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August Newsletter: Final OTC Ruling

August 17, 2022

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.



June 19, 2022: Brandon Sawalich - The hearing aid conversation that needs to happen

"The root of the confusion around hearing aids, and the point that must be addressed to open access even more to care, is not cost; it's expertise and care. For three decades, consumer electronics companies have repeated one line: A hearing aid is a consumer electronics device, and manufacturers are overcharging people. These companies think the device is the "solution," disregarding the hearing professional's role. A hearing aid is one piece of the puzzle that must include expert care to ensure patient safety and satisfaction."

April 6, 2022: Letter to FDA - McCollum and DeLauro Send Letter to FDA Commissioner Regarding OTC Hearing Aid Rule

"However, the proposed rule allows OTC devices to be amplified up to 120 decibels (dB) without imposing any hearing gain limit. This threshold allows those with hearing loss greater than the intended mild-to-moderate level to benefit from OTC hearing devices. This hurts consumers and patients..."

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