Sponsored by Oticon Inc. We are so thrilled you could be here today to learn more about what is shaping the future of hearing health care and how you can stay competitive. Your moderators for today are me, Fran Vincent, Director of Membership and Marketing. And Esther Waldman, Membership Specialist. Our expert co-presenters today are Gary Rosenblum, President of Oticon Inc. and Vice Chairman for the Hearing Industries Association. And audiologist Douglas L. Beck, Executive Director of Academic Sciences for Oticon Inc. Gary has been President of Oticon Inc. since 2016 and is responsible for the floor direction of Oticon's leadership. He is passionate about developing and implementing market-changing growth strategies. Prior to Oticon, Gary ran several medical device and health care businesses for Fortune 500 companies, including Johnson & Johnson and Abbott Labs. Gary earned his MBA from Cornell University and his BA in Psychology from the Washington University in St. Louis. Doug Beck, AUD, earned his Master's Degree from the University of Buffalo and his Doctorate from the University of Florida. He began his career in Los Angeles at the Hollis Ear Institute in Cochlear Implant Research and Interoperative Cranial Nerve Monitoring. He joined Oticon in 2005 as the Director of Professional Relations, and in 2017, Doug became the Executive Director of Academic Sciences for Oticon. We're very excited to have Gary and Doug as our presenters today, but before we get started, just a few housekeeping items. Please note that we are recording today's presentation so that we may offer it on demand through the IHS website in the future. This webinar is available for one continuing education credit through the International Hearing Society. We've uploaded the CE quiz to the handout section of the webinar dashboard and you can download that at any time. You can also find the quiz and more info about receiving continuing education credit at our website, IHSinfo.org. Click on the webinar banner on the homepage or choose webinars from the navigation menu. You will find a CE quiz along with information on how to submit your quiz to IHS for credit. If you'd like a copy of the slideshow from today's presentation, you can also download it from the handout section of the webinar dashboard or you can access it from the webinar page on the IHS website. Feel free to download the slides now. Tomorrow, you will receive an email with a link to a survey on this webinar. It is free and your feedback will help us create valuable content for you moving forward. Today's presentation is sponsored by Oticon, Inc. and represents your view on industry trends and changes. The content of this webinar has been developed especially for you by Oticon, Inc. and may not necessarily reflect IHS policy and stand in hearing health care issues. Today, we will be covering the following topics, Medicare updates every hearing care professional must know, what the Hearing Industries Association predicts about over-the-counter hearing aids for 2020, top industry trends such as using telehealth to remotely expand your patient support capabilities, and at the end, we'll move on to Q&A sessions. You can send us a question for Gary and Doug at any time by entering your question in the question box on your webinar dashboard, usually located to the right or top of your webinar screen. We'll take as many questions as we can in the time we have available. Now I'm going to turn it over to Gary and Doug who will guide you through today's presentation. Gary? Thank you so much. Good afternoon, everybody. This is Gary Rosenblum, President for Oticon. It is a pleasure to be here. We did this last year. We had a great time. We thought we'd do it again. Fran asked us to put together another seminar for you all. The question was, what do we want to cover, especially when you think about the topic of trends and developments impacting the hearing health care industry? There's probably 35 different things that we could talk about. We could probably spend about eight hours doing that. Well, we thought we want to consolidate it into one hour. We thought there would be really a big focus on three main topics that I thought were probably the most relevant. One is Medicare, which there are three bills currently being reviewed in Congress right now that are related to the hearing health care world. Those bills will be discussed in today's conversation. In addition, Medicare itself, just as a topic when it comes to hearing health care, a lot of people question whether or not hearing aids are covered by Medicare. We're going to answer that question specifically. Second topic that I thought we would cover today is OTC. OTC is a topic that we talked about last year. That was our only topic last year. We're going to be talking about that today because there are several new developments that have happened, and we're much closer to OTC becoming a legal reality. We will be chatting about that. The last topic, which I thought was probably the most important topic for us, and not necessarily the most important but the newest, is the topic of telemedicine or teleaudiology or telepractice, depending on how we define it. It has become a reality. It is happening right now in the United States. I thought we would chat about that. Those three areas, Medicare, OTC, and telemedicine slash teleaudiology or telepractice, are really the three topics for today. The first area that we wanted to chat about, as I said, was Medicare. The first question that might come up in everyone's mind here, because we are dealing with very much the senior population, is how many people have Medicare, and that's for people over 65. It's about 60 million people, about 18% of the U.S. population are enrolled in Medicare. That enrollment is anticipated to be 79 million within the next 11 years. Right now, there are about 10,000 people per day turning 65, and they're eligible for Medicare. It is obviously something that is not slowing down. It is essentially the largest managed care organization in the United States. The big question about Medicare is, does Medicare cover hearing aids? We have this question come up all the time, and the usual answer when you speak to the FDA or speak to trade organizations, et cetera, is no. Hearing aids are not covered by Medicare. I want to be very, very clear that in today's conversation with you all, that hearing aids are covered by Medicare, and I'm going to explain exactly how. When you look at the Medicare program, which was created in 1965 by President Johnson, which was part of the Social Security Act, this was essentially an insurance coverage for senior citizens, senior Americans. The original Medicare, which was back then in 1965, is a fee-for-service health plan. What that means is every pay period that Americans go through, a certain percentage, about 2.3% of their paycheck is put away towards Medicare. Medicare has really broken up into, now it's broken up into four different parts, but it was originally launched, it was launched in two parts. Part A is hospital insurance, and part B is medical or doctor insurance. This is fee-for-service. When you go in and you get serviced or you get treated through original Medicare, you pay coinsurance, which is usually about 20% of an allowable amount. The fee-for-service Medicare, which covers about 63% of Medicare beneficiaries, does not cover hearing aids. However, the other part, which is now 37% of Medicare, is Medicare Advantage. Medicare Advantage, which is typically administered by private insurance companies, but is under all auspices and rules of Medicare, that's absolutely covering hearing health care today. The situation with Medicare Advantage is that it is the fastest-growing area. The government has realized that private insurance actually does a better job of administering health care than they do, hence why they have pushed Medicare Advantage so aggressively. When Medicare Advantage became a reality in 1997, only 1% of Americans adopted it now as Americans that is on Medicare adopted it now. As you can see, 37% of Medicare beneficiaries are using Medicare Advantage. Medicare Advantage, like I said, is an area that essentially allows the government to outsource the care of health care benefits. It's essentially Medicare in the private sector. The U.S. government is subcontracting to the private sector, so the government pays a per member per month to manage Medicare members. Medicare Advantage plans bundle these benefits, such as VIN, vision, gym memberships, dental, hearing health care, et cetera, into their plans so that there's no need for a supplement or a Medigap plan. Medigap is a topic for another day, but it's really for those people who are not engaged in Medicare Advantage. When you enroll in a Medicare Advantage policy, you get your benefits from the plan, not Medicare. So companies like Aetna, Cigna, Kaiser, et cetera, they're all offering Medicare Advantage solutions to their members, to their patients. Like I said before, Medicare Advantage covers 37 percent of Medicare beneficiaries. The majority of those beneficiaries who are in Medicare Advantage do have access to a hearing health care benefit. Again, I think it's going to be really clear to you all on the phone, and most of you probably know this already, but you hear a lot of press about hearing aids not being covered by Medicare. Hearing aids absolutely are, and they're covered through the Medicare Advantage plans. And like I said, that's 37 percent of all Medicare beneficiaries, and that is by far the fastest-growing area of Medicare. So what the administrators of Medicare are is the Center for Medicare Medicaid Services. They have realized how effective Medicare Advantage is, hence why they are pushing this, because it actually minimizes their costs as well. Approximately 22 million – yeah, this shows you the growth. So 22.6 million members in 2019. So of the – like I said on that first slide, about 60 million Americans in Medicare, close to 23 million members are in Medicare Advantage. And you can see just how quickly this membership is growing. It's growing at about 11.6 percent, and that brings the total Medicare enrollment to about 37 percent. So it's pretty significant, and this just shows you how much the Center for Medicare Medicaid Services has embraced this program. They are actively engaged with companies like Aetna, Cigna, et cetera, in order to get more people into these programs, because they realize they are essentially not administering these costs. They're paying one fee, and they're outsourcing the administration to these private insurance companies. So what's also interesting about this is the Medicare Advantage plan holders – that's, again, the Aetna, Cigna, Cignas of the world – they are all realizing how important hearing health care is in order for them to be competitive. So when you go through an open enrollment period or you're a senior citizen and you are looking at different plans, if you see hearing health care in there, you may be more inclined to engage in that specific plan. So it is becoming a competitive element to them, hence why you're seeing such growth here. So this slide shows, in the last three years, the number of Medicare Advantage plans with hearing care benefits. So back in 2015, less than half had hearing care benefits. In 2018, it was close to three quarters. So it's growing dramatically. Again, it's not only the competition factor. It's also the fact that patients are demanding it. They're realizing that it is an important part of their future health care. So therefore, they are looking at plans that offer this. So it's key. This shows you – this next slide is actually pretty important, too. This shows you all the different Medicare Advantage plans. Basically, it looks like it's about the top ten or so. UnitedHealthcare, by far, the largest, and Humana coming in second place there. Seventy-three percent of these Medicare Advantage groups have a hearing aid benefit. And hence, it's obviously a pay-to-play element now, where if you're going to get into the Medicare Advantage business, you're going to offer a hearing aid benefit. The other thing that they say, which I think a lot of you may agree is controversial – and trust me, when we talk about Medicare Advantage, which falls under managed care, and I know to a lot of us, managed care is a bad term, right? Because we look at managed care as an entity that is pulling profits out of our businesses. And trust me, even at Oticon, we kind of walk a thin line there because it is not necessarily helping us to drive overall revenue and profits every day of the week. It's something that we have to look at very, very carefully. But what the Medicare Advantage plans are saying – and again, these are owned by the managed care companies – they're saying that 74 percent of hearing aid users through managed care via Medicare Advantage are new users. So they're incremental. Now, that's not a very easy thing for hearing instrument specialists like yourselves. When you had a patient four years ago who was paying you full price, private pay price, now all of a sudden they have a hearing aid benefit and you're getting an $800 or $1,000 fitting fee. That stat of 74 percent new users doesn't necessarily make you feel that great when that patient you had four years ago was delivering a much higher revenue level for you. However, but if you look at the overall United States and you look at the overall statistics that the Medicare Advantage plans are saying, they're saying that by having a hearing aid benefit, it is driving people into our category. Hence, the 74 percent new users that are coming in. And I think a lot of you are probably smirking about that, but that is what they are telling us. Of course, they're, of course, very biased when they tell us that, but that at least was one stat that I asked for as part of this presentation was to really understand what percent of users that are coming into the category are being driven by Medicare Advantage slash managed care. Something else to just to be aware of is, you know, we, whenever we talk about, I'm sort of interchanging the terms of managed care and Medicare Advantage. There is, of course, a pure private element to managed care, people who are under 65 who have a managed care benefit. That's really not the main topic for today. We really do want to talk specifically about the Medicare Advantage element within managed care. Again, we're trying to keep this to an hour, but Medicare Advantage by far is the largest percentage of managed care transactions that are going on in the United States today. Hopefully that's clear. I know I'm throwing a lot of terms out there, but we kind of use this general term in this industry of managed care. Medicare Advantage, as I said, is the majority of those managed care units that are happening, especially for those over 65. This next slide shows the list of hearing health care third-party administrators. These are companies that you're probably already working with. These are the companies that contract with Medicare Advantage plans to offer a hearing aid benefit. So a Medicare Advantage plan may be a plan like Cigna or Humana or Blue Cross Shield. The hearing health care benefit companies essentially are the intermediaries between the Medicare Advantage plan and the patient. That's True Hearing, HCS, Epic, et cetera. You can see those are the hearing health care companies that are aligned with the specific Medicare Advantage organizations. Again, to be really clear so we're all totally understanding this, the managed care company is a company like Humana. They're the insurance company. The hearing health care benefit company is a company like True Hearing or HCS. They act as an intermediary between the Medicare Advantage plan and the patient by leveraging their network to find people like yourselves to send patients into your offices. That is becoming a very significant growth area in the hearing health care world, but again, not necessarily coming at no cost. Because this is growing, in fact, about 30% to 35% of all transactions right now in the United States are involving somewhat of a third-party administrator in each transaction. Hence, Medicare Advantage slash managed care is definitely here to stay and it is growing. Some retail data that we've seen recently puts the number at close to even 40% or 45%. It is definitely something that we have to be aware of when we look at our businesses overall. Medicare Advantage impact. As I said before, 22 million members, 73% with a hearing aid benefit. That means the number out there of people with a hearing care benefit is about 16 million people. What is really interesting about this number, though, is the 16 million Medicare Advantage members, only about 1% are actually accessing that hearing care benefit today. The range could be completely free hearing aid to about a $2,500 benefit. Like I said, it is only about 1% right now accessing care. It says that if you think about this, Medicare Advantage has 16 million people with a hearing care benefit. All of these people are over 65. There is clearly a huge opportunity to leverage the managed care or Medicare Advantage organizations to access more of these patients to drive them to your offices. At Oticon, we definitely look at this as an opportunity where, again, it is very important that we work with plans that are driving good reimbursement rates to our customers. And that is always going to be the MO of a company like Oticon where we don't want to just contract with any hearing benefit organization because they could be potentially pulling money out of your pocket. We want to make sure that what we're doing is working with these organizations so they're driving leads to your locations and you're paying minimal marketing costs to get them there. So that's the ideal relationship. There are always going to be challenges and issues with that but when we our approach to Medicare Advantage and managed care in general is let's make these let's make sure these patients that are coming in are filling in you know unwanted or unused slots and they're coming in they're driving a decent profit level for you. So the last thing I wanted it I wanted to discuss with you is three bills that are that are in Congress right now that are very important for us to be aware of and for us specifically at HIA to to look at because because they are potentially affecting the 67% of Medicare beneficiaries that we haven't been talking about and you've heard a lot of a lot of conversation on Capitol Hill about Medicare for all and these three bills kind of fall under that overall movement and it's an interesting concept and to be completely frank with you being vice chair of HIA we are monitoring this and investigating this and we haven't necessarily developed a full decision or picture yet because it's unclear how these bills are going to transpire and let me just talk about the bills for a little bit and then I'll tell you about some of the questions that we still have before we can we can identify an opinion or a strategy. Three bills are really they're all very similar but let me I'll take you through them a little bit here. The first is HR 1393 it's to amend the Social Security Act which I talked about before to allow for coverage of dental vision and hearing care. This bill and the second bill really are very very similar this is HR 1518 one of them requires one of them is just specific to hearing aids and the other is specific to hearing aids dental and vision and the the bills are essentially asking for the Social Security Act from 1965 to be expanded to include these other elements that is hearing dental and vision and basically and to be honest with you all of these bills are very very close. One the last bill the Seniors Have Eye, Ears, and Teeth Act is is requesting a study to be done to investigate what is the current status of the the coverage in the United States but in general all of these bills are asking for an expansion of the Social Security Act so that like I said before where Medicare was covering your sort of your traditional medical elements and challenges this would expand to hearing care and other and other areas but the real questions that I have and this really goes to this next slide is and again this is only for the 67% of fee-for-service Medicare that's not covered by Medicare Advantage and the implications for this is if there is a an element of Medicare coverage what will the reimbursement rate be that is probably the most important that's by far the most important question because that's the reimbursement rate that goes back ultimately to the practitioner and if the practitioner is purchasing hearing aids for a certain from a manufacturer whether they're fitting a certain amount from the patient the patient through fee-for-service Medicare just pays a co-insurance or a co-pay and that would go to you but also a certain amount of allowable would come back to you from the government and that allowable amount the reimbursement amount is the biggest question so in other words what is your profit going to look like if you're buying hearing aids from Oticon or GN or Starkey or whomever for you know X that I know I say it's $1,000 is the reimbursement going to be more than that so that you are making a certain amount of profit and how much more that's the biggest question second question is well it's still well obviously will still make you profitable will patients be able to top up this is a concept that exists in other categories and in other countries where there is a reimbursement set for a specific type of hearing aid technology and if so well patient who doesn't want that technology and you want to trade up to a better technology will be able to either pay more or an essentially top up these are again questions we need to figure out if fee-for-service Medicare is covering hearing it will be featured as a DME this is a durable medical equipment or a specialty product if it's durable medical equipment it essentially creates one category for a product a traditional DME product is a wheelchair or a cane it basically lumps all hearing aids together as one specific category it really doesn't allow for customization and specific and we all know in this category there's a lot of customization every year is essentially customized if and this leads to the next question if it is does become a durable medical equipment or is considered a DME in the DME category is it then subject to competitive bidding this is a whole other concept that occurs in DC where the Center for Medicaid Medicare Services offers a bid or a bid process for only a certain number of practitioners that are allowed to actually fit a certain product and they can limit this to you know to 20 30 40 different practitioners across the United States so it's a very strange element but again it's sort of a wild west right now we don't really know what they're what they're planning so we're we're interested in finding out as this as this moves along the other couple questions you know that we have is related back to OTC which is you know OTC is approved as of you know August of 2020 so will OTC products be approved or be fall under Medicare or be covered by Medicare again big questions that we need to figure out so like I said we still don't really know we don't know how these things are going to net out these bills are very vague once we have more clarity we will of course share with you what our plans are from an HIR perspective. Defining over-the-counter just for those of you who weren't on the call last year or are not or sort of new to this situation I'll give you really a high-level overview about what's happening what is what is over-the-counter over-the-counter is defined as off-the-shelf products no interaction with the healthcare professional the FDA regulates this as a defined approval process so how do you actually get go to market what happens if there's a recall what does the labeling look like what is the return policy these are all questions that are that are defined via the regulatory process right now if you think about what type of products out there out there like PSAPs and hearing assistant devices these are all not really regulated so by defining the OTC category the FDA would ultimately and hopefully regulate everything that helps patients here in the hearing assistance or PSAP or hearing aid categories the other over-the-counter element is specific to the hearing aid world is as soon as the patient can self-diagnose self-select and self-fit this is definitely something that the FDA will have the outlining in the regulatory guidelines that they will share with us later this year in draft form so what does it truly mean if you have an OTC hearing aid is it and how do you actually self-fit it is there an off instrument app that helps you do that which will also would have to be approved as a medical device a lot of questions that we have about what the draft guidelines you're going to say really quick and I'm not going to go through all the details here but this and I'll show this to you this is sort of the development of where we got to where we are the the concept of over-the-counter hearing aids as a law was brought up in two studies in 2015-2016 that's PCAST and NASM it then very much started a very quick development of an OTC law which first hit in 2017 it was introduced to the Senate in the House it then got officially passed by the House in July of 17 and then Trump signed into law in August of 17 the other really important development is in October of 18 those received approval for a self-fitting hearing aid or hearing instrument however they cannot market this yet they got approval for it through it's a novel process which I'll share with you in a minute but they cannot go to market with it yet because the OTC category has not been fully defined however it's likely that they can launch that the day that the bill becomes let's say that the law becomes a reality the other really important thing that was really important development that was just announced several weeks ago is the FDA has finally announced when they will be releasing the draft guidelines this again they're draft these are the guidelines for the OTC category in draft form the data that gets released starts the 180 day clock for the final guidelines to be approved so essentially six months of public commentary review suggestions by manufacturers my audiologist etc such that the FDA can look at everything and decide on what they want to do to define this category so when I say April 2020 that's a real stretch it's probably later than that probably you know I'm assuming if it's if November 1st is the day that they can they launch the guidelines then it's likely that by the end of April they could be they could be approved that's probably the earliest the more likely day is is May or June of 2020 this is something I shared last year but it's also something that I think we bring up again which is really important for us all to remember if everyone is if anyone is nervous about OTC I wanted to reiterate this on a few slides with you today because to me it's the most impactful way to look at what we have in front of us with respect to OTC when it comes to hearing aids and again this is this is one manufacturers opinion nobody wants them that is clearly defined by if you look at the top of this pyramid where 70% of profound users wear hearing aids that means that 30% do not that to me says somebody who cannot hear without the aid of a hearing instrument and if they're not doing it that says that there's a significant issue out there that people are not willing to buy hearing aids nobody essentially wants our products I think we have to accept that right so by launching an over-the-counter category is that going to change things in my in my opinion not very much reason why I tell you that is over-the-counter hearing aids exist today you can go to walmart.com and buy a pair of hearing aids not PSAPs but hearing aids for $800 and you can go to Costco to get you know fitted with hearing aids really good hearing aids by the way for about $1,600 and that's with a hearing care professional so the differential between an over-the-counter hearing aid which might be five or six hundred dollars versus a true hearing aid that is fit by a hearing care professional is not very much so in my opinion over-the-counter where there's no hearing care professional involved is not going to affect our business very much there'll be a lot of hype might affect pricing a little bit of the retail level but I don't think it's going to be a tremendous change from what exists today a couple of a couple reasons why OTC concerns may be overstated and I'll go through this quickly I shared this with you last year but I think they still apply and they're very relevant in Switzerland where OTC has been available for years we already have consumers prefer to go to specialty retailers these are specialty retailers that utilize hearing care professionals and OTC hearing is readily available we meaning Demont actually sell hearing aids in Japan via an OTC model what's fascinating about this is that penetration is at 15% meaning the percentage of people with hearing loss who are using hearing aids is only 15% where in the US is 30% so that and the the price differential is dramatic thousands of dollars cheaper in Japan yet because there is no hearing instrument specialist involved penetration level is super low and the satisfaction level is extremely low so satisfaction is at 40% in Japan where OTC hearing aids exist this is a very interesting and sort of the right word here unexpected result in that you would have assumed because hearing aids are cheaper that the penetration will be higher as clearly not the case in this example and the US example you have some of the highest penetrations in the world also the highest prices but also the highest satisfaction rates so that number is a little bit high but in the latest hearing the latest market track information the level satisfaction rate was about 83% so very very high considering how expensive hearing aids are in the United States so important to realize what you guys do is very very important and you're the reason why it's satisfaction is so you know the other example that we talked about a lot is OTC readers these are the glasses that perfect analogy but it does show how OTC readers that negligible impact on consumer demand for prescription lenses and eye care professionals so ophthalmologists are still in business optometrists opticians they all still have thriving businesses today in some ways you can argue that OTC readers may may be a conduit for people to enter the category same same way that OTC they do the same for us a couple of the things about OTC that's really important just to mention is you know last year we worked with meaning HIA we worked with a number of different organizations to to give the FDA recommendations for how they should create the category so and our overall MO behind this was safety and effectiveness the focus was on safety and efficacy so when it comes to what the the IHS and HIA and AAA and ADA teams put together was you know establishing specific product requirements what are the game limits what are SPL limits out-of-the-box in-the-box labeling establish a name category that actually distinguishes it between traditional hearing aids and then also provisions for you know consumer protections in coordination with you know with the FTC so strong return refund policies claims should be verified etc so just just the point there was it was a really great initiative that we all got together on last year we had you know consensus among the you know some very important obviously the most important organizations within the hearing care world pulled together a document together in a coordinated effort to deliver to the FDA what our recommendations are and we'll see when the guidelines come back in November if they if they listen to us because there's clearly a whole other side to this which is the Consumer Technology Association and depending on what their recommendations were we'll have to see how the FDA responds to them as well a comment about Bose and really quick like I said before you know Bose got approval in October of 18 for a self-fitting hearing it looks very much like their their hear phone product but just to tell you a little bit about Bose they use a process called the de novo process for so this is a process that the FDA leverages quite often for low real low-risk products and what this what this is is a way for a manufacturer to essentially establish a category they release a predicate device a brand new device that has never been approved before and the FDA then uses this predicate device as a way to help define the category and they submitted that in October they got approval for it which was the de novo process by the way is confidential which is why no one knew about it when it was when it was approved and this was a a development where Bose received approval however they cannot sell it as an OTC device until the category is finalized so you can imagine on day one when the guidelines are final approved Bose will start marketing that product one of the things that we've noticed at at HIA is that there's a lot of bad actors out there there are a lot of companies out there that are advertising OTC hearing aids which you know to us that seems like they're jumping the gun and we think we believe it's inappropriate so we made sure the FDA knew about that and the FDA then responded by sending a letter to every hearing aid manufacturer stating that OTC does not exist and until the regulations are finalized so don't advertise OTC challenge there is that they're not necessarily enforcing this they've sent the letter out but you probably see press releases all the time for over-the-counter hearing aids being advertised or new clinics being opened or new products being launched that are OTC hearing aids so we're monitoring that very carefully and we react very strongly to that we let the FDA know every time this occurs the other interesting development just to share with you is that there's also a really interesting loophole that we discovered at HIA which is we challenged the FDA on direct-to-consumer over-the-counter hearing aid manufacturers and to be frank we sort of pushed the FDA a little bit into a corner where they somehow were able to say that OTC is illegal but DTC is legal and DTC direct-to- consumer is not an official FDA term so they were ultimately saying it's okay that to advertise via DTC but it's not advertised it's not okay to advertise OTC and you know we kind of looked at them sideways when they said this and they just had a little bit of egg on their face when we kind of called this out the reality is everything's going to be resolved with the guidelines anyway so their you know their underlying message to us was just sit tight all the stuff will be resolved once the final guidelines are approved I just wanted to share I'm going to depart a little bit away from my VP started my my vice chair role at HIA and talk a little bit about the month which is of course the parent company of Oticon tell you our position about OTC hearing aids so for the most part what I've been saying so far has been you've been hearing from Gary Rosenblum vice chair of HIA now to tell you a little bit about about the month we and I'm going to go through this just in a couple minutes here but first of all we you know we look at the OTC category as a category that has no really no specific interest for us right away there's we have no intention right now to manufacture market sell or license OTC hearing aids because again OTC hearing aids exist today they haven't really done much to the market we don't think that they will once they once they're launched. The one positive thing about OTC, and again, we were supportive of the OTC law, and we've been supportive since the beginning, we just haven't necessarily embraced it as a business opportunity, is that there's a high level of action among patients right now that are essentially getting traditional hearing aids in a traditional way. So there's really no reason necessarily to start offering hearing aids through a different channel. And the last thing that's also really important for us to realize is that evidence shows that patients are unwilling to pay a high out-of-pocket amount for OTC hearing aids, so essentially less than $300. So when you look at that, it doesn't look like there isn't necessarily a large business opportunity, especially from a manufacturer's perspective to go after this marketplace. Okay, so that's just our general position about OTC. The last topic, and I wanna make sure we cover this because I wanna leave about 10 minutes, 10 or eight minutes left for questions, is telepractice or telemedicine. Is telemedicine or teleaudiology, telepractice, whoever you wanna talk about it, is something that is definitely happening today. It is not vaporware, it is not something that is being developed for the future, it's already happening. First of all, how is telemedicine or teleaudiology defined? It's really two areas, remote patient monitoring, which is exactly the area in which we plan to play, or are playing today, as well as mobile health, where you have off-instrument applications that allow you to improve your overall perspective about your health, as well as allows you to interact with your healthcare professional without necessarily being there in the office. My former life before Oticon was at J&J, at Johnson & Johnson, significant amount of effort around mobile health, and specifically in diabetes care, where you're able to actually share your glucose readings with your doctor almost on a daily basis, so that they can help you monitor your diabetes more effectively, manage your diabetes more effectively. The area that I'm gonna really talk about today, though, with respect to telemedicine, is remote patient monitoring. Within that, for DeMott, two areas that we are looking at is live video, so it's a face-to-face, where the patient sits in an office, and the audiologists are hearing it from a specialist that's sitting in a remote location via a video feed, kind of like a Skype conversation. And through the technology that exists today, that patient can go through an audiogram, through a number of different types of tests in a remote way, where the hearing care professional can interact with them and have them walk out of the office with a sold hearing aid, without the hearing care professional actually being there. In addition, there's a concept called store-and-forward, where in a specific office, a certain amount of tests are done. That data is then sent to a hearing treatment specialist, who can then diagnose the issue and fit a hearing aid at a different time. These are two different areas that we're looking at that we are actually practicing today. The big challenge to our industry and your opportunity is, you know, there's workforce issues out there where you may have multiple offices, and some of those offices are dark, because you just can't hire the talent. Can you actually hire just a front office staff who can put a patient in front of the screen and speak to a hearing treatment specialist that's on the location? In addition, there's an experience around automated providers, so this is inconvenient to the consumer. So you just have your best people who are on your staff, who are working with your patients to deliver a much better patient experience. It's also difficult to schedule everything, because the number of offices you have, if you have teleaudiology or telemedicine, you can actually improve your overall scheduling process. And then in addition, I'm gonna share some stats about this, there's just an overall lack of graduates entering the profession, whether it's audiologists or it's hearings from specialists, the numbers are dwindling. And in order to hire people, and I'm sure you've all had this challenge, it's not that easy anymore, and not that it ever was, but it's getting harder and harder to tell audiologists to potentially solve some of those issues. What DeMott does, and this isn't really my area, my area is hearing aids, but my sister company, InterAcoustics and GSI, both offer solutions that essentially provide equipment to allow you to execute teleaudiology at your office. It solves challenges related to location, staffing, and it reduces patient visits overall. I'm gonna share a little bit about that in a bit. Why, and just an interesting quote from Barry Freeman, who you all probably have heard of, he's now in his e-power, a short film on the number of audiologists he's predicted to occur in the next future. If we do not address this impending crisis, any gaps in the care will be filled by alternatives outside of the profession. Print prophetic, interesting quote from Barry, and something we should all just kind of take in because of the challenges that are initial. And the next slide really shows you that the true challenge that we have, the shortage of hearing care providers in the future. Given the demographics of baby boomers getting older and in more need of hearing health care, the patient, if you look at the graph on the right, is patient demand versus patient supply. So the demand is a lot more, the growth is a lot faster on the patient demand side versus the number of physicians or hearing care professionals that are involved here. And again, this is just a very high level look. This is not specific to the hearing health care industry, but it shows you overall when it comes to medical professionals, how there's just a significant gap out there. But if you look at the stats on the left, number of audiologists in the US has decreased by 2016 to 12,000 from 16,000. HIS also has gone from 9,000 to 7380. And Fran, I'd be interested to hear if those stats jive with your data. So, but more HCPs are retiring and leaving than are entering. Hence, there's a leaky bucket when it comes to professionals. From a patient journey perspective with respect to tele-audiology, there's really three different paths here. First is, you know, obviously face-to-face, that's what we all work with today. Remotely-assisted is really where we're looking at with tele-audiology where there's a remote test and diagnosis, remote counseling, rehab and self-adjustment is also remote, and then of course, service and support. There's also the unassisted path where there's a self-test diagnosis, online purchase, self-fitting, rehab, self-adjustment, and then a web call center service and support. This is something that exists out there today. This is not something that DeMont supports, but we're seeing this as a model that exists out there. So this is just an example of a live face-to-face tele-audiology solution. It's essentially a kiosk that inter-acoustic cells with as a clinical audiometer, counseling screens, a video otoscope, circuit moral, headphones, insert phones, bone conductor, room noise monitor, all of the things that you need to essentially fit a patient. And of course, it's a very nice, compact way in which the patient can interact with a hearing care professional who exists in a remote location. Just one example, I thought I'd share with you inter-acoustics again at DeMont company. It has a remote slash telemedicine pilot going on in Portugal, okay? So there's a person-to-person between remote audiologists and clinics in the virtual waiting room software setup. This is implemented in four clinics with three field dispensers. The national rollout will exist when the inter-acoustic delivers, measures background noise and allows remote audiologists to be heard in the sound booth and consultation rooms. So this is just one example of a pilot that's happening. There's actually a fully active solution happening in Florida within the YHN network that uses inter-acoustics technology and Oticon hearing aids, where these are two audiologists, sorry, excuse me, one audiologist, one hearing issue specialist are sitting in Florida and they're treating other patients in Florida via the inter-acoustics telemedicine solution. The other thing I should mention is Oticon is launching a product this year called Oticon Remote Care. This is very much a product to assist you post-fit. So it allows for fine tuning to occur after the patient has been fit in your office. One thing to be really clear about is that we are never going to be in the game of launching our own tele-audiology solution, meaning where it essentially circumvents the great service that you offer. We will only be offering solutions that augment the services that you offer. So Oticon Remote Care basically allows you to have a Skype type of call with you and your patient that is live, real time, where you're seeing each other face-to-face and allows you to make fine tuning adjustments to their hearing aids after the initial fit. We have proof tested this at the VA and it's worked very well. Hence, we're rolling this out later on this year. We did a survey of patients that use telemedicine and of course you can imagine there was a lot of concern there, but you can see some of the verbatims that we got from the questions, more comfortable, enjoyable than a booth. Originally it was leery, but okay with this. Very interesting, painless, very good. Was upset that the doctor wasn't there, but lightened up at the end. So again, this is something for patients to get over, but it's clearly been something that has worked quite well via the solutions that we've provided to the market. We also look at ways that we can sell this and something that we offer to our customers all the time is sort of this list is what is your concern. You have patients who are waiting one to two weeks to have an initial evaluation. You can address that through a telehearing care solution. So we have this checklist that we use so such that we can really convey to hearing instrument specialists, office owners, et cetera, how they can use telehearing care or teleaudiology. And that's really it. And again, like I said before in the beginning, these are only three trends and these are only three things that are impacting you. I know there's a lot more and there's a lot of things that intertwine like OTC and managed care and Medicare, as well as teleaudiology. Is teleaudiology going to be covered by Medicare because it is essentially a service? So you can imagine there's a lot of stuff going on. I wanted to kind of hone in on the three things that are probably top of mind for you, hence why we structured the presentation that way. What I'll do now is I will definitely open up the lines to questions so that Doug and I can answer any that may come up based on the conversation so far. Thank you, Gary. And we are going on to our Q&A part of the webinar now. So go ahead and submit your questions. And I really want to thank Gary and Doug for presenting today. And Doug Beck is here to help answer questions as well. And everyone, we're so excited that almost 300 of your fellow colleagues have joined us today on the webinar. We do have a few minutes for questions. So if you have a question, go ahead and enter it in the question box on your webinar dashboard. Our first question, Gary, is from Kim. And she wants to know, does Medicare Advantage plans have hearing aid coverage or access to hearing aid discounts? She says this distinction is extremely important. Yes, they do. It very much depends on the plan. So one of the things, I may have buzzed through this in the presentation. Depending on the plan, and each plan has maybe five or six different elements to it depending on what the premium is at the ultimate that the patient is paying. It might be an absolutely free hearing aid. It might be a discounted plan. It completely depends. So the answer to that question is yes, they do have discounts. But it very much depends on what area of the country you're in, what insurance company you're working with, and the specific plan that you sign up for. This is Doug. And the majority of them do offer services at different reimbursement rates. But yes, so as Gary said, it just depends on the plan. Lots of different options on those menus. Thank you, guys. We have a question from Phillip. He wants to know, he says, when dispensers work on a commission basis, managed care fitting fee is much less than the private pay scale. Is there any plan to adjust commission on fitting fee? I think that is a great question. That is something that we constantly fight with when we negotiate with managed care organizations. Because if you, and I appreciate the question because the service that, Phillip, you are providing is the same depending on private pay or managed care. So we absolutely fight for that. It is unlikely that they will match it. But it's something that we're pushing for a higher level of fitting fee for managed care fitting. Okay, thank you, Gary. Okay, I have a question here from Jonathan. And he wants to know, how can you check EARS via telehealth? Oh, this is Doug. You know, everything depends on everything, not to be out of line here. But what Gary was talking about earlier was that the first visit would be in person and the person, the patient, the customer would come into the office. He would examine them as you normally do. But the follow-ups could be done electronically. Now, the thing about that, of course, we've had video scopes now for over 20 years. So, you know, you can, if you're just looking for wax or irritation of an ear canal or an eardrum, you can certainly have technical help hold a otoscope up and see a video representation of that. But again, the primary analysis of somebody's ear health would be done live and in person. Doug, just to counter that a little bit, there actually is, in the solution that we have through Hearing Life, our, you know, sort of our retail partner that we work with, they actually have, in some cases, audiological assistants who are helping with that first fit in a remote type of situation. So they are using an otoscope and holding an otoscope to that patient's ear and allowing the audiologist on the, or the hearing instrument specialist on the other line to actually see inside the ear. Because the interacoustic solution that we presented is absolutely a first fit solution. Thank you both. So Michelle wants to know, ideally, where would the telehealth kiosk be located in the PCP office? Who would be providing the otoscoposcopy, placing the inserts, et cetera? And you touched on that a little bit. Can you expand a little bit more on that? Yep, so it is in the PCP's office, or in the, in any, and we've seen it in multiple different places in the offices. The specifics around that, I think it's probably best for us to, for you to speak to an expert on the telehealth side to share that with you. So it'll probably take me too long to talk about it right now, because it's very specific information. So let me get, Fran, if you can provide the information of this person who's asking that question, and I can hook them up with the person at interacoustics who can walk them through all those details. I sure can, no problem. So we have time for one more question, and this is from Timothy. He's asking, is it your understanding that the FDA today not take any negative actions for the OTC violations, which are occurring regularly on TV with aids available from Walmart, and that they, the FDA, may send cease and desist letters, but that doesn't seem to have any impact on the commercials and promotion of these hearing aids? Yeah, so let me take a couple of minutes to answer that question in the right way. The FDA, the only thing that the FDA has done is that they've sent a letter to every U.S. hearing aid manufacturer or provider saying don't advertise OTC. When companies are advertising OTC, the FDA has done nothing about it. There's no cease and desist letters that have been sent. There's no specific messages that have been sent. It is simply this very generic letter that they sent out to everybody saying don't do it. My interpretation of this, and this is only my interpretation, is that the FDA is doing nothing right now because they're waiting for the guidelines to be finished. Once they are finalized, then the FDA is essentially compelled, because they're creating a law and they're creating regulation, to act. Because we're still in a gray area where there's no law yet that's official, because there's no regulatory guidelines written, they are fighting bigger battles, and hence why we have not seen the enforcement. Because I'll be just completely honest with you, a company like Interscope that advertises every week when they talk about OTC hearing aids, in our opinion, that's not appropriate. It's not legal to do that. The claims that they're making in the press releases are inappropriate. Again, when we see that, we immediately respond. We have our FDA attorneys send a letter to the FDA. We've just been met with deaf ears. It's not necessarily the FDA's fault in some ways, in that they're just not taking that battle yet. Again, like when the category is officially a reality, I think they'll be much more compelled to react. Excellent, thank you so much, Gary. And thank you, Gary and Doug, for an excellent presentation. And I wanna thank everyone for joining us today on the IHS webinar, Trends and Development, Impacting the Hearing Healthcare Industry, sponsored by Oticon, Inc. We didn't get to all the questions, but if you have additional questions, you can get in contact with Gary and Doug. You can email Gary at gary.oticon.com, and you can email Doug at doug.beck.oticon.com. And since we went through some of the slides quick, we have the slides available for you, so you can download them at any time on our website, and really look at those at your own pace, and we will have a recording available within the next week or so. So definitely you'll have the opportunity to review the content further. So for more information about receiving Continuing Education Credit for this webinar through IHS, you can visit the IHS website at ihsinfo.org. Click on the webinar banner to find more information on the webinar tab on the navigation menu. IHS members receive a substantial discount on CE credit, so if you're not already an IHS member, you will find more information at ihsinfo.org. And please do keep an eye out for that feedback survey you'll receive tomorrow via email. We ask that you just take a moment to answer a few brief questions about the quality of today's presentation. And I wanna thank you again on behalf of everyone. Thank you so much for being with us today, and we will see you at the next webinar. And we will see you at the next IHS webinar.

Medicare updates

Medicare Advantage plans

hearing care benefits

Medicare beneficiaries

OTC hearing aids

consumer demand

teleaudiology

workforce shortages

patient access to care

hearing healthcare industry