FDA Issues Over-the-Counter Hearing Aids Final Rule and Guidance on Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products

August 16, 2022

Today, the U.S. Food and Drug Administration (FDA) issued a final rule: Establishing Over-the-Counter Hearing Aids to improve access to safe, effective, and affordable hearing aids for millions of Americans. This action establishes a new category of over-the-counter (OTC) hearing aids, enabling consumers 18 years of age and older with perceived mild to moderate hearing loss to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription, or a fitting adjustment by an audiologist. The rule is designed to provide a reasonable assurance of safety and effectiveness of OTC hearing aids, while fostering innovation and competition in the hearing aid technology marketplace.

Concurrently with issuing the final rule, the FDA also issued the final guidance: Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products to clarify the differences between hearing aids, which are medical devices, and personal sound amplification products, which are not regulated as medical devices, and which help people with normal hearing amplify sounds in certain environments.

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"Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions," said FDA Commissioner Robert M. Califf, M.D. "Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to a wide array of safe, effective, and affordable purchasing options from their neighborhood store or online."

Questions?
If you have questions about the proposed rule or draft guidance, contact the Division of Industry and Consumer Education.

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