OTC Hearing Aids and How FDA Rules Might Change Hearing Care, with Dr Tom Powers

Karl Strom:
Welcome to The Hearing Review podcast. I’m Karl Strom, editor of The Hearing Review. And today we’ll be looking at the issues of OTC hearing aids and the FDA’s proposed regulations for them. My guest today is Dr. Thomas Powers PhD. Dr. Powers is a semi-retired audiologist and one of the most respected industry audiologist in hearing healthcare. He spent 35 years at Siemens hearing instruments, which has since become Cignia or part of the W.S Audiology group, where Tom was the chief research officer. And he was also the main U.S compliance officer for Siemens, which means he’s all too well acquainted with many of the necessary specifications and regulations that the FDA requires for put hearing aid on the market as a class one or class two medical device, which is how hearing aids are defined by the FDA.

Karl Strom:
Tom is now the founder and managing member of powers consulting, where he is working on several different hearing related companies and organizations, and one of the more recent ones being the Hearing Industry’s Association or HIA, which is the main U.S Trade organization of hearing aid manufacturers. He joins us today from his home near Oxford, New Jersey, Tom, welcome to the hearing review podcast.

Dr Tom Powers:
Thanks Carl. It’s a real pleasure to be here and great to, sort of, be out and about in the hearing world, again, talking to folks. So yeah, thanks for having me on.

Karl Strom:
Now, you’re semi-retired but I can’t really picture you as a retired person. You’ve been so active in the industry through the years, but I suppose you have more time now to tend to your farm a little bit.

Dr Tom Powers:
Yeah, I do, a little over 20 years ago my wife and I bought this farm, we call it. It’s about 10 acres in Northwest New Jersey. The house was built in 1843 by Ruben Mitchell and Reuben was kind of an interesting and colorful guy, but maybe that’s for another time. He was the local moon Shiner, which is maybe why I like [crosstalk 00:02:23] this place so much. The spring that runs through where his still was still is on the property. But we have sheep on the property here and some goats that allow us to be assessed as a farm in New Jersey. So you need a minimum amount of acres and also a minimum revenue per year. So we have lambs and the lambs go off to petting zoos around the country. They might go some other places, but people like to think they go to petting zoos and that provides the revenue. And so it’s kind of a great place. My neighbor across the street boards horses, and the property that backs up behind me is an orchard of 170 acres. So we’re sort of out here in rural New Jersey.

Karl Strom:
That sounds idyllic.

Dr Tom Powers:
It’s great.

Karl Strom:
I want to get into the OTC hearing aid regulations today and, specifically, what’s your take on them? I mean, you’ve been involved with the hearing industry, like I said, for 35 years and you’ve helped out the HIA in a lot of capacities and consulting through the years. Before we get into it, these FDA proposed regulations, they weren’t churned out haphazardly. Were they? I mean, the agency really did do a lot of careful listening and the 114 page document reflects that. Would you agree?

Dr Tom Powers:
Yeah, I think so. I mean, I think when you read through that and I have to admit I’ve done that several times more than I probably want to think about, but I think there’s quite a few references in there to what led up to the regulation. And certainly now the proposed rule, both from a lot of the federal agencies, the FDA themselves, the FTC, the PCAST and National Academy of Science Engineering and Medicine NASEM previously, Institute of Medicine. And there is some semi-references, also, to the consensus paper while it’s not specifically referenced per se. They do talk about some of the things that were in the consensus paper from the main audiology and dispensing organizations.

Karl Strom:
And that was the American Academy of Audiology, the Academy of Doctors of Audiology and the International Hearing Society, as well as the American Speech Language Hearing Association.

Dr Tom Powers:
Right? Yeah. The three main audiology groups, as well as IHS. So yeah, they all collaborated on that document and it was I thought a pretty comprehensive document as it related to comments on where they all thought this should go to primarily, I think, protect consumers in an environment where there’s not a professional involved,

Karl Strom:
Right. So let’s get to some of the finer points of the proposed regulations, starting with the FDA’s proposed maximum output for OTC hearing aids. What is the FDA proposing and what was the position of the consensus statement on output limits?

Dr Tom Powers:
Yeah, the current rule proposes two levels. The initial level, I’ll call it if you will, or the 115 DB output limit, for OTC devices in general. And then I don’t know if it’s really an exception, but a secondary rule where the output could go to 120 DB. If those devices included a volume control and input controlled compression to have some protection against high output levels. The consensus paper on the other hand, proposed an output limit of 110 with a gain limit of 25, there is no gain limit or any mention of a gain restriction in the rules from the FDA. So in essence, the only rule part of the gain and output equation that’s in the document is the 115, 120 levels in the new rule or the proposed rule. It’s not final yet.

Karl Strom:
Do you agree, I mean, I’ve heard some people say that there really ought to be some sort of gain limit in there. I mean, is that a hearing industry or audiology type of thing where we need a gain limit or do you think that’s a valid comment?

Dr Tom Powers:
You know, I think the issue there is the consensus paper indicated that it would be difficult, not impossible because they did recommend 25, but, it would be difficult to establish a specific gain requirement, particularly because you’re talking about mild to moderate hearing loss. And whether you’re talking about someone who’s been tested or someone who has perceived mild to moderate hearing loss, which could be anywhere as we both know, people tend to under or overestimate their hearing loss. So I think gain is a difficult thing to specify. If you look at what the NAL predictions would be from somebody from 25 to a 55 DB hearing loss, the gain’s going to vary quite a bit in that range. And so to say maybe it should be in the middle, should it be at the upper point, should it be at the lower point?

Dr Tom Powers:
So, as an audiologist, I would say, yes, I think we should be looking at some type of gain. I don’t know if we want to call it a limit or at least a proposal. The industry felt pretty strongly for the most part. There were comments on the other side that also felt that there shouldn’t be a gain restriction. And also on the output side, there were comment on both sides from organizations and people that thought the 120 was okay. For me, the 120 is a bit of an issue only because of the way it was defined. And that is, it was defined by OSHA and NIASH requirements that you have 30 seconds in that environment.

Karl Strom:
Right.

Dr Tom Powers:
And really then you have 30 seconds to rip your hearing aid off if it gets too loud. I think that argument was a little strange to me as an audiologist and having fit hearing aids on patients years ago when I was in private practice. It isn’t always that easy to find the volume control and take the hearing aid off. But, that’s what’s in the rule and a thousand comments went to the FDA. So they’re now working their way through them.

Karl Strom:
The comment that people just will take off the hearing aids, if they’re too loud, I mean, there are also people who can’t, people who are intellectually disabled and things like that, that might not be able to take that off. There’s also a paper that we published from Tom Todeshi and Christine Jones about how the 110 OSPL 90 is applicable really to a very wide swath of people that we treat or audiologists treat.

Dr Tom Powers:
Yeah. I think that’s where a lot of the audiology groups and individuals fall, is that it’s a reasonable level. And, I think some of the comments also were, this doesn’t necessarily have to be the rule for the ages. I mean, we could initially look at 110, I think I read some of the comments, I didn’t read all one thousand, but I read a lot of the comments that went in, that proposed potentially reexamining not only to gain and output in other requirements of this in the next three to five year period as the FDA gains more experience. And we learn what other types of things, I mean, we’re going to talk about consumer protections maybe later, but the whole gamut of things that are in this proposed rule.

Dr Tom Powers:
And so, 110 I think is reasonable for a lot of people on the other hand, if I step back and say, let me say what some of the opposing comments were is that that’s restricting the people who could use the devices, by limiting the output to only 110, and that if there is input compression in the device, then maybe 115 or 120 would expand the population and provide better affordability and or access. You can debate either of those, but those are the reasons why we’re here, right. Is the affordability and access part. I’m an audiologist, not a lawyer, but if I were, I could argue, I guess, both sides.

Karl Strom:
Right, right. You had mentioned consumer protections. And I think one of the murkiest parts of the FDA regulation had to do with return for credit policies and complaints, when the OTC devices don’t work. Can you give me your take on what the FDA is proposing here?

Dr Tom Powers:
Yeah. You know, the FDA is proposing that the manufacturers of the devices state their return or credit policy, however, they’re not requiring them to necessarily accept returns. Their position is that consumers, as they review these OTC devices and find that there is not a return privilege, for example, that, that would limit people from trying the device, because I want to be able to return it. While I understand that position. And I think that certainly could be a deterrent. I’m not sure that everybody’s going to dig that deep into the return policies and what else is in the device. If I really want to buy it, because it has Bluetooth, am I going to get something and find out at the doesn’t have any kind of wireless capabilities? So, I think it’s really trying to ask consumers to make a choice about what’s in the device again, without the help of a professional and make sure that they get the right device and that if they don’t, what happens? Are we going to end up with, as Sergei used to call dresser drawer comments, back in the old market track days.

Dr Tom Powers:
So I think it’s really something that I believe a lot of the comments were that there should be a set of policies. One of the more interesting comments was from one of the companies, that there should be only a sellers return privilege, not the manufacturers. And so you get the idea that potentially they want whoever the retailer is to take that responsibility and really that risk. If it’s one in a hundred, that’s one thing. If the returns are 40-50%, it’s another thing. So I think this, [crosstalk 00:13:15]

Karl Strom:
It’s a huge issue because right now for hearing aids, it’s around 15, it’s historically been around 15 to 20%, right. Depending on and higher for devices like CIC’s. So that’s something that you really have to focus in terms of a business model on, and the thing that strikes me is that why wouldn’t hearing aid manufacturers just say, well, this is an OTC hearing aid.

Dr Tom Powers:
Well, that’s an interesting part of this discussion is, how does this all move forward. But I think this whole return privilege thing is a really interesting thing and you’re right, a murky point of this whole thing, because if the whole idea, again, is access and affordability. Access, you can get these devices, we’re going to make it as easy as possible, let’s say that. But then affordability is you can’t then say, you’re trying to do that. And then when somebody buys something, say, we’re sorry, you can’t return it. And you just got to stick it somewhere when you’ve spent three, four, $500 pick a number or more. I don’t think that really should be the spirit of what this rule should be about.

Dr Tom Powers:
So I hope that they actually come back and say, yes, there should be a specific return privilege, because you’re right in hearing aids, it’s at the manufacturer level, 15%. Probably at the clinic, it’s a lot less than that because sometimes somebody wants a CIC and then they can’t handle it. Right. So now that CIC comes back and they get a full shell ITE, or they get a BTE, well, the manufacturer sold two to get one. In the clinic, they sold one. I mean the other one came back, the money, it all washes out in the wash. But again, with no professional there, the consumer has no recourse. And so I think that’s an important part. And maybe a little later we’ll talk about, one of the responses was from the attorney generals, which was to this point. So we’ll maybe come back to that.

Karl Strom:
I also want to touch on something that I know very little about it, 510(K) pre-market clearance documents that you’ve done a ton of them in your career. I know they’re tedious and painful to put together from the people like you, who I’ve talked to about with them, but they are important. Aren’t they? And can you tell us what a 510(K) is, why they might be important for OTC hearing aid devices to have and how they fit or how they don’t fit in FDA’s proposed regulations for these OTC aids.

Dr Tom Powers:
Yeah. The 510(K) is a filing document to the FDA when you intend to market and for some of them, obviously they’re, pretty comprehensive. You can imagine, an implantable defibrillator or other things that end up in your body. It is a pretty extensive device. Hearing aids, we’re certainly not implanting them in your skull. Cochlear implants, certainly, they have a very high bar. They’re a class 3 device, of course, hearing aids are class one and two. But, the device that the filing document itself has all the information about, the product that you intend to market. So the basic technical requirements; gain, output, the distortion, the things we would normally think about, but also there’s a whole series of measurements on the radiated output of that device, if there’s wireless capabilities, make sure that’s in line with the wireless capabilities, that it doesn’t exceed safe levels for humans.

Dr Tom Powers:
So there’s a whole series of measurements that the manufacturer of the device needs to make to ensure that it is safe, it’s effective, and it does what it’s going to do. And it’s pages of documents in the case of some of the 510(K)s or with the de Novo process that BOSE followed in others. There’s some clinical data that has to be collected and submitted along with that document. So it’s a pretty substantial document. And as this relates to OTC, the 510(K) is only proposed for the self fitting OTC. For people that haven’t been around this, there are two classifications. One, OTC devices, and then self fitting OTC devices. And self fitting have what the FDA calls tools and tips and software.

Dr Tom Powers:
In other words, an app, or some way to adjust its sliders, gain output, frequency, response, based trouble, all of those things that would allow the consumer to self fit and adjust the device. An OTC might have a push button that lets you cycle through pre-programs that are in the device.

Dr Tom Powers:
And so when you take it out of the box, there’s really no adjusting. And so that’s the difference. Where a lot of the comments came in is that why not make a 510(K) required for everybody the first time that they submit one of these devices? That’s not the way it’s proposed in the rule, but I think that would ensure that not only do those companies register with the FDA as a medical device manufacturer, but also have some requirement to disclose what their device is going to do, what’s the gain? What’s the output? How much radiating output do you have? Are you going to follow quality standards, et cetera. It’s a relatively comprehensive document here, even for hearing aids, certainly for higher level devices. It .gets pretty complicated. I knew some of the guys that did the ones for MRIs and I wouldn’t want to be involved in that when I was back in Siemens. So yeah.

Karl Strom:
But they are important for establishing a baseline anyway. I’m just throwing this out. They’re all the same for hearing devices? There isn’t a 510(K) light or anything like that, that you have?

Dr Tom Powers:
No, there are minimum requirements that need to be contained in the document that show, again, what the device is doing from a performance standpoint. Early on, when we started having wireless devices, there are all kinds of measurements that had to be done when it was either between the ear or when we started streaming. How much is that putting out and comparing it to other devices like cell phones? You’re talking about hundreds of times less the power. Yet, you still have to make sure that those measurements are done and that the FDA can make a decision. Is this a safe and effective device that’s doing what it says it’s going to do? So it can be approved for market released. The FDA doesn’t really approve devices, per se.

Dr Tom Powers:
They say you’re approved to sell it into the marketplace under whatever controls are required. Hearing aids do have some general controls, prescription devices. On quality standards, testing that has to be done, design requirements. So good manufacturing practices, as they’re usually referred to. And so if none of that is there, there is no guarantee that even if somebody puts a spec sheet on their website, that device is going to do that. There’s no guarantee without any kind of oversight, if you will, by the FDA. Right.

Karl Strom:
Now, there also seems to be a lot hinging on whether the state laws pertaining to hearing devices will remain, or if the FDA’s regulations will basically make them moot. And I know a lot of people have fears about what happens if the various local and state regulations get wiped off the books. Can you tell us about what you might think will result if something like that would happen?

Dr Tom Powers:
Yeah. I think this goes back to what we were talking earlier about, consumer protections, because most of the state licensing requirements for either audiologists or for hearing care specialists or dispensers, whatever term we want to use there. All of the things that they’re, A, required to do, in other words, you have to do a hearing test, you have to do air bone. I mean, there are certain things that you’re required to do as a part of that license, but the other part of it is, as a licensed professional there are things that flow through your license, like the return privilege, what is the trial period? Do you have to have an itemized receipt? What are the things you have to tell people, et cetera, as you are selling them a hearing aid in this particular environment.

Dr Tom Powers:
So if those go away, in many places, there will be no consumer protection because that typically is done through the license. Now, there are still some laws, state laws, that govern all things that are sold. So these are usually sometimes called lemon laws. So if you buy something and it’s just horrible, you do have some rights under a lot of state law to get it replaced or repaired or whatever. But in terms of having professionals that, I have to follow some rules, we’re going back pre-1977 when it was the wild west. And I guess I can say people were selling hearing aids out of the trunk of their car. [crosstalk 00:23:13] And so I think a lot of that is an issue.

Dr Tom Powers:
And, one of the things that’s a concern is that the states don’t want it to be necessarily dependent on the fact that you have to see a professional, because that’s certainly excluded by the legislation. But I think the states want to say, listen, we want to reserve the right to keep these licensing restrictions and consumer protections in place through the licensing requirement. And I think that was very strongly sent to the FDA by the state attorney general. There were over 40 of them that sent a letter to the FDA requesting that these are important and that they’d like to keep them in place. That this is how consumer protection works at the state level. In many cases, it’s not a federal thing it’s a state thing, right.

Dr Tom Powers:
And so they really want that requirement. They should not be exempted and it should put a process in place, also, for how these may or may not be exempted. And then also that there could be an appeal. Right now, if they just get wiped away and there’s no recourse. Now you’re leaving the states with some real dilemmas, in terms of how do you enforce any of the other laws that are on the books? So, that is just a real quagmire. I usually do my white coat, blue coat little talk where, somebody walks in and I tell them, I’m a new audiologist, I’m Dr. Tom powers. I’m here for a hearing test. I have my white coat on Dr. Powers. I tell them afterwards, you have a mild hearing loss.

Dr Tom Powers:
You could have an OTC device, or you could have a prescriptive hearing aid. Well, now, if I want an OTC device, do I have to run in the back and find a different color coat and come back out that says Tom, and now all the stuff that I told him about all my training and all my… all that goes away. And I’m just Tom, again. You can see how this just becomes so confusing, especially for consumers, forget about the professionals. Somehow we’ll find a way, but I think the consumers are really the people here that I think we have to do our best to try and give them the best of both access affordability. This is the whole point here, but also provide some protection so that they don’t get a device that doesn’t work or causes them harm. Those are the two things we want to be sure of.

Karl Strom:
But, also from a professional standpoint, and most of the people listening to this will be hearing care professionals. Your licensure and how you jog that white coat, blue coat kind of thing is, there’s some real fundamental ethical types of things here, if you ask me. And you are kind of playing with your board licensure for the state.

Dr Tom Powers:
Exactly. And, it puts you, in many ways, at a complete disadvantage. Let’s assume that some of the state regulations stay in play. Somebody could open two doors down in a strip mall where you’ve got my office and there’s John down there and he’s just got a big sign OTCs, come get them and no return privilege again. Let’s assume what we’ve talked about before, that there isn’t a specific… And he could state a policy on a little sign somewhere in the corner, once you buy it, you own it. Sort of like when you break it, you own it in a China shop. Right. And so it’s a real dilemma, I think. And again, I don’t want to play that professionals are being preyed upon here, but it puts them in a tough position, I think when you’re trying to encourage people to come in.

Dr Tom Powers:
And I think that’s something that the industry and audiologists, and I think consumer groups, HLAA, everybody is we really need to make sure that we try to encourage people to at least have a hearing test, because then you know whether you are really mild to moderate and or you have something else, Even though PCAST way back in the…you were there for some of those discussions. I don’t want to say didn’t really have any concern about the 1 or 2% of people might have acoustic tumors. Somehow that red flag, we will find them somehow, but the last thing we want is to have people have medical issues and think they can solve this problem with an over the counter device.

Dr Tom Powers:
So above all, let’s be safe and effective. That’s the job of the FDA. And I think as professionals, that’s what we want to try to do, is get people in and give them their options and then let them make informed decisions. And if they decide to try an OTC device great, but if it doesn’t work, give them the ability to send it back and then maybe seek a prescriptive solution as it’s now going to be called, OTC, Self fitting and now the prescriptive side.

Karl Strom:
Right. Anything else that really hits you when you’re reading through the FDA reg? Proposed regulations about what hearing care professionals or consumers in general really need to be alert about on this issue? And how would you recommend that hearing care professionals prepare for these upcoming regulations?

Dr Tom Powers:
I think to me the best thing, and I know it’s a long document, but I encourage anybody who hasn’t already read it to read it. To read it and really try to understand how it’s going to impact where they are. Whether it’s consumers, how am I going to access these devices and professionals? How am I going to potentially include these in my practice? I think we’ve hit what I think are certainly the main points. There are some that are, the labeling requirements, if you know, if you look at the document there’re huge things and hearing aids are small little gadgets. So if I look at the labeling requirements, I could see a little box that’s two by two with an eight and a half by 11 piece of cardboard attached to it with all the labeling.

Dr Tom Powers:
Well, in some ways that seems a little silly. So, somehow we’re going to have to figure that out too. So there’s a lot of other aspects to this, but I think read the document and if possible, go into the FDA site. You can go there, you can read the comments that are from all the organizations, et cetera, et cetera, consumers, and sort of be educated. I think to prepare for this, I think you need to take a look at your practice and decide how can this work for me. And I say it that way, because I believe that if I was still in practice, I would be including OTC the license of some kind into my practice, because we have a huge group of people with mild hearing loss, maybe even moderate hearing loss who are situational wearers as I call them.

Dr Tom Powers:
And they’re not ready. They may need it, but they’re not ready to wear something full-time or at least feel that they have to wear something for full time. They certainly could wear a prescriptive device part-time, but then the cost becomes an issue and so forth. So I think to get people to at least start the process from market track four years, six years before you do anything. So let’s try to do that. And then how do I integrate this into my practice? I’m going to need to think about which devices I’m going to include. So, start checking out the websites of all the new people that are coming in. We could spend the next half hour listing them all, because there’s quite a few. Right. But, look at them, decide if they’re right for your practice, how do they work?

Dr Tom Powers:
Do they let you return them? If you’re going to sell them to consumers and then I think the other big thing here that, I don’t know if it’s really the elephant in the room or what it is, but, it’s the unbundling part of our whole industry. If these devices start looking like hearing aids, walking like hearing aids, talking like hearing aids and cost much different than hearing aids, prescriptive consumers are going to ask what’s the difference. And I think we need to have that discussion with ourselves and say, how am I going to do that in my practice? How am I going to sell these devices? What’s the cost structure? What services should I add? At least a hearing test, one or two follow ups, some counseling. Where do you sit when you go to dinner, all those kinds of things that we try to counsel patients about and maybe find a way to do that. Maybe with some help from your office manager, depending on how busy they are, audiology assistants are becoming more common. So,

Karl Strom:
And it might necessitate tele audiology components and that type of thing too. So,

Dr Tom Powers:
Absolutely. I think the other piece of this is going to be the tele audiology solution, the audiology speech compact is coming and one of the things I think about with the audiology compact is your competitors aren’t only going to be in your state. They’re going to be from other states because once you get privileges, if you live in Colorado and get privileges in Nevada. I don’t know. I can’t remember which states they’re in [crosstalk 00:32:35] so nobody quote me, but let’s assume all of a sudden somebody could walk in your office and say, I bought this from somebody in Colorado. And you’d say, well how did that happen? Well, he has privileges in your state and he sent it and as long as mail order is not prohibited, blah, blah, blah.

Dr Tom Powers:
So, I think it really changes the whole dynamic here in terms of how we provide care to patients. Not only across products, but across state lines and across the world potentially. So I think getting ready has to start now. The FDA has, in theory, six months, July is about when we expect. The comments closed in January so in July we could see the final document in the federal register. When that happens, everybody’s going to get a chance to read it, but the comments are done, that’s it? This is now the rule. And 60 days after that, the rule goes into effect. And in theory, if people are pairing their documents and pre-filed FDA 510(K)s, et cetera, et cetera. August, September, you could start seeing some really defined and called OTC devices on the market. I know we have some that are out there today that are masquerading as that, but we could see them later this year, who knows. That all depends on the FDA, getting their job done [crosstalk 00:34:05] in six months. And they got a lot of comments to run through.

Karl Strom:
And it’s a big task. Yeah. [crosstalk 00:34:10].

Dr Tom Powers:
A big, big task,

Karl Strom:
Tom, I know there’s a lot more to talk about on this issue but I think that’s all the time we have today. And I really thank you for your expertise and chiming in and helping with the HR podcast. Thank you, Tom.

Dr Tom Powers:
You’re welcome. Good to talk with you, Karl and hopefully we’ll see you in person sometime along the road here.

Karl Strom:
Truly. Dr. Thomas Powers is the founder and managing member of Powers Consulting. And he spoke with us today on March 8th, 2022. I’d like to thank him and MedCOR marketing manager, Bryce Lockman for their help on this podcast. Relevant links and correspondence can be accessed on the landing page of the podcast at hearingreview.com. For The Hearing Review, I’m Karl Strom, thanks for listening.