COVID-19 UPDATES: Find news and resources for audiologists, speech-language pathologists, and the public.
Latest Updates | Telepractice Resources | Email Us

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.

Questions?

Contact Bill Knudsen, ASHA's director of education policy, at bknudsen@asha.org


ASHA Corporate Partners