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The FDA Issues Proposed Rule for Establishing Over-the-Counter Hearing Aids and Draft Guidance for Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products
Hearing loss affects an estimated 38 million people in the United States and can have a significant impact on communication, social participation, and overall health and quality of life. Only a small proportion of people who could benefit from a hearing aid seek one. Several barriers prevent hearing-impaired individuals from getting hearing aids, such as: access, social stigma related to hearing loss, perceived value of the devices, cost, and certain state and federal regulations.
To help enhance access to hearing aids for persons age 18 or older with perceived mild to moderate hearing loss, the U.S. Food and Drug Administration (FDA) published a proposed rule, Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids. If finalized, it would establish a regulatory category for over-the-counter (OTC) hearing aids and make related amendments to update the regulatory framework for hearing aids.
The FDA also issued the updated draft guidance, Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products, which supersedes the November 7, 2013 draft guidance. This updated draft guidance, if finalized, would describe hearing aids, personal sound amplification products (PSAPs), their respective intended uses, and regulatory requirements that apply to both types of products.
Submit comments
Upcoming webinar
On December 7, 2021, from 1-2pm, the FDA will host a webinar on the proposed rule and draft guidance.
Questions?
If you have about the proposed rule or draft guidance, contact the Division of Industry and Consumer Education.
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