In this special edition of This Week in Hearing, Dr. Tom Tedeschi breaks down the FDA’s draft proposal for Over The Counter (OTC) hearing aids. The presentation and subsequent panel discussion was part of the Academy of Doctors of Audiology, AuDacity 2021 conference in Portland, Oregon.
We would like to thank Dr. Tedeschi and ADA for allowing us to publish this special edition for our audience. Slides for this presentation are available here.
Bob Traynor 0:10 Welcome to This Week in Hearing where listeners find the latest information in hearing care, hi I’m Bob Traynor. I’m your host for this special episode of This Week in Hearing, because we have some very important issues that need to be at least addressed and inform our listeners about relative to the new regulations in over the counter hearing instrumentation. Today, my special guest is Dr. Tom Tedeschi. Dr. Tedeschi is the Chief Audiology Officer for Amplifon. Thanks so much for being with us. Today, Tom. And now and I know that that that you and I have known each other for longer than we want to admit to anybody in the group. But most of, many of our colleagues out there don’t know who Tom Tedeschi is. And could you tell us just a little bit about yourself? And maybe how you ended up as the Chief Audiology Officer at Amplifon. And then your role in the development of the regulations because I, you sent me some stuff a few, a couple years ago, even and, and I know you’ve been involved with these since their inception. So here we go. Tom Tedeschi 1:30 Well, thanks, Bob. And thanks for having me this this afternoon. So a little bit about myself. I’ve been an audiologist for about 45 years. And, you know, when I first finished graduate school, I started at a children’s hospital, and was the head of Audiology for a large Children’s Hospital. And while there, I wanted to expand my roots a little bit. So started a small private practice on the side, seeing adults, and that’s when we were just starting to do hearing aids as audiologists. And so that blossomed, and over the next seven years, I went from, from the hospital to the private setting fully, and also started then teaching and doing some political studies. And Bob, you and I did some studies back in those days together. And so after about 22 years, I was approached by a startup company called Sonic Innovations at the time, and where I left the clinical world and joined the industry side and became the director of train, worldwide training. And so then learned how to globe hop for the next 10 years and built that company up and then was approached by Amplifon about 12 years ago to start out to head up one of their divisions at the time called Sonus. And I did that and we sold that division off and later I then transitioned into the becoming the vice president of training and development for Amplifon in the US, and from there, hearing aids, and the whole hearing industry started to get involved in politics. I was kind of volunteered into that world and my role has changed in I became the chief audiology officer and started working on the political side and watching for the Amplifon in the US all of our clinical work as far as audiology is concerned, etc, but also, probably about 75% of my work now is in the regulatory space, looking at all of the government regulations that are coming out and how we can shape that and work with that to in, you know, further the field of audiology. So, that’s pretty much my, my journey over the last 45 years. Bob Traynor 4:08 And, you know, it’s interesting that everybody, everybody has – all of us that have been around a while have our own little kind of, kind of road that we took and, and went maybe to the left or to the right or to the, to the middle and, and backed up a little bit and then kind of went forward some more and all those kinds of things and and now we did the Academy of Doctors of Audiology meeting at the same time. And during that meeting, you had a fabulous presentation on the over the counter hearing products, a little bit about where the regulation is, what we need to do, what kinds of things are in it to some degree and and I know here in a minute or so we’re going to to be moving to your actual presentation, I would also like to tell by my colleagues in the audience that Dr. Tedeschi was the recipient of the Presidential Award from the Academy of Doctors of Audiology, and for a lot of his work that he’s been doing with the academy, but also on the regulations. So without further embarrassment of my old friend, Tom, let’s move in to his presentation from the Academy of Doctors of Audiology on over the counter hearing regulations. Tom Tedeschi 5:46 The next point we’d like to talk about is an overview of the OTC regulation. This came out, let me see if this came out. A week ago today. Matter of fact, at 7:45am. On Eastern time, my phone became a Christmas tree. And, and so the the regulation came out. And this is just a high level overview of what it is we’re still looking at it ADA’s board is looking at it. We have attorneys looking at it, we have all the other associations are looking at it. So we’re trying to digest it’s like any other federal regulations 114 pages long, how many have read it? Okay, there’s a few hands. Where’s Kim? Kim, I know you’re here somewhere, I know, your hands better be up in the air. And so there’s Alicia. And so yeah, it’s, it’s, I had now have gone through it a number of times, I have yellow, red and green, my, my copy looks like a Christmas tree, and trying to figure out cuz every time you read it, you take a little different slant on it. And so, so we’re all trying to figure it out first, before we start to make a lot of comments on it. But first of all, the FDA is proposing to establish a new regulatory a whole new regulatory framework, what and I’m going to applaud the FDA in a lot of this, because a great deal of this is really shaping our industry in a different way. As we go forward. And it’s cleaning up a lot of things have taken place because if you remember the last time the industry had a federal guideline was in the early 70s. And so, this has been a long time coming. So there’s established a new regulatory framework, we now will have two categories of hearing aids, we will have ‘prescription hearing aids’ and we will have ‘over the counter hearing aids’. So two new categories of hearing aids and all hearing aids will fall within those two categories. The device types are not changing. So that means you know hearing aids today are either Class I, Class II, Class III devices. And so that’s not changing. And and also at the same time the PSAP regulations came out because it because they kind of float hand in hand. So the OTC and prescription the difference between these two. And so the FDA is proposing that on the OTC hearing aid, these devices are to be for individuals with perceived mild to moderate hearing loss. That’s the definition of the category these hearing aids are to work for. They are subject to technical requirements and we’ll talk a little bit about the requirements that have been given. Then they, then under OTC we have two categories. Now I’m Italian, so my hands start to work. And so, we have OTC and we have self fitting OTC. So we have two brackets under the OTC category, ‘self fitting OTC’ will require a 510k. A 510k is a submission that you have to submit to the FDA to review your specifications of your product to see if there’s a clinical studies that have been done to show that this product meets the requirements of the FDA. Traditional that other OTC side that non-self fitting will not require a 510k as we understand it. And so the difference between self fitting and the OTC is self fitting are devices that the individual can shape meaning they can change either through an app or whatever the tone may mean bass, treble, if they can adjust the volume, if they can move programs around there different parameters in it. That’s self-fitting. And Kevin Franck gave a nice in his talk yesterday, Dr. Franck talked about the work that Bose did. And Bose was the one who established this self fitting category. And so today, there’s one hearing aid that sits in the self fitting category. And that’s the Bose self fitting hearing aid, the OTC category will be devices that do not have that shaping capability. And so, so we’re looking at that does that mean you can still have a multi memory, maybe – we’re not positive on that. But it will be something that’s not subject to shaping for the patient. So that’s, that is the self fitting, and OTC… also, under that category – anyone can sell that type of, it’s over the counter. And so, so it doesn’t have to be a licensed individual. Now, if we go to prescription hearing aids, which are the most the hearing aids that we fit today, this is a change. Today, hearing aids are classified as restrictive devices under the FDA. And now it’s going to go into a prescriptive device. What that means is, which is great for us, as in, I need to state the state this too “in my opinion,” this is great for us, because it now allows that you have to have a prescription, an oral or written prescription to dispense a hearing aid and that prescription can be given by a physician, an audiologist or a licensed hearing instrument specialist. So, but it is a prescriptive device now. And so these, these can’t be sold just by anybody. And so this and this I in my opinion, right now, as I look at it, it may help clear up some of our DTC ads and stuff that you’re seeing on the on the television and things like this. And so that’s the prescription side, you’ll still have the same classifications, class one, class two and class three as we have today. And, and so that, but it now makes it two categories. And then we have the PSAP guidance, and the only thing I’m gonna talk about the PSAP guidance is that PSAPs are intended for the use of people with normal hearing. And what the FDA has said is that they will police – so they will really start to watch – the advertising of PSAPs to make sure that they don’t start, that they’re not advertising, that they are for hearing impairment or help you hear better for hearing loss. And so now the question will be is how well will the FDA really police it and we’ll see in the future, but now it’s in statute. And so, or eventually will be in statute. So that’s the, that’s the categories that we now will be dealing with is prescriptive hearing aids and over the counter hearing aids. In 2017, is when the, the over the counter, the FDA over the counter hearing aid Act was signed into law by President Trump. And at that time, it was given three years, and there was four pillars that OTC devices were to have. The four pillars were affordability, accessibility, safety, and effectiveness. Those are the four pillars, that these devices were to look to work to be kept in mind. And so we looked at that, and we brought together the four major Hearing Associations. So we had representatives from the academy, Academy of Doctors of Audiology, the Academy, the American Academy of Audiology, the American Speech, Language and Hearing Association and the International Hearing Society. I was privileged to be part of that group. The first meeting, I will tell you, was an interesting meeting. I didn’t know if everybody was going to walk out after breakfast, or, or what, and, but, you know, the, to make a long story short, it took us a year to write the consensus paper, but we all came together and it was a good working relationship that we had. We had a lot of discussions we had a lot of disagreements. And and finally coming to a consensus agreement. This consensus report was then once the the the the committee had put our recommendations together. It was taken them to the boards of all four organization where it was vetted them And, and it had to be approved by the boards of all four organizations before we released it to the public. And so in August of 2018, we released the regulatory recommendations for OTC and we just looked at safety and effectiveness. Now, how many have read the consensus paper? Okay, so go to the Academy website and read the consensus paper, if you want to have input on OTC. So I really do. And if you don’t want to read 40 pages that it is there’s also a condensed version of one and a half pages. So, at least know that part. And so what did we come up with what we came up with five key points. And the number one, the first recommendation was that the FDA was to establish product requirements for over the counter hearing aid devices targeting mild to moderate hearing loss. That’s the category we looked at, because that’s what was specified in the statute. And so we we came up that to effectively and safely amplify a person with a mild to moderate hearing loss. And we used our definition of moderate as up to 55 dB, that 25 dB of gain was what we recommended, and an output of 110 dB SPL as measured in a 2cc coupler. And that was the definition that we utilized for recommendation number one, recommendation number two, was to define concise outside of the box labeling, appropriate for medical devices sold over the counter, we wanted to make sure that people who bought these products were aware of what they were. And so we had a lot of amusing conversations about this, because we said, well, you know, over the counter hearing aids, it could be in a little box like this, but how are we going to put all of this out of the, you know, outside the box labeling on it. So I think you’ll see a little bit larger print, and a little bit larger boxes. The third recommendation was what needs to be inside the box. As far as labeling. And so you know, if you buy any over the counter prescriptive. Or I should say over the counter medications or whatever, you see that when you open the box up, you get this pull out that’s like 20 pages long and in point six print type. And so we wanted to make sure though, that in inside the box, that there were instructions, we want to make sure that this was also not used on children, because it’s recommended for individuals 18 and older. And we also want to make sure that a user manual was included. The fourth recommendation was that we recommended that the FDA establish a new category as self fit over the counter hearing devices we wanted to, we wanted the FDA to say that there needs to be a distinction between traditional hearing aids and these over the counter hearing aid so they don’t get mixed up. And then the fifth recommendation was that the FDA, in coordination with the Federal Trade Commission, established strong consumer protection laws, advertising, and those types that come under the jurisdiction of the Federal Trade Commission. And unless it’s a direct violation of something that’s in the regulation, by the Food and Drug Administration, so we want to make sure that the Federal Trade Commission was working in concert with the Food and Drug Administration, because that becomes very important. And so those were our those were the five recommendations of the consensus group. Now you can read in the consensus paper, all of the scientific and information that went behind this because we wanted to make sure that as we made a proposal, as we talked about gain, we talked about output, we talked about these five other categories. We wanted to make it that this wasn’t just our opinion, but this was based on acoustic science, on you know, information from the World Health Organization, information from the National Institutes of Health, etc. So we wanted to have this with information behind it to support what we were thinking. We also put in there minimum requirements, technical requirements for the product. So we talked about the frequency response. We also wanted, we talked about how smooth it should be the input noise, etc. So we had number of categories because remember, the four pillars was two of those were effective and safe. So we want to make sure that also, you know, we know that it takes seven years for an individual to get into, you know, amplification. So if somebody starts to dabble into an over the counter product, we, we hope that they will have a good experience that will lead them to then seek professional help, eventually. And so we want to make sure that these products are good. So these people, patients will have a good experience, because what would happen if a patient had a bad experience with an over the counter product? Well, then they would say, you know, they could possibly delay, delay getting help, or they could, or it could spur them on. So there’s, there’s a debate there. But we want to make sure that least these products were good, safe and effective. So what did the OTC proposal do the draft regulation? So this slide shows you a side by side comparison of the federal the FDA proposal, versus the consensus paper recommendation, and about 80% of the consensus paper recommendations were included in the FDA proposal, the draft regulation proposal, so we applaud the FDA for doing this. The one thing that we that was not included was the gain in output. And so for maximum output, we recommended for the consensus paper was 110 dB SPL. The FDA has proposed a output of 115 dB SPL or 120 dB SPL, if you include an input compressor and a volume control. And so that was number one, that’s one area where we didn’t they did not agree with the consensus paper, the second area was the gain, we wanted to keep this to the mild to moderate hearing loss. So we included a 25 dB gain recommendation, and the FDA in their draft proposal. draft regulation has said that there’s no limitation on gain. So they could have whatever amount of gain they would like to include into that device. Now, the rest of everything else is pretty much lined up, labeling was lined up 510k, pretty much lined up. So everything else. So that’s the two things. Now the one thing I need to point out, and I’ll see it that’s in is that the FDA, and I’ll share the timeframe in a few moments. This is we’re now in what is known as the ‘comment period’. So if you agree, and you don’t have, you know, one thing I would strongly recommend is that everybody comment, whether you agree with it, you don’t agree with if you agree with that, tell the FDA Thank you, you’ve done a great job, and we applaud it and why you applaud it. If you disagree with any of it, say ‘we disagree with this’ or you agree, whatever, but make comment because this is your time to get involved in the regulatory process. If you sit back and let the government take care of this, well, then they will. But this is our time to shape and I’ve talked to a number of FDA, people who have worked at the FDA and have been legal experts with the FDA. And the FDA does look at the comments, they will publish all comments. So it becomes part of a public record. But they will change if they feel that it’s appropriate to change based on the comment period. So don’t think that you know your comments are not really needed or wanted, they are very much. So the draft regulation utilized mainly the ANSI Consumer Technology Association 2051 standard proposed for hearing aids and PSAPs. The association consensus paper was not referenced, but in saying that most of our recommendations were included in the findings. And but there was not a standard definition set for mild or moderate hearing loss at one of the things we noted. And you know, one of the one of the and I’m trying to give both sides of the scale. And so you know, one of the things that in the regulation says for perceived mild to moderate hearing loss. And so but we thought that there should be a definition of mild to moderate. And one thing you need to recognize also that this regulation when it does take effect will preempt all state laws. So if you have a state law that is in contradiction to the FDA ruling, it will be preempted, but There is still, if you look at this a lot of regulation activity that will take place at the state level. And so, again, you know, I’ve heard it said many times on this podium, but not this podium, but the podium at the ADA meetings, that, you know, we need to be involved in our state associations also, because there’ll be a great deal of things taking place at the state level. So. So what’s our timeline? let’s look at the timeline for this regulation. So October 20, is when the regulation the proposed regulation came out, we have the public comment period, which is now 90 days, it will conclude on January the 18th, 2022. Now, what’s interesting, the FDA generally with most regulations, proposed regulations has a 60 day comment period. So they expanded it on this one to 90 days, as you know, it took four years in the making to make this regulation. Generally, you know, they were, they were by statute, supposed to only take three years, the pandemic hit in there. So part of that, part of that delay was due to the pandemic. And part of it was due to there was a number of preemption issues that they were looking at. And so that, so that made the delay, I think one of the things that helps speed this come out, was President Biden’s executive order that came out in July saying that he wanted to have the regulation out by November the sixth. And so they beat that deadline. So, but they’ve increased the time period for comment. So you have 90 days till January, the 18th 2022. After that, the FDA goes into a situation where they will start to look at the regulation. And they will start to decide they have 100- they can take up to 180 days, which we anticipate that they will probably do. Before the final rule comes out, the final rule will come out in September of 2022. And we expect devices to start being noted on the marketplace in September of 2020 to those that may require a 510k will come out generally three to five months later. So more in the self fitting category. So that’s kind of the timeline. What the FDA is now is doing, they’re in what is known as a listening period. So that means that they are just listening, they will not make any comment. You know, you if people want to make an appointment with the FDA to talk to them, they’ll listen. But that’s about it. We, the OMB, the Office of Management Budget looked at this before. And we did make comment to the OMB. I did. And in that session, it was listening so they could ask questions of us and but we couldn’t give only answers to the questions that they provided. So this listening period, though, for the FDA is a little different. They won’t ask questions, they just sit there and say thank you, goodbye. And, and that’s it. So that’s where we are. We’re going to we’re trying to get the consensus group back together, over the next hour before the 90 day comment period, just we’re trying to make sure that we again, try to speak united as a profession, because that means a great deal to the Food and Drug Administration that we can speak together. So we’ll, we’ll start to bring the consensus group back together, we’re giving all of the academies, I can since since I live and breathe this, I wanted to have the groups together within three days. And they all said Thank you, Tom, we appreciate your, your willingness to do this in three days, but let us have some time to look at it. And so I said, Okay, how about five days? And so, so But no, but we’re looking at it now. And then when we bring the group together. And so with that, I’d like to now have we’re gonna have a small panel discussion. Oh, one last thing. There is a website, where to go there it is. There is a website you can go to if you would like. It keeps disappearing. It’s called Did I hit something wrong up here? Okay, oh, just oh, just flashing on my monitor. And so okay. It’s called hearabouthearing.org. This is a website that you can go to it uses voter voice. It has a direct link to the FDA comment site. You can put in your comments, if you whatever comment you would like to give to the FDA, but it’s a it’s a non, non-partisan. I guess that’s the word I want to use or whatever is just devoted to over the counter hearing aid regulation. And so, if you want to use that, you please feel free Do that hearabouthearing.org. And you can make that comment. And submit that directly to the FDA during the comment period. So you don’t have to look up the, you know, the website and everything to go through. So that’s just one, one avenue that is provided for you. Now, with that, we’re gonna have a panel discussion panel. So I’d like to invite up Dr. Alicia Spoor from the advocacy group from ADA. And Dr. Dawn Heiman, your President-Elect, and Stephanie Czuhajewski. And I know Stephanie’s around here somewhere if you’d come up and we’ll turn that time over to the panel. And they’ll they’ll have some comments. And then if we have time, we will see if we can take any questions. If not, we’ll be available for questions later. Thank you Alicia Spoor 31:06 Good morning. We all know I’m not a morning person. So I’m glad you get to see my face. First thing. My name is Alicia Spoor honored to be your advocacy chair for ADA. I just want to say that, as Dr. Tedeschi mentioned, we’ve been working on this for a very long time. And actually, if you’ve been at the OTC discussion that we had back in 2017. At AuDacity, when we had our panel, we spoke very much about how this could be a great opportunity for especially private practices, who could sell devices to patients that maybe weren’t coming into the office, to those patients who just wanted that little bit of boost but didn’t want to spend three or five or $8,000 on devices. And how this could really move audiology forward, much like optometry move forward when they had reading glasses. So I personally was super excited to read all 114 pages. And yes, I have read the 40 page consensus paper multiple times as well. But I hope that Dr. Tedeschi has shown that there are some extremely bright lights coming out and that we can all benefit from that. So I’m going to turn it over to Dr. Heiman actually to talk a little bit maybe about some practice implementations and how we can look at this and get ready and move forward. Since we might have about six months before we start seeing anything come to market. And then I’m happy I was always to answer questions at any point in time. So thank you. Dawn Heiman 32:51 Do you mind if I just said, Good morning, I see this as an advantage for us all. I think it’s wonderful that this statement, position paper came out before we’ve all met because then we can all discuss together through the next few days, I see this as an opportunity for us to continue doing great care. And to swerve if we need to continue to do your diagnostic testing. Give people a way to navigate the waters in a way that they feel like they can definitely keep trusting the individual and let them know this might not work for you. Or let them know it’s okay, if you tried something that didn’t work because we got you. In our practice, we’re embracing the idea of We are the clinician who is taking you through a long process that is more about the therapy and the counseling and the encouragement and being there with you as your ears change. And whatever products you bring us, it’s okay. And we could do Real Ear measurement and find that it’s not working for them. And we can help them into a better product. I do want to say the one thing that bothers me about what the FDA came up with was that they forgot about the idea of locking devices. It was not included. And I in my comments that I’m going to send is is to say, hey, if we want easy, we want accessible, and we want it to be economical. You can’t allow for the devices to be locked. So that’s my position. And if you all have ideas, please suggest them. Also discuss with your colleagues over the next couple of days of how we can embrace this. Because as time changes, if we say well, I’m not going to change, we’re going to end up like Blockbuster and Nokia, which we don’t want. Thank you Stephanie Czuhajewski 35:02 Those are excellent points. Dr. Hyman. Thank you from a staff perspective. As Dr. Tedeschi mentioned, I’m looking forward to working with my colleagues at AAA and ASHA and IHS to sort of analyze the proposed rule that the FDA has put forward in the context of the consensus paper that we did in 2018. To see where everything aligns, and where there are deviations. One of the areas that I think was not addressed in that original consensus paper that the FDA seemingly has done very, very well, is to address some of the concerns that ADA has had about devices being restricted, versus a clear delineation between OTC and prescription, and how in some cases that really impacts what goes on at the state level. So they’ve come out in this proposed rule to say, if it is not an OTC device, it is a prescription device. And for those a licensed professional would need to be involved. And we applaud that, because for anyone who, who read the issue brief that we released last spring, you’ll see that a lot of the challenges that that people have with some of those state laws is that they’re so nebulous, and in probably in many cases not currently enforceable. So it’ll be very nice just to have a clear understanding of what’s what. And with that, the FDA has said in the proposed rule to that they’re going to repeal all of those state exemptions to preemption that they had made prior except I think, for one from California, which is more broadly related to products and not just specifically to to hearing aids. So I thought that that was fantastic. So if anyone has not read that, I encourage you to look at the at the proposed rule. Tom Tedeschi 37:02 So we still, excuse me, so we still have a few moments left. And so we will take a few questions from the audience. I always am hesitant to do that. But ‘oh, you better be when I’m up here’. I hear Amit there. I see. Okay. I mean, go ahead. I can hear you. audience 37:23 You can hear me. All right. You talked about the Telehealth is, can you talk a little bit about the interstate licensure compact and how that might affect telehealth? Tom Tedeschi 37:33 Sure, I look at Stephanie, Stephanie is my best friend. And so I think there’s probably not a day that goes by that we don’t talk to each other over the last several years, at least once or twice a day. And so, so the interstate compact, the interstate compact, as I’m going to get my understanding, and then I can get corrected from the panel. I think it’s 15 states now we are 16, 15? So we have 15 states. And that’s what we needed to get the interstate compact. And so under this Interstate Compact is that that applies to licensure and registration for professionals to work within those states. As it relates to telehealth, it will depend upon as I understand that it will depend upon always, I become a politician. And I for working on Capitol Hill so much so I always either state, in my opinion, or as I understand it, and so as I understand it, you will still have to follow the state licensure laws within those states that you’re going to practice telehealth. But for licensure, you will have the ability to practice in those states are registered in those states. According to their state licensure, the Compact is a great thing. But there’s still some laws that you have to follow within that state. Panel, any other comments with it? Stephanie Czuhajewski 38:56 That’s exactly right. So the commission is actually in the process of being formed. And will meet for the first time in January of 2022, to start putting together rules around that compact. And so the way that it’s been legislated, is that it’s a privilege to practice. So for those states who participate in audiologists who participate in that you wouldn’t actually be licensed in all of those states, you would have the privilege to practice in the states that are participating as you you can select which states you’d want that privilege in. And as Dr. Tedeschi, you mentioned that you would be bound by their scope of practice in the state that you’re practicing. Alicia Spoor 39:40 I would add one thing and I say Dr. Schmidt Bauer and Dr. Cavitt are up so I don’t want to harp on it. You would also be licensed – your actual physical licensure would be in your resident state, not the state in which you practice. So I’m in Maryland, I know Dr. Lumley is probably around here she’s lives in In West Virginia, and practices in Maryland, Maryland and West Virginia have both signed on to the compact. And therefore, when this is formed, Dr. Lumley will be licensed in West Virginia, and have the privilege to practice in Maryland under this compact. So it’s a little bit different, but it will be based off of your home residential state. Tom Tedeschi 40:24 Thank you. And if somebody if anyone’s interested I can you send me a, I can send you the map, I have a colored coded map that I put together. And so Dr. Cavitt, Kim Cavitt 40:36 isn’t there a question about though? How is this going to be funded? Like, how is the compact going to be funded? And I actually heard this, recently, I chair a licensure board around, it came to the board’s question from this group wanting to talk about money, and we’re not in the compact, and probably never will be, but to talk about to talk about the money, where how is this going to get funded? Exactly. Stephanie Czuhajewski 41:04 At this point for this startup funding, I think there are some discussions among the professional organizations around that. There is the intention that this will be self sustaining after about three years. So we don’t know at this point, nor do we have like a final budget on that. But eventually it would be a pay for, as part of for those who want to practice. So Kim Cavitt 41:30 what would licensees I mean, do they have any idea what that would look like in terms of cost? Stephanie Czuhajewski 41:35 No, it’s too early, we’ve really, they’ve really got to get formed. But they did come to our Kim Cavitt 41:39 board in the in the last week or so asking about money, even though we’re not in the car. We’re not in the compact. Yeah. Dr. Schmidt, audience 41:50 I’m gonna want to go back to the regulate the OTC regulation, the 120 output and no gain specification. Do you expect that to change? After the comment period, to be revised more toward what the association’s recommended? Tom Tedeschi 42:15 I’ll go first. I don’t know the I mean, the the? The answer is, I don’t know, the FDA has that authority to change before the final regulation comes out. And so, you know, we’ll wait, we’ll have to wait and see on that. From a personal standpoint, I hope it does change the consensus paper recommendations, I think that would be in my view, that was what the professionals who really deal with hearing loss and with acoustic science came up with. And so but, you know, the FDA is open. And that’s why they have the comment period. And so what does take place, we’ll wait and see. Alicia Spoor 43:02 So if you read the consensus paper, which I’ve done a few times, in the last week, as well, we made a big deal. And I was part of that working group full disclosure, we made a big deal about how it was very hard to put a game number on, there’s so many different ways of figuring out gain. And there’s so many different algorithms. And I’m not a manufacturer, and I’m not a researcher, but we made a big deal about gain is really hard to identify. And when you make this number, you have to take into account these 18 other things. And then when the proposed rule came out, they took into account that 18 Other things, but didn’t put a gain number on. And so I actually wonder, did the FDA listen to us? Because we said it’s really hard to put a number on the game. But you have to look at distortion, you have to look at input output function, you have to look at EIN you have to look at all those different things. And ironically, the proposed rule has all of those things and no key number. Tom Tedeschi 44:07 Interesting perspective. Yes, I can’t see who it is, though. audience 44:13 It’s Kurt Kalise. I was wondering who the FDA is listening to if they’re not listening to us on these proposed changes. So our organizations represent the hearing impaired, and we have all the technical information that was provided to them. And so who else is providing something contrary? Tom Tedeschi 44:38 So there are a number of groups who weighed in on the on the when it when the proposal first came, not the proposal, but when the law first was sent to FDA. And so we have the Consumer Technology Association we have, you know, the different consumer groups we have individuals Who have you know, weighed in we have the Hearing Loss Association of America. We have, you know, the association retired, you know, AARP. So there’s there’s numerous groups that have weighed in on it at this point. So we were just we were one that we hoped were vocal enough, but we will see. Yes, audience 45:19 yeah. Just to take that a step further for for those of us who are under initiated in this, to take that step a step further. What does the panel look like? Is there an FDA panel of experts that are better that had been put together to to do all of this work at the FDA? Do you know what it looks like? Who the members are? Unknown Speaker 45:40 Yes. So the the answer to that question is yes, the FDA does have a group, it’s called CDRH. There’s a group that fit within the ENT. It’s called Ear, Nose and Throat device category. So it’s it there’s clinician, there’s audiology clinicians in there. There are acoustics experts, and there’s there’s engineers in there. And there’s a physician, Dr. Eric Mann heads that group up with that. And so they do have a broad panel, we have met the consensus paper, we had a, we had a group that actually went to the FDA, we provided them with a consensus paper. We’ve met with them. We have met with him on numerous occasions. And so we have, I believe we have a good working relationship with the chairman of that committee. And so So yes, they do have an actual team that has been working with this from day one. Yes. audience 46:35 My name is Dr. Strickland. I’m from Boise, Idaho, and I live in a real rural area over there and fairly conservative state. So there’s one company in that area, this is about the life the compact Is that what it’s called the Impact, whatever. So there’s a company there that would like us to do some of their industrial audiology, and they have some like in Oregon, they have some in northern Idaho, some down in Nevada, and Utah and Wyoming. So I neighbor, all of those states. And then because I have family in Utah, I actually licensed myself there as well, just so that everything was on the up and up, it was fairly easy to get licensed there. I also did my rotations in Texas. So I continue to keep that license just because it’s easier to keep it than to redo it right. Same thing in California took a job in California before I started my practice in Idaho. So I mean, literally, I you know, I’ve got whole western states, you know, west of Colorado, and Texas. So I just think that’s interesting. What does that what does that mean? You know, does that apply? I guess I don’t know all the ins and outs of that. Stephanie Czuhajewski 47:44 So it’ll depend on the states that are included in Adam Haley, who is our state’s specialist is over there in the back, he can help anyone who has any questions about their specific state. I will say that you still have a choice just to tag on to what Dr. Sports said earlier, you can maintain your licenses individually in the states where you’re practicing. If you are not, you don’t have to participate in the compact in that way. So you can still do that. And And with that, because I want to be respectful for the time for all of the things that are upcoming. I think we will have to defer other questions but are happy to take as many as you have outside of outside of this session. Tom Tedeschi 48:26 Thank you, everybody.