Disrupting Hearing Aids: How Hearing Loss Help is Becoming More Accessible

48 million Americans suffer from mild-to-moderate hearing loss. And only 14% of Americans with hearing loss currently own a hearing aid. As we move into a new era of over-the-counter (OTC) hearing aids, and telehealth-facilitated hearing care, startups like Lexie and Nuheara are looking to capitalize by offering more convenient, more affordable hearing solutions. And, established industry players are also looking to get in the game too, with GN (ReSound's parent company) bringing a new self-fitting Jabra hearing aid to consumers.

In today's episode we talk De Wet Swanepoel, Scientific Advisor at Lexie Hearing, about selling telehealth-supported FDA-registered hearing aids over the internet. We also check in with Justin Miller, Co-Founder and CEO at Nuheara, about his company's IQBuds, which offer personalized hearing amplification for under $500. We also talk to Laura Baney from GN, about the currently delayed Jabra Enhance Plus, which is a self-fitting hearing aid that GN plans to distribute through audiologists.

Consumers now have more options than ever when it comes to shopping for hearing aids. And navigating those options isn't easy. In the last part of the episode, we talk to Heather Malyuk and Danny Aronson, from Tuned, a new startup that promises to help consumers understand the options through direct telehealth counseling.

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Podcast transcript

Steve Taddei: Last month, we talked about remote health care. Dr. Cliff Olson shared his experiences during the pandemic and some of the ins and outs of telehealth. This led to a discussion with Dr. De Wet Swanepoel and HearX.

De Wet Swanepoel: HearX is a digital hearing health tech company. And the mission that HearX has is really to provide affordable access to hearing care that anyone can use anywhere.

Steve Taddei: If you missed it, be sure to check it out as it was the first episode of our telehealth mini-series. This month, we'll highlight three innovative hearing devices, Lexie Lumen, Nuheara IQBuds Max, and the Jabra Enhanced Plus. Tying it all together, Dr. Heather Malyuk and Danny Aronson of Tuned share their thoughts on the various delivery models and introduce a brand-new platform which may just set the bar for the new age of hearing care.

Ad: Support for the Hearing Tracker Podcast comes from Nuheara. Nuheara is transforming the way people here by creating personalized hearing solutions that are multifunctional, accessible, and affordable.

Steve Taddei: This is the Hearing Tracker Podcast from HearingTracker.com. Traditional hearing care requires you to visit a clinic and meet with an audiologist who performs various tests, outlining your hearing profile. You then discuss the results, your lifestyle, needs and other medical follow-up, and any technologies or strategies that can improve your quality of life. This can include the prescription of hearing aids.

With developments in telehealth, we're seeing a progressive new wave of devices that are quite different. I reached out to a few of the companies to better understand some of these devices. For example, who are they for, are they safe, and can they provide a similar benefit as traditional hearing aids?

Our first stop is continuing our conversation with Dr. De Wet Swanepoel of HearX. We spoke with him last month about telehealth, but there's another branch of HearX offering an FDA approved hearing aid called Lexi Lumen.

De Wet Swanepoel: The Lexie offering is a direct-to-consumer offering. Consumers are able to go onto the Lexie Hearing website and what they can do then is purchase a pair of Lexie hearing aids. They're also available in many of the Walgreen’s stores at this stage. Once you have the pair of hearing aids, you can download the Lexie app. It has very detailed instructions, user-friendly. It's been developed with a user centered design approach so that people can kind of put on the hearing aids, get the right fittings in terms of slim tubes.

As De Wet mentioned, these are direct to consumer devices, meaning you acquire them without visiting a hearing specialist. You can either purchase them for roughly $800 or order a two-year subscription at $49 a month. They are a behind the ear style, having a slim tube that carries sound from the hearing aid down into your ear canal.

Lexie Lumen hearing devices are programmable. The first step is connecting it with your iOS or Android smartphone.

Once they're connected, we run them through a hearing test. So it's an in-situ pure tone audiometry test because now we're using calibrated hearing aids. We can actually do a very accurate pure tone audiometry. So, we do this across four frequencies: 500, 1000, 2000 and 4000 Hertz.

Steve Taddei: More frequencies can also be tested remotely over telehealth with a hearing expert. We'll talk more about remote assistance in a few minutes.

De Wet Swanepoel: Once they've done the hearing test, we can then immediately from our digital platform program it through Bluetooth according to NAL-NL2 fitting algorithm.

Steve Taddei: Fitting algorithms, such as NAL-NL2, are extremely important as they define compression levels to help keep speech clear and the overall sound quality comfortable. De Wet went on describing other features of Lexie Lumen device.

De Wet Swanepoel: It's a 16-channel wide dynamic range compression device. It's got Bluetooth capabilities, adaptive directionality, and noise reduction. And its range is very generous. So, if can fit mild to severe hearing losses.

The beauty of this is that it's entirely integrated into our digital platform. So, we can also track the data logging, the use of the device, etc. It has a lot of similarities to the audiological model. It doesn't happen in a clinic, but it happens based on pure tone thresholds with a validated fitting algorithm.

Steve Taddei: Lexie devices try to emulate the traditional model in a remote fit, direct to consumer format. Follow-up care, such as reprogramming, counseling, and education are an invaluable part of the hearing aid fitting process.

So, I asked De Wet how users can receive further assistance when needed.

De Wet Swanepoel: We also have a call center available six days a week where we have relationship managers and we've got hearing experts. We can provide tele-audiology through the app. So someone can connect through video calling right through the Lexie app with the call center at any time.

If there's any difficulty with the device, we can connect with the hearing experts directly to the device through Bluetooth. We can do fine tuning adjustments and changes to the settings until the patient is happy with the device. Some of the really exciting features, you know, in the Lexie platform is that we've tried to kind of take all the elements that make for a successful fitting and good satisfaction and outcomes with patients and try to make it digital.

So for example, we know that patients who get fit with a pair of hearing aids need a lot of handholding after the fitting, right? There's an adjustment period. There's acclimatization, it's extremely important. What we've done is we've built that into the application. So, we have what we call a Lexie rewards program.

It's in essence, a behavioral incentive program. So, it incentivizes you to wear your hearing aids and to go through the training little videos that we've included and the animations on how to clean your device, how to look after the device, how to care for your device, but also what are the tips to actually adjust to the device?

And how do you involve family members? It’s really person centered. We based it on the latest evidence. The beauty of the behavioral incentive is that we then reward them in terms of discounts on the monthly subscription, if they wear their hearing aids according to their goals and if they go through the various activities that support the acclimatization.

Steve Taddei: As a user of these devices, you received in-app activities and questionnaires which provide feedback to the call center and relationship managers. If your responses suggest you are struggling, they'll reach out to you for assistance.

There really isn't a one size fits all approach to hearing health care. And I'm not sure if we'll ever have one device that meets everyone's needs. In that vein, I asked De Wet to share his thoughts on Lexie and some of the limitations they face given their unique product and model.

De Wet Swanepoel: We know certain patients are really difficult patients. They need special assistance. They have more than one issue, right? It's not just the hearing, or their hearing loss is just so severe, or it's got the kind of configuration that makes it really difficult to fit with a device like this. The challenges that we've seen here is that the device can fit a range from mild to severe, but there are some severe clients who are actually wanting severe, and even severe to profound, who are trialing this device.

Those are probably the clients we're seeing who are not benefiting sufficiently from this solution. And in those cases, we would refer them once they return the devices to audiologists.

I think the beauty of this is the fact that it's making it more accessible to people. People who previously may not have ended up in an audiologist office are now actually trying and taking up a device.

Steve Taddei: There are companies like Lexie offering FDA cleared hearing aids with remote assistance. However, not everyone is ready or needs this style of device or care. What if you only want situational help, such as while streaming music or listening to television? What if there was a wireless earbud that still allowed you to personalize your listening experience?

Well, the next company in our lineup is Nuheara and they make the IQBuds2 Max.

Justin Miller: From app perspective, we just trying to address an unmet need in the market. It wasn't necessarily, and it's still not, about replacing the traditional channel. We're not designed to be worn all day. We're not a hearing aid. We are a situational product that's used for multiple purposes, whether that's entertainment, whether that's phone calls, whether that's some form of sound augmentation or hearing assistance.

Steve Taddei: That's Justin Miller, the CEO and co-founder of Nuheara.

Justin Miller: We're proving that with the right product, you can actually get people moving into the hearing space a lot earlier. And that was always our desire. How do we drive into that unmet need?

Steve Taddei: According to the National Institute on Deafness and other Communication Disorders, almost 40 million Americans have hearing loss. Of those people, only roughly 20% actually seek help. Furthermore, studies have shown that it takes an average of 10 years before people get hearing aids after an initial diagnosis. This illustrates the unmet need Justin mentioned. People need help, but for one reason or another, they're not getting it. Some reasons for this are the cost of traditional hearing aids, the stigmas, and not everyone needs to wear a device full time.

This is where products like the IQBuds2 Max can come into play. I asked Justin to describe the difference between Nuheara's device and other wireless earbuds.

Justin Miller: We've always had a hearing focus and I think that's the first thing that makes them stand out. Our EarID is an example. It's a clinically validated hearing assessment, right?

And that's embedded into the product. We use hearing aid prescription formulas to tune the device. We use now NAL-NL2, which is the protocol that most audiologists would use to configure an individual's hearing aids. So, we've embedded that into the product.

Steve Taddei: If you recall, this is the same fitting algorithm mentioned before.

Nuheara IQBuds offers a similar in-situ, or on ear threshold check. This is called EarID and it's available through their app. Here's an example of what that sounds like. Justin also mentioned that these devices process sound differently than some of the other wireless earbuds available.

Justin Miller: One of the biggest differentiations between what we offer and what a truly wireless earbud would do, we're not sending a signal back to the smart device, allowing it to process, and back to the ear. We're processing in real time.

Steve Taddei: This allows for quicker processing, without a noticeable delay. IQBuds offer other features such as noise reduction, multiple microphones, and active noise cancellation. Which is something not found on hearing aids. There are other features too, and though I'd love to get into them now we're actually devoting next month's episode to these devices. So stay tuned.

I'd like to clarify that the Nuheara IQBuds2 Max are not hearing aids. They are advanced wireless earbuds that you purchase as a consumer. A hearing care professional is not involved in the purchase, fitting, or programming of these devices.

So, they are very different from what we've discussed so far, but that doesn't mean that they can't offer a benefit given the right person and circumstances. While advanced wireless earbuds or not hearing aids, it's easy to make a price comparison between them. A pair of professionally fit hearing aids will cost on average several thousand dollars. The IQBuds2 Max cost just under $500.

Justin Miller: So, we've taken steps, validated steps, into hearing health care. And I think that's the important thing. We don't talk to hearing as a pure marketing play, we're actually backing ourselves through having proven and validated solutions.

It's the interesting thing when you build tech and you build some of these solutions is that we couldn't have anticipated the different types of hearing issues that ultimately people are one looking to solve, but two, ultimately did solve through the use of our product. That's super for us. And, you know, over the course of the next few years we're going to try and more deeply understand that.

Steve Taddei: So far, we've discussed Lexie and Nuheara devices. Both are direct to consumer and don't require the typical visit to a doctor's office.

However, what if you still wanted the accuracy, professional guidance, and peace of mind from in-person audiologic care. Well, the next product we'll discuss is another wireless earbud offering a hybrid delivery model.

Laura Baney: The Jabra Enhance Plus, they're miniaturized earbuds engineered for hearing enhancement, music, and calls.

So it's a three-in-one concept that gives you seamless access to situational hearing enhancement in a discreet, comfortable, stylish, and very portable solution. It's quite small, people will be impressed.

Steve Taddei: That's Laura Baney. She's an audiologist who's been instrumental in the development of products like this for GN Resound in Jabra.

One of the unique elements of the Jabra Enhance Plus, is that it involves the help of a hearing care provider.

Laura Baney: We feel it is important that the candidacy of the consumer is evaluated by a hearing care professional. So, the Jabra Enhance Plus requires the support of a licensed hearing care professional.

Once the candidacy has been determined, then it is designed that the patient can personalize it themselves. Kind of our benchmark is if they can do Facebook, they're able to personalize this device. You use the Jabra Enhance app and you do the personalization process through that. And so it's something called Bayesian pure tone audiometry.

Steve Taddei: The personalization Laura mentioned, is a similar in-situ test as we've already talked about. And it's accessible through their accompanying phone app.

Laura Baney: This is still considered a medical device, and so it still has to go through that rigorous testing. And even more so, because this is a new form factor, and the personalization process has to be verified.

There's been a lot of testing.

Steve Taddei: Jabra has traditionally offered consumer level products, such as headsets and other equipment for conference situations. However, their parent company also owns Resound, which is one of the main hearing aid manufacturers. This offers a unique combination between consumer products and medically researched hearing devices.

If you do any research on the Enhance Plus, you'll likely come across another device from Jabra called the Pro. I asked Laura to help clarify the differences between the Enhanced Pro and Plus

Laura Baney: Jabra Enhance Pro is a traditional hearing aid, while Jabra Enhance Plus are hearing enhancement earbuds in a miniaturized consumer electronics design.

And so, Jabra Enhanced Plus will also be a regulated medical device, which we will certify under the appropriate regulation. But there's definitely specific differences with design, where the Jabra Enhanced Plus are true wireless earbuds, and the Jabra Enhanced Pro is a RIC form factor.

Steve Taddei: So, the Jabra Enhanced Pro is a traditional receiver-in-the-canal device that can be purchased through Costco. Resound also offers medically researched traditional hearing aids. So when deciding between all these, it depends on the style, level of care, severity of hearing loss, and lifestyle improvements needed. This is where it's helpful to have a hybrid model with a hearing care provider by your side.

The Jabra Enhance Plus is unfortunately not yet on the market. They're currently in the certification process and it should be available soon through your hearing care provider.

Laura Baney: It's really impressive to have all of the hearing enhancement features that are in it, the streaming of the music and calls in such a compact device.

Steve Taddei: All the devices we've discussed offer in-situ audiometry, or a hearing threshold check directly through the on-ear device. While these are great, it's important to note that they are not as accurate or reliable as having your hearing tested in a sound booth.

There are many reasons for this such as the devices speaker, the acoustic coupling, or how well it sits in your ear. The environment is also a big consideration. Sound booths are... well sound treated rooms. There's absorption on the inside. There's a hard outer wall to reflect external sounds. These tests environments must meet regulations set by the American National Standards Institute.

For example, here's a 500 Hertz pure tone. What if you were taking the hearing test in a typical living room? It's much harder to hear the tone if there are distractions. All that said in-situ tests can be extremely useful given a good product, fit, understanding of testing, and a quiet environment.

When we come back from the break, we'll hear from an audiologist who's thinking outside the box and integrating alternative forms of amplification into her practice.

We'll also learn what happens when a similar mentality is the driving force behind an innovative new hearing care platform.

Ad: Support for The Hearing Tracker Podcast comes from Nuheara. Nuheara is transforming the way people hear by creating personalized hearing solutions that are multi-functional, accessible, and affordable.

Steve Taddei: 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 at Nuheara.com and you can now get a 10% discount using promotional code HEARINGTRACKER.

The traditional hearing care model can leave some feeling excluded. By this, I mean that services are commonly linked with the sale of a several thousand-dollar hearing aid.

Not everyone can, or wants, to afford that. Others simply don't need it. Additionally, not all professionals acknowledge the devices we've been discussing. I don't think it should ever be a choice between $4,000 and no hearing help. Fortunately, there are hearing care providers who adopt a broader range of technologies and embrace these changes in hearing care.

I spoke with Dr. Heather Malyuk who is a music audiologist. She's primarily worked with music industry individuals. However, her practice changed slightly when COVID hit and most of the music world when silent.

Heather Malyuk: One of the things that I did alongside all of my music industry work, was I would see non-musicians who were interested in non-traditional audiology.

Meaning, they may have been to see another audiologist and wanted to go beyond that model and they would hear about me. So, I would either go to their home or I would see them online, discuss hearing aids, second opinions, over the counter devices, and would really just assess them for where they were. If they weren't ready for hearing aids, we would talk about something else.

If they didn't want hearing aids, for whatever reason, we might go with a different type of device. Or maybe sometimes we'd ended up with hearing aids.

What I find often with individuals who have hearing aids is that they really liked their hearing aids, but they might not like their hearing aids in every situation in their life. You know, people wear glasses and then they have sunglasses. And so, it's very similar with hearing. Music would be a great example.

And actually, I just had someone call me yesterday to schedule a visit with me. Hearing aids are working great for speech. He really wants to sit and listen to his stereo. And he doesn't like the way it sounds through the hearing aids, and he doesn't like the way it sounds without the hearing aids. And he called asking, what are my other options here for listening to music?

And we know there are a bazillion options now, you know? And so it's just a matter of sitting down and discussing what might be best for him. And his hearing profile.

Steve Taddei: Hearing care professionals do offer multiple options. But they're often all linked with the main hearing aid manufacturers. This has its limitations.

So what Heather's doing is very unique and interesting. I asked more about her experiences and what it's like for patients that reach out to her.

Heather Malyuk: I will get a person in the clinic, or they'll call me and they'll say, you know, I have mild hearing loss. And maybe the audiologist said that they weren't a good fit for hearing aids, or maybe they're not ready to pay, you know, four or $6,000 or whatever it is from that clinic. And that's fine. I often see this with younger individuals as well, where they say, "Can't I use one of these devices that I see online or that I see in an ad?" And my answer is always, absolutely if you're going to get benefit from it. But that's the key is benefit.

Steve Taddei: When we look at benefit, there are two major points to discuss. First, traditional hearing technology has to go through rigorous research, certification, and FDA approval. The lines are still very gray though when it comes to over the counter devices and wireless earbuds offering personalization. The second point is that all hearing devices, even the best hearing aids available, require validation testing on your ears.

This means performing real ear measurements, subjective testing, and completing questionnaires to make sure you're receiving the most benefit. Now there's nothing stopping us from applying these same validation measures to say Apple Air Pods.

Heather Malyuk: So how are we measuring that? I mean, I really love validated questionnaires. They're sort of a thing with me in my clinic.

I'm someone who gives a lot of questionnaires and if I can measure some benefit, I'm happy. If I see someone and they get a device, and even if they think in their head it's helping a little bit, but I'm not really measuring good benefit we move on. We might try something else. Or I might say you really would do better with hearing aids at this point.

Steve Taddei: Imagine if we could take everything we've discussed so far and combine it into one easy to use platform. Remote care with an audiologist, access to all possible hearing technologies, validations. Well fortunately, there are others who share the same model and vision for hearing care as Heather.

Danny Aronson: One of the things that I learned is the absolute essential role of the audiologist in the success story of somebody going through a hearing care process. It is not one and done. It is not just fit in goodbye.

People are looking for different solutions for different problems.

Steve Taddei: That is Danny Aronson, he's a musician, audio engineer, and entrepreneur. He's also experienced firsthand what it's like to have hearing loss and go through our current hearing care model.

His experiences led him to be a co-founder and CEO of Tuned, a new platform for hearing care.

Danny Aronson: Tuned is a new kind of tele-health service that allows audiologists to lead the hearing care revolution. And we believe that audiologists as hearing care professionals are the most important elements to a successful hearing care journey.

So, Tuned the platform features a brand agnostic marketplace for audiologists vetted hearing devices, apps, and other solutions that help patients across the spectrum of their hearing goals at price points that everyone can afford.

Steve Taddei: So, Tuned is an online platform where you can seek hearing help from an audiologist. They're brand agnostic, meaning you have access to all hearing devices, not just those from the main hearing aid manufacturer.

Furthermore, providers are not paid directly or indirectly through commissions.

Danny Aronson: We want to be able to give you as the patient, but also as the practitioner, the ability, and the access to all of these devices. Some of them cost 50 bucks, some of them cost 500, some of them cost 900. But when you think about a four to $6,000 average hearing aid, it makes it very very affordable and very very accessible.

Steve Taddei: We've already discussed some of the concerns between FDA approved hearing aids and programmable wireless earbuds. I asked Dr. Malyuk, who's also a founder of Tuned, how they vet devices on their platform.

Heather Malyuk: Everything that's on the site is verified in some way by our audiology team. Meaning, we think it meets certain spec. We believe in the science we're reading behind it, et cetera. There are certain devices, or apps, or things that we have not allowed on the website. So, everything that's on there we've put through the ringer.

Steve Taddei: So, the research is reviewed and in-house testing is performed. Heather also indicated that the information, and other educational content, is made available to providers through something called Tuniversity.

Heather Malyuk: Tuniversity is... there are many aspects to it. One of which is what we call "Listening Club" and Listening Club is where an audiologist who is registered with Tuned gets every device on the website. And they get to try it for a couple of weeks or so and send it back. And the reason why we're doing this is because you need to have it in your hands, you need to wear it, you need to know how it works. In addition to that, we have what I'm calling "One-Sheets" on each product which goes over frequency response, headroom, spec, hardware, even reviews from Amazon, and reviews from audiologists. We're giving everything a rating. We also do real ear measures on many of these devices, and we give that information to the audiologists. And then each device will also have a video.

Steve Taddei: Another consideration is your safety in the hearing healthcare process. There are many audiologic conditions that can be treated with medical management. Tuned indicated that they have checks during their onboarding process to make sure you're receiving appropriate in-person medical and or audiologic treatment.

Danny Aronson: One of the things that we do as part of the hearing screening, is a very rigorous process to try and find red flags. Patients can test this from the comfort of their own homes. And if we find a red

flag, we will send you to a clinic because you need to see an audiologist in person.

Heather Malyuk: I absolutely think that 99.5% of red flags will be caught based on how we've structured, what we're calling, our hearing workup.

We have so many modifications of validated questionnaires, a thorough process of threshold testing, digits in noise testing, and we have sort of a criteria where we will be looking at these things. And if someone has any hint of a red flag, they are getting a referral.

Steve Taddei: Tuned is still a very new platform, and there's much to be learned yet in this new telehealth world. Hopefully though, with the development of new products and platforms like Tuned, we will see better hearing care for a broader range of people.

Danny Aronson: I've spoken to a lot of people. The one thing that is consistent is that they are looking for information and they're looking for guidance and they're looking for somebody to tell them what is best for them. And they want to believe them.

They don't want to feel like they're being sold something just because somebody is making commission off of it. They want to believe that the person they're talking to has their best interest at heart and is telling them this is what you need, because I think this is the best solution for you, even if that means tweaking your iPods.

Heather Malyuk: Why wouldn't every audiologist want to be the family audiologist and be the person that someone can contact and do a consultation with? It does not have to be device related. We need to get beyond that.

You know, Tuned has come about putting audiologists in the center. Well, what comes with that? Putting patients in the center... because that's the main priority of audiologists. So, if we're not doing that off the bat, we shouldn't be doing this.

Steve Taddei: Tune-in to next month's episode where we'll dive deeper into the Nuheara IQBuds2 Max. I'd like to thank Dr. De Wet Swanepoel of HearX, Justin Miller of Nuheara, and Laura Baney of Jabra for speaking with us about their innovative technologies.

I'd also like to thank Dr. Heather Malyuk and Danny Aronson of Tuned. You can learn more about Heather and her practice at soundcheckaudiology.com. You can also visit Tunedcare.com to find an audiologist in your area or explore how this platform can benefit your existing practice.

The Hearing Tracker Podcast is hosted by me, Dr. Steve Taddei. This episode was written, produced, and sound designed by me with help from Dr. Abram Bailey, and Bruce Smith. Before we wrap-up, take a moment and think of just one person who has hearing struggles. Do me a favor and share this episode with them. I'd really appreciate it and thank you for listening.