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Volume XII, Number 272

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Hearing Aids: More Accessible to Consumers After FDA Issues Final Rule

Many people experience hearing loss and related hearing issues. To date, to get a hearing aid, people needed a prescription and to see a licensed hearing aid specialist in order to be properly diagnosed and fitted for a hearing aid. Now, as outlined below, the U.S. Food and Drug Administration (FDA or Agency) has issued a final rule that changes the requirements so that no prescription is necessary for people with perceived mild to moderate hearing loss. The result will be that such people can have more ready access to hearing aids.

On August 16, 2022, the FDA finalized a long-awaited rule establishing a new over-the-counter (OTC) hearing aids category. This final rule only applies to individuals who are age 18 and older with perceived mild to moderate hearing loss. The final rule will take effect on October 17, 2022.

The FDA estimates that approximately 30 million people in the U.S. are affected by hearing loss, but only about one-fifth of this population seek intervention. According to the FDA, the final rule aims to encourage competition and facilitate the sale of OTC hearing aids in an effort to improve access to these devices for individuals with perceived mild to moderate hearing loss.

Under the final rule, consumers with perceived mild to moderate hearing loss will be able to purchase hearing aids directly online or in retail stores without a medical exam, prescription, or a fitting adjustment by a licensed audiologist. Hearing aids that do not meet the OTC regulatory requirements (e.g., intended for severely hearing impaired or for individuals younger than age 18) will be deemed prescription devices by the Agency.

The final rule will require OTC hearing aids to comply with regulatory requirements under 21 C.F.R. § 800.30, which include labeling, performance, design requirements, and other applicable requirements such as special controls. OTC hearing aids will also be subject to quality system requirements under 21 C.F.R. Part 820. Furthermore, the final rule amends existing rules that apply to prescription hearing aids, repeals the conditions for sale for hearing aids, and addresses preemption issues including state consumer protections requirements. 

In response to comments submitted to the proposed rule issued last October, FDA made several notable changes in the final rule. These changes include lowering the maximum sound output, revising the insertion depth limit in the ear canal, requiring that all OTC hearing aids have a user-adjustable volume control, and simplifying the wording on the product labeling. Additionally, under the final rule, FDA will not require age verification for the sale of OTC hearing aids and will not require OTC hearing aids to be self-fitting devices. 

Manufacturers of hearing aids sold prior to October 17, 2022 (i.e., the effective date for the final rule) will have 240 days to comply with the new or revised requirements. For hearing aids that have not been offered for sale prior to the effective date, manufacturers must comply with the new or revised requirements before marketing their devices, including obtaining a premarket notification if applicable.

FDA’s change in hearing aid requirements for people with perceived mild to moderate hearing loss will make it significantly easier to get access to hearing aids.

© 2022 Foley & Lardner LLPNational Law Review, Volume XII, Number 229
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About this Author

Devaki Patel Healthcare Lawyer Foley and Lardner
Associate

Devaki (Devki) Patel is an associate with Foley & Lardner LLP, based in the firm’s Washington D.C. office, where she is a member of the firm’s Government Solutions and FDA Regulatory Practices. She is also a member of the Life Sciences, Food and Beverage and Cannabis Industry Teams. In addition to being an attorney, she is a licensed pharmacist. Devaki is admitted to practice only in Maryland. She is practicing under the supervision of a member of the District of Columbia Bar.

Prior to joining Foley, Devaki worked for the Food and Drug Administration as a legal intern,...

202-295-4174
Kyle Faget, Foley Lardner, Government policy lawyer
Partner

Kyle Faget is a Partner and business lawyer with Foley & Lardner LLP. She is a member of the firm’s Government & Public Policy Practice and the Health Care and Life Sciences Industry Teams. Her practice focuses on advising clients on regulatory and compliance matters involving the Food, Drug & Cosmetic Act, the False Claims Act, the Anti-Kickback Statute, the AdvaMed Code, and the PhRMA Code. She also regularly drafts and negotiates agreements required for the development and commercialization of pharmaceutical and medical device products. Prior to joining...

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David L. Rosen, Foley Lardner, FDA Regulatory Lawyer, Life Science Industry Attorney,
Partner

David Rosen is a partner and public policy lawyer with Foley & Lardner LLP. Mr. Rosen has extensive experience in health law, life sciences, and food and drug regulation, including a range of Food and Drug Administration (FDA) regulatory issues affecting prescription and over-the-counter pharmaceuticals, medical devices and biologics. He is co-chair of the firm’s Life Sciences Industry Team and is also a member of the firm’s Government & Public Policy Practice and the Health Care and Food & Beverage Industry Teams.

Mr. Rosen was...

202-672-5430
Nathan A. Beaver, Foley Lardner, FDA Enforcement Lawyer, Regulatory Attorney,
Partner

Nathan A. Beaver is a partner and food and drug lawyer with Foley & Lardner LLP, where his practice focuses on the representation of manufacturers whose products and activities are regulated by the Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and the Federal Trade Commission (FTC). He advises clients on regulatory issues affecting prescription and over-the-counter drug products (including animal drugs), medical devices, dietary supplements, cosmetics, and foods with special emphasis on the strategic considerations involving the approval...

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