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October Newsletter: OTC Ruling Preview

Bridging the conversation between hearing health professionals and lawmakers in Washington

Please take 30 seconds to watch this video, and share it across your social media channels and email lists. If you have a relationship with your elected officials, please share it with them as well. Together, we can make a difference.

FDA Releases Proposed OTC Regulations

As you may know, the U.S. Food and Drug Administration released proposed OTC hearing aid regulations on October 19th. This started a 90-day public comment period to ensure all voices are heard and lawmakers get these rules right.

We are in the process of thoughtfully reviewing the 114-page document, in coordination with the Hearing Industry Association. Our goal is, and always will be, to ensure the best hearing health outcomes for patients. We are encouraged the FDA repeatedly encourages comments in each section of the proposed rules.

It is our hope they will #listencarefully.

Keep an eye on your inbox for updates on how you can make your voice heard!

This timeline is based on current intel and is subject to change.

Why OTC Hearing Aid Regulations Matter

Hearing loss is unique to each individual, which is why it’s important that licensed, trained hearing health professionals continue to play a key role in a patient’s hearing loss journey. In the absence of proper regulations, companies are currently marketing unregulated, low-quality amplification devices as hearing aids. This has prompted more than 17 states’ attorneys general (AGs) – both Democrats and Republicans – to warn consumers about these harmful products.

It is critical OTC hearing aids are properly regulated and labeled to protect Americans’ long-term hearing health.


Relevant News

October 25, 2021: Forbes – Clarifying the Noise in Hearing Healthcare – Starkey CEO Brandon Sawalich

“Hearing loss impacts every facet of a person’s life — their ability to connect with family, friends and their community. Untreated hearing loss can have serious, lasting effects on physical and mental well-being. Adults with hearing loss are up to five times more likely to develop dementia. They also have an increased risk for social isolation, loneliness and falls. Despite this research, on average, people wait roughly 7 years between first noticing their hearing loss and finally addressing it. It’s time for that to change. Here are three things that must happen first.”

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