Patient Safety Must Be the FDA's Priority
On October 19, the U.S. Food and Drug Administration (FDA) proposed rules for over-the-counter (OTC) hearing aids. As you likely know, this started a 90-day public comment period to ensure all voices are heard and lawmakers get these rules right.
These rules are designed with the purpose to provide greater access to hearing assistance for those with mild-to-moderate hearing loss. However, without proper guardrails in place to protect patient’s long-term hearing health, these products could result in more harm than help.
A hearing aid is not a consumer electronics device; they are medical devices and should be regulated as such.
Federal regulations should encourage stronger protections, not weaken them. We encourage you to learn more and submit comments through the below buttons to strengthen these proposed regulations and ensure OTC hearing aids are used as intended, for those only with mild-to-moderate hearing loss.
It is our hope that the FDA will Listen Carefully and put patient safety first.