OTC Hearing Aids and Legislative Changes in Hearing Healthcare: Interview with Brandon Sawalich

Bob Traynor
Welcome to This Week in Hearing where listeners find the latest information on all things related to hearing care. And as you know, we look at current developments in politics legislation, innovative technology, pharmaceuticals, therapeutics. And of course, we’re always looking for the latest innovations in practice management. Hello, I’m Bob Traynor, your host for this episode of this week in hearing. Today, we have a critical issue that we need to discuss relative to hearing care. And this issue deals with the over the counter hearing aid legislation, and specifically President Biden’s executive order requesting the implementation of this as soon as possible. And today, where we have our guest, Brandon Sawalich, who is the President and CEO of Starkey laboratories, thanks so much for being with us today, Brandon to discuss this. I, I know that many of my my colleagues may have seen it in Hearing Review or they may have heard a talk here and there. But I my guess is most of them are seeing their patients all day. And they may not have actually heard what you have to say about this important topic.

Brandon Sawalich
Well, thank you for having me, Bob. And, you know I, like you and many others are very passionate about our industry and I embrace what’s going on in Washington DC and and around the world on really spotlighting the importance of hearing health care.

Bob Traynor
You know, if you could give us a little bit of an idea, I understand. Starkey has a program called Listen carefully. And it has a lot to do with the over the counter legislation and Biden’s executive order and so on. Could you tell us a little about Listen Carefully. And maybe how Starkey and yourself really got involved in all those steps?

Brandon Sawalich
Well, for myself, I’ve been around the industry most of my life. And as far back as I can remember, and I was never going to get into the hearing aid business. I was going to be an astronaut. But we all have visions and dreams and sometimes plans work otherwise. And I’ve been in the industry at Starkey for 28 years, great industry great people. And I learned, I’ve learned a lot over those years. A lot of you know small industry. So mutual friends, and like you and myself, the passion and really learned a lesson, going through the whole OTC, over the counter discussion in 2015, really 16 and 17 and understanding what people perceived our industry to be, and you know, kind of fast forward and there’s a lot of information in between 2016 and and where we are today. But you know, Listen Carefully, which is ListenCarefully.org really is focused on the information on hearing healthcare. It’s not just on OTC but it’s the facts about our industry, because whether it’s, you know, manufacturing associations, you know, go down the list, I know that we can do a better job, all of us in stepping up and really educating on hearing healthcare solutions and the role of the hearing health professional. Because that was my biggest moment over the last five, six years is how a lack of knowledge and uneducated, I would say that we’ve done in cap on Capitol Hill and with the general public overall on the role of the hearing healthcare professional, and what today’s technology can do to help hearing and so it’s not to beat or out, out discuss, I’ll say the narrative that’s going on in DC. We have to have our own narrative on the facts.

Bob Traynor
So are there specific things that hearing healthcare professionals can do to be supportive of the efforts that you and Starkey and others of our colleagues are doing on Capitol Hill?

Brandon Sawalich
Absolutely. And it’s really here, you know, listen carefully, is yes, something that is Starkey initiated, and we started with this site really in July, meaning wanting to do something after President Biden’s executive order came out, and then the follow up the next couple days on from I think it was Good Morning America, Wall Street Journal, New York Times on articles about commoditizing a hearing aid. And we all know that it’s much more than this. And we’ve been talking about it as my role as chairman of HIA, HIA’s involvement and everybody has the same intent. So we put together our website, with the right facts and really for it’s not As Brandon at Starkey it’s about, you know, again, listen carefully and getting that information out for whether it’s consumers, patients, it could be associations, and of course, hearing healthcare professionals could go on and get involved through your local member of Congress. And state, because it’s not just a federal level where this discussion is being had, it’s at the states too. So it’s, it’s sending letters, it’s letting them know who you are, and educating them on why the role of the hearing professional is important, from the examination, as we all know, the testing, to the selection, fitting counseling, and the years of service and care, because it’s not just the cost where they look at, you know, everybody uses in the media, the $6,000. It’s much more than this in what’s involved, as we know, so we have to educate. And we have been doing a good job, and everybody has been helping,

Bob Traynor
I had the opportunity to go to listencarefully.org, which I would highly recommend to colleagues that watch This Week in Hearing, simply because it has some great information in there about what’s going on the kinds of things that not just Starkey, I think, and not just Brandon are doing for our profession. But it’s an overall kind of picture of what we what we do and what’s happening in various states and various issues. So consider going to that particular site and see what happens with with what you think about it, but I think could be very impressed. The other thing is, um, what are some of the current hearing health care issues that are being debated in DC, that might be of importance, importance for all of us? Well,

Brandon Sawalich
for for me and I for our industry. And that’s what you’ll see on on Listen Carefully, but also initiatives with HIA, the other manufacturers and associations, where it’s really, it’s about educating and having the conversations with the members of Congress, Senate, I’ve had several calls with the White House, some staff at the White House, and you’ve got to just be repetitive because when you’re tired of hearing yourself talk and having these conversations, it’s just now maybe sinking in on the reality. There’s so many things going on in DC that this is, you know, one of a lot. But it’s also explaining to not just the member of Congress, or the US Senator, it’s also talking to the staff, because it’s the DC staff that you want to build that relationship for the long run for all the right reasons, and educating them on hearing healthcare, because some may be around a lot longer than members of Congress. So you have to think, big picture. And that was my biggest one of my biggest learning lessons in the OTC discussions in ’16. And ’17 is the audience and you have different members in the audience that you must build relationships and talk with talk to.

Bob Traynor
So where do these regulations stand today? Brian, or Brandon, I’m sorry. Where are we with these at this point in time?

Brandon Sawalich
Well, I think with the OTC and and your, your question, you know, what is going on in DC to is, you know, there’s several fronts, there’s the over the counter, that’s just in my opinion, it’s going to be any day, um, over the next couple of weeks. I do believe that the FDA will issue their ruling and meet the request of President Biden’s executive order. And I, we welcome it, because it’s it has been too long and others have, you know, startups and, you know, as I say, kind of some bad actors have started taking advantage or manipulating the wording and confusing, because for us and Starkey, you know, I get I do a lot of interviews. And over the last several years and people automatically the media and some things that we’re against as an industry, over the counter hearing aids, it’s furthest from the truth because we’re the ones making the products they’re trying to make more available. And for us is – I’m against doing it for the revenue, the profit and making that more, over the people and the patient satisfaction. Because you have to make sure that we protect the patient satisfaction which then protects the reputation of hearing aids. And we don’t want a $50 or $100 here, PSAP per se that’s called a ‘hearing aid’ be confused with what we all know to be better hearing. And there’s also the Medicare discussion as we know, and that’s kind of up and down and where that’s going to land but HIA and associations have been united on this front, in working with members and educating members in the Senate on if they’re going to be expanding Medicare, what’s the right way to do it, if we want the people to have access, here’s what we feel needs to happen. And then again, having those continued conversations, because if it doesn’t happen this time, you know, the conversations gonna come up in the, in the coming years because hearing healthcare is on the radar period.

Bob Traynor
Well, the, the idea of Medicare with hearing instruments has been a recurring episode for many, many years. I mean, I remember it back in the 70s, back in the 80s, back in the 90s, and so on. So we, we have seen this on and on and on. Now, with the climate in Washington at this point in time, there’s probably a little more a little more likelihood than there would have been before. However, one of the one of the things that that, that I had a lot of experience with over the years is the stigma of hearing instruments. You know, when I started in the, in the 70s, and my, a lot of my friends are out there that started but same time, we remembered that you’d have to be half dead before you’d come to an audiologist to get a hearing aid. And, and, of course, it’s not quite that bad now, but it’s still not like some of the other handicaps and so on, you would think that, with everybody having strings hanging out of their ears, and all these things these days, that would be a lot better. But there’s still that reservation among patients that really need to do that. We’re where we, from, where you sit and HIA. And, and as, as a mover and shaker kind of in the in the in the industry. What do you see the stigma factor these days,

Brandon Sawalich
I think it still exists, it’s, there’s more people that need what we all provide. As I, I kind of joke at times, but it’s the truth, we engineer design, manufacture and deliver a product that really nobody wants, unless they have to, you know, you know, life changing moment that makes them go and do something about their hearing loss. I think it’s getting better, I really do. But it still exists no doubt and, and it’s a it’s part of that education and us being more vocal, and it starts it, you know, to me, hearing healthcare is community based. And if you’re in your community, you’re known as the one the clinic, the practice that’s going to help people with their their hearing needs, and then educating the community but also then the media because we all see, you know it, it just raises their hair up on the back of my neck. It just drives me crazy when I see these pictures of hearing aids that aren’t hearing aids and, you know, it’s the big we write the big, big, thick BTE and tube and then the bud in the ear and it’s like, Where are these pictures coming from? And whether it is Starkey or any other manufacturer. Well, you know, there’s pretty slick looking products. And the best hearing aid is you know, for the patient of course is yes what they need but the one that’s not seen and you know, there’s so much great technology out that it really starts with us as a profession. And then of course educating and continue to educate in the media because it’s that, you know, that visual that they see in Wall Street Journal on on us in the USA Today. Good Morning America, but also in the movies, TV, you know, it’s the stereotype, you know, where we all saw

Bob Traynor
the movie things, they seem to find the ugliest thing they can find and put it on grandpa. Right or put it on on somebody so that and likely that stood there so that they could so people will know that there’s a hearing loss and that kind of thing. But still it would be nice to notice that there maybe there’s an impairment there and then they put on something nobody can see. And then it would be it would be part of the deal. So

Brandon Sawalich
what’s the one thing they always do right the hearing aids whistling in the movie? Yeah. And that’s the that is you know, 1980s and 90s it just doesn’t it doesn’t happen today. I remember that what was the movie Disney Up, right? And the same type of thing and I coudl go on it’s it’s just that when people see it it’s it stays in their their mind that’s the stigma because you’re not you’re not going to die from hearing loss. And people who need to have that you know fear desire obligation. What is that motivation: fear losing their job, connected the family, the pandemic, that’s going to move them to do something about it.

Bob Traynor
It’s like the the article that we saw from Sarah Sydlowski where they were talking about ‘the biggest competitor that we all have in clinic is the ‘do nothing’ patient who has decided I’m not going to do anything at all. And that could be stigma, it could be cost could be this could be lots of other kinds of variables as well. So what rules would you like to see from, with all your perspective on on the way legislation that has been formed, and with HIA, as well as a being so, so long in the industry? What kinds of things should there be in those FDA regulations that we’re going to see on OTC products?

Brandon Sawalich
I think what’s important, you know, we talked about the protection and safety of the patient. And I think that goes without saying, no matter what product and channel that is, you know, you don’t want to over amplify, but it’s also it comes down to, you know, Roy, Dr. Roy Sullivan, who we all know, is been a lifetime friend, he’s always told me and he’s never been afraid to call me up and remind me that the product, the hearing aid is a third of the process. And, you know, for us is… people in DC or with the OTC is simplifying an art and a science. And, you know, The very thought of ‘do it yourself’. Some it might, might work it may work for, but when they say, well, this is only for mild to moderate, well, there is no mild to moderate cholesterol score. So how do people know what is mild to moderate hearing loss, they could try it, depending on the device. But you know, it’s going to be about the fitting, we have talked to the FDA numerous times at their request, and they’ve partnered well with us and, and others and just collecting input, that the role of professional my opinion still needs to be involved, if they want to buy something through a different channel, per se, go see a professional make sure it’s fit well, because again, it’s that reputation of hearing aids, patient satisfaction is at 88%, according to last MarkeTrak 10 from HIA, we don’t want to go backwards. And then the labeling package labeling, you know, what, what is the consumer protection, per se, and patient protection on these devices, because it’s not a consumer electronic and return policy, proper labeling, I, you know, go down the list. And then if they’re looking at mild to moderate, you know, what is the gain and output and, and there’s a consensus, consensus paper that came from all the associations that ha endorsed, kind of providing those guidelines. So I’m optimistic, you know, I think, you know, we’ll see what they come out with, and they have a comment period, but I’m optimistic that you no good will come from this. And the patient is going to decide at the end of the day,

Bob Traynor
patients will decide at the end of the day, and many of them will end up with some of these products, I think, and it really behooves colleagues in in practice, to develop a program whereby they can actually assist those patients that obtain these OTC products for a certain fee of some kind. And maybe even once they figure out that they’re not really what they think they’re going to be, they might end up putting something on them that is more appropriate for their particular impairment. And

Brandon Sawalich
I think we see it in our I know, with our customers, and you’ve probably talked to some of your colleagues and, and others that they’re buying these products online. They think it’s the hearing aid, it’s a PSAP, whatever it might be, and they’re going into practices, wanting them to fix it, or wanting them to make it better. And, you know, obviously the hearing professional, whether it’s a hearing aid specialists or an audiologist, they can’t and it’s again, then the patient it feels, you know, misled and that’s also why you’ve seen 17 State Attorney General’s which you look at Listen Carefully. We’ve had them outlined 17 State Attorney General’s that have come out and warning consumers about the misleading hearing aid advertising that’s going on from some of these pop up and startup companies.

Bob Traynor
Yeah, well, in your opinion, why does the hearing professional need to stay involved in this process? And how should we go about doing that? I mean, we’ve kind of alluded to that a little bit but but you know why and how do we go about supporting the efforts of HIA and and those of you that are involved with our with the DC people

Brandon Sawalich
Well I think, for why stay involved or why the role of hearing professionals is service and care, right? It’s of course the hearing, hearing test and I’m not sold that a you know, the online hearing test is the magic bullet for people that are looking for hearing help, we know this.

Bob Traynor
Many others, either our committee others actually

Brandon Sawalich
and it’s all about that. We In a people business is, you know, it’s the human touch. Whether it is yes, you know, people don’t want to be sold, they want to be helped. If somebody is coming to, whether it is online, or practice, they’re saying they need hearing help. And then what is that role the professional that’s going to provide that elp of solutions for them, and that then help them and care and service for that product that fitting for the years to come. The same can be done with online, I mean, over the counter product. It’s now visible, it’s the marketing from it because of this bill. But you and I both know, for the last several decades and well beyond I started this industry, whether its catalog sales, or cheap hearing aids have been around, I mean, it’s it This isn’t, respectively, anything that’s brand new, it makes for good discussions and making sure it’s done right. So you know, our industry and the in the patient satisfaction doesn’t go off course, and backwards. But a hearing professional can offer an over the counter product. I mean, again, it’s it’s a cheaper solution, per se, but it’s about access, the whole thing with over the counter started with access and affordability. And professionals can hit both of those as its community based if they like,

Bob Traynor
you know, I have always been an advocate of practice differentiation by technology and product and product. You know, if you have, why should somebody go to Best Buy and buy a piece app or buy a headset or buy a something else, they should buy that at the Hearing Center. And, and and and honestly when you when when you offer these OTC products in your practice, you get to choose which ones are the best ones that you want to offer in your practice. And then you can offer a different program for people. I think first of all, I want to encourage all of you to look at listencarefully.org because it does have some fabulous kinds of information there some things going on in various various states by the Attorney General’s and so on, as well as some other great information that you can use with your patients as well. And certainly want to thank Brandon Sawalich from Starkey laboratories for being with us. And then in his position as president of HIA as well as kind of the looking at the at the profession not only from the 10,000 foot level but also right in the trenches at meetings where we just crossed paths here just a couple of weeks ago. Again, thanks so much for being with us. And and with that. I will just say that I’m Bob Traynor and I’ve been your host for for this week in hearing with Brandon siwalik. President and CEO of Starkey Laboratories.

Brandon Sawalich
Thank you, Bob. I appreciate you having me on and please anytime love to come on and have continued conversations for the greater good of our industry.