OTC Hearing Aids: Hearing Professional Perspective on FDA’s Final Regulations

audiology opinion otc hearing aids
August 30, 2022

After years of debate and discussion, the FDA has finally issued its ‘final rule’ for over-the-counter (OTC) hearing aids in the United States. After hearing from numerous stakeholders and thousands of comments following the publication of the draft rule in late 2021, the FDA made some changes to the previous draft version of the regulations.

How do hearing professionals feel about the changes that were made? How do they see the market developing in the United States and do they think it will have a negative impact on patient care? In this special episode, we hear from three hearing professionals who are all also private practice owners.

To provide a wide range of perspective, we also sought out opinions from consumers and from the hearing device industry, which can be viewed here:

Full Episode Transcript

Dave Kemp 0:10
On August 16 2022, the FDA issued its final ruling on the guidelines surrounding over the counter hearing aids. So here at This Week in Hearing, we’ve gathered a variety of different opinions from folks working in and around the hearing industry to weigh in on this historic ruling that has been years in the making. Enjoy.

Madison Levine 0:35
Hi, I’m Madison Levine at Levine hearing in Charlotte, North Carolina. So over the counter hearing aids are here, we now have gotten to see what are the regulations that the FDA has actually put in place. So I think where we’re at right now is still a lot of speculation, we don’t really know what things are going to look like, until we see some OTC hearing aids available. come October. So right now, there’s a lot of questions spinning around about what this is going to mean, for patients and for hearing healthcare providers. My hope is that this is going to add accessibility for a broad swath of people who would not have been able to invest in professional hearing healthcare, I hope that it adds accessibility for them, and improves improves their quality of life, we know that treating hearing loss improves so many different health outcomes for a person cognitively and in their overall wellness. Now, I’d be remiss if I did not say that I believe that seeing a hearing health care provider first is essential. We are the frontline that are able to catch all kinds of issues, that could mean that a surgical intervention is a possibility to correct that hearing loss. And even in rare cases, we’re catching things like tumors that are going to that are going to need a referral to an ear, nose and throat doctor and possibly surgery. So one of my concerns as we go forward is that consumers may have a little bit of confusion, as the marketing on both sides is going to be very strong. And I hope that the message that comes through is that hearing healthcare providers need to be the first visit. And if you have questions about OTCs, asking that hearing healthcare provider is going to be the place to send those questions and to see could this be a solution that could work out for you? Or is it more prescriptive hearing aid going to be a better fit, we have equipment diagnostics, that we’re well trained on that are very important to actually getting an effective fit for hearing aid. And I am interested to see the technological advances that are going to come with OTCs to try to rise to meet those expectations, I think it’s going to be very tough, it’s already tough when you have a professional working on it, let alone something bought out of a box with perhaps an app or an app or a website to support it. So I think there’s a lot of unknowns. I’m personally very excited about the horizon, and how the future looks for access to hearing care for patients and for what this career in this profession has to look forward to in terms of technology and growth in the sector. So stay tuned, I can’t wait to find out what comes next.

D’Anne Rudden 3:46
My overall take on the FDA releasing the OTC guidelines is that in many ways, this is hopefully a step forward in getting a greater amount of awareness about hearing loss in general, and potentially in a a package where consumers can seek out hearing care in an affordable way and have greater exposure by seeing it available in you know supermarkets and online and drug drugstores and grocery stores and all of that. The concern, as we all know as audiologists is that the caveat around the whole thing is the perception of mild to moderate hearing loss. And, you know, obviously we know that patients have had difficulty determining the own their own severity of hearing loss. And I would definitely say you know, for a certain number of people, this is going to be a great solution for them. Those people that just need a little boost, something that gives them a greater level of portability. So at the end of the day, I do think that there is a potential that we’re going to help a whole lot more people than we have in the past. At the end of the day, I don’t think that it’s necessarily going to delay people from getting help I, you know, I think that may be a short term consequences, people explore the possibilities of devices online, and something where, you know, they don’t feel like there’s the, you know, the loopholes, or the things that they have to jump through to get access to things that there may have been for them in the past, you know, especially those that really don’t see a lot of communication difficulties. So they just haven’t reached that pain point, per se. I tend to feel more optimistic that instead of it being a negative, that, you know, people will delay their care, my hope is that it actually shines a bigger light on hearing loss in general, and the need for people to care for their hearing loss throughout the lifespan, not just, you know, when things get so severe that their families are, are bugging them. I do think that, you know, the existing prescriptive hearing market will always have a place. But I do think that audiologists need to look a little further up the food chain, so to speak, you know, the low hanging fruit has always been audibility. And that’s something that we have taken hold of, and it kind of runs the vast majority of our clinical practice. But I would say, you know, really, where the rubber meets the road is a little higher up in the brain, having a greater impact on people, you know, diagnosing auditory processing issues, tinnitus issues, really providing more specialized care, and care beyond just placing hearing aids on people and prescribing the settings and walking them through how to use products, I really do believe that we can help more people and have a greater impact if we start doing the rehabilitation around it that we probably should have already been doing. And I choose to be positive, you know, I choose to feel like this is an opportunity as opposed to a threat. It’s something that we’ve known would be here for a long time. And in fact, you know, I actually did some talks in my community about peace apps and over the counter, which, you know, what it was interesting is when I said to them, that the caveat being perceived hearing loss, they all said pretty much the same thing. Well, how would I know? Isn’t that what a hearing test is for? And the answer absolutely is- yes. So I think the tools for consumers to self diagnose hearing loss have improved a great deal. There’s a lot of reliable tools out there. And I think where audiologists sometimes get hung up is that that’s not the end of the road. For us. That’s actually the beginning of the road for us. So I choose to feel like this is potentially going to enhance what I’m already doing in my practice, it’s going to look different, but I’m extremely optimistic and about the future.

You know, one last thing that I wanted to mention is that, you know, this actually can be used as a profession for us as a springboard to talking more about MAASA, the Medicare Audiologist Access and Services Act. So it is even more important that we rally behind MAASA and work towards getting that past access to getting better hearing shouldn’t stop at the drugstore counter, it should actually be something that that we are able to help our patients achieve both in a clinical setting as well as providing them some entry points through things like over the counter hearing aids. So that’s that’s my take on it is that it’s it brings us a little closer to masa is my hope

Laura Pratesi 9:53
my name is Laura Pratesi. I’m a hard of hearing bilateral hearing aid user and a doctor of audiology. I opened my own private practice Citrus Hearing Clinic in Clermont, Florida in 2018. The Americans with Disabilities Act defines a disability as a physical or mental impairment that substantially limits a major life activity. Hearing loss and communication are specifically listed as major life activities under the ADA Amendments Act, which was signed into law in 2008. But most major insurance companies classify hearing aids as cosmetic devices and audiologists as equipment suppliers and not as doctoral level practitioners. While the new FDA over the counter hearing aid regulation will hopefully help to destigmatize the utilization of hearing aids and decrease the average time a patient waits before trying amplification. It does not go far enough. Currently, OTC devices are for adult patients with mild to moderate hearing losses. This continues to leave children and patients with greater than moderate hearing losses without access to Hearing and Balance health care. As someone with hearing loss and as a hearing aid user myself, I am acutely aware of the impact of untreated hearing loss can have on financial, social and emotional well being. There are studies that demonstrate this. For audiological care to truly be affordable and accessible to all Americans. We need legislation that takes the next step, including recognition of audiologists, not only as diagnosticians or equipment suppliers, but as rehabilitators. We need insurance companies to recognize hearing aids as medically necessary devices, and mandatory insurance coverage for all deaf and hard of hearing children regardless of Medicaid eligibility. Patients on Medicare deserve direct access to audiologists without the need for a physician order. This barrier results in multiple doctor’s visits to obtain referrals or prior authorizations simply to see an audiologist for the first time, costing taxpayers millions of dollars every year for additional unnecessary and arbitrary visits. We should also calculate the burden on caregivers in terms of time and lost wages for additional appointments, which is a cost not levied on those with most private insurances. Insurance companies must begin to recognize the importance of the work that goes beyond the hearing device itself, such as oral rehabilitation, and hearing aid verification measures like real ear measurements, electro acoustic analysis, and functional listening assessments. Putting a hearing aid in an ear can only do so much on its own. As a bilateral hearing aid user myself, I should know. So while I celebrate with the 5% of patients who can likely benefit from the new OTC regulations, I cannot be complacent as our profession must continue to fight for the other 95% of patients who are affected by hearing and balance disorders who could benefit from more affordable direct access to audiological care. Our work is not done yet. Change doesn’t happen overnight. This OTC regulation passed in 2017 after all – as someone with a personal and professional interest in these matters. I will continue to do what I can to advocate lobby and educate others on how we can continue to work to make audiological care affordable and accessible for everyone.

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About the Panel

Madison Levine, BC-HIS, is the owner of Levine Hearing and is nationally Board Certified Hearing Instrument Specialist. She is a second-generation professional in hearing healthcare. She holds a Bachelor of Science degree from the University of Georgia.


Laura Pratesi, AuD, is the owner and founder of Citrus Hearing Clinic. She was born with a progressive hearing loss, and is currently a bilateral hearing aid user. She graduated from Auburn University with her Bachelor of Science in Communication Sciences and Disorders in 2008. She then was the youngest person to complete Auburn’s Doctor of Audiology program, graduating in 2012. Since that time, she has been named an Orlando Magazine Woman of the Year (2020), had publications featured in The Hearing Journal, and been a presenter for AudiologyOnline.

D’Anne Rudden, AuD, is the owner of Longmont Hearing & Tinnitus Center. Dr. Rudden serves as a Global Hearing Ambassador for Hearing the Call. In fact, she is one of the founding members and the current Project Manager for Hearing the Call Colorado. In addition, Dr. Rudden is the host of The Hearing Journal Podcast. She is an industry leader and respected expert with published articles in Seminars in Hearing, Audiology Today, Audiology Practices, and The Hearing Journal. She travels nationally as a sought-after public speaker, thought leader, and greatness enabler. 

  1. Hi. In the unlikely event that some of your readers might want to read the content, is there a transcript available? Thanks.

    1. HHTM Author

      Hi Grant, thanks for your comments. Please look directly below the video in the above article where it says ‘full episode transcript’. Click this to expand to view the transcript of the discussion. Thanks!

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