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Guidance Issuing OfficeCenter for Devices and Radiological Health
This guidance document identifies applicable legal requirements under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) for hearing aids and for personal sound amplification products (PSAPs). Hearing aids and PSAPs both affect a user’s ability to hear sound, but the products have different intended uses, and are therefore subject to different regulatory controls. Unlike hearing aids which are intended to aid a person with or compensate for hearing impairment, PSAPs (as defined in Section III) are not intended to diagnose, treat, cure, mitigate, or prevent disease and are not intended to affect the structure or function of the body. Therefore, they are not considered to be “devices” as defined in the FD&C Act.
A lack of clarity between PSAPs and hearing aids has contributed to stakeholder and consumer confusion. This guidance is intended to describe hearing aids, PSAPs, their respective intended uses, and the regulatory requirements which apply to both types of products.