|Maine Medicine Weekly Update
October 31, 2021
FDA Moves to Allow Over-The-Counter Hearing Aids
The Food and Drug Administration (FDA) is moving toward making hearing aids available without a prescription to those with mild or moderate hearing loss.
The goal is to boost accessibility and lower costs for the devices Hearing aids can cost thousands of dollars ($5,000 on average) and aren't usually covered by traditional Medicare or private insurance, and advocates argue that making them available over the counter can drastically lower the price.
The FDA’s proposed regulation implements the Over-the-Counter Hearing Aid Act, which was signed into law in 2017. The FDA is expecting opposition from hearing aid manufacturers and audiologist groups.
FDA statement announcing the rule
Interested parties can submit either electronic or written comments on the proposed rule by January 18, 2022. Submit written comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 by November 19, 2021.< Previous Article | Next Article >
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