OTC Hearing Aid Regulations: Has the FDA’s Proposal Become Obsolete Before it Even Begins?

otc hearing aid regulations
March 22, 2022

Is it possible that the FDA’s proposed rule on OTC hearing aids is already obsolete – even before it becomes finalized?

Andy Bellavia and Dave Kemp discuss how the long-awaited regulations from the FDA may already be obsolete, five years after the Over-The-Counter Hearing Aid Act was signed into law.

Full Episode Transcript

Dave Kemp 0:10
All right, and welcome to another episode of This Week in Hearing where we break down the latest news innovation and trends occurring in all things hearing. So I’m joined here today by my good friend, Andy Bellavia, Andy why don’t you share a little bit about who you are for those that aren’t familiar.

Andy Bellavia 0:27
So I’m Andy Bellavia, I work for Knowles Corp, in the hearing, health tech division, and we make microphones and speakers for all kinds of in ear devices. And I’m responsible for everything but hearing aids, I’ve been involved in the hearables industry forever, also in ear monitors for professional musicians, radio communications, earpieces, and the like. And I also advocate for accessibility and hearing health, and greater adoption of both hearing health solutions and hearing production.

Dave Kemp 0:56
Fantastic. Good to have you on really looking forward to this conversation today. So Andy wrote a really a fantastic piece, he put it out on World Hearing Day, back on March 3, and the title of the article, his quote, “Is the FDA OTC hearing aid rule already obsolete?” And I thought that this would make for a really good conversation. This is something that Andy and I have been discussing really for years, whether it’s been on this show, or on my podcast, future ear radio, just talking through the implications of what’s happening on the consumer tech side. And I think Andy makes a really good case in this in this article about, you know, how a lot of the underlying technology that’s driving that side of the industry, you know, whether it be air pods, when all the way down to 100, pair $100, pair of Skullcandy headphones that’s got, you know, all kinds of different technology baked into it, I believe the newest is Jacoti, you know, hearing technology into it. So, you know, I think that it begs this question of like, and I think you make an amazing point here, right at the beginning where you say, you know, “five years will have passed before the OTC rule takes effect later this year. That is an eternity in consumer tech. We’ve already moved beyond the devices envisioned when OTC was first proposed, becoming ability to load hearing software from a third party into unregulated consumer devices after purchase, threatens to render the OTC regulations obsolete, even as they are finalized.” So let’s just start there, kind of start to unpack your article and some of the ideas contained with it. But let’s just kick things off and have you kind of frame the the macro theme of this article and some of the different insight that you shared within this article.

Andy Bellavia 2:47
Okay, and I’m not really the first person to think of this. I mean, I’m going to go back. I mean, you had that piece that’s really popular to this day, where you write about the the benefits of the smartphone wars and how that filters into hearable devices, right the mass production of the processors and how that drove mass market, hearable devices. But I’m going to actually go to something earlier you wrote and everybody tip your head that day for this one. This is his very first FutuEar radio blog he ever wrote. And he says that the shift of Bluetooth connected devices represents a fundamental change, as this new generation of connected devices are able to leverage the power of software. So these connected, I’m excerpting here, these connected devices are exotropic, with air qoutes, meaning that they appreciate and value as long as the hardware permits through over the air software and firmware updates as well as software app integration. I mean, you wrote that in 2017. A while ago, and a little while ago, but it was very prescient. I mean, thank you, you were thinking about over the air updates provided by the first party. And you You gave an example, for example of a hearing aid being software updated, which I’ve done several times to mine. So I know how that goes. But the real question is what happens when you really have an app based economy for your ear? Now, Apple is almost there, okay? Because you have air pods, and when you buy air pods, air pods pro, right out of the box, they don’t do anything of the kind with respect to hearing. But the updated operating system provides those features. Now. It’s a closed ecosystem. Apple could choose to let third party app developers get in on it. We’ll see. But I’ll think more about the Android ecosystem and how this would really work. Because Android is device agnostic. A phone can use Android whether it’s got a Qualcomm Snapdragon processor in it or a media type processor. It doesn’t matter Right, as long as a processor meets the basic requirements, Android is processor agnostic. And so you have an app based economy with Android, third party, app writers, you know, go to the Play Store, put their apps on, and you can run anything you want. The base smartphone has a certain set of core functionality, but you personalize it for your own use by what apps, one person may get Strava, you know, one person may, you know, this app or that right? They know they’ve done that for smartwatches, as well, they’ve got Wear OS, which is Android for smartwatches. And so they’ve carried that app ecosystem also to the smartwatch. What happens when they do it for the ear? Okay, imagine a year or two from now there is Hear OS, you know, or Ear OS instead of Wear OS, and you have a fully fledged app economy, within the airspace. And that’s where things get really interesting. Kim Cavitt had had touched on this in her comments to the FDA for OTC hearing aids. She had a paragraph within her greater comment, you know, mentioning that the FDA has to consider what is software hearing aids are, you know, to regulate software, hearing aids. And she was thinking more about app based in a run Mimi on your phone, for example. But when you can actually download an app from anyone into an ordinary earbud, then it changes the environment completely, because it’s almost impossible to regulate. And that was really the point of the article.

Dave Kemp 6:37
Yeah, and I want to go back actually, I love everything that you said there. And I kind of want to like, get from your perspective, you had touched upon what I previously mentioned about, you know, the peace dividends in the smartphone war, I’ve referred to this a lot on different podcasts. This was a an article that Chris Anderson wrote in 3d robotics. And again, the whole idea behind this is that when we had the whole, basically the smartphone race of all these different device manufacturers, over the last 15 or so years, because of the economies of scale of the actual components inside of the devices, it really provided so many cost savings, and therefore, it just kept driving the cost down so that you then had a proliferation of all these other consumer devices, from smart speakers, to drones, to all these different things that all use the same chips and radios and microphones and all these different things. And from you your perspective at Knowles as a supplier that is in this ecosystem, you can see it probably better than anyone. But I do think that it’s it’s a really good testament of understanding that, you know, a lot of the things that have always sort of made hearing aid unique with the ASIC, chips, you know, the app specific integrated chips, these are things that had just sort of been, like limited to those types of chips, because of the fact that a lot of the more general chips like the digital signal processing chips hadn’t quite matured yet. And that’s what we’ve really seen, I think over the last like 5-ish, 10 years, is this whole idea that like the things that are powering smart speakers, and drones, and all these different things are the same exact types of components that are within all kinds of different ear worn devices. And so you couple that with this explosion, and in the ear devices that are, you know, from air pods on down in terms of the popularity and just the amount of devices that are being sold, like you mentioned in your article, that on it, you know, on an annual basis, about 20 million pairs of hearing aids are sold, we’re at the point now, where about 300 million pairs of true wireless headphones are sold, and that number is only going to continue to increase. And so again, the point is, is that the actual, the components that comprise these devices, because of the economies of scale in the mass proliferation of all consumer tech, that these devices that these components are populated within, it lends itself to this idea that there’s going to be so much innovation upon those components. And that’s what’s ultimately going to drive all kinds of new different feature sets. That will be you’ll have like, hardware that is really affordable, that’s going to increasingly become more and more robust with the types of functionality that can support. So it’s almost like the playing field is now available for all this new, all of this new, you know, feature sets that are going to be layered on top of this economy, as there is increasingly more incentive to be building for these things. So I just wanted to preface things a little bit and just say that, from the hardware side of things, I think that it’s important to understand just how much has changed in terms of what’s become even feasible now, because of this massive proliferation of the underlying technology.

Andy Bellavia 10:01
Yeah, I completely agree. I mean the hardware is basically already there, that’s almost a given. And if you think about any market, any market at all in which 80 to 90% of the need is unfulfilled, it will get filled somehow. And it’s just a fact of life. And right now, only 10 to 20% of people need hearing assistance of some kind are getting it for whatever reason, and they’re, you know, there are reasons, but those reasons will be accounted for, and that market will be filled somehow, right? nature abhors a vacuum, and so does consumer tech. And so it’s going to get done. Now, I think we still have to distinguish between a regulated hearing aid and a hearable device, because, I mean, today, the state of technology is such as wearable devices are perfectly capable of serving on situational basis, but they don’t have the battery life yet. Or realistically, the comfort to be worn 16 hours. So like my hearing aids, I still now going on 4 years after wearing them, I still forget, I have them in some times and jump in the shower, you know, still glad they’re waterproof. So hearable devices, you know, are perfectly functional for you know, six or eight hours situational use, which is where most of the unmet need is anyway. And the other one too, is once you start to get beyond moderate, or you know, even in the upper end of moderate, it’s really true that a person cannot get an optimal solution at home. Right. I mean, I know, I know all the ins and outs of this industry. I don’t regret for a moment that I went to an audiologist, at the level of severity where I’m at, I could have never tuned a set of hearable devices to give me the level of performance I have now. And those things will always remain in fact, I actually think hearing care professionals value increases as the solutions proliferate. But on the regulatory side, it gets to be much more difficult. Because right now, if you look at OTC there’s a lot of hardware specifications, distortion, volume, limit, noise, from the microphones, all this sort of thing, all bets are off the minute I buy a completely unregulated earphone and then later load hearing software into it. The only possible thing you could regulate in that case, unless the FDA chooses to regulate all earphones, the only thing that could really be regulated is gain, it could regulate the amount of gain that the software allows when you install an app. And even then, you only you really can only regulate those apps that are downloaded in United States. And so it all gets very difficult to actually manage this in actual practice. And, and today, when you look at, you know, the the hundreds of bad quote unquote registered hearing aids being sold and the FDA’s inability to rein that in. I think there’s, there’s a lot of work ahead before a software based set of hearing solutions could be regulated by any means. Yeah, I

Dave Kemp 13:01
couldn’t agree more. And I think that, you know, as you mentioned, there, it’s like, first of all, we’ve kind of had a semblance of OTC for a long time, whether it be with PSAPs, or it be with, you know, some of these like, things that are in this gray zone of like, completely unregulated, it seems as if it flies in the face of the FDA regulations, but yet they still exist, just search ‘hearing aids’ on Amazon, and you’ll get, you know, hundreds of results with these five star reviews, and you kind of scratch your chin you’re like, where did those come from? But I think that this, this, the broader point, though, is that, you know, with these devices you have, ultimately, we’re talking about trying to solve for a very specific thing, which is, you know, we all know in this industry that there is this really long delay in terms of when you the realization that you need something and then when you ultimately take action and that number is fluctuates somewhere around 7 to 10 years and and I think that it’s like we kind of in OTC I think is a probably kind of emblematic of this is like – is the solution here really another hearing aid? And that’s where I think that things are going to become really interesting as this all unfolds, which is I agree with you that there is absolutely a place for hearing aids, they’re an FDA grade one medical device that I think by and large right now are kind of servicing the population that really needs them, you know, people that have high levels of severity of hearing loss. And you know, so I think that those are the kinds of people that are already kind of entering into the funnel to begin with, there’s a there’s more that can be done there. Don’t get me wrong, and I think that having more affordable options, more accessible options will do good. But I continue to think that that’s kind of, again, trying to just it’s like the definition of insanity. It’s like you know, you just keep coming up with the same solution every single time. And I think that the fact remains is that you have there’s a lot more to this whole idea of like, why are people not really that compelled to take action on this thing? Is it because possibly they’re not really all that infatuated with the idea of wearing hearing aids? And that’s where I think this gets very, very interesting is that when you start to look at it from the standpoint of well, what if it’s something that is a little bit more situational? You know, where are those frequently had instances throughout your day that you are challenged? Is it largely a speech in noise issue, something that frequently occurs within your work environment or in your social environment. And that is, you know, it presents, I think, some really interesting questions like the social environment, we’ve talked a lot this about a lot about this, which is, you know, okay, so if I don’t want to wear hearing aids, but I also want to be able to hear in these noisy situations and not feel like I’m kind of being left out of the mix. Would I be willing to wear something that calls attention to myself? Because I’m wearing earbuds and at what point does that become socially normalized to wear? In the same sense of wearing cheaters out at a restaurant when you’re looking at a menu. Does it become normalized to wear cheaters for your ears at the dinner table? To better hear at that, in that conversation? I think those are the bigger questions that we need to understand and figure out what’s actually going to, to normalize this type of behavior so that people will feel like this is a more approachable thing, then maybe some of the connotation that comes with the associations that people have with the idea of wearing hearing aids.

Andy Bellavia 16:46
Yeah, there’s, there’s a lot of really good thoughts to unpack there. I mean, the wait time especially because, as its presently constructed, OTC hearing aids don’t really address the wait time, because you still have to acknowledge that you have some level of hearing loss, and then act on it. And that’s whether you go to an audiologist or you buy an OTC device. And, you know, a lot of conversation about exactly what is the mix of reasons why people wait the 7 to 10 years. But I don’t think OTC in itself addresses that very well. I think it gets addressed more when consumer products company move into the sort of enhancement features. And then so you buy an earbud primarily to listen to music, or maybe use your voice assistant or whatever. And, you know, it has a restaurant mode and you go to a restaurant and you throw it in and try it out. Okay, this works pretty good. The problem is, is that technically, I mean, if you if you read the OTC regs, the draft regs and you follow the letter of what they’re saying. Any device that provides a customized hearing profile is going to fall under OTC. So, if you’re ruling with an iron fist, it means what Apple’s doing with AirPods Pro is now an OTC device and they would be required to submit. Okay, now how is the FDA actually going to treat that I mean, there there are people who point this out Kim Cavitt did and, and others as well as that the dividing line between a piece app and an OTC really needs to be defined. And it needs to be something reasonable so that innovation in the hearable space can continue. And this is something that Kim said because she and I’ve had several conversations about this, should OTC be required to file premarket notification with the FDA? And my thinking was, yes, they should to keep those 1000 you know, five star reviewed $50 bad hearing aids off the market. But that only depends on proper enforcement. And her feeling has been since the FDA isn’t enforcing now they’re never going to enforce it. So why put a stranglehold on innovation in the space when you’re not going to enforce the bad actors anyway, and, and I can I can see that Why not allow a certain level of unregulated hearing assistance to take place and let that innovation happen? And in fact, as soon as you have a software based app economy for your ears it’s going to happen whether you want it to or not. And there when you have any number of devices what happens when Skullcandy opens up the microphones to personalization as well as it streaming music right in everybody’s walking around trying those features you know or it down the road a little bit they may even just pop in when it’s super noisy. Like my hearing aids automatically adjust to their surroundings All right, well hearables devices can do that though. Sony is already doing that on a certain level where the ANC changes depending on your environment. So these sorts of things start to happen automatically and people kind of get, you know led in through the back door. To the value of hearing assistance, and you start to break down that barrier.

Dave Kemp 20:04
I love that, I love the back door notion I’ve thought of it as like a Trojan horse in a sense, because, you know, you have, again, 300 million pairs of these kinds of devices sold in an annual year right now. And that number will just keep going up. So this presents a gigantic opportunity in the sense that what this provides is exposure, it provides subtle exposure to a lot of these types of features that people probably a lot of which were completely unaware of even at the point of sale. So I think that it’s, you know, it sort of presents this new opportunity of, well, maybe that’s one way that you can start to kind of bring people into the fold is by casually exposing them to the features of this. And I keep thinking about, you know, you’re mentioning this app economy. And I think to make it a little bit more concrete for some people, look at what Nuheara has just done with this Oto app around tinnitus, right. So just through a, basically an app integration with your Nuheara devices, you can now get, like tinnitus therapy delivered directly through your Nuheara devices. And again, like if you kind of watch how this space is unfolding, right now, with going back to this whole theme of the underlying technology is and continually improving. One such area is like sensors. And this whole notion of sensor fusion. So you mentioned Sony, and this AI ability to have like dynamic and see. So it’s sensing using the microphones, and a combination of that and machine learning. It’s understanding like the acoustic environment that you’re in. And it’s just sort of automatically increasing and decreasing the ANC in your headphones at all times. And so you can imagine that like, as these devices become more laden with intelligent sensors that are able to detect and determine different elements within your current soundscape, it’s going to be able to do all kinds of dynamic things like that. And I think that, you know, for example, it with tinnitus, where if there is some trigger that it can identify through, you know, your behavior or through the inflection of your voice through that being captured with the microphones or something that identifies that maybe you’re having an onslaught of, an onslaught of tinnitus, it will maybe start to play some of those noises in that tinnitus therapy for you on your behalf. So I think that these are the kinds of things that really excite me when we talk about world where the hardware is important. But I think that it’s the software that’s going to be layered on top of it that’s going to allow for all kinds of new, really innovative things that we’ve never seen before. And again, like what does the end result look like for that? Well, it just could be that people are actually really incentivized to want to wear these things. And they feel as if there’s increasing amounts of features that come along with it, there are these use cases that are becoming more and more a part of their life, whether it be I just increasingly like to stream music, I like to listen to my podcasts throughout my day, because I have my air pods in. And that’s just how I go about my day because I have a job that allows for that. Or I have this dynamic active noise cancellation that’s just constantly sort of protecting my ears. So I have something that’s in my ears, like the Sony devices, that, you know, I’m not even listening anything, I’m actually wearing them from a hearing conservation standpoint in so because of the fact that you have these things now in the ear already, that presents the opportunity for all kinds of things that can be added on to this. And that’s I think we’re at like the really early stages of this, which is step one was you needed to have a foundational, you needed to have a foundation of devices in the years more or less. And that’s what we’ve really seen post AirPods era is this mass proliferation of the TWS devices. And I think that the really important thing that those of us in the hearing health industry need to really understand from this consumer tech side, like the probably the biggest implication of the growth of that industry, is that because of the fact again, that you have 300 million devices being sold on an annual basis, you have so much more incentive as a developer to be building in this ecosystem applications or something in regards to the fact that you have a target audience now that are wearing things in and around their ears for extended periods of time in hearing aid wearers are a secondary beneficiary of pretty much all of that technology that’s about to be unleashed.

Andy Bellavia 24:45
No, absolutely. Well, I think, I think everybody who cares about hearing and hearing hearing professionals and advocates all benefit because We’re bringing the level of awareness of hearing up and making people comfortable with it, right? That’s the Trojan horse, I think it’s gonna come more directly, you know, it’s Trojan horse for the moment, but the minute one of the mass consumer companies approaches us in a more straightforward manner. And I think we were talking with cat when he gave this example, like, I love the apple ads for air pods, you know, various versions of a person listen to music, and dancing up the walls, and you know, this sort of thing, right? They’re really stylish and cool. And the minute they make an ad that shows somebody walking into a crowded restaurant, and it’s a cacophony, and they just go like this and touch their air pod Pro, and the noise dims down, and they walk up to a friend and greet them, and, you know, and look like they’re having a perfectly good old time with a noise muted. And, you know, all of a sudden, the whole, the whole situation changes, that would be a step change in the way people think about hearing. And at some point that’s going to come at some point or consumer company is going to address hearing in a big, big way.

Dave Kemp 26:07
I couldn’t agree more. And again, like, think about what’s going on in the Bluetooth LE audio space, too, this is where things start to get really fun is, okay, so you have all these people that are wearing these Bluetooth enabled devices, you have protocols that are not allowing for a lot of tethering between different devices. So, you know, again, we hear about this, you know, one, one particular instance that’s frequently cited as a challenging listening situation is the dinner table and allowed restaurant Well, again, this cheaters idea Well, what if you have, everybody is tethered into just one iPhone, or even directly tethered into each other’s airborne devices, so that you have direct streaming into each other in a sense, so that you’re almost like, in a in like a calm system, like, you know, walkie talkie type system that historically had been like limited to these like, you know, literal comms headsets, to where now, that’s all becoming more commoditized and commercialized and made more available through all kinds of innovation happening on the wireless technology side. So I think that again, like, it’s really important to be aware of all of the different things that make all of this work in the first place, and what’s coming in every new phase of what’s on the horizon, and what that will lend itself to. And I do think that the foundation has been laid these last five years for the next phase, which will now be all the new things that are built for that foundation. And that’s where I think that you’re right that like an apple, for example, has tremendous ability to really change the way people think about something like hearing health. You know, I think that Apple’s biggest contribution to hearing health might not really be on the hardware side, you know, it’s yet to be seen what they’ll ultimately do with air pods, like if they’re going to continue to go down that path, or if they’ll kind of always just be in the baby pool, in a sense. But the bigger contribution might just be with Apple Health, and making people really aware of like, what an audiogram is, what your hearing test looks like, like your current hearing profile, being able to monitor that and being able to see on a year over year basis, like how beneficial would it be to have a have public awareness of how much you’re hearing depreciated on a year over year basis, and who better to facilitate something like that, then one of the big smartphone providers that can house that information, and that’s the third party app ecosystem that we’re talking about, which is, you know, if you have these apps that are able to conduct those hearing tests, and basically capture that information, and then you can store it in Apple Health, that presents a number of really exciting opportunities to so I agree with you, like we could totally see an ad in the next few years. That’s all around, you know, basically the the the the hearing portion within hearing health and making it a public, basically like a public ad about you know, the importance of hearing health and making sure that you take good care of your ears kind of thing.

Andy Bellavia 29:19
Yeah, you’re right about Apple and their whole health ecosystem and the big Hearing Study they did and being able to see your noise level on your your Apple Watch. And, I mean, they’re building a lot of awareness around hearing issues already. I just love it. I love it. I want to go back to Bluetooth 5.2 You mentioned in the beginning, because that’s a perfectly good use case. For people wearing their true wireless earbuds in public places. There’s an app called tunity that I use on occasion well, more so before the pandemic than now because we’re still not hanging out in sports bars all that much but, but it’s coming back. But with with Tony What you do is you point the you point your phone camera at it at a screen. And it will, it will determine what the channel is and then stream the audio out of your phone. And since my hearing aids are Bluetooth connected, I could go into a sports bar, the game I want to watch, you know, is on the other end of the room, I could capture the video and the audio starts streaming. And I am listening to the audio of that screen way over there. And because I can mix it in, so I would have it playing in the background, and I could still talk to the people at my table. Bluetooth 5.2 will bring that to everybody. Yeah, totally. So now you go to a sports bar, you want to watch the game, you put the audio for that game on to a Bluetooth channel, everybody at the table does this. Your buds have gone into noise reducing mode, you know, into restaurant mode, essentially. So you can talk to the people at your table and hear them while hearing the audio for that game. That is one of the most compelling reasons why you would go to a public place wearing two wireless hirable devices. And now once you’re going to a public place, and you’re putting them in restaurant mode, you are now being introduced into hearing tech. And so Bluetooth 5.2 is going to be one of the accelerants. I mean, there are multiple accelerants and that’s going to be one of them. And that’s this whole underlying thing. And this is where I kind of hope. You know, in the regulatory environment, we that proper accounting for this sort of innovation is actually done in the right way we want people to innovate in the hearing space, certainly up to a certain level, you’re never going to address severely hearing impaired people with a consumer device. And in different people have a different feeling about where the line is. But there is a line which is not zero, in which you want to allow innovation to take place. And really allow the consumer adoption of hearing solutions to accelerate in the appropriate way.

Dave Kemp 31:58
I couldn’t agree more. I love that example. And I think that you know, you can see it too with what’s coming in from Bluetooth broadcast mode. So right now, you know, you have the what’s kind of an interim solution is looping different environments. So you can have, you know, the telecoil loops in a church or in a theater, whatever it might be in these public places. There’s a lot of capital investment and time that needs to go into that though, like there’s a lot of a burden on, on on establishing the infrastructure to facilitate that. Not to mention that in order to take advantage of that you have to have a device that is T coil enabled. So again, this is what I think that this is, this is a good representation of what I mean by like, when we start to see things that are being developed for the masses, we in the hearing aid industry get to take advantage of that too, because you’ll see that like you’ll have Bluetooth connected hearing aids that have the ability to tap into these broadcast modes that are being built both for hearing aids, but also for air pods, and for all of these key ws devices that can be taken advantage of those different feature sets. So again, I think that it’s like it’s this really exciting era that we’re kind of entering into where you when it when hearing health is being developed for the for the masses, if you will, it’s going to a lend itself to more use cases for the hearing aid population, but be it’s going to provide that exposure. And to your point, like, I don’t know if it’s a contrarian take or not. But I think that I’m of the mind that this market is going to expand considerably over the coming years because of the fact that you’re going to just have so many more people aware of what it even means to have hearing loss and what it feels like to treat it. I think you and I have had a bunch of conversations about this, like you can attest to this personally. But part of the biggest problem with hearing loss is that for most people, it’s a gradual progression. And so because of that, it’s hard to really actually tell that it’s happening. It’s a slow fade. And so I think that

Andy Bellavia 34:02
was easy to deny that it’s easy to deny that

Dave Kemp 34:05
it’s happening. And so this is what makes me so excited about this whole exposure pieces. How many people that have gradual hearing loss have even realized some of the sounds that they’re no longer hearing. And if you even give them a taste of what that sounds like, again, they’re going to have this epiphany where they’re gonna say, I had forgotten what the birds chirping sounded like. So you go from something that is in order to get that quote unquote taste in the old paradigm you would have had to go and do all the steps involved to get fit with a hearing aid in order to get that now we’re talking about this backdoor that you’ve been describing of buying a pair of $100 headphones that you were completely oblivious that this feature existed, you know, through an advertise it through word of mouth or whatever you come to realize, oh, there’s this feature that exists you turn it on, boom, you hear this? You hear the birds chirping again in that’s the exposure effect that I think’s coming where people are Gonna legitimately say, I had no idea what I was missing out upon. And if it means that it goes from taking them from seven to 10 years down to three years, because in that three year period, they’re using something that’s more situational, and they’re really cognizant of this. And then they’re going to be I think more, they’re gonna, they’re going to be way more open to this idea that there are more sophisticated solutions up the ladder that you can move into that provide higher levels of sophistication of care. And there are experts that are facilitators of that called audiologists, and hearing professionals. So that’s the whole argument that I see for this, for this industry, broadly speaking, is that I actually think the biggest thing that this whole consumer tech boom, thing that’s happening as it relates to hearing health is it’s just going to create a massive amount of exposure and the likes that we’ve never really seen before. I feel like that’s what’s different this time around.

Andy Bellavia 35:56
Yeah, I completely agree. And in what you just described is really the hope for all this innovation taking place is that it compresses the time to treatment at all levels. So in the beginning, people are working situational image today go beyond the need for situational, they don’t wait nearly as long to go to a full audiological solution. In in half of those cases, people who are situational, may very well end up going to a hearing care professional anyway, to help them sort out all the options, which I think is a wonderful thing. To separate out a limited set of hardware from hearing care professionals. In other words, if I walk in situational, I might get set up with a consumer solution or like the job or enhance plus, right, which is kind of an in between solution, what have you more solutions for people at all stages of their journey, engage with them earlier, keep them at the proper place in their journey sooner without the wait. But I also want to mention that you know, everything we’re talking about is kind of a United States centric, or at least not only developing countries centric. All of this innovation really promises to address what’s ultimately a pandemic of untreated hearing loss worldwide. Think about countries where access to audiological care is very, very limited or almost non existent. All the innovation taking in this taking place in this space, also can have profound effects globally. And really, if you’re in a place where you you have limited means no access to an audiologist at all, but you have access to a local clinic, and they set you up with something which may not be exactly right, but gets you 70 or 80% of the way there, your life has changed, your life has changed completely. And so the really exciting thing about all the innovation taking place here, which will be driven by the OTC regulations and awareness being built here is going to have positive global effects.

Dave Kemp 38:00
You said two things? Well, I want to unpack both those because those are such good points. First thing being that, you know, this idea of having more optionality for the whole spectrum of hearing loss is only a boon for the provider. In my opinion, I think that if you can establish that relationship really early on in in really kind of move up the ladder with them in time to the point to where they have something that resembles a premium level hearing aid. Great, you know, but if you’re able to establish that relationship early on, I see nothing but a net positive, because there’s a lot more going on here, you know, you can screen them for cognition early on, you can look at some of the different things that are going on beyond just the peripheral auditory system and really get into the central auditory system. You You know, audiologists are doctors of science, so there’s so much that they can, I think, understand about these patients and help the patients to understand the value of the provider isn’t just that they’re able to calibrate these devices. It’s understanding what the underlying issues are, and give you strategies to preserve what you have and make it so that you have the best experience with your hearing for the rest of your life. So that’s my argument for why I think it’s really important that providers look at anything downward from hearing aids down from these things that are these hybrid devices, like you said the job or enhance plus, all the way down to understanding like What do AirPods pro do today and having a finger on the pulse of like that particular portion of the market, how that’s progressing. So there’s that and then the other thing that you said about this whole idea of, you know, treating the the unserved portion of the world, which is massive, I think is another one of these things that will be a huge driver of innovation in and of itself because of the fact that, you know, you’re gonna see the portions of the world that you’re right, like they don’t have access to the traditional means of hearing care that we’re accustomed to here in the US or in parts of Europe. But I think that will will happen is that just by means of necessity, you’re gonna see a lot of innovation on the self self fitting aspect of things, you know, the ways in which these devices are able to kind of calibrate themselves. I think you’re right that like the that portion of the world. Like you said earlier, you know, if 80% of the total market isn’t really being served, it’s going to get served in time. And I think that that’s what this commoditization and proliferation of, of TW s headphones, coupled with all of these new, you know, innovative hearing, like augmentation software capabilities that can be layered on top of that, because of the fact that you have parts of the world now that can get access to an Android smartphone for like 100 bucks. And, you know, who knows, maybe there’ll be tethering into like SpaceX is, you know, Starlink satellite system, like as their internet provider, I mean, there’s so much happening, just broadly speaking, and consumer technology right now that you’re going to see so many interesting little bits and pieces pulled together in a way that it will make what had previously been totally untenable, like it will make it feasible in increasing amounts of waste. And it will probably help to drive how the whole lower end of the market really starts to take shape.

Andy Bellavia 41:18
Yeah, very well said very well said. I mean, it’s ultimately, both people and technology driving towards the future, or people where there are no people with untreated hearing loss.

Dave Kemp 41:30
Totally. All right. Well, I think this has been a fascinating discussion. You know, I again, we’ve talked about some of this stuff before, but I do think it’s really relevant now that, you know, again, I think you make such a good point, like, is the OTC law sort of irrelevant at this point? I would say no, not really, because I think that it is still important. It does fill a particular void, having more accessible, affordable. Hearing aids is really important. But it’s not a silver bullet. I think that there’s a lot more here that we need to understand of what’s kind of going on. And I think he makes some really good points about considerations that I really hope the FTC has the FDA has right now around regulating this and making sure that they do not stymie the level of innovation. In some sense. So those are some of my closing thoughts.

Andy Bellavia 42:22
Yeah, no, you’re exactly right. I mean, irrelevant wasn’t a word I used to obsolete was the word meaning that it fulfills a need for today’s condition. But you can already see, when you think about it, how many years did it take from the P cast until it’s released is five or six years, something like that, right, potentially

Dave Kemp 42:44
be six if it goes into 2023.

Andy Bellavia 42:46
So you know, you’re talking five or six years between conceiving the need. And I don’t mean originally, because people have been talking about it before, but the peak has really kicked off the process. And it was six years until we see regulations five or six. So if you take another five years, you know, it’s it’s not that it’s irrelevant. But we’ve got to get going now on thinking about what’s coming, and how to appropriately allow innovation, and as available appropriate regulation to protect people from generally bad actors. for what’s coming five years from now, already, right, the five year clock has already started. And I that was really the point of the article,

Dave Kemp 43:29
that five year clock. And in consumer tech, like he said, that’s an eternity, especially it will feel it will feel even more like an eternity five years from now, because every single year, it’s like exponential ism. You know, it just seems to kind of be in a hockey stick up. Right. So I think that we’re due for just so much that will transpire around the software around the hardware. You know, again, I’m firm belief that one of the big things that will really reimagine hearing aids will be the sensors that are going to be laid on to these devices and onto just your worn devices in general. And again, my big, big point that I always try to articulate is like, put yourself in the shoes of the mobile developer that struggled back in 2010, when they made an iPhone app, you know, a lot of those still same people. They’re there. They’ve been bouncing around building applications for all kinds of different products. And I think that the year now is definitely a spot that a lot of people are looking at as there’s some really interesting applications that can be built upon the notion of, hey, look around. Everybody seems to have something in their ear right now. There’s a lot of doors that opens up I think.

Andy Bellavia 44:43
Yeah, absolutely. That’s a that’s a great way to end this as the doors are opening up.

Dave Kemp 44:48
The doors are opening up. Awesome, Andy. Well, thanks so much for joining me today. And thanks for everybody who tuned in here to the end. We’ll chat with you next time.

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About the Panel

Andrew Bellavia is the Dir. of Market Development for Knowles Corp, a leading acoustic solutions provider to the hearables, smart speaker, mobile, and IoT industries. He has been personally involved in supporting the development of many innovative hearable devices since the beginning with pioneers like Bragi and Nuheara. Andrew is also an advocate for the role technology can play in addressing hearing loss, and in the practical use cases for voice in the coming hearables revolution. When not in the office he can usually be found running the roads of N. Illinois, and until recently, the world, often photographing as he goes.


Dave Kemp is the Director of Business Development & Marketing at Oaktree Products and the Founder & Editor of Future Ear. In 2017, Dave launched his blog, FutureEar.co, where he writes about what’s happening at the intersection of voice technology, wearables and hearing healthcare. In 2019, Dave started the Future Ear Radio podcast, where he and his guests discuss emerging technology pertaining to hearing aids and consumer hearables. He has been published in the Harvard Business Review, co-authored the book, “Voice Technology in Healthcare,” writes frequently for the prominent voice technology website, Voicebot.ai, and has been featured on NPR’s Marketplace.

  1. I keep hearing that those with more severe hearing loss will only receive benefit with professional intervention, however based on nearly 30 years of direct participation in consumer hearing loss groups has shown me that the majority of professionals are no longer facile in more then very mild hearing loss. More specifically, they (we) have been trained by the industry to focus on very low-complexity patients (the very ones that could benefit from OTC/DTC).

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