Exploring the the FDA’s Newly Proposed OTC Hearing Aid Rule and the Medicare Hearing Benefit

Bob Traynor 0:10
Welcome to This Week in Hearing where listeners find the latest information on hearing care. And we’re interested in all kinds of issues relative to hearing care. But this is almost an extra special, particular This Week in Hearing episode, because the new OTC regulations just came out. I mean, what a week it was the with these regulations coming out and ADA and all the other things that are happening for all of us. We may take a couple of minutes and also talk a little bit about Medicare’s entry into hearing care as well. I’m Bob Traynor. I’m your host for today’s episode. And my guest is – thanks for coming back again – Brandon Sawalich, President and CEO of Starkey, and the, So my first question for you today, Brandon would be what are your initial thoughts on these proposed rules? Were they kind of the way you and many of our colleagues shaped them? And, because I know it’s a lot of work that went into this over a long period of time. So what are your initial thoughts?

Brandon Sawalich 1:24
Well, first, thanks for having me back. I think it was just over a week ago, and it was last Monday released the our discussion, and then the proposed ruling came out right from the FDA, we kind of thought it would be coming soon… And my first, you know, glance and looking through, I think it was 114 pages and, you know, asked by President Biden to speed it up, they meet the, they met the deadline. And overall, for the FDA, it’s – It wasn’t an easy project for them, of course, I mean, it’s, you’re dealing with a lot of variables in our industry and understanding it at first, but if my first glance through and still digesting it, you know, the FDA put in a lot of work. And it still allows for, you know, some good comments and discussion, to have in some areas that might be a little gray. And I think that’s part of the comment period, where we can speak up and provide input, I know that whether it’s HIA, and industry, and associations having that opportunity, because they know the patient. And for us again, FDA you know, we support the FDA, and it’s about patient satisfaction, safety, and not confusing the issue of what could be an over the counter hearing aid.

Bob Traynor 2:44
So, now, there, this is a comment period. And as I understand that, it’s what about a 90 day period,

Brandon Sawalich 2:51
yes, it’s a 90 day and then if I recall – 90 day and then they take 120 days to, to comment and there’s more, so for it to, you know, technically become effective, or the law of the land, as you might say, as it comes to OTC hearing aids, you’re looking at spring-summer of next year. So I mean, they’re not rushing it. And I we appreciate the comment period. And it’s not about who’s first to comment. It is about digesting and thinking through, and then focusing on the priorities because you’re not going to go through everything in that document. They did what they felt was right in the best that they could provide to meet the President’s deadline. And now we provide our comments and have the discussion.

Bob Traynor 3:42
Is there a particular place where dispensers and hearing care professionals can actually go to make those comments? Can we make comments as professionals as well, in addition to the ones the manufacturers are?

Brandon Sawalich 3:59
Absolutely and I know that the I’m sure that whether it’s AAA, ADA, IHS, ASHA, state associations, will be providing those links. And I know at Listen Carefully, as we talked about last week, we provide guidance there, because it’s, it’s again, you know, getting through and understanding what to, how to engage and how to have a seat at the table. You need it’s, it’s a roadmap because it’s no clear path of how to comment. And you can go to the I believe is regulation.gov. And if I recall, that was the website where you can look it up and comment but my message has been this week, or my opinion, I should say, to people’s like – digest it. We don’t need emotions right now. We need very thoughtful and productive comments, and the patient is the priority.

Bob Traynor 4:55
My understanding is at the beginning of the process, there were a whole lot of emotions going on anyway, that emotional period is probably really already been there. And, and so now we, those those kinds of things and and my understanding is you also now have a new video on ListenCarefully.org, which is can help people kind of be direct them a little bit in some of the things that they may want to do.

Brandon Sawalich 5:22
Yes, yes and Starkey and HIA is doing the same – is educating now, what does it mean? What are we looking at, the industry is working together, of course, HIA and its board and providing the right input to the FDA. As I said earlier, it’s not about who comments first. They don’t look at it in that way. It’s the thoughtful comments. And then Starkey, you know, is providing guidance to our customer base on, you know, what the process is, how you get involved, and how to think about it, you know, we’re not trying to form or, you know, form opinions you want to influence but the reality is, we’re all in this together. And whether it’s AAA, ADA, IHS and Starkey, Oticon, Widex – I could go down the list. We have more in common than differences, and then, you know, and the reality is, if you start with the patient, you can’t go wrong. So, you know, we’re really focused on doing what’s right. And not, you know, trying to limit access, or the affordability. It’s we want to promote it because we’re all in the industry of, you know, increasing that 34% penetration rate?

Bob Traynor 6:35
Yes. So I’m now the it from where you sit, my guess is that if manufacturers haven’t got something kind of in the pipeline already for OTC products, they, they they’ve been kind of sitting on their laurels. So and I and I don’t know think that many of the people that I know in the industry have been sitting around waiting just for this regulation, that the that there are products that are going to be coming on the market, from the from the Big Five, as well.

Brandon Sawalich 7:08
Yeah, I I’ve it’s one of the first questions I’ve been asked over the last five years. I can’t speak for the other four. I know for Starkey, there is no super secret plan to be honest with you. But it’s a cheap, cheaper hearing aid or it’s a a device that’s going to help somebody that you know, if that’s what they’re looking for some type of mild to moderate, do it yourself, you know, why can’t we provide those to the hearing healthcare professionals, anybody could sell over the counter. You know, I have no interest personally of guiding Starkey to go to a big retailer and hang them on shelves, because that’s not the right thing to do. And I think you get, you know, when it comes to service and care, we can’t commoditize better hearing. So for me as president, CEO of Starkey and the team here, because we got a lot of great talent, we got a lot of good people that are excited about the future. And when they read the articles, and, you know, we’ve recruited and hired a lot of great new talent from other industries the last four or five years. And they’re learning and they see the articles, they get excited, like, what are we going to do? What are we going to do? I want to wait and see, you know, this isn’t something you want to, my opinion for Starkey, you know, you want to go out and be the first on because, you know, it is about the patient. So we’ve got such strong relationships with hearing healthcare professionals in the United States and around the world. You know, how are they involved? You know, think about it differently, because, you know, I’m putting the patient and our customers over the profit. And, you know, the possibilities, which, again, I think it’s going to be a long evolution and learning curve, because you got to worry about the returns and the care of the service.

Bob Traynor 9:00
Most of us and I heard around ADA that most of my colleagues were embracing the OTC projects, and the OTC products, because we can start somebody at pretty low, and we can move them up or we can move them up or we can move them up. And of course, as you mentioned earlier, it allows us to, to embrace that, that extra part of the market that we’ve never been able to penetrate as manufacturers and as clinicians and so on. So, so I I think that that the embracing of the products is really where we’re probably going to end up

Brandon Sawalich 9:39
Yea and you know, HIA as an association, Starkey we embrace over the counter hearing aids, we embrace what the work the FDA is doing. The what, the thing is, you know, many of us maybe fewer than before, remember Songbird, right Johnson and Johnson you know, we can… We were all, you know, everybody was going to be out of business and you know in X amount of months or years. And it came down to the same thing. The patient’s in charge, the patient’s going to decide. Over the counter product to me is saying, you know, you, it’s out there right now, because you don’t know what it is what’s direct to consumer, over the counter, a cheaper hearing aid, online, telehealth and fitting, what’s all – what’s the difference? I mean, you’re talking about a product versus different channels and services. So it’s available now. You know, and it comes down to the satisfaction. And it’s somebody is saying, you know, what, they’re raising their hand, and ‘I have a hearing problem, I need help’. And they really don’t know what to do. Because they really don’t understand the model. Because I know if that if I need a physical or my cholesterol checked, or whatever, I know what to do with that. But if I have a hearing loss, you know, they think well, I go to the doctor get a physical, no, it’s not part of it. So, you know, if they need hearing help, and they’re looking at over the counter, and all they hear in the media for a “Well they cost too much”. They don’t understand the art, and the science that comes with it. So if anything, over the counter hearing aid, basically, you know, people declare they need hearing help and the professional should embrace that.

Bob Traynor 11:20
Oh, and, and I think as we talked about last time, a brand in the the idea of modifying your pricing structures, so you can obtain a good benefit as a practice from those patients that tend to purchase products elsewhere, by making certain programs available for them. And no, I think that the the, the OTC products are, are here to stay. And, and I would encourage my colleagues, either on the dispensing side or on the audiology side to have a number of those products in their clinics that they feel comfortable with that they really feel will be a benefit to patients who don’t want to spend a lot for products, and have those available to them.

Brandon Sawalich 12:08
And the right ones,

Bob, I would say – just to finish, it’s the satisfaction, there’s going to be a lot of bad actors that are going to come out even more. And we have to focus on, you know, not the confusion of the reputation of hearing aids. But what is a real over the counter hearing aid and how a professional can introduce them correctly to you know, amplification, and what that means for better hearing health. And then, you know, move them up in technology as the patient needs it based on their lifestyle.

Bob Traynor 12:37
So now, now, there was part of the regulation that talked about over the counter, but another portion of it talks about a prescription for patients with severe to profound hearing losses, that should be of some benefit to all of us in practice, I would think to have to actually be a be writing prescriptions to for certain products for certain patients.

Brandon Sawalich 13:02
Yeah, and I’m not, you know, it’s again, digesting that one and working through and how we respond because I’ve heard the, you know, that word, the prescriptions we use it a lot with, or excuse me, I’ve heard it from people outside your industry or the media, they use that word, but it still comes down to patient safety and satisfaction. So if it’s a, you know, severe profound loss, what is that, you know, prescription or recommendation by the professional that they need? And that’s been our big focus, too, on the discussion going on with Medicare

Bob Traynor 13:34
Yeah. So speaking of Medicare, um, so how, how do we have any idea how that might affect the, the industry? I know on one side, if you if it’s, if it’s a durable medical care, durable product, where they where the government purchases it, and they pay us a dispensing fee and a follow up fee, but if it’s, if it’s something like like a walker or whatever else you get at a, at a medical supply store, then that’s more like the model that we’re used to. So where do you where do you sit with that one?

Brandon Sawalich 14:21
It’s kind of like bringing both sides of the aisle together just on if it’s daytime or nighttime outside because it’s, you know, one thing that with the Medicare discussion that’s going on, is, you know, there’s the media and the politics to set that aside, because that is the front and part of the process. We have been very engaged HIA partnering also with others and HLAA’s has been part of that discussion. And, you know, they’ve really been working with us being Capitol Hill on you know, How is this done right? They’re asking the right questions. Because our concern isn’t about, you know, if it’s, you know, Medicare is expanded to cover hearing – do it right. Just like with over the counter, yeah, because you have a lot of good smart people doing a lot in a very large reconciliation or infrastructure bill. And then you’ve got the politics side of it, which is, you know, perfectly normal of, you know, we’re reducing, you know, cost of hearing aids and, and expanding Medicare. Well, that that’s the quick, you know, talking points, but then then, of course, you get got to get down in the details, make sure it’s done correctly, for the patient. That’s been our biggest fear. But I, you know, I know that we’ve been having the right discussions or listening. You see that I think in the House bill, where we talked about prosthetics, the top up, you know, people being able to, you know, upgrade, and then you know, including if we talk access, right, that’s the big word in DC on expanding Medicare and access and affordable hearing aids. And, you know, it’s – you got to include hearing specialists. I mean, it’s, it’s, it is what it is there, it’s because you can’t have access and try and help, you know, increase the penetration rate, and focus on one, you know, a profession being if it’s just audiology, and I love audiology, I got plenty of friends in audiology, of course, plenty of friends, plenty of friends as hearing aid specialists, but this is about an art and science of the fitting and helping somebody hear better. You’ve got to have hearing aid specialist included, because that’s how you have true access. And that’s how you help you know, 45 million people that have hearing loss, or the

Bob Traynor 16:51
the idea that that it’s always been one of those questions, that there’s not quite enough audiologist to go around. And the dispensers may need to be they need to be involved as well to really do the service for the hearing impaired as necessary.

Brandon Sawalich 17:08
And I you know, we very much respectfully, because Starkey is very proud of, you know, being a partner with the VA for our veterans, and you’ve got very hardworking audiologists that are doing everything they can to help the veterans with tinnitus and hearing loss. And, you know, their their wait time is, you know, incredibly long. So now imagine if you single focus this outcome, this this Medicare expansion, to again, maybe just audiology or something else, you know, think of the waitlist for people that really do need the hearing help that they’re trying and wanting to expand Medicare for. So it’s it’s all about the access is making sure that hearing aid specialists are included. And I know the VA has done a great job with their programs over the years to better serve the veterans and get more hearing out to them.

Bob Traynor 18:04
So it sounds like one of the big things that we have to look for in the Medicare expansion would be how, how we go about how it’s being set up, and how it’s being organized, and us and so on. And, and I know that there’s a lot of things that would still need to be done with the expansion of Medicare and hearing care as well. So this is gonna happen tomorrow for sure.

Brandon Sawalich 18:31
Exactly. I was just gonna say this is a long way from being over. It could it could change, you know, you’ve got the the House bill that’s out. Senate, we’ll have a bill. You know, we’re working closely, advising, you know, answering their questions, and they’re being very thoughtful, and they want to do it right. But again, this is a pebble in a rock quarry. I mean, it’s one thing in a very large bill that Congress wants to pass and the Biden administration, but it’s, you know, it’s, you know, I think we’re in the third inning is, is my sports reference, it’s still has a long way to go. And we, we all have a seat at the table for doing this right in the discussion

Bob Traynor 19:18
Right, I think I think the manufacturers, the HIA. And the associations as well as all my colleagues on the dispensing side, as well as on the audiology side, will will have their input through their various channels to facilitate hopefully doing the right thing. And so it’s, it is one of those things that is quite different and quite interesting. And, let’s hope it all goes the right way. We’ll we’ll encourage our colleagues to make their comments on the current OTC regulations within the 90 day period. My understanding is we may not see products in in that marketplace. until around next fall sometime, that’d be that was what the estimate was, if I remember correctly,

Brandon Sawalich 20:06
correct. That’s that’s the overall estimate. You know, there’s some that have been out there. We discussed I think just last week. But you know, that’s causing some confusion. But you know, there, you have stated, AG’s Attorney General’s that are handling this. And again, it’s just about doing it. Right. And probably June to August, given that timeframe. And then again, with with the Medicare expansion, who knows when, or if that happens, but, you know, we’re doing all weekend to make sure that they’re wanting to do it, you know, let’s get this right.

Bob Traynor 20:41
Well, what, what I think is interesting is, there’s so many things changing right now in the area of hearing care. And, and, and as those things are happening, it seems like we we now have three audiology organizations talking to each other. Now, if we can get those organizations to talk with the dispenser organizations, and we get all of everyone on board, it’ll probably take all of that to to get the Medicare system set up for for the hearing impaired the way it should be. And, and then, and then I know that the HIA works together with all the manufacturing entities to facilitate the same thing. So it sounds like like, you know, way, it’s been kind of good to wait this long for some of these things to happen. Because it seems like we’re set up on both sides of the practice spectrum, as well as with the manufacturers to facilitate a good result.

Brandon Sawalich 21:41
Yeah. And I’ve, you know, I’ve been around the industry for, gosh, probably 35 years, 35 years, 40 years. But I’ve been at Starkey for 28 and I will tell you, for the for the first time. Look, the positive that’s coming out of all of this is the discussion is happening. Hearing Healthcare was under the radar – for years, right? We know this. Oh, yeah. And now we’re being reached out. It’s, it’s in the spotlight. And we have a podium, we have a microphone. You know, we have what we need as an organization, or excuse me, as an industry to have the right discussions to educate, because it’s not that ‘$6,000 device’ ..that one tagline, that one soundbite that they all use and in my 28 years, I will say for the first time that I can recall, you have you know, all three of ASHA, ADA, AAA, IHS, HIA, HLAA, I mean, everybody is aligned around the common purpose. And that is, you know, doing what is right for the patient and better hearing. So, the discussions are happening HIA in the board, as you mentioned other hearing aid manufacturers, yes, we’re competitors, we compete out on the street. But when I started as chairman, in 2016, serve two terms and just stepped down July 1st, Gary Rosenblum, US president of Oticon’s chairman, US president of Phonak, Sandy Brandmeier is Vice Chair, and we have an engaged board. And it’s for the greater good. It’s not about you know, the business side, because obviously, that’s separate. And we don’t talk about that. For the board of HIA, we talk about what is best for the greater good of the patient. And when these discussions are coming up, and they’re going to come up at federal more, and states and the state level that’s going to be next, in my opinion. And you know, what, we have a very engaged board that’s doing the right thing for the patient. And we talk, we’ve been having meetings every two weeks. And once and, you know, Gary’s leading those discussions with the rest of the board. And, of course, my involvement and Kate Carr is president of HA, Bridget, who’s out there, Bridget Dobson, who’s out there on Capitol Hill every day meeting, and educating staffers and members of Congress. And then Lindsey Robinson, who’s organizing and, you know, she’s kind of she’s the air traffic control tower basically for all the meetings and communications so we have a very strong, HIA, Hearing Industries Association and board that is doing right things and partnering with associations. We’re not lone wolves. We’re not out there trying to do it. For other reasons, patient safety, patient satisfaction, and having a seat at the table.

Bob Traynor 24:36
Great. Well, I think we’re at this point in time, we probably have gotten about as far as we can go with a discussion with with where with this particular issue, and the Medicare possible involved with Medicare as well. And I want to thank Brandon so much for coming back and having a discussion with us again, regarding these important issues and hopefully another day, another time when something else comes up or another one of the issues that we’ll have, we’ll have another discussion on these issues.

Brandon Sawalich 25:12
Anytime. I appreciate just the chance and, and sharing because we’re passionate is you and I talked last time – whether its when we were at the Mid Atlantic Conference or last week you know, your passion or I’m passionate about our industry and doing what’s right and hey, just like you want me to be a reoccurring guest just pick up the phone and call happy to share anything with you. I’m pretty transparent

Bob Traynor 25:35
Thanks again brandon for, for your insight, not only from from the manufacturer side, but also from the HIA side, because I think that to many of my colleagues HIA is kind of this nebulous kind of a thing out there. It’s like it being in the cloud. And and they’re kind of looking down, and Who are those guys? And what are they doing and those kinds of things. And so, thanks for the update actually, on the HIA. And, and again, again, thanks for being with us, and hope to hope that things will go well with the comment period on the OTC regulations, and we will all continue to watch what happens with Medicare as they may be moved into the hearing care profession.

Brandon Sawalich 26:23
Thank you again, Bob. Thanks for having me. We have better days in front of us. I’m not worried about the future because more people are going to need what we all provide as services and products to help

Transcribed by https://otter.ai