A landmark proposal that is intended to improve access to and reduce the cost of hearing aids for millions of American has been issued by the US Food and Drug Administration (FDA). This proposal includes a rule that would establish a new category of over-the-counter (OTC) hearing aids, allowing select hearing aids to be sold directly to consumers without a medical examination.

“Approximately 15% of American adults [37.5 million] aged 18 and over report some trouble hearing,” the FDA noted in a statement. “However, despite the high prevalence and public health impact of hearing loss, only about one-fifth of people who could benefit from a hearing aid use one.”

The proposal aims to address “barriers to use” such as cost, access, social stigma, perceived value of the devices, and certain state and federal regulations.

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Health and Human Services Secretary Xavier Becerra states that this move by the FDA brings America one step closer to the goal of making hearing aids more accessible and more affordable for Americans who experience mild to moderate hearing loss.

To lower the cost of hearing aids, this proposal aims to facilitate innovation and increase competition by lowering barriers to entry for hearing aid manufacturers. “Under the proposed rule, hearing aids would be sold over the counter in more traditional brick-and-mortar retail stores or and will likely be less expensive than those currently sold – giving consumers greater choice at lower prices,” the FDA said.

“The proposed rule would also amend existing rules that apply to hearing aids for consistency with the new OTC category, repeal the conditions for sale for hearing aids, and address state regulation of hearing aids,” the FDA said in their statement.

Once finalized, the OTC category will apply to certain air-conduction hearing aids intended for adults 18 years and older who have mild to moderate hearing loss. Patients with severe hearing loss or who are younger than 18 years would still require prescription devices.

The rule will require certain device performances and design requirements and includes labeling requirements for OTC hearing aids. The proposed rule also addresses the maximum output limit for OTC hearing aids to prevent injuries caused by overamplification of sound.

The FDA also issued an updated draft guidance that is “intended to provide further clarification regarding the differences between hearing aids and PSAPs [personal sound amplification products], which help people with normal hearing amplify sounds, to inform consumers that PSAPs are not considered OTC alternatives for hearing aids.”


FDA issues landmark proposal to improve access to hearing aid technology for millions of Americans. News release. US Food and Drug Administration; October 19, 2021. Accessed October 19, 2021. https://www.fda.gov/news-events/press-announcements/fda-issues-landmark-proposal-improve-access-hearing-aid-technology-millions-americans