Even though OTC devices don’t exist yet as an FDA-regulated product category, direct-to-consumer hearing devices have existed for decades. In this week’s episode of This Week in Hearing, Brian Taylor interviews Professor Sterling Sheffield, AuD, PhD, of the University of Florida.
Professor Sheffield has authored soon-to-be-published research comparing DTC devices to medical grade hearing aids. During the interview, Sterling also shares some results that may surprise you.
In addition to his studies in this area, Dr. Sheffield provides valuable insights on how both hearing care professionals and consumers should approach an evolving hearing care market that includes OTC devices.
Brian Taylor 0:10
Hello, everyone, and welcome to another edition of This Week in Hearing. I’m Brian Taylor. And today’s topic is direct to consumer hearing devices and how they compare to traditional hearing aids. And with us to discuss the topic is Dr. Sterling Sheffield, who’s an assistant professor at the University of Florida. He’s done a lot of important work in this area that I think people are going to start to read and learn about. And we’re really excited to have him on our broadcast today. Welcome Sterling, to the broadcast.
Sterling Sheffield 0:39
Thank you, Brian, it’s great to be here. I appreciate your interest in our research here at the University of Florida and for having me on the show.
Brian Taylor 0:47
Sure, it’s great to have you. I think the first thing is, maybe talk a little bit about your background, what brought you to the University of Florida, and also your interest in the topic.
Sterling Sheffield 0:59
Excellent. Yeah. So I am an audiologist licensed and certified and did my AuD at the University of Iowa. And so from the beginning, you know, interested in patients, how we can improve treatment and outcomes for individuals with hearing loss. And you know, pretty quickly during my AuD program and externship I was really interested in research and wanting to put to push the field, gain more evidence for you know, better practice and treatment of hearing loss. And so I went on to do a PhD, and then a post-doc and the University of Florida attracted me, because of their large clinic, all the patients that they see here and the opportunities for research, and excellent students we have here. And that’s actually how a lot of this work started is through some of our great students. So two of our AuD students and particular interest in over the counter and direct to consumer devices, how they work and how effective they can be for patients. And so we we started into this work.
Brian Taylor 2:14
Gotcha. Well, I think another place that we should probably visit before we dive into some of your work in this area is around terminology. I’m guessing that most hearing care professionals most audiologists have some familiarity with OTC, DTC, PSAPs, but maybe for those that aren’t all that familiar. Could you kind of update us on what’s the difference between a medical grade hearing aid a PSAP an OTC a DTC, self-fitting hearing aids?
Sterling Sheffield 2:43
Yeah, thanks. Great question, because there is a lot of terminology as is common in audiology. And it can get confusing because there’s a lot of overlap between these terms as well. So medical grade hearing aids are, you know, our traditional hearing aids that have been sold by the major manufacturers, they’re fit by hearing instrument specialists or audiologists, by hearing professionals, at least for individuals. And as is traditionally been the case, they’re only available through a hearing professional, to where all of our direct to consumer devices fit into different categories. And the piece apps are probably the simplest to describe. So these are personal sound amplification products, or PSAPs. And these are devices that are sold directly to patients, whether it be online or in stores, but they’re not marketed for hearing loss. And that’s according to FDA regulations. So typically, they say something like these devices are designed to help people hear better in noise in their marketing, but they never mentioned hearing loss and they’re not marketed to individuals with hearing loss. But if we look at the the research literature, we know that people with hearing loss of course buy these devices sometimes to help them here to wear so in 2017 when the FDA first came out with a designation of an over the counter hearing aid device, this this OTC hearing aid term came out. And these are the device, devices that are marketed to individuals with hearing loss. They say something similar to what hearing aid say in their, their marketing materials, that they’re to help people with hearing loss hear better and have access to sound but the specific li note that therefore one adults and two adults with mild to moderate hearing loss. So that would be the big difference between medical grade hearing aids and over the counter hearing aids
Brian Taylor 5:14
Right. And OTC, even though it’s sort of an outline by the FDA, is that correct me if I’m wrong, but that category doesn’t officially exist yet?
Sterling Sheffield 5:25
Yeah, that’s a great point, Brian, it’s one of the confusions is basically right when that legislation was was published in 2017. From that point on, we already started to see these devices marketed on, you know, online and other places in the market. But as you pointed out, they’re not officially approved yet. So in that 2017 document, the FDA said that these are approved pending proposed regulations for safety and efficacy. And then
Brian Taylor 5:59
the other thing I wanted to, if you could clarify is the we hear a lot about self fitting hearing aids. So how might those differ from this category of over the counter?
Sterling Sheffield 6:10
Yes, great question. So you can have some over the counter devices that don’t require an individual seeing a hearing specialist, or hearing professional, but that are fit by the company. So they’re specifically fit to a hearing loss or something like that. They’re not self fitting in the sense that they’re not just fit by the consumer, where they buy it and, and set the device themselves to where the self fitting are typically, those devices that are fit or can be fit either consumer themselves, so they come with an app or simple buttons on the device for fitting,
Brian Taylor 6:49
right. So taking a lot of the things that an audiologist might use in their clinic to fit the hearing aid in putting on an app and allowing the patient to potentially do it themselves.
Sterling Sheffield 6:58
Yes. And so the last talk or term that you brought up was the direct to consumer devices. This is also used in the literature. And as I understand it, it’s sort of a combination of OTC and self fitting, meaning that these are any devices that can be sold directly to the consumer. And they might be self fitting, or they might be fit by a manufacturer, but they can be sold directly to the consumer. They don’t need need to go through a hearing professional.
Brian Taylor 7:32
Right. And again, correct me if I’m wrong, but that kind of that category has kind of been around for 30 or 40 years when you think about mail order hearing aids, right?s
Sterling Sheffield 7:39
Yes. Yep. That’s a very good point.
Brian Taylor 7:42
So it’s not exactly new, it just has maybe a new spin on it, because people can buy things on the internet now so easily. Definitely. Correct. I think another point I wanted to kind of clarify with you, is the whole idea, the whole idea of why do we have OTC as a category?
Sterling Sheffield 8:00
Yeah, great question. So this came out in reference to accessibility and affordability. So there was a big push from, you know, the, from the public, from the hearing professionals in general, to Congress to make these things more affordable. And so that’s why the FDA came out with this legislation. For over the counter hearing aids. We know that cost is consistently one of the barriers to people purchasing hearing aids, although there’s also a lot of other factors that consistently come up, which is important to recognize as well.
Brian Taylor 8:45
Exactly. Well, thank you for that. I think it’s good to kind of lay the foundation for what we want whatever they really wanted to talk about with you today is your research in this area. So maybe I first learned about your research just a few months ago at the AAS, American auditory Society Meeting other was really interesting, your poster, the podium sessions. So maybe talk a little bit about big picture. Some of the work you’ve done comparing medical grade hearing aids to these direct to consumer devices.
Sterling Sheffield 9:17
Yes. So it’s not surprising that you haven’t heard that much about it, because we are fairly new to this area.
And hopefully, as you pointed out, we’ll be happy people seeing it much more in the literature here soon.
But what we’ve been looking at are a few areas First, do these do current over the counter devices, whether they be PSAPs or hearing aids, meet the proposed guidelines published by the FDA. So the FDA published some proposed guidelines for safety and efficacy in October of last year. And then, in conjunction with that, how well can these devices meet prescriptive targets for amplification, and some work has definitely been done in this area before. But we wanted to look at current devices that are on the market as well as a number of different hearing losses and how well they fit them.
Brian Taylor 10:20
Right. So maybe walk us through the design, the study that I’m thinking of is the poster where you compare it, I think it was maybe three medical grade traditional hearing aids to maybe six direct to consumers. Tell us a little bit about the design of that study.
Sterling Sheffield 10:36
Excellent. Yeah. So we did some work there on speech, perception and sound quality. And exactly as you described, we compare three medical grade hearing aids to six over the counter devices. Three of those were marketed as peace apps and three of them as over the counter hearing aids. Although, as you said, that category technically doesn’t exist yet. And for speech, perception, we did a QuickSIN. We made the signal to noise ratio poor just to avoid signal ceiling effects, because we did this in normal hearing listeners, just as a baseline. And each of these devices were fit in KEMAR an acoustic mannequin for three different hearing losses. The hearing loss, they’re typically marketed for a mild sloping to moderate hearing loss, more of a flat moderate hearing loss, and then a little bit more of a ski slope of mild sloping to severe hearing loss. So we fit them in the KEMAR, we made recordings in the KEMAR, and then presented these recordings over headphones to normal hearing listeners to see how they did with speech perception. And then we also used a really rigorous sound quality rating measure. If you’re familiar with the multiple stimulus with hidden reference and anchor test,
Brian Taylor 12:07
right, MUSHRA is that right?
Sterling Sheffield 12:08
Yes, MUSHRA is exactly right.
Brian Taylor 12:11
if clinicians don’t know about MUSHRA, they probably should, because like you said, it’s a really rigorous way to evaluate sound quality.
Sterling Sheffield 12:17
Yes, and one of the great things is it’s double blind it so both the tester and the listener don’t know which device they’re listening to, whether it’s a hearing aid or an OTC, and they have to rate on a scale of zero to 100, the quality of the sounds that they hear.
Brian Taylor 12:35
So they can go ahead and what did you find in your study?
Sterling Sheffield 12:40
Yeah, so what we found is that for speech perception, these devices did pretty well, for a mild moderate hearing loss, which is what they’re designed for marketed for, again, and what the FDA approved them for, to where if you get a more severe hearing loss like flat, moderate, or the mild to severe, then we start to see speech perception not be as good with these over the counter devices compared to, to medical grade hearing aids. And for sound quality, the results were really pretty variable. People rated music and nature sounds generally better than party multitasker, sounds and traffic, which isn’t surprising, but that was consistent across essentially all of the devices.
Brian Taylor 13:34
Hearing aids and DTCs. Right,
Sterling Sheffield 13:36
and, and etc, is yes. And then we did find that to two of the direct to consumer over the counter devices tended to over or outperform the other the other four in our study.
Brian Taylor 13:51
Which is interesting, because they’re all from the same category. So
Sterling Sheffield 13:55
yes, definitely. And I think that points out and I know, I think that points out that difficulty for both clinicians and consumers in in, you know, looking at devices and want to purchase.
Brian Taylor 14:09
Yeah, let’s talk about that a little bit. Because it seems to me that the implications here are exactly what you’re saying. There’s a lot it’s uneven, it’s really hard to know. So what are your thoughts on thse implications?
Sterling Sheffield 14:22
So for clinicians, I think in particular, if you’re going to sell or recommend these devices, make sure you do your research to choose quality devices because there are poor devices. And unfortunately, at least in our experience, it doesn’t necessarily correlate with costs. Some of the most expensive ones that we tested were performed the poorest. So making sure you know which devices are of good quality and that you can, you can confidently recommend to your patients or sell to your patients.
Brian Taylor 14:58
That’s interesting because As I know, some I can think of one study from maybe five years ago that I think showed that cost was kind of a proxy that the more expensive the device was, the more likely it was to be better sound quality. But it’s interesting that you didn’t find that.
Sterling Sheffield 15:17
Yes. And I’m not sure why – I know the study you’re talking about, and I’m not sure why we’re seeing something different than they did back then. I don’t know if it has anything to do with this new category of over the counter hearing aids versus, you know, back then it was more strictly PSAPs.
Brian Taylor 15:36
Right, right. It could be. Yeah, so we have a lot of consumers that actually watch this channel. What advice might you have for consumers that might be in the market for hearing aids and want to know more about DTC versus medical grade hearing aids?
Sterling Sheffield 15:53
Yes, um, so I would give two primary pieces of advice. One is to get a hearing test before you consider these devices to determine if you’re a candidate. Because again, some of these devices in particular can work well, if you have that mild to moderate hearing loss. If you don’t, I wouldn’t recommend these devices. And then second, I would consider getting a professional recommendation for a device. And whether that comes, you know, from someone that you see, or another reliable source looking for professional recommendation, because the quality of these devices just does vary so much,
Brian Taylor 16:34
right. Another thing that I’m curious about about Sterling is, if I’m a clinician, what can I do with my hearing instrument testbox, to maybe evaluate these devices? Like what – what quality control measures? You know, based on your information in your study that you’ve conducted? What quality control measures might you look at in your clinic when you’re testing these devices or evaluating them?
Sterling Sheffield 17:02
Yeah, that’s a great question. I’m glad you brought it up. Because we have done just the basic ANSI set, set of test measures, so maximum output frequency response, total harmonic distortion, and equivalent input noise. And those are also the regulations that the FDA has proposed those core values. And going back to our six devices that we have tested, three of them met all of those regulations, and three did not missed at least one. And so so that could be a simple test box measure.
Brian Taylor 17:40
Right. And the ones that didn’t meet them, are those the ones that tended to not perform as well?
Sterling Sheffield 17:48
In in some cases, yes. For the so the two that were the best performing, as far as speech perception and sound quality went, did meet those regulations. And so
Brian Taylor 18:00
yeah, so that makes sense. Like, it’d be a nice way to kind of evaluate them quickly, just like you would hear me. Make sense. Okay, so you that you you answered my question about consumers What thoughts do you have for audiologists and hearing instrument specialists in regards to OTC and sell fitting hearing aids? What are your thoughts on how they should look at this new category of products?
Sterling Sheffield 18:28
Yeah, that’s a great question. And it’s tough, I feel like it really depends on, you know, your business model, and the population that you serve. For me, this, you know, new, these new products have opened up a lot of exciting avenues for research. But for our clinic or a private practice, especially if they serve a lot of adults who might be likely to purchase these devices, it could impact their business model. And I think they have to decide on how that that impacts their business model. And then another, another recommendation I just want to make is I think we as a field, have a and as clinicians have the responsibility to educate physicians and other professionals on these devices, the variability that you see who they’re appropriate for, because we’re the most familiar with them, and what works. So I think we have a responsibility for a lot of professional education in those around us that we collaborate with.
Brian Taylor 19:35
Right. Well, let me ask you about that. Then if you were going to be educating some physicians about this topic. What are some things top of mind that you might share with them?
Sterling Sheffield 19:47
Yes, and I think it would be really similar to what I brought up with with consumers is, first make sure that that you recommend that they get a hearing test to determine if they’re a candidate for these devices, or if medical grade hearing aids are what, what would work for them. And then second, just that these devices vary in quality. And so I wouldn’t, you know, expect them to keep up on what are quality devices, but just to make, make them aware of that, and that they can help make patients aware that, you know, all devices aren’t created equal, and you want to be informed in what you choose.
Brian Taylor 20:30
Right. Well, I have one final question for you. And that is, how do you think audiologists can prepare for the future with over the counter as a viable patient option? I mean, we know this category is not going away. How do we prepare for this category being available to consumers?
Sterling Sheffield 20:47
Yeah, great question. I think, you know, educate ourselves on the regulations published by the FDA, and she has put out some good responses and thoughts on them. The available devices, including manufacturers cost fitting options and quality, and then consider how OTCs will fit into your personal clinic or practice service model. So whether that’s, you know, you’re going to sell or fit them, and how you’re going to make that work, if you’re going to recommend them to patients who don’t want hearing aids. And then you can know, okay, we have to be familiar with them and have a list of of what we’re going to recommend and and update that periodically. Or, yeah, just how it’s going to fit into your, your business model. Because as you pointed out, they’re not going away. You’re gonna have patients asking you about them, you’re gonna have patients asking you to fit them, sell them everything, I
Brian Taylor 21:49
you have to have a well thought out opinion about them, I think. So we rely on folks like you and other researchers out there to help us to better inform us about how to approach the topic. So Sterling Sheffield Assistant Professor, University of Florida. Thank you very much for your time. This is a incredibly timely topic. And we thank you for all of your contributions that you’ve made. And we look forward to seeing some of your work published in the relevant journals and other places. So maybe after it’s been published, we can have you on again to discuss even more of this topic.
Sterling Sheffield 22:27
I would love that. Thank you so much, Brian.
About the Panel
Sterling Sheffield, AuD, PhD, is currently an Assistant Professor at the University of Florida in the department of Speech, Language and Hearing Sciences. His research focuses on improving clinical and research tools to measure the benefits of cochlear implants and hearing aids as well as the effects of hearing loss. Current studies focus on complex measures of speech perception and spatial hearing. Dr. Sheffield received a clinical Doctorate of Audiology degree in from the University of Iowa and completed an externship at the Mayo Clinic Rochester. He received his PhD in Audiology from Vanderbilt University. Dr. Sheffield then worked as a postdoctoral research audiologist at Walter Reed National Military Medical Center and an Adjunct Professor at the University of Maryland College Park.
Brian Taylor, AuD, is the senior director of audiology for Signia. He is also the editor of Audiology Practices, a quarterly journal of the Academy of Doctors of Audiology, editor-at-large for Hearing Health and Technology Matters and adjunct instructor at the University of Wisconsin.