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CHC's Comments to FDA on OTC Hearing Aid Draft Regulations

Updated: Jan 27, 2022

Dear CHC Friend,

Laurie Hanin, PhD, CCC-A, Executive Director

We're pleased to share with you CHC's official comments to the FDA regarding draft regulations for over-the-counter hearing aids.


You'll recall, the Over-the-Counter Hearing Aid Act was signed into law over four years ago, creating a new category of low-cost, self-fit hearing aids for adults with perceived mild-to-moderate hearing loss. The intent was to make hearing aids more widely available so that more people will take action to treat their hearing loss.


The FDA released initial regulation for OTC aids in October, 2021, and solicited feedback from the public at large. Final regulations are expected by the summer of 2022, and OTC aids will be available for purchase in the fall of 2022.


CHC is supportive of this initiative to increase access to hearing health care and has recommended that the FDA consider certain changes to the rule to increase consumer safety. Please click below to read our comments.

We will continue to keep you up to date as we learn more about this important development in hearing health care. Should you have questions, please check out our FAQs for OTC Hearing Aids or contact me at lhanin@chchearing.org.

Sincerely,



Laurie Hanin, PhD, CCC-A

Executive Director

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