FDA Released Proposed Rule for Over-the-Counter Hearing Aids and New Draft Guidance for Personal Sound Amplification Products

The Food and Drug Administration (FDA) today released the long-awaited proposed regulations for the over-the-counter (OTC) hearing aids.

The Federal Register notice this morning includes the pre-publication release of the proposed rule, “Medical Devices: Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids,” for public inspection and notes that the FDA will accept comments for the next 90 days. The FDA issued a press release about the proposed rule of the new OTC category for adults age 18 and older with perceived mild to moderate hearing loss.

The FDA also released today updated draft guidance about the intended uses, regulatory requirements, and differences between hearing aids and personal sound amplification products (PSAPs). The guidance document, “Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification,“ is also available for public review and comment.

The Academy has established a subject matter expert (SME) work group to review the proposed rule and new guidance. The work group will prepare comments for board review, and the Academy will submit comments to the FDA on behalf of the organization.

The Academy will keep you further informed on these rules and implications for the profession.