FDA issues proposed OTC hearing aid rule

Regulatory NewsRegulatory News | 19 October 2021 |  By 

The US Food and Drug Administration (FDA) has issued a long-awaited proposed rule to create a new regulatory category that would allow the sale of over-the-counter (OTC) hearing aids for adults with mild and moderate hearing loss.
Implementing the proposed rule would make good on requirements established by the Over-the-Counter Hearing Aid Act of 2017 passed as a provision of the FDA Reauthorization Act of 2017. The act directed FDA to create a report available for public comment by the end of 2020 on creating a new regulatory class for OTC hearing aids, but the process was delayed due to the COVID-19 pandemic. On 9 July, President Biden requested the Proposed rule be published within 120 days of issuing a wide-ranging Executive Order on promoting competition in the US economy.
“Too often, patients have needed to make an appointment with a doctor or a hearing specialist to receive a hearing aid,” Health and Human Services Secretary Xavier Becerra said in a media briefing. “And with today's proposed rule, we would usher in a new system of over-the-counter options; we open the door to an easier process and a more affordable process for people to have access to good quality hearing aids. Today’s action by the FDA takes us another step closer to the goal of making hearing aids more accessible, more affordable for tens of millions of people.”
Hearing aids are currently regulated as restricted class I or class II devices in five classifications: air conduction (class I, 510(k) exempt) and bone conduction (class II) hearing aid devices, wireless air-conducting hearing aid devices (class II, 510(k) exempt), tympanic membrane contact hearing aid devices (class II), self-fitting air-conduction hearing aid devices (class II), and transcutaneous air-conduction hearing aid system devices (class II).
According to the proposed rule, certain air-conduction hearing aids would meet the new OTC category, while hearing aids intended for children and adolescents under 18 years of age or anyone with severe hearing loss would still require a prescription. OTC hearing aids under the new proposed rule will have limits on insertion depth, maximum output to prevent injury, as well as a limited range of frequency, distortion control limits, self-generated noise limits and latency limits. Additionally, OTC hearing aids would be subject to certain labeling requirements.
“[W]e would realign the existing classification regulations for hearing aids by sound conduction technology. However, the realignment would not affect the device class or premarket notification exemption status of any existing device,” FDA explained in the proposed rule. “On the effective date of the final rule, we would realign current product codes to correspond with the revised regulations for consistency but would not otherwise change the codes.”
PSAPs vs. OTC hearing aids
In draft guidance for industry and FDA staff, the agency clarified the difference between OTC hearing aids—devices that aid impaired hearing—and existing personal sound amplification products (PSAPs) meant to amplify sound for individuals without impaired hearing who are engaged in activities such as hunting or birdwatching.
This difference in intended use is critical to differentiating products whose technology may be similar, notes FDA in the draft guidance. In the document, FDA also reminds developers of these devices that intended use “refers to the ‘objective intent’ of those legally responsible for the labeling of the product.” Claims made in advertising and on labels are some of the means by which FDA determines objective intent.
Attorneys general in US states have previously issued consumer alerts warning residents to be cautious of companies marketing PSAPs as OTC hearing aids, and the FDA has acknowledged the situation has caused confusion in the marketplace.
“Manufacturers making claims or statements suggesting that their products may be used for hearing loss must comply with all applicable regulatory requirements for medical devices, including those specific to hearing aids, to market their devices legally,” Jeffrey Shuren, Director of the Center for Devices and Radiological Health at FDA, said of OTC hearing aids under the new classification.
Answering a question during the media briefing about what measures the FDA intends to take against manufacturers with products that don’t meet the classification requirements under the new proposed rule, Shuren said the agency would “take appropriate actions” if the rule is finalized to ensure those products marketed inappropriately aren’t being sold on the market.
“[W]e’re going to have to make sure that we’re very careful in what we do and how we both implement and enforce, because what we don’t want is for people to be sold by those who would claim that they now have FDA approval, there’s some kind of ‘Good Housekeeping Seal of Approval’ to what they do, and ultimately they defraud consumers even more,” Becerra, a former California attorney general, said in the briefing.
Draft Guidance: Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products
Proposed rule: Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you