The Hearing Matters Podcast discusses hearing technology (more commonly known as hearing aids), best practices, and a growing national epidemic - Hearing Loss. The show is hosted by father and son - Blaise Delfino, M.S., HIS, and Dr. Gregory Delfino, CCC-A. Blaise Delfino and Dr. Gregory Delfino treat patients with hearing loss at Audiology Services, located in Bethlehem and Nazareth, PA.
In this episode, Blaise discusses over-the-counter hearing aids and Medicare benefits for hearing instruments with Michael Scholl, chief compliance officer and vice president of corporate relations at Starkey.
The Beginning
Talk of OTC hearing aids started back in 2016-2017 when President Trump signed the FDA Reauthorization Act. The FDA was to create an OTC category by August of 2020. In October,2021 the FDA finally released the draft of OTC hearing aid regulations that is available for public comment over the next 90 days. The public comment period concludes on January 18, of 2022. The FDA will take all of those public comments into account, and then promulgate a final rule. By summer of 2022, we will see a final OTC regulation, and it will go into effect 60 days after they finalize that rule.
More Harm than Good?
There are a few safety concerns about the OTC aids. The auditory industry, consumer groups and audiologists are asking for the aids to have a maximum output of 110 dB and a maximum gain of 25 dB. In the proposed regulation, the max output could get to 120 dB. The difference between 110 and 120 is significant and could cause damage to someone’s hearing. Also, consumers need to clearly understand who and where there is enforcement over the hearing aids. Only those over 18 should be able to purchase these hearing aids.
Medicare Coverage
As Congress looks to pass the Build Back Better law, there are two things the hearing healthcare industry has to focus on. The first is to get Congress to get the bill in the best possible shape before it goes to a vote. Once it is passed, it goes to the Centers for Medicare and Medicaid will write part of the language of the law. There are a few items that are really important. First, a hearing aid is a prosthetic, not durable medical equipment. A hearing aid is not a cane, it's not a walker, it's not a one-time product. it's a medical device that is continually fine-tuned. Number two is that the hearing aids are exempt from competitive bidding. And third is that an audiologist and a hearing instrument specialist can provide the help to Medicare recipient.
Listen Carefully
This fall, Starkey launched Listen Carefully. People can find out what's happening with Medicare coverage and OTC hearing instruments in Washington. The public comment period is happening now. People can write comments, and there are draft comments people can use and add their own thoughts. Starkey works very hard to educate legislators at the state and federal level. Michael encourages all audiology practices to get involved at the local level as well. Hearing healthcare is a non-partisan issue. Everyone every
The Hearing Matters Podcast discusses hearing technology (more commonly known as hearing aids), best practices, and a growing national epidemic - Hearing Loss. The show is hosted by father and son - Blaise Delfino, M.S., HIS, and Dr. Gregory Delfino, CCC-A. Blaise Delfino and Dr. Gregory Delfino treat patients with hearing loss at Audiology Services, located in Bethlehem and Nazareth, PA.
In this episode, Blaise discusses over-the-counter hearing aids and Medicare benefits for hearing instruments with Michael Scholl, chief compliance officer and vice president of corporate relations at Starkey.
The Beginning
Talk of OTC hearing aids started back in 2016-2017 when President Trump signed the FDA Reauthorization Act. The FDA was to create an OTC category by August of 2020. In October,2021 the FDA finally released the draft of OTC hearing aid regulations that is available for public comment over the next 90 days. The public comment period concludes on January 18, of 2022. The FDA will take all of those public comments into account, and then promulgate a final rule. By summer of 2022, we will see a final OTC regulation, and it will go into effect 60 days after they finalize that rule.
More Harm than Good?
There are a few safety concerns about the OTC aids. The auditory industry, consumer groups and audiologists are asking for the aids to have a maximum output of 110 dB and a maximum gain of 25 dB. In the proposed regulation, the max output could get to 120 dB. The difference between 110 and 120 is significant and could cause damage to someone’s hearing. Also, consumers need to clearly understand who and where there is enforcement over the hearing aids. Only those over 18 should be able to purchase these hearing aids.
Medicare Coverage
As Congress looks to pass the Build Back Better law, there are two things the hearing healthcare industry has to focus on. The first is to get Congress to get the bill in the best possible shape before it goes to a vote. Once it is passed, it goes to the Centers for Medicare and Medicaid will write part of the language of the law. There are a few items that are really important. First, a hearing aid is a prosthetic, not durable medical equipment. A hearing aid is not a cane, it's not a walker, it's not a one-time product. it's a medical device that is continually fine-tuned. Number two is that the hearing aids are exempt from competitive bidding. And third is that an audiologist and a hearing instrument specialist can provide the help to Medicare recipient.
Listen Carefully
This fall, Starkey launched Listen Carefully. People can find out what's happening with Medicare coverage and OTC hearing instruments in Washington. The public comment period is happening now. People can write comments, and there are draft comments people can use and add their own thoughts. Starkey works very hard to educate legislators at the state and federal level. Michael encourages all audiology practices to get involved at the local level as well. Hearing healthcare is a non-partisan issue. Everyone every
You're tuned into the Hearing Matters Podcast with Dr. Gregory Delfino, M. Blaise Delfino of Audiology Services and Fader Plugs, the show that discusses hearing technology and best practices and a growing national epidemic, hearing loss. On this episode, we would like to welcome Michael Shoal from Starkey hearing. Michael is the Chief Compliance Officer and Executive VP of Corporate Relations. Michael, welcome to the Hearing Matters Podcast. It's great to be here. Thanks for having me today, Blaise We are just so grateful to have you on the show. Michael, it seems that two topics related to hearing are getting a lot of attention in Washington. One is Medicare coverage. And the other is OTC hearing aids. Can you please provide an updated timeline of both?
Michael Scholl:
Yeah, no, that's certainly two timely topics, you know, one would not have expected six months ago that hearing would be one of the topics of conversation in Washington, but clearly with the FDA now acting on OTC and Congress considering Medicare coverage as part of the BBB or the reconciliation package. Both are, you know, timely topics of conversation. So, why don't we maybe start with OTC first that's one that you know, more people are probably familiar with.
Blaise Delfino:
Absolutely.
Michael Scholl:
You know, obviously this started back in 2016-2017 when President Trump signed into law, the FDA Reauthorization Act, which included OTC hearing aids, and the deadline that was given in 2017 was for the FDA to create an OTC category by August of 2020. The FDA missed that deadline. But in July of this year, we heard President Biden come out with an executive order. And one of the elements of the executive order was FDA, you need to finalize an OTC regulation within the next 180 days. So in October, the FDA finally released the draft over the counter hearing aid regulation that now is available for public comment over the next over 90 days. So that public comment period concludes on January 18, of 2022, following the public comment period, the FDA will take all of those public comments into account, and then they will promulgate a final rule, they have 180 days to promulgate that final rule. So one should expect summer of 2022, we will see a final over the counter regulation, and then it will go into effect 60 days after they finalize that rule. So you know, again, late summer, early fall. Now granted, the FDA has 180 days to finalize the rule. They could move faster than that, right? They can maybe take 90 days or maybe take 120 days but if they take the time given and if history proves itself they have taken all of the time and then some we're probably looking at you know summer late summer 2022 for a final rule to be released. So you know, everybody in the industry understands what what this new over the counter hearing aid is
Blaise Delfino:
Michael the acronym OTC especially with regard to the overall hearing healthcare industry. This has been a quote threat to the hearing healthcare industry for many years now. And it seems as though after speaking with Brandon about the OTC regulation and the executive order, a lot of what was shared coming from Washington was somewhat inaccurate with regard to hearing aids and our main concern is hearing healthcare providers is does the proposed rule follow the industry consensus paper and ensure that OTC products will not cause more damage to individuals with hearing loss? Please tell me more.
Michael Scholl:
Great, great question to your earlier point right OTC, DTC Products have been available for years, right? This is not a new phenomenon in the industry. What we're really focused on with the OTC piece is, you know, everybody is for more access. Everybody understands the importance of affordability. We can't have access and affordability if we have to sacrifice safety and satisfaction. So to your point, the regulation that that has has been released by the FDA, there are a few concerns around the safety piece. You mentioned the consensus paper, you know, you're certainly familiar that the consensus paper which was supported by you know, all the audiology groups, industry, consumer groups, called for a maximum output, for example, 110 decibel, and a maximum gain of 25 dB. Well, in the in the proposed regulation, the max output could get to 120 dB. And you know, the difference between 110 and 120 is more than it sounds right. I mean, that's yes, it is significant, that is significant, and no Max gain. So that's concerning, right. 120 dB, as we have told, you know, regulators and folks in Washington and the general public that's that's the equivalent of chain soft, right? I was at a football game You know, a few weeks ago was indoors. At one point, the stadium got up to 119 dB and others around me are covering their ears. And I'm thinking to myself, this could be the equivalent of an over the counter hearing aid, that somebody is purchasing without the professional involvement, this truly could cause more damage. So first priority is to ensure that we get those those if we can work with the FDA to get those output and gain limits. But then, but then consumer satisfaction, warranties repairs with some of the preemption language, the way this is written, you know, some would view it as pre empting. All state laws governing hearing aids, not only OTC hearing aids, but they classify prescription hearing aids or hearing aids, traditional hearing aids for people who may not have mild to moderate. And we need to ensure that at the state level, the state, you know, authority still have the ability to enforce whether its returns or warranties or you know, marketing and what have you. So, you've seen probably there have been 17-18 state attorneys general in the last year who have come out against companies selling OTC or DTC or FDA cleared hearing aids before the category even exist. So in our mind, and Starkey's you know, from our perspective, there are three things safety and satisfaction, we got to make sure we get the output in the game, right. Number two is making sure the preemption language is very clear. So everybody understands, you know, where, and who has enforcement over hearing aids and people bad actors trying to manipulate the market? And then the third point is consumer protection, right? Making sure you know, they're designed for people who are 18 and older. Well, how do we ensure that only people 18 and older are getting them and elements like that? So, you know, we're certainly supportive of OTC and this idea of more access, we just now as an industry have to work with the FDA to make a few tweaks that largely follow the consensus paper that you mentioned earlier,
Blaise Delfino:
Michael, to echo everything that you just said there as a hearing healthcare professional and growing up in hearing health care. My biggest concern is exactly what you just said, how do you know an individual who is 18 years and older will only have access? How do you know that a parent won't just buy this for their child who's 10? Because they're having difficulty understanding speech in the classroom? Michael, how would the Medicare covered program be implemented? Because there's a lot of quote unquote, stuff going on with Medicare now, and a lot of our patients are asking about Medicare coverage when it comes to hearing technology.
Michael Scholl:
Sure. So if over the counter and creating this new, you know, quote, unquote, new channel wasn't enough, Congress decided, hey, let's talk about Medicare coverage of hearing aids as well. So too, you know, pretty major items to discuss in Washington related to this. So when we talk about Medicare coverage might just give a little bit of background on where we are. Yeah, I think that would help a bit. Just if I know you, I understand you have patients coming in. But you know, first and foremost, it hasn't happened yet. Right? And and look, as we sit here today, it may or may not happen. And why do I say that? The Medicare coverage for hearing aids is part of the build back better plan that you hear folks in Washington talk about? I refer to it as reconciliation. But what does that mean? Each budget cycle, you can pass one reconciliation bill and reconciliation can be done with a simple majority. Democrats have a majority in the United States House, they have a 5050 split in the Senate. However, you've got the vice president casting the tie breaking vote, and then obviously the presence of Democrat. So they have the ability because of their majorities to pass a reconciliation bill. The reason that you're hearing all of this focus on Senator Manchin of West Virginia, Senator cinema of Arizona, is because the Democrats cannot afford to lose any votes, right? All 50 Democrat senators have to support this. So that's why I say we don't have it yet. Because it's not clear as to whether they will have all 50 senators at the end of the day, let's say they do. And reconciliation does come to fruition with the Medicare provision in it. As of now, the language as written, this Medicare coverage would begin in January of 2023. So the Center for Medicare and Medicaid Services CMS is the organization that would have to create the new program similar to the FDA is creating the OTC program, CMS would have a year to create what this Medicare program looks like. So when we say Congress is creating the program, we have to remember Congress creates the this Medicare coverage high level conceptual, this is what we want it to look like. It's CMS, who really puts the ink to paper. And they define the specifics of the program. So it's two battles that we have here right are to negotiations. Number one is with Congress to get it in the best shape that we can. And then number two, if it does pass and it goes to CMS, we have opportunities with them to encourage them to do X or to do Y to make sure it's best not only for the patient, but the the hearing professionals all over the country. So, you know, this is something you know, it's clear to us that that you know this is something that Senator Sanders of Vermont is a priority of his he has, you know, support from his colleagues. So it's thing that if they pass reconciliation, it's likely going to happen. So, you know, our view several months ago, the industry's view was okay, if it's going to happen, how do we make it the best that we can, right? And there were a few items that are really important number one, that a hearing aid is a prosthetic, not durable medical equipment, right? A hearing aid is not a cane, it's not a walker, it's not a one time product. A hearing aid is something that you buy, it's a medical device, you continually fine tune it, etc. So it's so it's a prosthetic. So the language as written does define hearing aids as a prosthetic. So that's important. Number two is that the hearing aids are exempt from competitive bidding. This is the most unclear section of the bill. It sounds that it is right. Because Because it says certain products are exempt certain individuals are exempt. So this is what we're working with Congress on right now, to really clear up that competitive bidding, our preferences, hearing aid should be exempt from competitive bidding. And then the third piece is not only can audiologist provide the help to Medicare recipients, but the hearing instrument specialists can as well and the bill is written that language is in there. Very wonderful. So that's a huge, huge step forward. So those are three big pieces, you know, the category would apply to Medicare recipients who have moderately severe to profound hearing loss. It's interesting, we were talking about OTC, FDA did not define mild to moderate hearing loss, which is a you know, which is a question in the Medicare provision who will define moderately severe to profound right, so that so that is an open question. But like I said, if this is going to happen, we have three major issues. Two of them, we're very confident are in there. The third piece, that competitive bidding, there's some language in there. But you know, it can be interpreted multiple different ways. So like I said, we're working with members of Congress, members of the Senate to really clean up that language. But at the end of the day Blaise, let's remember, the bill hasn't passed it very well, May. It's something that we'll have to stay tuned over the next 30 days, we'll probably know whether they're going to pass the reconciliation bill and whether this will be included or not.
Blaise Delfino:
Michael, I have a huge smile on my face right now. Because I am so excited for what is to come with regard to the hearing healthcare industry, because we have thought leaders like yourself, that are so in tune with what is going on on the playing field. Of course, that is what you're passionate about. As Chief Compliance Officer, you need to know this information. And if you recall, when COVID-19 first entered the US and our offices were shutting down, you took the time to speak to me personally on the phone, because my biggest question is, Michael, we have been shut down for how many months now? What can we do to continue to raise awareness of hearing healthcare and continue to build the relationships we need to build with elected officials. And I just want to thank you for all that you're doing and Starkey's doing for the industry because you support the hearing health care provider.
Michael Scholl:
Well, I appreciate that. And certainly during COVID, that was an important time because nobody knew what to do. Right? That was we've never faced anything what's going on? Yeah, right. And it's great to work for a company for an organization like Starkey that first and foremost values, the, you know, the the end user, the patient and the customers. And we made it perfectly clear, that hearing is essential. That was our contribution during COVID. And because of that a lot of folks were still able to get the hearing help that they needed. I think Pennsylvania actually may have been the only state that specifically called out hearing health care as as an occupation that could not continue to remain open during during the pandemic. But what I'm immensely proud of as of late is, look, OTC Medicare, a lot is happening. We have always, you know, had folks in Washington and state capitals to monitor what's happening. We have a new advocacy site, listencarefully.org, right. We made the decision that there's a lot happening, how do we best educate providers and patients and professionals in this industry. So this fall, we launched listencarefully.org and I encourage everybody to take a look, because you can go there to find out what's happening with Medicare, you can go there to find out what's happening with OTC I mentioned earlier that the public comment period is happening. You can go to listen carefully.org And you can navigate through that website on how to submit public comments and there's some draft comments you can add some of your own comments. So you know, I'm proud of our work to ensure that the the professionals in this industry have a voice it's it's a complex process and I think Starkey we do a good job keeping our ear to the ground and bringing all of the necessary information back so you can help us and we can help you make sure the hearing industry has a voice in Washington and state capitals across the country.
Blaise Delfino:
Michael you just brought up Listen Carefully which for our fellow hearing healthcare professionals tuned in right now. Please visit this site. It is essential that you as a hearing health care professional visit listencarefully.org. Share it with fellow hearing healthcare professionals because this is a way that you can reach and touch your elected officials to raise awareness of hearing health care. When we had a discussion with Brandon and I asked him, you know, what sort of sparked this fire with getting the correct information out. And it was, again, as I said earlier on this podcast that the guidelines with regard to the executive order that was released in summer of 2021, the majority of the bullet points were inaccurate, and we want to ensure not only at audiology services and hearing matters podcast but Starkey and your fellow manufacturers want to ensure that the correct information is getting out there. What is the vision of listen carefully.org? How can we as hearing healthcare providers continue to use this platform and share it with our patients and fellow hearing healthcare professionals?
Michael Scholl:
Well, first and foremost, listen carefully Dotto are will continue to exist beyond OTC and beyond Medicare, right? We expect it to be a tool that will continue to monitor what's happening in Washington as we roll into 2022. That's when you generally see state legislatures and state governments starting to enter their legislative session. There were some issues in Florida last year that Starkey took the lead on, we were able to stop some organizations trying to expedite OTC and direct to consumer in the state of Florida, right? We may see other issues like that pop up at the state level and when that happens, listen carefully to or will be equipped to handle not only the federal issues, but the state issues as well. But to your point five years ago, I came to Starkey internally five years ago and and the number one priority was to educate individuals about our industry, elected officials, other public policy leaders. And I think you know, as a company as an industry, we've done a much better job doing that we've had probably 100 members of Congress, United States senators come through our headquarters over the last couple of years. And it's unique experience, right? They have their ears cleaned out, they do a hearing test, they can see we're hearing aids are made. That's something that they remember, we want them in Washington, when they're hearing about audiology, when they're hearing about hearing healthcare when they hear the term hearing aids etc. We want them to think about Starkey. We want them to think about, hey, I had experience working with folks in the industry that's important for us. So we have to continue to do that. But you need to do it in your local communities as well. You know, we've worked with some with, you know, some hearing healthcare professionals who have hosted members of Congress or state elected officials, at their clinics or in their offices, I encourage you to do that. Listen carefully can be the tool to help you get in the right direction. But reach out to me reach out to us. We can work with you to arrange that because it's one thing for them to come to Minnesota to see Starkey but it's something else for them to witness their own constituents in their own community and the important work that hearing healthcare professionals are doing so listen carefully will continue to be the the aggregator that repository for anything policy dealing with hearing health care, but I encourage you know, all of you listening that, you know, reach out how can we how can we partner with you? How can we get your local elected officials to learn more about what you're doing in your local community?
Blaise Delfino:
Michael, after you and I had the conversation of how we can raise awareness of hearing healthcare in our community because Starkey says that hearing healthcare is community based. We recently had Senator Civello at Audiology Services, and we recorded a 30 minute legislative report talking about the importance of visiting a hearing healthcare provider. And it doesn't matter, Republican or Democrat, we believe in policy. We don't infuse politics into our practice by any means. At the end of the day, we are people that need to be aware of the importance of hearing health care. So for individuals and other hearing healthcare professionals that may be worried that well, what if I invite a Republican senator or a Democratic senator, what will that do to my business? Can you sort of expand on that?
Michael Scholl:
Well, the exciting thing is the issues that we're talking about are not partisan issues, right? Everyone, Republican, Democrat, Independent, every buddy wants people to be able to hear better and get the hearing help that they need. I can tell you, we have people from all political parties. We have people from, you know, different parts of their political parties come through here and to a tee, it doesn't matter because they all want to know how they can help their local constituents, people in their states get the hearing help that they need. So, you know, it's never it's never a political question. For us. It's an education question. And and what you just talked about elected officials, they're looking at ways that they can help educate their constituents. So the 30 Minute, recording the legislative recording that you did, that's something that he can go back and share with his constituency. That's what they want. They need content like that, that they can share and show how they're helping, you know, their legislative district or their state. So I certainly wouldn't worry about Being partisan one way or the other at the end of the day, and you'll look at hearing aid legislation that's been introduced in the past and will be introduced in the future. It's always bipartisan. Look it over the counter, for example. Right. You had, you know, you had Elizabeth Warren, and you had Chuck Grassley. Right. You had Republicans and Democrats mourning that. So I certainly wouldn't get caught up in that. At the end of the day, everyone wants to help people hear better, and they're learning more about the comorbidities of hearing loss, right. That's something where we've really focused is, you know, you've got members of Congress, you have elected officials who who may not understand and everybody's learning, you know, the the comorbidities related to hearing loss, right, the the maybe the isolation or the dementia, the depression, all of these comorbidities and the importance of getting the hearing help. So we can stave off some of these long term health issues. So there's a focus of overall health care, there's a focus of helping people hear better, and it's not a partisan issue. So that's what's so great about being in my role, right? We can talk with anybody, everybody wants to support, you know, what we're trying to do and what the industry is trying to do.
Blaise Delfino:
Michael, before we wrap things up here on the Hearing Matters Podcast, I just personally want to thank you so much for donating your time this morning to again, raise awareness of the importance of visiting a hearing healthcare professional, and creating these professional relationships with your community, but more so elected officials. Michael, I've personally been around hearing healthcare essentially my whole life, when I got into my early 20s, if you will, and started actually interfacing with patients. I feel as though that as hearing healthcare professionals, we've almost always had to be on the defense. Truly. So will there be a day and and this could be in any industry, right? Do you believe there will be a day where hearing healthcare professionals won't have to be so much on the defense words? It's it's more offense? I welcome your thoughts on that.
Michael Scholl:
Yeah, no, I think that's a good question. I think that day is coming. I think you're seeing a lot of changes. I see. I think you're seeing a lot of focus on this industry. And, you know, it's incumbent upon us, it's an incumbent on you as a hearing professional to continue to educate, but I think people are listening, I think people are learning. They're understanding the great work that all of us are doing in this industry that professionals are doing, and the importance of the work, right, I think for sue for far too long. You know, whether they're elected officials, whether they're policymakers, whether they're media personalities, they didn't understand the importance of the work that we are doing. So as they understand that it will become easier for you as a professional or for us, as an industry to continue to get our message out there and continue to help help patients. So I do think that time is coming. You know, when you've got the President of the United States who starts out a speech talking the first line about hearing, you know, you know, times have changed, right, so I think we're moving in that direction. And I think in the end, we'll open up access for more people and we'll get people who need the hearing help the help that they need. So I think I think that time absolutely is coming.
Blaise Delfino:
You're tuned in to the Hearing Matters Podcast with Dr. Gregory Delfino, and Blaise Delfino of Audiology Services and Fader Plugs. Today, we had the opportunity to speak with Michael Scholl, the Chief Compliance Officer and Executive VP of Corporate Relations at Starkey Hearing. Until next time, hear life's story.