrected as an outcome of the OTC legislation.
Amyn Amlani 44:13
Yeah, we’ll make that available for folks so that they can access that. So David, we’re now down to perspectives. What does this mean for consumers? And what does it mean for our peers? Our provider peers?
David Akbari 44:29
Yeah. Oh, that’s so that’s a really interesting conversation. So you might categorize it in terms of benefits and risks. So there have been a lot of pieces out there in various print media and other media. But for consumers, you know, I think a lot of people have pointed out certain risks that there is perhaps a lack of understanding of their condition. They might be confused about product quality, unsure of next steps, you know, once they engage with OTC hearing aids, but there are potential benefits insofar as they could have As a means to do what some have called comparison shopping, not so much shopping in the sense that you’re picking out a car or handbag. But comparison shopping in terms of understanding the effect of various features and how they relate to perception. I think it’s an important piece, because the idea is if you go to a bunch of different audiologists, you may get a bunch of different things because everybody’s making decisions. But it allows users sort of that health literacy improvement. And that’s what I kind of mean, when I say comparison shopping, it’s sort of a metaphor, more or less for the idea that you’re linking your perception with something that we now are able to develop a common lexicon around. They also benefit from long term reduced prices due to competition. So we talked about access and affordability. Well, the reality is, and I think it’s true that perhaps these won’t be cheap hearing aids, and there probably won’t reduce the price in the short term. But long term due to competitive market pressures, there probably will be some downward pressure on price. And that would benefit consumers in this space, purchasing OTC hearing aids. And of course, as far as the access piece, there’ll be available more places, I think that’s a really important piece for consumers, especially those who live in rural environments, or areas where audiology best practices care isn’t as available as we might like it to be that they’ll at least be able to get something, you know, whether it’s from a Fleet Farm, or Menards, or hardware store, whatever, they might be able to find something where they might not otherwise be able to find it.
Amyn Amlani 46:25
I was just going to add, you know, you brought up this piece at the very, very beginning where we don’t have enough providers. And so, you know, this is one way to to allow individuals who need our help or need these, these devices in order to be able to function on a day to day meaningful way to move forward and, you know, it would reduce some of the comorbidity issues that they face with social isolation, depression, anxiety, and so forth and so on. So the accessibility piece, I think, is a really, really critical point, given the fact that we can’t supply everybody that’s in the marketplace.
David Akbari 47:03
Yeah, that’s a great point. And I think a lot of that literature is still emerging now, with relation to its hearing aids availabilities, interaction with cognitive decline and advanced cognitive processes. And I think it’s just now people are starting to accept the idea where social connectedness as a marker of public health, you know, when you’ve got people who get isolated into advancing age, you do see, we’re starting to get that literature now and establish this, that there are more issues with cognitive decline and cognitive function that are sort of directly proportionate to one’s degree of social isolation, and hearing aids, potentially, OTC hearing aids have the opportunity to ameliorate at least some of that.
Amyn Amlani 47:45
Yeah, yeah. Yeah. And, again, do I apologize for cutting you off, I, I just thought we would add that in there. Because I think that’s a really, really critical piece to this whole component. And then for providers, I think there’s huge opportunity here. And, you know, some people have looked at this with with a with a sour face. And I can certainly understand that, because it’s going to, it’s going to impact folks from a business standpoint in various ways, but it’s also an opportunity. And I think people are just gonna have to rethink their business models. And the way that the consumer now is going to not only be aware of the products and services that are available, but also in the way that they view you as a professional, you know, in this ecosystem that we keep talking about, towards better hearing health.
David Akbari 48:34
Well, that’s absolutely right. And that’s where I see, you know, one of the biggest benefits for the provider is this OTCs ability to provide an on ramp to best practices, audiology care is you know, I firmly believe that that, you know, when you look at OTC as part of a holistic health care journey, there is no better equip profession, then audiology, to provide that best practices, ongoing high touch care that we know is going to be so critical to success. I also think that there’s a huge opportunity for providers to increase their education, like their materials, the awareness, the health literacy of those we serve, either through counseling or print materials, what have you. And I also think that it allows audiologist a historic and unprecedented opportunity to decouple our services and the value we provide from you know, salespeople of devices. And I think what that will do is increase the value of our profession and also our independence and autonomy.
Amyn Amlani 49:33
Yeah, David, I think those last points that you make are really, really critical to our future. And, you know, I am looking forward to having reviewed this conversation a number of years down the road to see if we were here, and this is where we are now and this is where we’re headed. So kind of looking at that trajectory. And David, you’re always so insightful with your comments and, and always so gracious with your time so, really appreciate you guys On the road to the show sharing this information with our viewers, and we look forward to having you on again at some point in the near future.
David Akbari 50:08
Thank you very much Amyn and it’s great to be with you
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).