FDA Outlines the Proposed Rule for OTC Hearing Aids

The Food and Drug Administration (FDA) recently posted a page in the Federal Register, which outlines the Proposed Rule for Over-the-Counter (OTC) hearing aids. The Public Comment period on these self-fitting, non-prescription devices opened on October 20^th 2021 and will end on 18^th of January 2022.

The goal of OTC hearing aids is to produce affordable, FDA-regulated devices for those with a perceived mild to moderate hearing loss and who are 18 years of age and older. The buyers are left to diagnose and treat their hearing loss themselves.

Get ready to comment

The following link leads directly to the Federal Register page. Here, you find instructions for submitting comments. But once those details are reviewed, the easiest way to get to the comment box is to click “Submit a Formal Comment” at the top of the page. To start a comment, always reference Docket No. FDA-2021-N-0555

Federal Register

Those who want to read the “Proposed Rule” as it stands right now only have to page-down in order to find that language. Inconsistent and vague statements prove that public comment is indeed needed. We have one chance to get this right.

Advocacy for telecoils

Among other wishes and questions, this is a prime opportunity for telecoil advocacy. As a matter of equitable access, OTC hearing aids should connect the customer wirelessly to hearing/induction loops for clearer understanding of speech in background sound.

Hearing loop technology meets the “assistive listening system” requirements of the ADA (Americans with Disabilities Act) for those with telecoils in their hearing aids. Loops are quite popular overseas and they are on an upswing in the U.S. Still, many patients are not told about telecoils and hearing loops, even in professional setting.

Asking for telecoils to be installed in OTC hearing aids not only allows for access to communication in looped venues, it will also popularize the loop/telecoil assistive system in a major and permanent way.

And so, for so many reasons now is the time to act.

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For those who want to learn more about ears and hearing loss issues, please see my website hearing-loss-talk.com