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ASHA Responds to FDA on Proposed Rule for OTC Hearing Aids

January 13, 2022

Today, ASHA submitted comments [PDF] to the U.S. Food and Drug Administration (FDA) concerning draft regulations for over-the-counter (OTC) hearing aids, a new regulatory category of medical devices intended for persons with mild-to-moderate hearing loss. These OTC devices are expected to be available later this year. 

In the letter, ASHA focused on a maximum output level of 110 dB SPL; full-on gain limit of 25 dB; compression and volume control; outside-the-box labeling; and clearly defining the device types.

ASHA is committed to continued advocacy as the process for regulating OTC hearing aids continues.

Audiologists are encouraged to sign onto a member wide letter reiterating the significant concerns on output level and gain limits.


Contact Bill Knudsen, ASHA's director of education policy, at

ASHA Corporate Partners