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Regulatory Focus™ > News Articles > 2022 > 1 > Stakeholders split over FDA’s contentious proposed rule for OTC hearing aids

Stakeholders split over FDA’s contentious proposed rule for OTC hearing aids

Posted 27 January 2022 | By Jeff Craven 

Stakeholders split over FDA’s contentious proposed rule for OTC hearing aids

The US Food and Drug Administration (FDA) has received a number of comments over the past few months on its proposed rule that would create a new regulatory category for over-the-counter (OTC) hearing aids for adults with mild or moderate hearing loss.
The proposed rule was written in response to the Over-the-Counter Hearing Aid Act of 2017 passed as a provision of the FDA Reauthorization Act of 2017. (RELATED: FDA issues proposed OTC hearing aid rule, Regulatory Focus 19 October 2021)
Overall, more than 1,000 comments were submitted by consumers, audiologists, industry-aligned stakeholders, healthcare systems, government entities, and Members of Congress. In general, most commenters agreed that OTC hearing aids are needed, but many had varying differences of opinion on what FDA should include in its final rule.
In a wide-ranging comment, the Hearing Industry Association (HIA) said it “strongly supports the introduction of safe and effective OTC hearing aids in the United States,” but took issue with some details in FDA’s proposed rule.
Stakeholders raised concerns about the safety of OTC hearing aid devices, requested clarification for how these devices would be classified, wanted more detail on package labeling, and asked FDA for more guidance on what the agency defined as mild or moderate hearing loss.
Many commenters, including the American Academy of Audiology (AAA) and International Hearing Society (IHS), pointed to consensus guidelines created in 2018 by a working group consisting of members representing AAA, IHS, Academy of Doctors of Audiology (ADA), and American Speech-Language-Hearing Association (ASHA) as a proper framework for implementing OTC hearing aids. The guidelines recommend product requirements, package labeling, an OTC regulatory classification, and consumer protection provisions.
“In its totality, the proposed rule fails to target the intended audience for OTC hearing aids and does not offer any assurance of reasonable safety measures. Rather than ‘protecting the public health,’ these regulations as drafted may instead put at risk the very people they are supposed to benefit,” AAA wrote in its comment to FDA.
Comments on lack of gain limits, high output limit for OTC hearing aids
By far, the issue that garnered the most comments was the decibel limit specified in FDA’s proposed rule. The rule would allow OTC hearing aids without a gain limit, and with an output of 120 dB SPL limit as well as devices with input-controlled compression and user-adjusted volume control.  
Some organizations, such as the Center for Medicare Advocacy and Consumer Technology Association, support the output limit as it is written. Senators Elizabeth Warren (Massachusetts) and Senator Chuck Grassley (Iowa) also supported how the proposed rule defines the output limit. “To ensure the final regulation is consistent with congressional intent, it must not contain any unnecessary restrictions that hinder access to over-the-counter (OTC) devices or their utility for Americans with mild or moderate hearing loss. For these reasons, we strongly support maintaining the maximum sound pressure level identified in the proposed rule and oppose the introduction of any limits on gain,” Warren and Grassley wrote.
However, organizations like the AAA and HIA disagreed. In particular, AAA was concerned that consumers may not know at what point a sound could be potentially harmful, and the removal of any gain limit could further damage hearing. “The Academy feels strongly that the inclusion of an effective and safe gain range (lower and upper limit) requirement is essential for the purposes of patient protection and to ensure that OTC hearing aids are appropriately targeted to individuals with perceived mild to moderate hearing loss,” AAA wrote.
“Without gain limits, there is no reason to believe that OTC hearing aids would not present the same risks as portable listening devices with respect to the risk of noise-induced hearing loss,” HIA commented. “Further, once a hearing aid is perceived as a ‘consumer’ product—combining ‘hearing aid’ function and streaming function—patients likely will use the hearing device for 12 hours a day or more; FDA should ensure that OTC hearing aids can be used for this purpose safely before any damage is done.”
Comments by the National Council of State Boards of Examiners in Speech-Language and Audiology, Medical Device Manufacturers Association (MDMA), Medical Alley Association, National Caucus and Center on Black Aging, and National Indian Council on Aging all appeared to agree with the assertion that there should be a gain limit on OTC devices and that the decibel limit should be reduced to safer levels.
‘Substantial unmet need’ exists for affordable hearing aids
In their comment, the Federal Trade Commission (FTC) provided a brief history of how it enforces consumer protection for eyeglasses and contact lenses and hinted at its decades-long struggle with preventing certain hearing aid manufacturers from defrauding consumers. “[T]hese rules enhance consumer access to optical goods by fostering competition in retail sales of eyeglasses and contact lenses,” FTC wrote.
FTC argued that current distribution channels and regulations at the federal and state level are partly responsible for less widespread adoption of hearing aids. Factors such as cost, and price transparency also play a role. “There appears to be substantial unmet medical need for hearing aids. While extrapolation of commercial demand from data regarding untreated hearing loss is not necessarily straightforward, it appears that many more consumers would purchase hearing aids were it not for certain barriers to hearing aid sales and acquisition,” FTC wrote.
“We believe that the proposed rule would, if adopted, serve to enhance competition and innovation among hearing aid retailers and manufacturers. Most important, as a result, enhanced competition and innovation will make lower-priced hearing aids available to the millions of American health care consumers who live with untreated hearing loss. For those reasons, we support the adoption of the Proposed Rule,” FTC concluded.
In their comment, the HIA expressed concern about lack of regulation in this area. “Pursuant to FDA recommendation, states historically have required licensing for the fitting, dispensing, and sometimes sale of hearing aids, and, through those licensing provisions require consumer protection from potential problems arising from the purchase of hearing aids,” they wrote. “Indeed, these consumer protections, including receipt requirements, mandatory return policies, and assistive technology device warranties, are imposed specifically through state professional licensing laws and regulations. If these licensing provisions are preempted, HIA is concerned that, without analogous consumer protection provisions integrated into federal regulations, these consumer protections will be lost.”
The National Association of Attorneys General noted in their comment that the proposed rule as written could have “unintended negative consequences” for consumers. “The proposed rule includes broad language that could be interpreted to repeal virtually all the state-requested exemptions from preemption issued by the FDA since 1980—even those related exclusively to non-OTC hearing aids,” they wrote. Such language could create unneeded confusion and the potential for unnecessary litigation.”
“Ultimately, it is unacceptable for us as primary enforcers of our respective states’ consumer protection statutes to step aside and cede the responsibility for protecting consumers that use hearing aids to the companies supplying the product,” the National Association of Attorneys General said. “We must be allowed to continue with our traditional consumer protection role and we strongly encourage the FDA to make that clear in the final OTC Rule.”
PSAPs vs. OTC hearing aids
While some organizations believed the FDA successfully outlined a distinction between existing personal sound amplification products (PSAPs) and OTC hearing aids, other groups wanted more clarifying language.
The Consumer Healthcare Products Association (CHPA) requested more information on what FDA considers a PSAP device or a hearing aid from a technology standpoint, as both devices can be similar.
“CHPA recommends that FDA further clarify and illustrate technology and design that is consistent with a PSAP intended use for non-hearing-impaired consumers as compared to technology and design that would be indicative of an intended use for individuals with perceived mild or moderate hearing loss,” they wrote.
Instant vs. custom-fit ear tips
Another issue raised by commenters is whether there should be a limit for inserting OTC hearing aid devices in the ear canal. A variety of devices currently exist on the market that use instant-fit ear tips, semi-custom or custom ear tips, or are self-fitting.
“We encourage the FDA to stipulate that only instant-fit eartips, or custom/semi-custom eartips that were fabricated based on non-invasive scans of the patient’s ears, be used as the forms of coupling between the OTC device and the wearer’s ear canal,” AAA wrote in its comment. “In the case where a custom earmold or ear shell would be required, based on current and future techniques that require inserting impression materials or scanners inside the ear canal, the service of a licensed hearing healthcare professional should be required.”
Sonova, a hearing assistance device company that helped contribute to HIA’s comment, commented separately to emphasize “adequate protections” for consumers in this area. “Sonova agrees that OTC hearing aids should be designed to limit the insertion of the eartip to the bony-cartilaginous junction of the external auditory canal and no deeper. Placing instruments too deep in the ear canal may result in damage to the ear canal and to the tympanic membrane,” they wrote. “Accordingly, FDA should implement additional safeguards to prevent consumers from placing OTC hearing aids too deep in the ear canal.”
Several comments said it is unclear whether FDA will require 510(k) clearance for OTC hearing aid devices. AAA in particular said they encourage the agency to “specify that all OTC hearing aid devices will need 510(k) clearance prior to marketing and sales.”
Other groups, like the National Indian Council on Aging, also requested clarification on whether different types of fitted hearing aids were subject to 510(k) review. “We are proposing to codify the requirement that an OTC hearing aid must include tools, tests, or software through which a lay user can control the device and customize it to the user’s hearing needs,” they wrote.
Questions about package labeling
Writing to the FDA, the National Council of State Boards of Examiners in Speech-Language and Audiology (NCSB) requested the agency create a package warning on the outside of the box to prohibit the sale and use of OTC hearing aids for individuals 18 years and under.
In addition, NCSB wanted FDA to create a package warning on the inside educating the consumer about hearing damage prevention. “Information should provide consumers with warning signs the amplified sound from their OTC aid might be too loud and damage their hearing, e.g. the consumer is having difficulty talking or hearing others talk over the sound, the sound makes the consumer’s ears hurt or ring, or other sounds seem muffled after the consumer leaves an area where there is loud sound,” they wrote.
“Additionally, NCSB recommends inside product labeling include information advising a consumer to seek help from a hearing care professional if they have any of the FDA’s listed warning signs or are concerned about their hearing after use of the device,” they said.
Definition of mild/moderate hearing loss
The NCSB had more to say about the agency’s definition of mild to moderate hearing loss as written in the proposed rule.
“NCSB believes the best way to determine hearing loss is through audiometric data. The FDA is proposing scenarios that suggest mild to moderate hearing loss,” they said. “As noted these may also be experienced by persons with normal hearing in poor acoustic and difficult listening situations. It is exactly this population who could be potentially over-exposed to the decibel levels in the proposed regulations.”
“Consumers need to be aware that there are different types, degrees, and configurations of hearing loss that can have significant implications for them and their success with any device,” they added. “Specialized evaluation may be needed in order to benefit from appropriate amplification. Clarification of what constitutes ‘mild to moderate’ hearing loss will help consumers make an informed decision on whether to purchase an OTC hearing aid or seek professional help.”
The HIA also requested FDA include a defined range for mild or moderate hearing loss. A lack of a range “raises concerns because the patient perception of hearing loss, which governs the appropriateness of an OTC hearing aid, can be an unreliable gauge of actual hearing loss,” they said. “Without a clear and well-understood definition of the intended user group for whom manufacturers should design products, there is significant risk that products marketed as OTC will not be safe and effective for patients with ‘perceived mild to moderate’ hearing loss.”
Proposed Rule: Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the- Counter Hearing Aids


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