In Episode 7 of the Hearing Tracker Podcast, we had the pleasure of interviewing Kevin Franck, PhD, MBA, Director of Audiology at Massachusetts Eye and Ear and Otolaryngology–Head and Neck Surgery Faculty at Harvard Medical School. In the interview, Dr. Franck discusses the future of hearing aids and hearing healthcare in United States, with a focus on disruptive technology and how he sees over-the-counter hearing aids improving access to hearing help.

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Podcast transcript

Steve Taddei (Host): This is the Hearing Tracker Podcast from HearingTracker.com. Today we are joined by Dr. Kevin Franck, and he is the Director of Audiology at Massachusetts Eye and Ear. He's also Faculty of Otolaryngology at Harvard Medical School. Thank you so much for joining us.

Kevin Franck: Hey, thanks so much for having me. It's a pleasure to be here

Host: Before we get started, can you give us a little bit of a background about yourself and what you do within the world of hearing?

Franck: Sure. I grew up with hearing loss in my family, which is what interested me in the career. And I started it at the university of Michigan, kind of in the clinical academic realm. So I did research and saw patients and after university of Michigan, I moved onto the Children's Hospital Philadelphia. But when I was there, I kinda got the corporate bug and I took a job on the other side of the world and worked for Cochlear. Cochlear is a cochlear implant company. Located in Australia, it was a great way to introduce my family to the down-under way of life. After my time at Cochlear ended, I moved back to the United States and got involved in a number of startups. One was a healthcare medical consulting startup for cancer drugs, and then another bionic limb company, a bionic ankle, and then a hearing device startup called Ear Machine. That Ear Machine startup was bought by the big corporate audio maker Bose. And now I'm back in the clinic, academic realm at the Mass Eye and Ear.

Host: What are some barriers you see in the current way people are obtaining hearing aids through hearing care professionals?

Franck: Well, there are a lot. In the United States. I think the biggest barrier is a bit of a historic one. Medicare, our main government coverage, statutorily excludes hearing aids as well as vision aids and teeth aids from coverage. And private insurers often follow Medicare's lead. So because hearing aids are medical devices, this whole aspect of care is excluded from the healthcare insurance market. So we've ended up with a private regulated market that's subject to the competitive market dynamics. Often this ends up with a bundled price model where hearing aids seems so expensive. Now some states have done a great job of covering hearing aids, but money is one big barrier. But that's not the only thing. Hearing aids aren't corrective like glasses often are. Hearing loss is both an inability to detect sounds as well as an ability to really understand them once you can detect them. So hearing aids do a better job with allowing you to hear sounds than they do with understanding them, particularly in noise. And people with hearing loss need to understand this, what they can and can't do and how they can use them with other technologies to really optimize success. And that's another barrier. It's not as simple as just hearing aids. So there's a whole bunch of reasons, but I think there's things we can do about each one of these.

Host: I do like that distinction you made. Hearing aids are not correcting your hearing. They're not fixing the injury to your hearing system. They're doing their best to accommodate whatever injury you have. And then it's still ultimately up to whatever fidelity is left in your hearing system and how well your brain can interpret that information. So what are some of those things that people can do to start overcoming some of these barriers?

Franck: Well, you said it right there is protect your hearing, right? Because you can't get it back, do everything you can to keep it, whether you're a child or an adult. If you ever hear that sound in your ears after whatever you did, did you did too much and never do that again. So I think it's really important for each of us to realize that we have a big role in causing our hearing loss. Not always, but sometimes. So the first one is really pay attention to what your ears are telling you. And if you happen to have technology that can help you figure out when things are too loud, use it. One other thing I'd like to talk about in terms of things I do in my spare time is I'm on the board of the Hearing Loss Association of America. The Hearing Loss Association of America is strongly advocating for changes to the Medicare law. Helping legislators understand that treating hearing is treating more than just understanding. And it's a great way to change the system to change the laws. Another thing we can do for the fact that hearing aids aren't corrective, as you said, is have people with hearing loss talk to people who've been successful managing their hearing loss. Those are the best people to give the perspective of saying, oh yeah, these hearing aids, don't correct my hearing, but they help me hear a lot. So that empowerment that comes from people who've talked to people who've had similar challenges, there's nothing like it. There's an exciting thing coming. Which are these self fit hearing devices. If you don't have a lot of hearing loss, there's all kinds of great technologies to help you hear better. And these self hearing devices, there's more that are on the way.

Host: I agree that so much of the problem is just awareness of hearing loss and what causes hearing loss. Because there are many things that can cause hearing injury. One of the most prevalent causes being something that is completely preventable for the majority of us. And that is noise exposure or music exposure. It's funny that you bring it up because I had a patient this past week who came in for a hearing screening, he had normal hearing, but he was describing that he listens to his music on a regular basis and afterwards his ears are fuzzy and he has ringing in his ears. And I was actually like struggling to get him to understand the severity of that. And it is a cumulative effort. Every time you have tinnitus in your ears or a fuzzy feeling after a significant sound exposure, that is an indicator that you have caused some damage to your hearing system. But you mentioned this concept of new hearing devices and they're self fitting. Can you describe what self fitting is for someone who might not know?

Franck: Sure. Self fitting, I think refers to actually the opposite. Most hearing devices are clinically fit. We go see an audiologist who does a bunch of measurements of your hearing and of your ear canal and of different things and comes up with an optimal fit for that person. And now that technology results in connected hearing devices and smartphone interfaces, we're beginning to move some of those techniques onto the smartphone itself and put it in interfaces that are simple enough for someone to use it without training the opportunity to take some of what a professional would do typically and put it into an app, really opens the door for some of these self fit devices. I want to go back to one point you mentioned around hearing protection, I've become such a headphone snob. I can only use noise canceling headphones. I take the train to work and if I'm on that train without it, I'm so bothered by the sounds around me because when I wear those noise canceling headphones, I can listen to my content quieter. So not only is the noise quieter, but the podcast, what I typically listen to, they're quieter too.

Host: I had the same occurrence when I was in college. I was going in to uh Columbia college in Chicago and I would take the L there. And that is exactly what happens when you're listening to music or podcasts, anything over your headphones. You have to set the volume louder than everything else around you in order to hear your music clearly. Which then if the L or the train that you're riding is at 90 decibels and already potentially hazardous level over a long period of time, then you're just going to put your headphones that much louder than it.

Franck: Exactly. I agree. And I think the challenge for self fitting devices is to be creative and to be more effective for the platform. When you and I have fit someone with a hearing aid, we do a really accurate job measuring how well they can hear. We also measure the size and shape of their ear canal because the acoustics really matter. And they matter when you use what's called a prescriptive hearing aid fitting, where you need to know everything about the acoustics, from how much you hear all the way to the eardrum and that's how they were built to work. And if you try to replicate that in a self fit device that might be used in your living room or somewhere else, you might miss a few important steps, like calibration, attention, or even what happens when you compete with background noise. So I think the real opportunity for self fit devices isn't to try to replicate what audiologists do, but try to come up with something unique, something new, something that really is best suited to the platform. And I think we're going to start to see some different ways of people to fit their own hearing devices. And I think those are going to be really successful.

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Host: There are quite a few of 'em out right now. Both in wireless earbuds and also headphones where you can purchase them online. You do not have to go to a hearing care professional, but what do you see being the biggest benefit of this new wave of ear technology, where people can take all of that autonomy and addressing their own hearing loss and hearing difficulties?

Franck: Well, you said it, Steven. It's that autonomy. It's access. I think it's universal design. Universal design is one of these words I learned a number of years ago when. When we designed for particular people, often on a whole bunch of people benefit. And the technologies that help people hear better. Aren't just relevant to people with hearing loss. They're relevant to people with normal hearing who are trying to hear in noisy places. So if we start to incorporate great hearing technology into typical consumer devices, everyone's going to hear better. We're all going to have super hearing. And then those people with some hearing loss are actually going to start to benefit from hearing technologies before they even realize they have hearing loss. And if we can blur the line between what's considered normal hearing and what's considered hearing loss, and just make everybody hear better, then I think these self fit devices just extend the utility of devices that are built for everybody. And the opportunity there is to say, great while you've got normal hearing, you can hear better in a restaurant. While you've got hearing loss, a little bit of hearing loss, you can hear better... more like you used to hear and better in noise. And maybe just, maybe these devices could say, Hey, now you've got the amount of hearing loss that you need someone to help you with this. Or with that. So I really want to blur the lines here. I think right now, hearing care is so divided up. We go from normal hearing to clinical hearing with hearing aids and then an entirely different market of cochlear implants. And there's no easy trend between them. If we can blur it a little bit so that that customer's journey, the patient's journey, just the person who lives, can easily transition from an Apple AirPod to maybe a, an over-the-counter hearing aid to a hearing aid to a cochlear implant, they may never have to miss a word.

Host: That's an awesome point that you made that these devices can be like early indicators that there is a hearing loss present.

Franck: Yeah. You know, self fit, hearing devices have been around for a very long time. And it's only now that we're talking about them in the context of this care, because of the interface that comes along with it. And that interface is far more relevant and capable of telling people what they need to know and what they need to do next. So my real hope is this time around, as we try to use self hearing devices, we imbue them with the intelligence to give that person the steps of what to do next.

Host: Something I wanted to ask you about Kevin is with this new ear tech, what are some of the things that we should be cautious about in pursuing self fitting devices? Is there a risk? Is there a reason for us to be cautious?

Franck: So the cautions of having a medical device in the self fit world are real. But the reason that so many people advocated for this class to exist is because the belief that the risks are worth the access... that so many more people can get access to hearing healthcare, that it is worth the small risks. The risks I hear talked about the most, first are that the wrong person will try to use the device and then say up see hearing aids aren't right for me. And I think that's possible. But it's similar to, if someone goes to the drug store for a headache and they can't be solved by aspirin or Tylenol, does that mean they won't pursue anything else? I think as consumers, I really hope that we try these technologies. And if it turns out that you have got too much hearing loss, either the technology or you yourself say, well, maybe there's something else that can help. I think access is far worth the risk of the wrong people using it. Now another way to say the wrong person is, well, what if someone's got a scary medical condition... that if they had seen a clinical professional, they'd find that scary medical condition. And again, I think they're rare and I think people still go see doctors when things go wrong. And again, I think the opportunity is for these devices to be even early detectors of these types of things, too. Another risk I hear people talk a lot about is, well, if we don't fit these well, we're going to cause hearing loss. I don't know that that's the case. Modern hearing aids don't just amplify sounds. And they haven't for quite some time. They use a special kind of amplification called compressive amplification. And what that means is only quiet sounds are amplified and loud sounds aren't. So if these devices are set in ways that are reasonable, the chances are, they will never be louder than typical headphones. So I think that risk of overexposure is also a bit overblown.

Host: I like how you mentioned that because that's a question I get often people will be fit with hearing aids, even in a professional setting, and they'll have fears that the hearing aid is going to damage their ears. Basically that if a loud sound occurs like an ambulance passes or someone slams the door, that it's going to turn it from an annoyingly uncomfortable level to now a hazardous level. And that is just not the case with our technology. Even the over the counter options, or these devices that we're talking about that you can purchase off the shelf. They do have limitations like that in them. So it's not like you are putting the equivalent of a rock concert straight in your ear, and it's going to just blow your eardrum completely out. You mentioned OTC designation. Can you describe what that means to someone who might not be following the legislature or the OTC bills that are currently out there?

Franck: Sure. It's really worth discussing. So in order to say you can treat hearing loss or to call yourself a hearing aid, you have to be a medical device. Anything that treats a problem, a health problem, is a drug or a medical device, and it's under the watch of the FDA. And the FDA ensures that the companies that make them don't lie about their benefits and make sure that they're safe and effective. Other devices that are on the market called personal sound amplifiers are exempt from the FDA. They don't, they're not under any regulation. So as long as they say they don't help people with hearing loss, they can do whatever they want. When the FDA makes this new class of over the counter hearing devices, they will provide a pathway for devices that have been proven to be safe and effective to be dispensed without a clinician, either an audiologist or a hearing aid dispenser. And I think that's the exciting opportunity where these devices will be designed to prove that they can provide the benefit safely of helping people with hearing loss.

Host: Yeah, that would lend itself back to what you were saying originally that it can be this continuum. It doesn't have to be this, you either have normal hearing or you have a hearing loss that requires this professionally fit. Something that I've spoken to you about before are they self fitting devices and the accuracy of the hearing test or the threshold check that they'll perform on there? Can you speak to that? And what are some of the issues. If it is an accurate test, if it is not an accurate test? Sure. So when we do something called an audiogram, we use a machine where we're very confident that the sounds we're putting out are the sounds that are actually heard. That's called calibration. And we also do it in an environment that we know to be quiet, because noise can interfere with what you're listening to. And importantly, we monitor the attention of the person being tested. Because a good hearing test is something that takes more than just a few minutes. All these things together, go into what we call an audiogram. And the typical way, the current clinical way of fitting a hearing aid takes an audiogram and applies some prescription to the sound changes that we make in a hearing aid. And it's based on accuracy. And it's based on that correction factor you mentioned, which would be a little bit different for you and me, and a lot different between me and a baby. Or someone who's 80. So if you try to do that on a smartphone, you are going to bring in some error... some loss of accuracy, that if you use that method the way it wasn't intended, you could end up with a poor fit device. If you get bad input going in, you'll get bad output coming out. So rather why not use self fit methods that don't rely on a whole way of doing it that needs calibration, attention, and noise mitigation. And it's a tall challenge. I'm not saying it's easy, but I think for the companies that can figure this out, they may be rewarded by people having a really good go at listening to these self fit devices. You mentioned a lot of considerations and recommendations. If you are going to use a self fit device, best thing you can do is make sure you're in a quiet environment where it will actually allow you to use the softest level as you can here. And the beeps you're listening for won't be covered up by let's say the television in the background. You can also make sure there's an appropriate fit for the devices, which is a little bit more difficult because that will depend a lot on the type of hearing loss that you have. But at least to get an accurate test, it does have to have a very good acoustic seal or good acoustic coupling with your ear canal. And I know some of the devices do walk you through a basic questionnaire to see how the acoustic coupling is. Beyond that though, you mentioned that there's this other approach for self fitting devices where it's maybe not based on a threshold search, which is what we're talking about. So what would that look like for someone, if they put on a pair of devices that had... they gave them the agency, but it wasn't based solely on a correction factor and a threshold search.

Franck: Sure. Well, I'll talk about some examples that I've experienced myself. So when I worked for Ear Machine and then Bose, we used one where we took two controllers and those controllers sounded a bit like volume, and the other like a combination of bass and treble, but that's just how they sounded. What was happening under the hood is they were sending you through hundreds of hearing aid fitting combinations. And because the interface was so easy, the user was able to optimize their hearing aid fitting settings on their own. And when I was at Bose and that Ear Machine, they did a good enough job to do the research to prove that was true. So that's one that works. Give people access to the actual parameters and they can actually optimize themselves. Another method I've heard of from a company called Concha Labs uses like an A/B comparison. So you listened to one, then he listened to the other, and then it adapts. Kind of like this vision tests where you look through A and look through B and which one is clear. Even a company called Sound World Solutions. You can either do a hearing test or it gives you access to sliders, low, medium, and high pitch sliders that change some of the hearing parameters underneath. So all three of these are examples that don't rely on a replication of an audiogram on a hearing device. There's another company called SonicCloud where you can input your audiogram, or if you went and got your audiogram, that was professionally calibrated in quiet and attention, you can type it in. It'll make that adjustment. So far, I don't know how to get a professional audiogram into the Apple device to program the Apple AirPods. But, um, I know you can get your audio gram in there from self-testing either on a different app, like Mimi, for example... but, uh, I don't know how to get a professional audiogram into the product itself. So I think there's an opportunity to both use the accurate results if you got them, as well as use interfaces that are really well suited to devices if you don't Advertiser: Support for the Hearing Tracker Podcast comes from Nuheara. Nuheara is transforming the way people here by creating personalized hearing solutions that are multi-functional, accessible, and affordable.

Host: Over the past few months, I've had the chance to try out Nuheara's latest product, the Nuheara IQbuds Max. IQbuds Max are wireless earbuds for people that struggle with situational hearing problems, like hearing in background noise. They offer personalized amplification with directional focus, active noise cancellation, seamless audio streaming, and hands-free calling over Bluetooth. Thanks to the large 9.2 millimeter dynamic driver Nuheara IQbuds offer best in class audio quality. They're available to purchase Nuheara.com. And you can now get a 10% discount using promotional code HEARINGTRACKER. So we've been talking about lots of hearing aid alternatives on the market. Like the Bose Hearphones, the Nuheara IQbuds Max, the AirPods Pro from Apple. And all of these devices do allow you to have some form of threshold based fitting. So what else should someone look for in these types of devices? What makes one of them stand out versus another?

Franck: I think the most important feature of any hearing devices is connectivity. And the reason for that goes back to what we started talking about way in the beginning of this, that hearing aids can't correct your hearing. There's always going to be some fuzziness that remains after correcting the audibility as perfectly as you can. And there are some great ways to help that. And connectivity is one of them. Connectivity means being piped right into the source of sound. So that that sound does not have to compete with all the noises around you. It's easy to think of the application when you're talking on your phone, right? Because your phone can stream the sound right to your ear. That kind of connectivity is great. And fortunately, it's everywhere in consumer products and most professional hearing devices have that too. But it's also connections to microphones. So if you're out to dinner with one person, which isn't always the case, if that person's wearing a microphone, it's almost as if they're talking right into your ear. So connectivity is really important. And there are great microphone systems that look like a pen, or it can be put in a table with directional microphones. So I think there's so much opportunity and connectivity. When you walk into a restaurant, you're around hundreds of microphones. Imagine if we can find ways to use all those microphones to separate what you want to hear from what you don't.

Host: That leads perfectly into this next question. And you may have just answered it, but in all the technology with the threshold based fitting, we've discussed before on this podcast the concept of an ecosystem. What else needs to be done? What's the next step. If we improve the accuracy of the threshold fitting, what's the next thing that we should look for?

Franck: We know that there can be incredible improvements to a device's ability to understand speech in noise. When you say Alexa, play this sound or do this activity, it employs really powerful processing both on the device and in the cloud. And it does so using relatively high bandwidth connections of wifi and is powered from a plug in the wall. So we know it's capable. And there's some great research being done that shows you can really, really clean up sound if you've got all the time in the world and all the power in the world. Well, hearing aids don't have all the time in the world, and they don't have all the power in the world, but they're going to get better and better.

Host: A question that I am asked in clinic from people very often is what is the difference between these devices that you can get off the shelf for a couple hundred dollars and then the professionally fit devices that you can get at a hearing care professional's facility. And generally what will happen is someone will bring in a newspaper ad showing a device for let's say $500, but then people understand that there are devices that they can get from hearing care professionals sometimes ranging from around a thousand up to several, several thousand dollars. And that discrepancy can certainly lend itself to some concern. And people may be feeling as though they're being taken advantage of. So, how do you describe that to people who have that exact concern?

Franck: I think if someone tries to sell you a single hearing aid for thousands and thousands of dollars walk away and go to a place that may not be as profit motivated. Really, really good top of the line hearing devices have a much lower acquisition cost to the person who's selling it. And a couple of things I want to say about that. A lot of the price of a typical hearing aid includes the services of the audiologist and this bundled model. The initial consultation, where you learn what your hearing loss is, and isn't, with the different types of products that can, and can't help you is bundled into the price of that hearing aid. And even if you walk away, all the people who walked away are bundled into the price of the hearing aid. When you get the hearing aid, the fitting of it, the dispensing of it, showing you all the parts and pieces, connecting it to your phone, the warranties, the repairs, are all bundled into the price of the hearing aid. So in a typical bundled model where a hearing aid costs on average $2,400 each, so a pair for $5,000, you're getting three years of professional services and a hearing device that costs more like maybe a thousand dollars. So I think we really need to appreciate what's in the price. If you buy a car with a 10 year warranty, you're buying more than just the car. So to try to compare a $300 hearing aid that you might get from a magazine to a thousand or two dollars of products and services you get from a professional is truly apples and oranges. Now, another thing is the quality of the electronics inside. Hearing aid companies have done an incredible job of putting as much processing as possible into a tiny little chip. And what they've done is nothing short of remarkable and no one really has done it better. And if cosmesis is important, the ability to hide things is important. Then hearing aids are the only ones that can do the trick. I think what I find really exciting is if we can let cosmesis go and allow devices to grow and be visible, they're going to be capable of so much more. And because we have this obsession with youth or invisibility, we're sacrificing performance every day. You know, when you have something big, it has reliable connections. It's got good power. So you can do far more with them. You know, I think the difference between a $300 device that comes with no services and a pair of devices that may cost in the thousands of dollars, has both to do with the sophistication of the electronics, as well as all the services that are wrapped up in there. And a number of audiology clinics like ours are separating those prices. So you can see them all. So you can see that yep, an MDHearingAid, for example, that's $300 may not be that much different from the same hearing aids that the audiologist is selling. But when you consider the counseling, the dispensing, the fitting, and the years of warranty, you see where those prices add up.

Host: A big thing in that is just educating yourself as the consumer. As hearing technology develops, there'll be more and more direct to consumer forms of hearing devices. So anything you can do, like listening to podcasts, such as this, reading articles, finding someone that you trust and whose information you trust can give you all the more power in making a decision that is appropriate for you. Is there anything else that you would like to add before we wrap up?

Franck: Well, there's all kinds of things happening in the hearing loss space. We've got regulatory changes. We've got insurance changes. More and more private insurance companies are covering hearing aids, which is great. There's data. We've long known that hearing loss is associated with things like dementia and depression, but they're just associated. They're all correlated with age. But there's data that's coming that's looking to see if it's causative. Is it true that hearing loss causes the falls and the dementia and depression. If that's true and we don't know yet, then it really could change things. All we know now is they're correlated. If it's causative, then we may realize that the price of not doing something really makes it worth doing. So I think we're going to learn more about that soon. And this really well-designed research trial's underway. The other thing that's exciting is new pharmaceuticals. For the first time in history, we might even have pharmaceuticals that could help. I don't think we're talking about curing hearing loss and, and taking, uh, turning deafness into normal hearing, but improving hearing. It's always been so far away. It's, it's, it's hard to touch, but now some of these technologies are a lot closer. It's an exciting time to be involved in this field. We've got a range of solutions for people with all levels of hearing, from just a little bit of hearing loss all the way to people who have lost all of their hearing. And we've got different dimensions of that now with devices, and maybe one day soon with pharmaceuticals. And we've got audiologists that are understanding the value of their services, separate from the products. And we've got competition now in the product space. And I think most importantly, I think people are giving up this notion of just fading away with age. To me, that attitude change is really the key to opening up all of this. It's just a thrill to talk to you and to talk about some of these possibilities and things that are right on our horizon.

Host: I agree. And a lot of positive things in what you just said. Really good information. It's all pointing in the right direction. Dr. Kevin, thank you so much for being on the show. It has been awesome talking with you and hearing your insights and everything that you have to say. Thank you so much.

Franck: Well, Dr. Steven, thank you for doing this. I think you're the one that's helping to get this information out to, to people who can use it.

Host: Thank you. And if anyone has any questions, feel free to visit us HearingTracker.com. If you have any specific comments or ideas for another show, feel free to email me at steve@heringtracker.com. Thank you so much for tuning in and take care.