Food and Drug Administration Slates Proposed Over-the-Counter Hearing Aid Rule for Possible June Release

The Food and Drug Administration (FDA) Spring 2021 regulatory agenda indicates the agency could as soon as this month release its long-awaited proposed rule to establish an over-the-counter (OTC) category of hearing aids. This would lay out safety, labeling, and manufacturing standards for the devices, coming as key lawmakers press the Department of Health and Human Services (HHS) to get the regulation out.

The regulatory agenda, released Friday, June 11, 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,” in June.

The FDA was supposed to publish the proposed rule in August 2020, per the 2017 FDA Reauthorization Act, but missed the deadline. Senators Warren and Grassley have pressed the FDA multiple times since August 2020 to prioritize the release of these proposed regulations.

In November 2020, Senator Warren and Senator Grassley wrote an official letter inquiring about the status of these proposed regulations. In a recent Senate Finance Committee hearing on June 10, Senator Grassley pressed HHS Secretary Becerra for an update on the status of the regulations.

The Academy will continue to monitor this situation very closely.