U.S. Rep. Tom Emmer (R-MN) recently expressed concerns to the U.S. Food and Drug Administration (FDA) about a 2021 rule related to over-the-counter (OTC) hearing aids, a new category of low-cost, direct-to-consumer medical devices designed for use in patients with mild to moderate hearing loss that may be purchased without guidance from a medical professional.
“Hearing loss is a serious medical condition and improper care can cause additional harm,” the congressman posted Feb. 11 on Facebook. “We must ensure that federal regulations strengthen patient protections, not erode them.”
Specifically, Rep. Emmer sent a Feb. 11 letter to FDA Acting Commissioner Janet Woodcock calling on the agency to amend the Oct. 19, 2021, FDA proposed rule, entitled “Medical Devices; Ear, Nose and Throat Devices, Establishing OTC Hearing Aids.”
In his letter, Rep. Emmer requested that the FDA 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, according to information provided by his staff.
“Low-cost care cannot be an excuse for low-quality care,” Rep. Emmer said in a Feb. 11 statement.