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.
