Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids
A Rule by the
Food and Drug Administration on
08/17/2022
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I. Executive Summary
A. Purpose of the Final Rule
Hearing loss affects an estimated 30 million people in the United States and can have a significant impact on communication, social participation, and overall health and quality of life. Despite the high prevalence and public health impact of hearing loss, only about one-fifth of people who could benefit from a hearing aid seek intervention. Several barriers likely impede the use of hearing aids in hearing-impaired individuals such as high cost, stigma of being perceived as old or debilitated, and value (perceived hearing benefit relative to price). FDA is finalizing rules to address some of these concerns.
Moreover, the FDA Reauthorization Act of 2017 (FDARA) (Pub. L. 115-52) directs FDA to establish a category of OTC hearing aids through rulemaking, and FDARA sets forth various requirements for OTC hearing aids, including for reasonable assurance of safety and effectiveness, as well as Federal preemption provisions. In addition to protecting and promoting the public health, these rules establish the OTC category and implement the requirements of FDARA.
B. Summary of the Major Provisions of the Final Rule
FDA is establishing a regulatory category for OTC hearing aids to improve access to hearing aid technology for Americans. OTC hearing aids are intended to address perceived mild to moderate hearing loss in people aged 18 or older. Along with the OTC category, we are finalizing multiple related changes to the overall regulatory framework for hearing aids to harmonize existing rules with the new OTC category. We have determined that the requirements set forth in this rulemaking will protect the public health by providing reasonable assurance of safety and effectiveness for hearing aids, as well as promote the hearing health of Americans by lowering barriers to access and fostering innovation in hearing aid technology.
Among other things, FDARA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by defining OTC hearing aids and providing the authorities to establish the OTC category of hearing aids among provisions that are, by definition, general controls. We are finalizing general controls for OTC hearing aids consistent with FDARA.
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It took the FDA a while to write the proposed rules.
B. History of This Rulemaking and Public Participation
On October 20, 2021, in the
Federal Register , FDA proposed multiple regulatory changes, including proposing requirements for OTC hearing aids, that would serve to provide reasonable assurance of safety and effectiveness of hearing aids, address barriers to access to hearing aids, and effectuate the requirements of section 709 of FDARA (
86 FR 58150). Although the October 2021 proposal was the first step in this rulemaking, the proposal followed other steps FDA had already taken to initiate an update of the regulatory framework for hearing aids. Please refer to the aforementioned issue of the Federal Register for further details on the proposal and other steps taken by FDA.
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