Let’s Talk OTC

In this special episode of Starkey Sound Bites, Brandon Sawalich, Starkey President and CEO, joins Dave to give his reaction to the FDA’s long-awaited over-the-counter (OTC) hearing aid regulation, and explain why the hearing care professional will always be integral to better hearing.

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SPEAKER_00 0:02

Welcome to Starkey Soundbites. I'm Dave Fabry, Starkey's Chief Innovation Officer. This is a special edition of the podcast that follows on the heels of the FDA's final regulatory guidelines for the new over-the-counter hearing aid category that came out of Washington in mid-August. Hearing care professionals have been seemingly waiting for forever. It's been a little bit like waiting for Godot since 2017 when the bill was first passed. But now we have better insights into the direction and guidance that the FDA is providing for this new hearing aid fitting category. Joining us today on the podcast is Brandon Sawalic, Starkey's president and CEO. Brandon, welcome back to the podcast.

SPEAKER_01 0:47

Well, thanks, Dave. I appreciate it. And uh a lot of a lot of good things going on in our industry that you know require a good conversation because it's opportunity.

SPEAKER_00 0:56

Well, yeah, and we we've seen and heard an awful lot about these uh FDA final regulatory guidelines. And first of all, I'd say, you know, should we just uh you know roll up the sidewalks? I guess we're just done now, right? If all of the the worry and fear over the last few years, I guess let's just go home.

SPEAKER_01 1:16

Well, I started at Stark in 94, and I remember hearing those comments. You and uh your career have heard those comments ever, you know, it's nonstop. And quite frankly, uh we know the industry, we know the patient, which is more important, and we know what better hearing looks like. And, you know, if anything, over the counter, it's a new category. It's not like it's something new that we haven't uh been around in the last 20 years, where there's catalog sales and such. So, okay, let's let's get more people into the uh wanting better hearing and amplification, and then educate them on what the options are because others have it wrong.

SPEAKER_00 1:52

Yeah, and and I think you you raise an important point and a good reminder for those of us who've been in this industry for a long time, we have to remember the sobering statistic is our biggest competitor is not brand A, B, or C, but non-compliance. Two-thirds of the people who have hearing loss don't do anything about it. And so if this new swim lane, if this new channel does raise awareness for the importance of hearing and gets more people to consider using amplification, we believe, as you've emphasized and been dead fast on this all throughout this process, our technology, in the hands of the professional, delivers the best outcomes. But now that we have this new channel, um if it raises awareness for and adoption of hearing aids, then it's a good thing. It's a great thing.

SPEAKER_01 2:45

I mean, you know, if the VA is not our largest customer and and uh, you know, more and more veterans need hearing help in 10 years, I hope they're not because we can do so much on the upfront to help active military men and women. The same thing goes with what we're looking at here, is where people assume they know our the industry and the patient and then hearing loss, and it makes for good articles, and it's like our industry is kind of becoming a little bit of um some of the media on TMZ about uh hearing aid cartel. And it's laughable because you have to care, and you and as a Starkey, we care about the technology and helping more people. You know, it's not profit over people, it's helping, not selling. Yes, and we provide the products that they're deregulating. And our only concern for seven years and even previous as this has come up, has been the confusion that this is going to cause with seniors from bad actors, right? The hundred dollar amplifier that they call a hearing aid is not a hearing aid that you buy from a uh a professional uh hearing health care provider.

SPEAKER_00 3:57

Yeah, and so well, let's let's look at let's look under the hood a little bit. You've had a a front row seat to all of this with your role uh as CEO and president at Starkey, but also your past chair of uh the Hearing Industries Association, and you've been involved in this from the start. Um, what happened in the final regulatory uh guidelines? Anything surprise you or any any anything that you want to um raise to our listening audience?

SPEAKER_01 4:25

I believe the FDA did a good job for the task they were asked to do. They didn't come out with this law. It was, you know, this has been what uh six years in the making, and it's it's complex. And they're trying to, you know, what we know is not a commodity, trying to make it a commodity in a consumer electronic. And you know, I believe that we uh provided good insight on the output with your help and and uh you know what that means to somebody looking for for better hearing. Nobody knows what mild and moderate is, it's not a cholesterol score for your hearing. Um, you know, so the the two things it's the uh preemption and by states where that's where it's kind of we're going back um to the 70s and and 80s of uh really the again the bad actors that could mislead people and really um uh I'll say provide uh a bad reputation for for hearing aids. And then the unlimited gain, that's surprising because we know what Apple and even other consumer electronics do for their products. Why would a hearing aid have unlimited gain? That one was a little um surprising, but again, they were tasked with a uh a hard um uh a job, and you know, as I said, they did the best they did they could, and we adapt.

SPEAKER_00 5:47

Yeah, I I I share your opinion on the gain. Um, you know, I was uh pleased that they responded to the science and the input from the professional communities that uh provided evidence that uh those output levels that originally were drafted by the FDA were too high for someone with perceived mild loss who may have normal audiogram, uh audiometric thresholds. And so bringing that down a little bit, I think, will provide some patient safety. The gain, as you already mentioned, uh remains a concern. The um, you know, I I think uh there's going to still be some voices heard from those attorneys general who had spoken up previously and wanted to be able to provide consumer protection at the state level uh from those bad actors that you mentioned. You know, and really the lack of clarity on a return policy could mean that someone might spend less money overall, but without a well-defined return policy that is in play, they could be out more money out of pocket, ironically, than if they'd gone through the professional channel and had that professional work with them to achieve an optimal result. So, you know, TBD on that.

SPEAKER_01 6:59

And I think, you know, from when this bill started to where it's at now, there's you know, there's a there's a lot of unintended consequences, and it's it's going to happen. And um, you know, nothing's ever perfect, but it's also, you know, others that don't know what the patient, as you do, you know, somebody that's sitting there that really needs that hearing help, you're not going to get that off the shelf. And I don't care if it's mild or or or moderate. Yeah, you know, you've got to make sure that every ear, as we know, we've talked about many times, is different, but you've got the right product. And the the other word, and you know, interesting to hear your perspective too, is the other word that that has been coming up in the last two weeks because of you know, this game outs of the media and the interviews, prescription.

SPEAKER_00 7:44

Yeah.

SPEAKER_01 7:44

It's like this is a commodity, it's a pill, or it's right, you know, write a prescription for your hearing aid. And that's not the right terminology. This isn't a prescription. This is something that you're going to see a professional about, and you're choosing based on your lifestyle and that professional's choice of what you're going to do right there in the office. You're not going to write a prescription and then just go to the pharmacy and pick it up.

SPEAKER_00 8:07

Yeah, I I you raise a really important point. And just for clarity, I'll I'll back up one step. So for those who haven't been following this as closely as we have, the um the over-the-counter category that the FDA created really has two subcategories there's over-the-counter hearing aids, and then there's non non-self-fitting and self-fitting devices. And then the other one, as you mentioned, the traditional channel that we've known and that has been regulated by the FDA in the past, now they've referred to this as a prescriptive category. It involves the professional doing the diagnostic testing, interestingly, because as you say, the prescription really is whether an audiogram serves as the central point. We know all too well from the work that Starkey's done around the world that the audiogram is an overly simplistic assessment of a person's disability that they have with their hearing loss. There's most of what we're hearing, it would be as if you went in for an eye exam and they just shine very faint light to see what you could see instead of asking you to have acuity on the Snellin chart. And there's so many things that the professional can do to really assess the individual's difficulty that they're having that go beyond the audiogram or the prescription. Um, and so even in that respect, the pre but but simply put, the prescriptive category and the label that's on that isn't like a medication, but rather it's the auditory and non-auditory challenges that a person who is having hearing difficulties or hearing imbalance difficulties uh experiences. And that differentiates now from the over-the-counter self-fitting and non-self-fitting category. And I won't go deeper into the weeds on that self-fitting, non-self-fitting, because it's really for the regulatory agents and the attorneys to hassle over what's self-fitting and what's non-self-fitting.

SPEAKER_01 10:04

Yeah. And, you know, the the prescription, and I bring that up because of the media, yeah, the interviews I've been doing, that's what they go to. And again, that's where the unintended consequences of, you know, they think, you know, they they have, you know, they're they're reporting on so much other health and other news. You know, they hear the word prescription, that's what they easily relate it to, then that causes confusion.

SPEAKER_00 10:26

Yep.

SPEAKER_01 10:27

And that is not our uh industry and how we look at it. So, you know, an opportunity for us to educate, absolutely. Um hearing healthcare professional associations, you know, should be uh would should be stepping up and I hope do to do the same thing. Yeah, because it's their profession, you know, they're the provider. It's not that we're against it, we just want it done right because patient satisfaction is at an all-time high of 88%.

SPEAKER_00 10:56

Absolutely. And, you know, and I think there's also this impression that while accessibility and afford affordability are very important barriers for some people, um, there isn't this expectation that we're gonna go from 37% of the people who have hearing loss and don't do anything about it, now we'll suddenly uh those other 63% are gonna all wear hearing aids because you and I both know stigma still remains, challenges still remain for uh beyond the accessibility and affordability. I I'm all behind anything that improves access, but safety and accountability is important as well. Stigma is number one.

SPEAKER_01 11:38

I mean, we we give hearing aid hearing aids away for for free. Countries, you know, around the world, as we've mentioned many times, and you know, others didn't seem to want to listen or hear that, but their states, uh Medicaid, uh, other types of programs that give them away for free. People don't want one until they have to have one. And it's usually for their career, their family, you know, it's a certain age that, okay, time to do something about it because you're not going to die from hearing loss. Right.

SPEAKER_00 12:06

Right. And so I guess our advice then for people who think that they have a hearing loss, if they're listening and they've been confused by what they're hearing in the media or what this category creates, you can go to Starkey.com and take a screening test. You can go see a professional. I mean, I realize again, for many, that's been a barrier that you know this uh this OTC channel is created by. But if you want to just do it from an app or from a website, you can do that at www.starkey.com. You can go and get a test uh from professionals in your area. We can refer you to one if you want to do, and even if you don't want to do anything. But then any other advice for for uh uh patients or end users who are contemplating trying a hearing aid and want to try out this new channel when it becomes available in October?

SPEAKER_01 12:55

Ask questions, be curious, know what the service levels are, what's the warranty, what's the return policies, because that's where the uh, as we mentioned, uh companies put profit over people. And this industry is about service and care. And if they're looking into this new category, make sure you're just being curious and and uh asking the right questions.

SPEAKER_00 13:17

And and any advice for professionals as to how they're gonna navigate this new um uh environment, should they be considering stocking over-the-counter hearing aids uh in their practices?

SPEAKER_01 13:33

Yes, they should have an option in in their practice and advertise it on their their website or however they do it in in uh their community. Because if it's a new category, a hearing professional should have that as well because it's about the art, right? Yep, you provide the science, but the hearing professional is about the art of the fitting and understanding and connecting with that patient for them to hear better and then yes, live better.

SPEAKER_00 13:57

Yeah, and and for those who do work with us professionally, thank you for your partnership if you're listening to this. But you know, we we will provide guidance moving forward as to how they should uh set a value for the role of the professional service for someone who tries over-the-counter hearing aids and how they can uh engage with with patients who who suddenly will uh realize the benefit of professional service when they want access to the latest technology, but don't want to do it themselves.

SPEAKER_01 14:27

All right. Well, I thanks thanks for the discussion, Dave, and and thanks again too, yes, for all those listening, whether a hearing healthcare professional or patient, uh, you know, there is better hearing out there. Just know your options, educate yourself, and there are really good people there to help.

SPEAKER_00 14:43

Well, and thank you, Brandon, for being and being with us to talk through this. And and thank you all for listening to this special episode of Starkey Soundbites. And if you enjoyed this conversation, please rate and review us on your preferred podcast platform. You can also follow us or hit subscribe to be sure that you don't miss a single episode. And we'll look forward to hearing you and seeing you next time.