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Emmer Sends Letter to Acting FDA Commissioner Regarding Over-the-Counter Hearing Aid Rule

Statement

By: Tom Emmer
By: Tom Emmer
Date: Feb. 11, 2022
Location: Washington, DC

Today, Congressman Tom Emmer (MN-06) wrote a letter to Acting Food and Drug Administration Commissioner Janet Woodcock expressing his concerns with a 2021 rule related to over-the-counter (OTC) hearing aids.

"Low-cost care cannot be an excuse for low-quality care." Emmer said. "Hearing loss is a serious medical condition, and insufficient or improper care can cause more harm than good."

"We must ensure that federal regulations strengthen patient protections, not erode them" Emmer concluded.

The letter urges Acting Commissioner Woodcock to amend the October 19, 2021, U.S. Food and Drug Administration (FDA) proposed rule entitled "Medical Devices; Ear, Nose and Throat Devices, Establishing Over-the-Counter (OTC) Hearing Aids."

Specifically, the letter calls for the FDA to preserve state and local public health and consumer protections, require warranties and returns for all hearing aids, validate labeling to ensure proper self-diagnosis, and limit the overall decibel output of OTC hearing aids.


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