FDA Adds Proposed OTC Hearing Aid Rule to Agenda for Possible June Release

June 17, 2021

The Food and Drug Administration (FDA) Spring 2021 regulatory agenda indicates that agency could, as soon as this month, release its proposed rule to establish an over-the-counter (OTC) category of hearing aids in the United States.

The regulatory agenda, released last week, says the FDA expects to publish the proposed rule, “Medical Devices; Ear, Nose and Throat Devices; Establishing Over-the-Counter Hearing Aids and Aligning Other Regulations”, offering the following abstract:

“FDA is proposing to establish an over-the-counter category of hearing aids to promote the availability of additional kinds of devices that address age-related hearing loss, and proposing related amendments to the current hearing aid regulations, the regulations codifying FDA decisions on State applications for exemption from preemption, and the hearing aid classification regulations.”

Essentially this would lay out safety, labeling, and manufacturing standards for the new category of OTC hearing aids.


OTC Hearing Aid Rules ‘Overdue’


As part of the 2017 FDA Reauthorization Act, the agency was supposed to publish the proposed rule for OTC devices in August 2020, but missed the deadline – much to the disappointment of advocates and legislators who supported the bill.

Senators Elizabeth Warren and Chuck Grassley, who were the original co-sponsors of the bill, have urged the FDA multiple times since August 2020 to release of the proposed regulations. 


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