Washington, D.C.— 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.
OTC hearing aids are a new category of low-cost, direct-to-consumer medical devices. They are designed for use in patients with mild to moderate hearing loss and can be purchased without guidance from a medical professional. OTC hearing aids might not be the best option for every patient. For example, OTC hearing aids can have amplification up to 120 decibels, enough to assist even those with severe to profound hearing loss. However, patients that rely on OTC solutions for these more serious forms of hearing loss risk improperly treating and endangering their hearing further.