Health Law Daily Wrap Up, MEDICAL DEVICES—GAO REPORTS: Report sheds light on FDA’s rulemaking on OTC hearing aids, (Jun 11, 2024)
Organizations Mentioned:Federal Trade Commission | Office of Regulatory Affairs
By Patricia K. Ruiz, J.D.
The FDA currently has no plans to revise its regulations on OTC hearing aids.
A report by the Government Accountability Office (GAO) provides information on a new FDA medical device category for over-the-counter (OTC) hearing aids. The GAO was asked to examine consumer access to hearing loss treatment following the FDA’s issuance of its OTC hearing aids final rule (87 Fed. Reg. 50698 (August 17, 2022)). The report describes the FDA’s rulemaking process for creating the new category for hearing aids, the FDA’s and other federal agencies’ oversight of OTC hearing aids, existing research on the effect of OTC hearing aids on access to hearing loss treatment, and key issues relating to OTC hearing aids (GAO Report, GAO-24-106854, May 7, 2024).
Rulemaking. In August 2022, the FDA finalized a rule allowing certain hearing aids to be sold OTC, or without the involvement of a licensed professional, beginning in October 2022. In drafting the rule, the FDA worked with internal experts, including audiologists, an ear, nose, and throat doctor, and engineers trained in speech processing, all of whom were already involved in the FDA’s oversight of hearing aids. Additionally, the FDA sought input from external stakeholder groups, audiologists and hearing professionals, and the hearing aid industry.
OTC hearing aids use the same fundamental scientific technology as prescription air-conduction hearing aids and are available without a prescription or the involvement of a licensed professional. OTC hearing aids are intended for those aged 18 and older with perceived mild-to-moderate hearing loss. Through its final rule, the FDA created limitations for OTC hearing aids by setting a maximum sound output and insertion depth in the ear canal, setting electroacoustic performance specifications, and requiring certain information on the device labeling.
Regulatory oversight. OTC hearing aids are subject to the same FDA premarket reviews and postmarket oversight as other medical devices. Within the FDA, the Center for Devices and Radiological Health and the Office of Regulatory Affairs have oversight responsibility for hearing aids. The FDA coordinates with the Federal Trade Commission (FTC) on trade practices involving hearing aids, with the FTC bearing primary responsibility for the truth or falsity of advertising for most medical devices, including OTC hearing aids. The FDA also coordinates with the National Institute on Deafness and Other Communication Disorders for purposes of developing educational materials consistent with the final rule and its regulatory effects. The FDA also communicates with CMS on device risk-benefit profiles and device performance to inform CMS decisions regarding health insurance coverage of medical devices.
Effects on access to treatment. Consumers have been able to purchase OTC hearing aids for less than two years, and there is limited research examining the effect on patient access to hearing loss treatment. Early research, however, has suggested that OTC hearing aids can be as effective as prescription hearing aids and may as a result expand access for those with mild-to-moderate hearing loss. However, research and external stakeholder groups reported barriers to accessing hearing loss treatment—such as consumer preferences and professional concerns, difficulty assessing hearing loss, and affordability—even with the availability of OTC hearing aids.
Recommended monitoring; next steps. Several external stakeholder groups identified issues relating to OTC hearing aids for which the groups recommended monitoring as the market matures, including children’s use of OTC hearing aids, return policies, and limits on gain, which is the amount of amplification added to incoming sounds resulting in sound output. As of February 2024, the FDA did not have any plans to revise its OTC hearing aid regulations but may issue technology specific regulations and guidance as new hearing technologies are approved and cleared by the FDA. The FDA is required to analyze adverse events related to OTC hearing aids and submit a report to Congress by August 2024. The results of the report may have implications for the FDA’s oversight of OTC hearing aids.
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