Listen Carefully

Listen Carefully Logo

August Newsletter: Final OTC Ruling

Bridging the conversation between hearing health professionals and lawmakers in Washington

FDA Releases Final OTC Hearing Aid Rule

In October 2021, the U.S. Food and Drug Administration (FDA) proposed rules for over-the-counter (OTC) hearing aids. This started a 90-day public comment period to ensure all voices are heard and lawmakers get these rules right. 

On August 16, 2022, the FDA released its final OTC Hearing Aid Rule.

We are currently in the process of reviewing the more than 200-page rule in its entirety and want to provide a brief update in the meantime.

We are incredibly grateful to all of you who shared with the FDA that without proper guardrails in place to protect patients long-term hearing health, OTC products could result in more harm than help.

We are encouraged that the FDA listened carefully and put in place an output limit of 111 decibels for OTC hearing products, instead of a 120-decibel output that was in their draft rule. This is a major step forward for patient safety.

Our position at Listen Carefully remains clear:

Hearing loss is unique to each individual, so it’s critical that licensed, trained hearing health professionals continue to play a key role in a patient’s hearing loss journey.

There may be more advocacy work to be done to protect patient safety and we will provide further information and updates soon. Thank you for your dedication to making hearing health policy the best it can be.

Related Posts