Michael Scholl Helps Make Sense of Changing Hearing Healthcare Regulations

Starkey’s Chief Compliance Officer and EVP of Corporate Relations, Michael Scholl, joins Dave to discuss how OTC, potential Medicare expansions and other developments in Washington, D.C. will impact hearing professionals and end users, what Starkey is doing to help guide new regulations, and how hearing professionals can ensure their voices are heard.

Link to full transcript

Transcript

SPEAKER_01 0:02

Welcome to Starkey Soundbites. I'm your host, Dave Fabry, Starkey's Chief Innovation Officer. And today my guest is Michael Scholl, Starkey's Chief Compliance Officer and Executive Vice President of Corporate Relations. Michael joins us today to talk about developments in Washington, D.C. regarding what has become a buzzword in the hearing aid industry, OTC, or over-the-counter hearing aids. He's here to help us make sense of some of the policy changes and what to expect in the months ahead. Michael, uh glad you're with us today.

SPEAKER_00 0:32

Well, Dave, thanks for having me. It's great to be here. It certainly is a timely topic with everything that's happening in Washington.

SPEAKER_01 0:39

Yeah, I mean I've been an audiologist for nearly 40 years this year, and for many of those, I've sort of arm wrestled with patients to get them to use hearing aids. And uh although we know that accessibility and affordability is a major concern, and we welcome that opportunity to provide new pathways for patients or end users, consumers to get hearing aids, um, we also know that stigma remains a big part of the reason why uh our biggest competitor is noncompliance. Uh the other issue is as I think we've said, oh, you know, hearing should really be recognized as an important health concern. And uh I file that under you better be careful what you wish for, because since the PCAST uh hearings that began during President Obama's term and then continuing into President Trump's term when he signed the OTC legislation into law, and then continuing uh recently when uh uh President Biden uh issued that executive order to hasten things along a little bit, I would say that uh we've achieved that goal because hearing has certainly uh got the attention in Washington, D.C.

SPEAKER_00 1:42

Well, when you have the President of the United States starting a speech talking about hearing aids, you know it's certainly a topic for discussion. So to your point, over the last decade, uh hearing aids continues and has been uh an issue that's now at the top of the list for policymakers in Washington.

SPEAKER_01 1:58

No question. And for many years we've seen slowly, insidiously, uh hearing loss and hearing aids has crept into uh television and movies. I mean, a quiet place and some of these places that that have hearing loss or hearing aids or these hybrid sort of cochlear implant devices featuring prominently in the role. I saw on a recent Saturday Night Live uh it led with a uh with a joke about hearing loss and hearing aids. So it seems as though it's everywhere. And uh so we're delighted to have you on board to serve as our eyes and ears to what's going on in Washington, D.C. But I think, you know, for those people who don't know you in your background, would you talk a little bit about uh, you know, what brought you here to Starkey?

SPEAKER_00 2:39

Yeah, yeah, for sure. So as Dave mentioned, I I wear a couple of hats. One is our Chief Compliance Officer and then our executive vice president of corporate relations. Uh my background before coming to Starkey is really on the policymaking uh regulatory front, uh working with organizations uh both uh on the for-profit and nonprofit side uh in Minnesota, uh my native state of Ohio in Washington, D.C., working with members of Congress and advocating uh for different policy uh changes over the last 20 years. I came uh to Minnesota. My wife is a native Minnesotan, so here I am in Minnesota. And when I moved here in 2008, I got to know um the Starkey and the and the Austin family and the Swalich family, and then came in-house almost five years ago and now serve in the roles that I mentioned earlier. And it and it's exciting because on the compliance side, that's really the work that that is done after the sausage is made, so to speak, right? So having my hands in policies, you know, related to hearing health, but just general compliance policies in health care. It's making sure we as a company are adhering to those policies, our own policies that we have. But then on the other side, on the corporate relations side, that is that's that's the exciting side, the government relations and interacting with uh elected officials, not only in Washington, but you know, in in each state. As you know, issues come up at the state levels that impact our industry. Um but some other exciting things, you know, some of our uh some of our partnerships that we have with organizations. Uh I have an opportunity to lead up our Starkey CARES program, which is our corporate social responsibility program that we've recently relaunched uh here this year, and we've got some exciting developments coming early next year. So um it's exciting, uh, you know, not only on the compliance side, but but the people and and individuals, the policymakers that you know we get to interact with uh on a seemingly daily basis. And you and you participate in in some of those meetings, Dave. You're a you're a great uh ally to have uh when we're talking with elected officials.

SPEAKER_01 4:37

Well, as they say, my expertise is a mile wide and an inch deep. And so I'm really glad that we have someone like you who can really help us stay, you know, the professionals, hearing care professionals, really see how these policies impact us in our profession.

SPEAKER_00 4:52

Well, if i if you think about it, I mean, you know, Starkey investing in somebody that does what I do and investing with uh people in individual states, and we have teams that we work with in Washington, it it's really for the for the professional, right? Because, you know, as as the largest U.S. hearing aid manufacturer, there's a lot that happens that impacts us, right? And impacts our customers all across the country. So we need to ensure that they not only have a voice um in the industry, but they have a voice with policymakers in their home state and in Washington. So I think it's something that we've been able to do over the last uh four to five years uh that's been a resource uh to the profession that they might not otherwise have.

SPEAKER_01 5:35

Yeah, and and we're gonna get to OTC in a minute, but I think you know you just raised an issue uh regarding uh the impact of legislation and uh of uncertainty on the discipline. And OTC has been hanging over our heads for a long time, the last several years. I think entering into 2020, uh, we all thought that the worst case scenario was that we would have to address this issue, which was the big unknown at that time. But boy, were we wrong that uh, you know, and you really were instrumental during the COVID pandemic uh in the early days when uh there was uh a lot of uh legislation about HIPAA compliance and telehealth and all of that in the U.S. And all the executive orders. You know, with all of those executive orders. Talk a little bit about that.

SPEAKER_00 6:19

Well, I think Starkey got out ahead of the game and uh again bringing resources to our customers. There was so much uncertainty happening in the country, in our industry at that time. Uh at one point, you know, the number that sticks in my head is that there were 935 executive orders across the country. And the question, you know, was how do these impact our industry, right? How do these impact professionals? How do these impact retail uh you know shops across the country? People still need to hear. And um we hosted town halls where we talked about this. We, you know, our team analyzed to the best of our ability how these, you know, these executive orders or these CMS changes to telehealth might impact uh their business. But I think what I'm most proud of during that time is, you know, working, you know, working with our president CEO Brandon Swalic and you and our chief health officer our we took the lead that hearing is essential. Yes. That was a line that we drew in the sand and flash became a flashpoint.

SPEAKER_01 7:18

That that the essential nature of hearing and many state uh governments tried to say that you know uh practitioners were non-essential. And uh and I think throughout the year, I mean we saw in quarter two of 2020, the industry in uh as a whole was off about eighty, eighty-five percent. Um but it came roaring back such that by twenty twenty-one, and we continue obviously uh with uh COVID uh during tw the year twenty twenty one, but our numbers now have shown that hearing in indeed is essential on the basis of how many hearing aids are likely to be dispensed this year.

SPEAKER_00 7:53

Aaron Powell And look, I think states listened, right? I mean if you look if you look at the executive orders and the way states reacted and they they would close down certain industries and and certain groups, but I think only only one state specifically prohibited, you know, hearing uh professionals to to open a retail or keep their retail locations open during the pandemic, and a lot of that was the work that we did, you know, educating those elected officials on the importance of hearing and the fact that hearing is essential.

SPEAKER_01 8:18

So um obviously and and I'll just interrupt for a minute, though, but although you know the eventual result was that everyone did recognize the essential nature, you were the calming force during the early days when there was so much uncertainty, many practices were uncertain how they were going to continue to put food on the table. And the other thing I'll say is I've heard personally from many uh of my colleagues who said that how how helpful it was to have you on guiding them through the process as to how they could get the small business loans. And and we were, you know, I again I'm not meaning to just say, but you were really out in front on that and guiding people through that process for how they could keep their doors open, keep themselves and their patients safe.

SPEAKER_00 8:59

Well, the the PPP uh program that you're referring to, I mean you may recall, Dave, we had one of our leadership team meetings early on where we had Senator Marco Rubio, right, join us on that on that call as he was the chief author of the PPP program in the Senate at that point, right? And and getting guidance from him and sharing that with our customers. I know many of them took advantage of the PPP program, and to your point, um they were able to keep their employees uh working and on payroll during that time. So, you know, a lot of that I I think I think that just shows our commitment, Starkey's commitment to ensuring that you know we provide as many resources and as much guidance, not only how it impacts us as a company, right, and all of this stuff does, but how it impacts our customers and making sure they have you know up-to-date information on things that's happening that impacts our industry.

SPEAKER_01 9:46

Uh ultimately, you know, coming straight from Mr. Austin, the company's founder, and continuing through uh our CEO uh and President Brandon Swalich, focusing the needs on what will benefit the patient, the end user, as well as our partners uh will uh generally uh win the battle. Uh and uh you may well you may lose a few skirmishes along the way, but you'll you'll generally win the war by focusing on the end user and the patient and then as well our partners uh who uh serve that valuable role and the important and essential role of identifying, diagnosing, treating uh their patients with our products. So let's let's move a little bit into that area and uh you know the this in the same way, but not to the same degree. But uh I think there's been a lot of uh anxiety over OTC. Uh when is it going to happen? And now we know it's no longer an uh an if, but uh but when, and we have a a better idea on the timeline. And I wondered if you could talk a little bit about the the situation and the timeline we're in and and and the uncertainty uh that's being removed, if you will. We're getting more certainty as we move into this next phase with OTC.

SPEAKER_00 10:53

Yeah, no, for sure. So I started in February of 2017, um full time in you know, uh on the inside, and and that's right in the heart of the OTC discussion uh in Washington. So, you know, if we if we fast forward, um the OTC legislation was eventually signed and passed in August of 2017, or passed and signed by President Trump in 2017. And the window uh in that legislation was for the FDA, they had four years, right? August of 2020 was their deadline. And you mentioned earlier uh President Biden's executive order. It was not until July of 2021 uh when the president issued an executive order related to hearing and 78 other different issues. Um and and that's where I reference on, I think it was July 9th, the president started a press conference talking about how this executive order is going to help people get hearing aids at a lower cost. And and we knew something was coming. We knew we would see uh a draft regulation from the FDA uh likely within his 180 days, which he outlined in the executive order. So uh October 18th is when we uh first saw the draft regulation. Uh remember they had been working on this for, you know, since August of 2017. Um it's 114 pages, as you know, Dave. Every one of them. Every every page. And so where are we today? So the dr the regulation came out on October 18th, and um in it calls for a 180 uh calls for a 90-day public comment period, followed by 180 days uh for the FDA to act. So that 90-day public comment period puts us somewhere around the January 18th, 2022 timeframe. So um obviously Starkey, uh, the Hearing Industries Association, uh our customers, patients, other industry groups, we're all working feverishly to make sure we draft our comments and make sure to make sure that they're submitted by by January 18th. So and we can come back and talk a little bit about what we're doing related to that. But from a timeline perspective, so January 18th is when the submissions are due, and then that 180 days that I referenced earlier kicks in. The FDA then has 180 days to review all of those comments and then release their final regulation, which will then go in effect uh 60 days after that regulation is released. So we're looking at July, August, somewhere in that time frame of 2022. Summer of 2022. Um, let's be clear, this is this is certainly a priority of the president. So when we look at that 180-day time frame that the FDA has, now if history repeats itself, they took more time than they were originally allotted, right? Okay. So will they take the entire 180 days? We don't know. They could move. So it could be faster than 100. If they decide that it only takes them 60 days to review all of the comments and then release their final regulation, it could be spring of 2022. So that's good clarity. Good clarity. Uh uh on the long end, you know, late summer, uh, it could be as early as spring of 2022. Chances are that July time frame, I think, is probably going to be the sweet spot.

SPEAKER_01 14:05

So uh can you talk a little bit about from the role of the industry, from the professionals, and from uh end users, consumers of this uh this category? Certainly we welcome and embrace the accessibility and affordability and the new competition that will result as uh uh you know from this new channel. But what about safety and efficacy that uh you know concerns you? And I know you're not speaking uh in a formal capacity for anyone, but you are our chief compliance officer.

SPEAKER_00 14:39

Well, you know, if we look back um you know, back in 2017 and even before, you know, Starkey was never opposed to expanding access, right? We just wanted to work with Congress, um, the Trump administration at that time to make sure that we did it the correct way. And that really led to the consensus paper, um, which came out in 2018, Dave, which you are you are part of played a very big role and you're very familiar with. And that was the document, um, five key points in that consensus paper that really focused on, you know, patient satisfaction, uh safety, you know, above all, um, you know, making sure that there were consumer protection elements, that they were labeling, right, efficacy. There were five major points that we used as a company and the industry used and and other organizations that supported that.

SPEAKER_01 15:26

Yeah, you said consensus documents, so in addition to the HIA representing the major uh manufacturers, uh it also included ASHA, the American Speech Language Hearing Association, American Academy of Audiology, American Doctors of Audiology, and IHS, uh the uh International Hearing Society. Um there any it was supported the Association.

SPEAKER_00 15:50

So that document is what we used in 2018, 2019, when we would meet with individuals at the FDA, right? You you're you're now tasked with drafting this regulation. We encourage you to follow what is laid out in this consensus document. When we would meet with members of Congress or others on the Hill, we would have that document in hand and we would encourage, if you're weighing in with the in with the FDA, this is the these five points are how we believe we can go about creating a safe and effective OTC category. Right. And now if we if we look at at the regulation, um, you know, the the proponents, uh Senator Warren, Senator Grassley, others who who really push this, um, their their focus on um access and affordability. Correct. Um, which obviously we support greater access and affordability for for hearing aids. But we can't forget about safety and satisfaction. We can't have access and affordability if it means compromising with safety and satisfaction. So I'll speak to a couple of the kind of high points in the OTC regulation and feel free to you know chime in with your expertise. But um if if we, you know, from our perspective, we really break it into three categories, right? That that safety and satisfaction category. Uh the consensus paper had a recommendation of a maximum output of 110 decibel and a maximum gain of 25. As you know, Dave, in the regulation that has been released, um, you know, you have the ability to have a maximum output of up to 120 dB, and they do not include a maximum gain. I think what's what's even more surprising is if we recall this category, this product is designed for individuals with perceived mild to moderate hearing loss. Correct.

SPEAKER_01 17:47

Let's go back, though, for a second to the 110 versus 120. Now, professionals know that that 10 dB difference on a logarithmic scale is a big difference. Some a lay person might say, oh, 10 decibels, what's that? Barely noticeable. Well, a ten as two sounds that differ in la in their intensity by 10 dB will sound twice as loud. One will sound twice as loud as the other. And we feel place considerably greater risk to the individual if they're listening at 120 decibels over the course of a day than if they're listening to 110 decibels of output. So we'll come back to that. But I just I want to frame that within the context of 10 dB, what's what's the big deal? That's a big deal.

SPEAKER_00 18:31

And and and so our task now is to educate the FDA, educate elected officials who will formally weigh in on this rule to to for them to understand the impact of 110 to 120. Dave, we were, you may re recall, we were recently at a football game, right? Yeah. And and you know, inside the the stadium, um, you know, on third down, right, with the home team, they always crank up the music and the crowd goes wild and and they have decibel readings readers. And and recently I saw it as high as 119 decibel indoors, and there were people around me that were commenting, boy, it's loud in here. People covering their ears. Covering their ears, right? And and my thought, and I told you, well, think about it, this could be an over-the-counter hearing aid.

SPEAKER_01 19:17

Right. It absolutely could. And 120 decibels, in addition to that crowd noise uh during that point in the game, um is similar to other sounds being in close proximity to jet aircraft and firearms. And it's getting in a level that can not only be um uh damaging to the ear, it can be downright painful to some people.

SPEAKER_00 19:38

But difficult for people to to realize, to comprehend that, right? Yeah, right. So so so the safety piece obviously is primary. We have to educate, we have to make sure the FDA understands um, you know, going to 120 and not having maximum gain could have some real negative impacts and could actually cause more damage to somebody's hearing. So that's so that's a takeaway of the of the regulation as written. Um another area is is preemption. So uh what does that mean? Well, right now, um you know, states really regulate hearing aid sales licensing um across the country. You know, the FDA has some regulatory authority, but it really uh relies with states. And and you know, as you know, there have been 17, 18 State Attorneys General who have weighed in over the last year about companies selling over-the-counter hearing aids before that category even exists, right? So that that just goes to show you of the state's authority in this area. So um one of the one of the provisions in the original OTC bill uh was a simple paragraph that uh preempts state law. So this new category will now preempt any state laws governing over-the-counter hearing aids. So um we were expecting for this new over-the-counter hearing aid category that it would be pretty clear that, you know, you you you could it wouldn't have to be licensed, right? You you wouldn't have to see a professional that it would preempt some of those burdens because this is now an over-the-counter hearing aid. Um our concern with the way the preemption language is written is there's the potential to preempt state laws that regulate any hearing devices. Right. So it sets, you know, the OTC regulation creates two categories. It creates OTC hearing aids and then a new category of prescription hearing aids for everything else. And then there's PSAPs over here. Don't forget we have to talk about it. What is what's a PSAP? So the personal sound amplifier, right, is just that it amplifies. It's not designed uh as a hearing aid. You can't market it as a hearing aid. It's not designed to to help somebody with hearing loss. It's simply you know, a lot of uh, you know, uh bird watchers and and folks use them to to amplify noise. So in it with the OTC regulation, one of the asks was to uh finalize a PSAP. directive that came down in 2013, which the FDA does uh in addition to the OTC regulation. But I want to come back to this this preemption piece. Think about it. If if if if this regulation were to preempt state laws governing hearing devices, then not only not only professional involvement, but but return policies, warranties, anything that a state currently governs may go away. And the FDA is already in this would move it would move hearing aids from restrictive devices into a category of non-restrictive devices. So the marketing claim enforcement et cetera um who would it would be left to the FTC, right? The FDA and states are losing a lot of authority with this. So this is really concerning because you know we know how important that that you know these these uh these laws are there for a reason, right? So now if you've got people buying products and that they don't work and there's no mechanism for return or or for refunds, um that's not only going to hurt that person by not getting the help that they need, but the industry in general, it's going to impact the reputation of the industry. And you know Dave, what the last market track it's 89% 83%.

SPEAKER_01 23:16

That's higher than cell phones. It's higher than a lot of consumer electronics.

SPEAKER_00 23:19

Trevor Burrus So when we talk about safety, we talk about satisfaction because people that are getting the help that they need, they're satisfied with that help. So that preemption piece and how it impacts states will play a is something that the FDA needs to clarify of what is preempted for OTC categories and what is not preempted for traditional hearing aids. And then the f the final piece I hit upon this a little bit that that I think we certainly will weigh in on is the consumer protection piece. Making sure that the right labeling requirements are in place, right? These are designed for somebody who has perceived mild to moderate you don't have to take a test. Yep. Really the only guidance is looking at the labeling on the outside of the package right the the FDA believes that you can pick up the over the counter product and you can say you know if this causes more damage or you don't get the help you need, you know, return that doesn't work or find something else. That's the only mechanism for individuals to buy this. You have to be above 18 but there's no enforcement that will you know it's not behind the behind the counter where you have to show your ID to buy this. So the only really consumer protection is the labeling not only on the outside that's on the inside of the package. Well if I buy it online Dave how do I how do I read the outside of the package right? We've got to be clear that there's some mechanism to ensure that the that the patient is is protected. So from our perspective and I know Dave you're doing a lot of work with HIA and obviously internally at Starkey but you know that safety satisfaction this issue of you know preemption and who now has enforcement authority and then just consumer protection those are three buckets that we will certainly be weighing in with the FDA on.

SPEAKER_01 25:03

Yeah and I would just add the the the that last part that you talked about perceived mild to moderate loss, we were a little surprised that there wasn't more clarity provided precision regarding the definition of mild to moderate. And a lot of attention has been focused on the upper end of that in that maybe those individuals with more significant loss who might need the help of a professional because they have more complex listening challenges provided by their hearing loss. I think an another part that has been not been given enough attention is on the low end that if someone perceives that they're having difficulty in the four environments that are in the the bill at the present the regulatory guidelines that maybe they have normal hearing and then go back to that situation where we were in the stadium and it was close to 120 decibels. The implication is well if you try these over-the-counter products and they don't work, no harm, no foul, then you can go see a professional and get more help if needed but the issue is is some damage may already have been done if you're listening at levels that could cause hearing loss.

SPEAKER_00 26:11

Well absolutely right and then the other piece is if you buy this product and it doesn't work and it doesn't help, are you truly going to then go see a professional, right? Or have you bought a hearing aid and it doesn't work? That goes back to the satisfaction piece that we talked about earlier. But I think it's a major concern and I and and I think um I think the FDA, you know, I the I hope they embrace this but you know being that it is perceived mild to moderate and the way this is currently written with output and gain, you know, you're the expert but you could go out and purchase a product that could absolutely cause more damage to your hearing.

SPEAKER_01 26:42

Yeah I mean I make the analogy I mean you can buy over-the-counter tylenol rather than prescription strength tylenol and it is still possible to overdose on over-the-counter tylenol. Similarly it is possible at these levels with this output level for someone unknowingly to listen at levels that could cause them to overdose on audio and provide noise-induced hearing loss that ironically OSHA or NIOSH would protect workers in noisy environments from levels that are going to be possible in these over-the-counter devices. And if someone has just a little bit of hearing loss but they perceive that they're having more difficulty, it makes them especially vulnerable to more damage that occurs. And that's in you know again I I go back to the safety and satisfaction or safety and efficacy issue.

SPEAKER_00 27:33

And we get one opportunity right the f we get one opportunity to get this right. Professionals won't be involved with these over-the-counter products so we've got to ensure that all of the guardrails are there to make sure safety and efficacy is is incorporated.

SPEAKER_01 27:45

Well thanks for going over those those details and for additional details on this I know that you've uh led the development of Listen Carefully an advocacy program.

SPEAKER_00 27:55

Talk a little bit about what motivated you to want to have this resource available and how do people find it so you know over the last few years certainly back in 2017 but then in 18 and 19 as as you know developments would occur or issues would pop up at a state level I often get calls or emails from customers, patients, what does this mean? You know, what what can I do? And you know our own our own team internally asking well you know what do I share with our customers and and it was pretty clear um to us Dave that you know I I hearken back to that president's speech when he talked about hearing aids that this was going to continue to become a topic. So what tools could we put together where folks can go to on a regular basis to get the most up-to-date information? And that's why we decided back in um August to launch Listen Carefully and it's listencarefully dot org and it is designed to be a repository for anything and everything that's happening right now in Washington. But as we get into 2022 that's when the state legislatures start to come together and and they may have legislation that impacts our industry. So right now it's designed to focus on what's happening with over-the-counter hearing aids, Medicare, which we can talk a little bit if we have time today. And then you know even hearing protection right what can what can we do on hearing protection to prevent some of this hearing loss. So listencarefullyorg is that repository where whenever something happens in the industry that's going to be the first place where we update and and we've had um over 6,000 emails go to elected officials on the Medicare topic because that's what we were focused on until this OTC reg came down. And so after the holidays after Thanksgiving we're going to move listen carefully from a Medicare focus to an OTC focus from the perspective of you know taking action. Right now if you go there you take action it's focused on Medicare but I just walk through those three buckets of concerns there will be um documents and information on Listen Carefully after the holidays where people can go and they can start submitting letters of the record of their own letters to the FDA as to why you know we should take into account the 110 max output or there should be a max gain. So we need all of our customers we need patients with hearing loss to proactively participate in this FDA comment period and the tools and resources that you need to to submit a letter will be there on listencarefully.org um uh to to you know to continue through with that process. Fantastic well and we'll stay tuned to keep watching for updates which are made as they happen as they happen and and many folks have signed up on the email list. So there's there's emails that come from Listen Carefully and from Starkey. So when when uh it's ready to to have folks start submitting comments we'll absolutely alert you. And look we have what we suggest that you say or at least include and and as patients well you know individuals with hearing loss or professional we encourage you to to to to include your own comments right if you've got stories or if you've had patients that have come in and and they they've got a, you know, they they had a experience with an over the counter product that didn't work, absolutely you should include that. But as an industry we need to make sure that we have as many people as possible you know submit comments with their own unique experience.

SPEAKER_01 31:20

Excellent well you mentioned Medicare expansion. We know the OTC legislation has been signed into law now these final regulatory guidelines are are are unfolding. Talk a little bit about Medicare expansion. I know there's a lot more uncertainty with that because it relates to big dollars and and being included really it's it's a small component of much larger Medicare expansion bills.

SPEAKER_00 31:47

But talk a little bit about what that means for the hearing industry, for patients again, and for professionals potentially if OTC wasn't enough we have to deal with Medicare at the same time we could spend another hour talking about you know Medicare but high level where we stand. You know the expansion of Medicare to cover hearing dental envision has been something that has been pushed for for you know the last decade by different members of Congress. Specifically Senator Sanders Bernie Sanders of Vermont this is a a priority for him to accomplish so you know everybody's talking about this BBB, this build back better the you know I call it the reconciliation package because that's what it is. You know this is a package that Democrats since they control the United States Senate and since they control the House of Representatives they can pass without Republican support. Right. But they have to have every single Democrat in the Senate support that so there's a reason why over the last couple of weeks or months really you've been seeing so much attention focused on Senator Manchin from West Virginia and Senator Cinema from Arizona because if they lose either of their votes then they don't have the 50 votes that they need to pass this. So you the the Democrats or the party in charge can pass reconciliation once a year. So they have one opportunity to do this. So when this when this topic came up you know again August timeframe that there was this consensus of a framework of a reconciliation package that framework back in August included Medicare expansion for hearing dental envision. And it was clear to us that we needed to do everything that that we could do as an industry to make sure if this is going to happen, it happens in a way that both benefits the end user, the patient, but ensures that hearing professionals are accounted for as well, right?

SPEAKER_01 33:42

You you mentioned earlier about the the satisfaction with hearing aids being 83 percent according to the latest market track survey of potential hearing aid users and existing hearing aid users. The other thing that often is overlooked is that that satisfaction with the hearing care professional was just as high. So they really in in existing hearing aid users even some of those PSAP users that you mentioned said that they feel that the role of the professional was as critical as the technology. And I think that's something that the Medicare expansion really needs to ensure as you said not only the payment for the devices but the support for professional services.

SPEAKER_00 34:22

Well exactly and and the the way that the the the legislation had been drafted in previous Congress there was a lot of uncertainty around that. So so as an industry we made the decision that if this is going to take place we have to ensure a couple of things. We have to ensure that a hearing aid is a prosthetic device and it's not a cane. It's not durable medical equipment it's something that you can constantly refine and tune and make better. So it has to be a prosthetic device. Number two, individuals have the ability to upgrade right I mean you may you Medicare may cover a X product and if you want more you know a premium and more features you have to have the ability to upgrade out of pocket like you can today with many third party and insurance programs. And then finally from an access standpoint i i if we want to improve access we need to make sure that individuals with hearing loss have as many access points as possible. So not only can you see an audiologist but you have the ability to see a hearing instrument specialist to be you know tested and fit for a hearing aid. So those were three big issues that we pushed for a lot happened over the months right you know Manchin said this or cinema said this and it was in it was out but at the end of the day the version that passed the House of Representatives recently does include Medicare expansion for hearing and those three pieces that I mentioned are included in that. So you know I it's encouraging you know I think as an industry we really did a good job of educating elected officials if you're going to expand Medicare coverage for hearing then you have to do it this way. And that's what they've done thus far but it's only past the House. Yeah the Senate is an uncertain future The Senate is an uncertain future I was on the phone this morning with folks in Washington you know trying to get what's the latest lay of the land and uh you know the House passed the bill it goes to the Senate. As you might imagine people are on recess now but um they're gonna review all of this and the Senate will adopt their own version. I think it'll be pretty similar to what the House adopts and then the question is um can they get the 50 votes to pass the the broader package reconciliation package. But we'll continue to work um continue to to do our best as an industry to make sure that the language is as tight as possible because with anything dealing with Medicare Dave Congress can only go so far and then it goes to the Centers for Medicare and Medicaid services. They really dictate the final regulation and how it's implemented. So you know we want to get as much in statute as we can to make it clear you know these things have to be part of the process. But then CMS has the ability to to finalize how it will be implemented and how it will impact providers. So I think we made a lot of good progress but question number one is will it go into effect? And if it does then we need to to spend a lot of time working with CMS to make sure the final regulation is as as we see. Similar to OTC right Congress passed it but yet it's left up to FDA to write it.

SPEAKER_01 37:24

Well this is a similar situation with Medicare coverage for hearing yeah and so stay tuned to uh listencarefully dot org for updates as they happen. And I think you know I'm sure that the industry and hearing care professionals feel the impact of these disruptions. You know disruptive innovation has become a buzzword but we feel like you know we our traditional model where it is professional driven in in the health care system and then on the other end OTC is creating this non-prescription approach that doesn't necessarily involve the role of the professional and the professionals probably feel like they're being squeezed in the middle by this but the beneficiary in my mind long can potentially be the patients in the sense that if it provides access, affordability while ensuring safety and satisfaction, that if more than a third of the people in the U.S. who have hearing loss use hearing aids everyone will will will win. And I think for professionals and for the industry it can potentially end up being the best decade ahead if we're raising awareness even further and reducing stigma around hearing loss and the use of hearing aids and it can it can be good things.

SPEAKER_00 38:39

But I I I just you know again a plug for Starkey I mean it's really important the work that we're doing, right? Because if we weren't at the table in Washington, in these state capitals who knows what the final regulation for OTC would look like? Who knows what the Medicare regulation would end up looking like, right? So again because we're active because we've invested time and resources and energy to working with members um I think we may end up to your point having the best decade in a long seat at the table may not always be comfortable but I'd rather have a seat than be in the other room.

SPEAKER_01 39:11

Absolutely so um with all of this experience and your five years, six years at Starkey, um can you talk a little bit about what advice you might give professionals based on your experience? What what pearls of wisdom do you have other than those that you've already dropped here?

SPEAKER_00 39:29

Well you know when I've given talks um you know on this topic before I I don't want to you know sound repetitive but I can't I can't highlight how important this is for folks to be involved at their state level. Right. You know everybody has a member of Congress everybody has two United States senators. Those people have a lot of influence and I think Starkey has done a a good job at setting the groundwork. If you talk to your member of Congress, if you talk to your senator I bet they know who Starkey is. I bet they know a little bit about the hearing industry that they wouldn't have known five years ago. But we're just one manufacturer and I I know it may be for some uncomfortable and out of their comfort zone but really reach out and try to build a relationship with with your elected officials at the federal level and the state level. Having that seat at the table that you just mentioned is so important. And hearing from a manufacturer is one thing but hearing from professionals who see patients every day and know the trials and tribulations and the stories that these people are going through and how getting the proper hearing help impacts their lives that's so much more powerful. So you know reach out reach out to me reach out to to our team and we can help you put you know put you in contact with these with these people some of you know I reach out if we have something in a certain state and proactively say will you help us with this or help us with that but being involved that's that's how we influence uh the future of our industry and and the regulatory regime that we may or or may not seem it's so so important.

SPEAKER_01 41:03

That's great Michael and um you can be reached at Michael underscore shool s c O L L at Starkey.com That is correct. So you know advocacy starts at home in in your backyard and uh so people can if they if they're looking for ways and they're really not certain what to do uh I've just gave them your email so they can get to you. Okay so um we call this uh podcast sound bites so uh uh one thing I'd like to do is maybe hit you up on a couple things of what are some of your favorite sound bites and uh let's start with one in terms of uh you know I've always said that movies without music um really would be a very different experience and whether you're thinking of a movie soundtrack like something my personal favorite would be Purple Rain I don't think that's your favorite but um what what what's your favorite movie soundtrack?

SPEAKER_00 41:54

Yeah that's a good question. I'm gonna give you two answers. Okay. One um is going to be the easy answer anything that John Williams had a hand in right it to me is is unbelievable. I had a we had an opportunity he was he was touring uh some years ago where he would travel around the country and conduct the local orchestra and then do all of his movie scores right and it was an unbelievable experience. And now having you know young kids who are watching the the Harry Potters and the Star Wars and the Jurassic Parks right I get an opportunity to relive some of those. The other one you know Dave you know I'm kind of a you know a music person. I think it's hard to beat the soundtrack from Saturday Night Fever. I think uh the BGs are probably the most underrated band of all time even though they're top five in all-time albums sold uh and number three in number one hits um that soundtrack just has so many classic hits on it that it's well it sets the tone from the moment the movie opens and John Travolta's walking down the street and you just see his legs and walking to the beat of the original you know the the the the opener song and so I'd agree with you on both accounts. And it and it never it was it did not win an Oscar. The BGs won every award possible and that was the soundtrack that was up for an Oscar and I don't remember what did win but it did not it did not win an Oscar for that soundtrack.

SPEAKER_01 43:12

But good trivia. Okay. So now uh what about when you think about the power of the spoken voice to communicate and we talk about uh Helen Keller's words is vision bringing in the beauty of the outside world and hearing connecting people to each other. When you think about your favorite celebrity voice uh whether it's in commercials or whether it's in movies or whether it was a character that they played do you have a favorite celebrity voice out of all that that's that's I mean I think I think it would it's pretty hard to beat James Earl Jones.

SPEAKER_00 43:46

I mean his voice stands out um as as I think you know heads and shoulder above others. The other voice and I'm not going to get the name you may know Dave that that's more recent um is is you speaking of commercials and he was in the C Is the Home Depot commercial? The voice of the gentleman who does uh the Home, you would if you if you heard it, it would it would still be listening for it. He's in a couple of a couple of different uh commercials. But I think generally, I mean James Earl Jones is hard to be. I mean, you know, Darth Vader.

SPEAKER_01 44:16

I mean how can you beat him on that as well as all the other voice work that he's done. Okay, last one. Um what is the quietest place that you've ever been or that you can ever remember being the quietest place that you've ever been? Natural or otherwise.

SPEAKER_00 44:33

The quietest place. Certainly not my house. Nope. I neither. I I would say probably um probably hiking or or in in the in the Tetons, right? In in the, you know, in the mountains, naturally quiet. Not not a lot of or no people around, right? Um, you know, occasionally you may hear a a bird or a waterfall, but it's just, you know, it's it's extremely quiet.

SPEAKER_01 45:02

Excellent. I had an opportunity to interview uh Gordon Hempstead, a guy that does a lot of movie work with audio recordings, and he is in a search for finding the quietest centimeter on Earth, a centimeter being roughly the diameter of the microphones he's using. And he'll never reveal because he wants to keep them uh free of noise pollution. But um I I I I got kind of a wink when I suggested that the Boundary Waters canoe area in northern Minnesota is one of those quietest places that I've been there. That's my place. That would be yours, the boundary. Yeah, so we're not too dissimilar there. Yeah. Nature. Right. So all right. Well, uh to our listeners, uh, you know, I want to thank uh Michael uh on their behalf for uh what you've done for the industry, uh, for Starkey, uh and uh as a colleague, I I can really say that I've enjoyed working with you these last five years and uh and I look forward to the future as well. We've got a lot in front of us, uh, but with that uncertainty, I think, as I mentioned at the start, you are a calming influence, and with your connections and with your experience, just you know, keep me from being I I'm a I come from a long line of overreactors and I awhalize everything when I first hear about it. Um but I really appreciate what you do to bring that stable uh force and and a sense of direction as to the uncertain environment that we live in. So thanks for sharing that with us today.

SPEAKER_00 46:29

Well, thank you. Thanks for having me. And uh, as you mentioned, there's a lot happening. I'm I'm most certain that we'll have opportunities to do more of these down the road um as things uh continue to change, not only in Washington, but across our country. So thank you.

SPEAKER_01 46:41

I look forward to that. And uh to our listeners, thank you for listening to this episode of Starkey Soundbites. If you'd like to learn more about Listen Carefully, please visit listencarefully.org. If you've enjoyed this conversation, please rate and review Starkey Soundbites on your preferred podcast platform. You can also hit subscribe to be sure you don't miss a single episode. See you next time and thanks for listening.