From the Desk of Gus Mueller
Not since the long-awaited arrival of the Western Electric 2-A audiometer has the audiologic world experienced such prolonged anticipation. Yes, I’m of course referring to the five-year wait for the FDA to release the final statement on the new category of OTC hearing aids. The 200-page document was finally filed on August 16, 2022, at 8:45 am (EDT), and went into effect on October 17, 2022. Products immediately were available at several outlets. Who knew that there would be the day when our patients could buy their hearing aids at the neighborhood grocery store!
While we all knew that the OTC hearing aid category was a done deal, and we’d had a long time to think about the potential impact, that didn’t deter a flood of comments appearing on audiology social media sites immediately following the official announcement. As one would expect, these comments ranged from the somewhat defeatist attitude “Is this the end of our profession?” or, “I think I hear the sky falling,” to the more moderate, “We’ve been through this before.” And, sprinkled in here and there were a few echoing this theme: “What a great opportunity” and “It’s our time to shine.”
Sell them? Service them? Ignore them? I guess I personally fall into the “who knows how this will turn out” camp. But before you even decide on a camp, it’s good to know the ins and outs of this new hearing aid category. There is a lot of misinformation out there, and many of you who do not even sell hearing aids are being bombarded with questions from your patients. In addition to the products themselves, there also are some quirky things related to licensure laws.
Who better to tell us about this new hearing aid category than someone who was one of the first to be involved in private practice hearing aid dispensing, beginning in 1977, shortly after it was deemed “ethical” by the ASHA. I’m talking about this month’s 20Q guest author, Tom Powers, Ph.D. Tom is better known, however, for his many publications surrounding hearing aid technology, and as the “audiologic face of Siemens Hearing,” where for 35 years he held several executive positions. Today, he is the Founder and Managing Member of Powers Consulting, LLC, providing consulting services to the Hearing Industries Association, Amplifi Hearing, and Healthcare Technologies and Methods, LLC.
Dr. Powers has appointments as assistant professor in the Graduate Faculty in Biomedicine at Salus University and as Adjunct Research Professor at Ohio University. He is a member of several professional audiology organizations and foundations, and has previously served as President of the American Auditory Society.
Sell them? Service them? Ignore them? Regardless of your thoughts or plans concerning this new OTC hearing aid category, you’ll find Tom’s 20Q article informative and helpful.
Gus Mueller, PhD
Browse the complete collection of 20Q with Gus Mueller CEU articles at www.audiologyonline.com/20Q
20Q: OTC Hearing Aids - They’ve Arrived!
After reading this article, professionals will be able to:
- Describe the regulatory changes related to OTC hearing aids that will impact the delivery system for hearing health products and services and discuss the candidates for the OTC hearing aids.
- Review the events and organizations that were involved in providing input to the OTC hearing aid legislation.
- Discuss the gain and output limitations contained in the regulations and compare the ways hearing healthcare professionals may be involved in the OTC hearing aid market.
1. It seems like I’ve been hearing about OTC hearing aids for a long time?
You have. After five years of waiting for the official document, consumers can now purchase hearing aids outside of a hearing aid office. Until now, almost all hearing aids in the United States were sold by audiologists or hearing aid specialists. There are now, however, a set of new rules published by the FDA that will regulate the purchase of over-the-counter (OTC) devices or OTC hearing aids that are being implemented. But before we go there, maybe a quick recap of how we got here.
To some extent, the OTC hearing aid process started way back in 2009 at an NIH conference looking into how to improve the access and affordability of hearing aids. A few years later there were a series of meetings and workshops that picked up on this topic and each group began to issue recommendations. One early group was the PCAST (President’s Council of Advisors on Science and Technology). Then in 2015 and 2016 the meetings really ramped up, with workshops being held by the FDA, FTC (Federal Trade Commission), and the National Academy of Science, Engineering and Medicine (NASEM; formerly the Institute of Medicine). The NASEM issued a final set of 12 recommendations of which two were critical in the development of what would become the OTC class of hearing aids. First, remove the requirement for physician clearance, and second, implement a new device category of over-the-counter wearable devices. These recommendations led to the introduction of the over-the-counter hearing aid act by Senators Grassley and Warren in 2016. It was passed and signed into law by President Trump in 2017.
2. If I am correct, this is 2022! And we just got the regulations? What took so long?
The legislation required the FDA to establish the new category of devices by August 2020. In early 2019 COVID hit, and the FDA was “all hands on deck” related to the pandemic and the OTC hearing aid issue went to the proverbial backburner. In July 2021, President Biden issued an executive order to urge the FDA to expedite the release of the OTC hearing aid regulations.
The next milestone was in October 2021 when the FDA released the draft regulations with a 60-day comment period. Over 1000 comments were submitted. The next step was a review of the comments and the issuance of the final regulations, which occurred in August 2022. These regulations officially became effective on October 17, 2022. At that time, device manufacturers that had met the FDA requirements for OTC devices could legally sell them.
3. I’ve heard that there are two different categories of OTC hearing aids - is this true?
Yes, there are, and the regulations classify these devices differently. OTC devices are any air-conduction hearing aid for mild-to-moderate hearing loss that includes “tools, tests, or software” to allow the user to “control or customize” the hearing aid and is available without the intervention of a licensed person.
The second category, self-fitting OTC devices are wireless air-conduction hearing aids that incorporate technology, including software, that allows users to program hearing aids, that integrates user input with a self-fitting strategy, and that enables users to independently derive and customize their hearing aid fittings and settings.
One additional difference is that for self-fitting OTC devices, the manufacturers are required to submit pre-market approval documentation referred to as 510(k). This is a set of documents that describe the performance data of the device, the safety and manufacturing standards that are applicable, and clinical research data on the device. As you might recall, an example of this process was a fairly extensive study conducted with the Bose self-fitting product, published a couple of years ago (Sabin et al., 2020).
I should also mention that what we commonly have called hearing aids, those only sold by a licensed professional, are now referred to as “prescription” hearing aids in the FDA document.
4. Prescription? That’s an interesting term to use.
In more ways than you might think. The AAA (and maybe other audiology organizations) asked for clarification. As stated in the AAA letter to the FDA:
“We are concerned that some interests may equate “prescription” hearing aids as requiring a “prescription” from an individual with prescriptive authority as that term is currently used. Prescriptive authority is currently defined at the state level for mid-level practitioners such as nurse practitioners and physician assistants—and may differ depending on the type of practitioner. Audiologists are not included in this classification. In many cases, the state definition refers only to the prescribing of prescription drugs and controlled substances; however, there are some states (including but not limited to PA, VA, TX, and WA) in which prescriptive authority is defined in some instances to also include devices and durable medical equipment.”
Because of concerns such as this, the FDA issued additional guidance on October 13, 2022, that clarified that the regulation. They stated that the regulation: “does not change the necessary qualifications of who may provide hearing healthcare with prescription hearing aids, including the recommendation, selection, fitting, and dispensing of these devices.” They further stated that “it does not in any way require a physician’s involvement prior to fitting [prescription hearing aids] and does not require an examination of any kind to obtain a prescription hearing aid.”
5. Interesting exchange. Who are the intended candidates for these new OTC devices?
The regulations establish that individuals with self-perceived mild-to-moderate hearing loss and who are over 18 years of age would be able to purchase OTC devices. They did not, however, establish a specific audiometric threshold level for mild-moderate loss. Therefore, it is up to the individual to determine this for themselves or to seek a hearing professional for a hearing test. It is clear in the regulations, however, that the hearing test is not a requirement to purchase an OTC or self-fitting OTC device. Even though the intended candidate is someone with mild-to-moderate hearing loss, someone with normal hearing or a severe loss certainly could purchase them if they wanted.
6. If these devices are intended for mild-moderate hearing losses, what are the gain and output parameters?
The original proposal from the FDA was no gain limit and 115 dB SPL (re:2-cc coupler) maximum output with an exception of 120 dB SPL output when the device has input compression. The final regulations remained without any gain limit, but lowered the maximum output levels to 111 dB and 117 dB for devices with input compression. All levels are peak level, not RMS levels. The regulations allow the manufacturer to provide either a physical volume control on the device or a user control via an app on a smartphone. In this way the manufacturer is free to develop smaller devices and will encourage innovation in form factors. Some opinion leaders have expressed concern that there is no gain limit, but to a large extent this will be indirectly controlled by the output restriction.
To ensure that the new OTC devices have their own set of device performance standards, the FDA regulations require OTC manufacturers to provide test data under ANSI/CTA-2051:2017. This standard was originally proposed for personal sound amplification products (PSAPs), however, was deemed appropriate for the new classification of OTC devices. Prescription hearing aids will continue to use the ANSI/ASA 3.22-2014.
7. I would guess that consumers are really interested in the introduction of OTC hearing aids?
Yes, that would be a correct guess. Data recently collected by audiologist Paul Dybala indicated that Google searches for OTC devices increased significantly after the release of the draft regulations, but then quickly dropped (Dybala, 2022). However, it did maintain a higher level of search than for “cheap hearing aids,” or “discount hearing aids.” The data also showed that searches for “hearing aids” continued to increase and have a significantly higher search rate than that of OTC devices. It’s possible of course that people looking for OTC products are just typing in “hearing aids.” The buzz on audiology social media sites also suggests a high level of inquiries from consumers.
8. What provisions have the FDA made to ensure consumers understand what they are purchasing?
The new regulations have extensive new labeling requirements for all devices. These include both inside-the-box and outside-the-box information. For the OTC and self-fitting OTC devices the user must be informed the devices are only available for adults over 18, they are appropriate for mild-moderate hearing loss, and that if they have medical issues (ear pain, drainage, etc.) you should see a physician. The return policy must be clearly stated, and the user manual must be provided in printed format or available via link or QR code. Extensive instructions on use and insertion of the device must be provided. For prescription hearing aids the labeling also includes specific information that children under 18 years of age should consult with a physician, warnings about medical conditions, and additional warning information for dispensers.
9. Do you think that these new regulations will make hearing aids more affordable?
The two drivers of the original legislation were access and affordability. It was assumed that eliminating the requirement to visit a professional would reduce the overall cost of hearing aids, and indeed, from what we have seen so far, OTC products are selling for less than “traditional” hearing aids. The notion also was that by increasing innovation and competition in the hearing aid industry, prices on prescription hearing aids also would decrease. We’ll have to take a “wait-and-see” on that one.
The regulations themselves do not deal with either issue, but with the safety and efficacy of the devices, as that is the role of the FDA.
10. What about access to hearing aids?
The OTC devices prohibit the requirement that a professional be involved in the sale of the devices. One concern from the NASEM about access to hearing care was the limited number of hearing professionals in the U.S., especially in rural environments. By increasing the points of purchase, consumers with mild-moderate hearing loss would have more access to hearing help.
11. Will audiologists embrace OTC hearing aids and include them in their practices?
The three major audiology associations (ADA, AAA, ASHA) have all encouraged their members to be active in the OTC channel. For some, this may only mean providing diagnostic testing to inform the consumer if they are indeed in the mild-moderate category and provide recommendations for specific devices. Others may provide the diagnostic testing and also sell the OTC devices. And some might not sell the devices, but offer a wide array of post-fitting services for the OTC users. I think initially we will see considerable differences from office to office. In a recent survey (August, 2022; n=730), 26% of audiologists and hearing specialists stated that they plan to sell OTC devices at their clinics/practices or via their websites, and 55% stated that they plan to provide support for patients who have purchased OTC devices (Bailey, 2022).
12. What retail outlets do we expect to find OTC devices for sale?
The regulations prohibit states from passing laws that would restrict the sale of OTC devices. It was announced that Best Buy will carry at least five brands. These include Jabra by GN, Nuhera, Eargo, Lexie B1 (BOSE), and Lucid. Walgreens pharmacy announced it would carry several brands in all its stores. It is also expected that other national chains such as CVS and Walmart may sell OTC devices.
13. You mention Walgreens. Will pharmacists be involved in the sale of OTC devices?
Yes, in fact, pharmacists have been preparing for the OTC channel for some time (Berenbrok et al., 2020). For example, the Pharmacy Association in cooperation with the Audiology Department at the University of Pittsburgh developed a training program for pharmacists to assist consumers with OTC devices. The course provides information on basic hearing difficulties, identifying “red flags,” and providing recommendations for further testing if red flags are present. Also, where to send the consumer for additional information. It is expected they would refer to local audiologists or hearing professionals for further testing. Earlier we were discussing access. One interesting note about pharmacies becoming involved in the sale of OTC devices is the statistic that 90% of the individuals in the US live within 5 miles of the 60,000 local pharmacies.
14. Will the existing major manufacturers develop/sell OTC devices?
Yes, we have already seen the Jabra device from GN enter the direct-to-consumer (DTC) market with an indication this device will now move to OTC. Several other companies have clinical trials underway to collect data for a 510(k) submission in the self-fitting OTC category. As we discussed earlier, others in the DTC channel have announced distribution in retail outlets. I do expect that devices from the “Big 5” and other major manufacturers will be sold in the OTC channel as well as through the existing “prescription” channel. Several recent announcements indicate that traditional hearing aid companies are engaging in collaboration with well-known consumer brands. These include Nuheara and HP, Demant and Phillips, and Sonova and Sennheiser, to mention a few. WS Audiology announced a partnership with SONY, and has introduced two different models that are SONY branded, using signal processing developed by WSA, now being sold at Best Buy, through the professional channel (and maybe elsewhere).
15. Will the patients have the same “return for credit” policy that we now have in place?
The FDA did not mandate that manufacturers were required to have a return privilege. The FDA concluded this is not a safety issue and should be left to the manufacturers and sellers of the devices. One unintended consequence of the lack of a return privilege is that most state licensing requirements do require both a return privilege and a trial period. This could potentially put licensed professionals at a disadvantage over non-licensed OTC sellers that are not required to offer these.
16. It seems that the pre-emption of state rules has created some confusion and concern for hearing professionals?
It is a little confusing. The FDA is allowing the licensing requirement for professionals such as audiologists and hearing care specialists to remain; however, those requirements cannot interfere with the sale of OTC devices. Or in other words, the sale of OTC devices cannot be dependent on seeing a hearing care professional as that is one of the core tenants of the original legislation, that no professional is involved, hence the term OTC.
This can be one of the more complex parts of the regulations, as licensed professionals will have to adhere to the state regulations while those selling OTC devices in a purely retail OTC store may only have limited regulations (e.g., state business regulations). This could impact issues such as trial periods, return for credit, and other consumer protections.
17. Once the dust settles, what do you see as some of the positive outcomes of OTC devices?
It is expected that the regulations will provide greater access by allowing sales of devices in non-traditional retail outlets. More access should translate to more people using hearing aids. It also is expected that OTC sales channels may put pressure on existing dispensing professionals to “unbundle” their pricing to reflect the cost of the device separately from the professional services provided. The regulations should move current DTC channel distributors into the OTC model, and provide improved regulatory oversight.
18. Are there any negative outcomes expected?
Yes, since the involvement of hearing professionals is eliminated, you may improperly treat your hearing loss or purchase a device that does not provide benefit, that you have trouble operating, and/or cannot be returned. Consider all the patients who have considerable trouble putting hearing aids into their ears, even with the help of a professional. Also, the “one-size” OTC device category that does not require pre-market clearance by the FDA may open the door to unscrupulous companies selling lower-quality devices.
19. It seems to me that many patients will struggle with the general operation of the products without any professional guidance?
That appears to be an opinion shared among audiologists. Abram Bailey of HearingTracker recently conducted a survey of audiologists and hearing specialists (n=730) regarding what they viewed as their greatest concern regarding the introduction of OTC hearing aids (Bailey, 2022). Several items were rated on a 1-5 scale. Here are the top ten issues from his survey (in descending order):
- Consumers will struggle to identify and address common problems (like moisture and wax issues).
- Consumers who purchase OTC hearing aids will not be educated on realistic expectations.
- Consumers who purchase OTC hearing aids will not be educated on effective communication strategies.
- Consumers will miss medical red flags and fail to have pathologies diagnosed and treated in a timely manner.
- Consumers are not able to accurately able to predict their level of hearing loss.
- Consumers will not have adequate access to services when their hearing aids malfunction.
- Consumers that purchase OTC devices will not be educated on hearing protection/conservation.
- The OTC class of devices will lead to greater confusion in the marketplace for consumers.
- Consumers will struggle to program their hearing aids appropriately on their own.
- OTC devices won’t provide the same level of benefit as professionally fitted hearing aids for those with mild to moderate loss.
20. It looks like the hearing aid industry could see significant change over the next year. What do you see in your crystal ball?
I think we all need to embrace the new OTC channel as this could bring new users into the market. Those with self-reported mild hearing loss currently have an adoption rate of only ~19%, so there is a lot of potential growth. New suppliers need to provide quality devices and ensure adequate customer support. We will continue to see known consumer brands entering the market, possibly with current hearing aid companies. One issue that OTC hearing aids may have an impact on is “stigma.” Will patients who “self-fit” their own hearing aids be more empowered to wear them? Also, will the new form factors that resemble today’s earbuds also reduce the stigma of wearing hearing aids? Time will tell.
Bailey, A. (2022). OTC hearing aids—From the perspective of audiologists and hearing aid specialists. HearingTracker.com. https://www.hearingtracker.com/pro-news/what-do-audiologists-think-of-otc-hearing-aids
Berenbrok, L., Ciemniecki, L., Cremeans, A., Albright, R., & Mormer, E. (2021). Pharmacist competencies for over-the-counter hearing aids: A Delphi study. Journal of the American Pharmacists Association, 61(4) e255-e262.
Dybala, P. (2022). I asked google - are consumers “interested” in OTC hearing aids? LinkedIn.
Sabin, A.T., Van Tasell, D.J., Rabinowitz, B., & Dhar, S. (2020). Validation of a self-fitting method for over-the-counter hearing aids. Trends in Hearing. 24.
Powers, T. A. (2022). 20Q: OTC hearing aids - they’ve arrived! AudiologyOnline, Article 28393. Available at www.audiologyonline.com