Category Archives: FDA

FDA Taking Public Comments on OTC Hearing Aids

Loop Minnesota Posted on by

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 20th 2021 and will end on 18th 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

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

Advocate for Telecoils in OTC Hearing Aids

Loop Minnesota Posted on by

People in Conference Room

In early July 2021, President Biden signed a comprehensive Executive Order. Among other issues, the Department of Health and Human Services is directed to consider the release of proposed rules for the Over-the-Counter (OTC) sale of hearing aids within 120 days.

We might remember that back in August 2017 the bipartisan Over-the Counter Hearing Act was signed into law. The FDA had up to three years to create an OTC, FDA-regulated category of hearing aids. The 2020 Notice of Proposed Rule Making (NPRM) was missed. COVID-19 was cited as a major reason.

Public comment period: don’t miss it!

120 days would put the time for the rules release into early November 2021. It is expected that after the rules’ release there will be a 60-day public comment period.  This is the opportunity for the public to speak up about likes, dislikes, recommendations and omissions in the proposed rules.

This is our chance! Watch out for the notice in the media! As soon as I know, I will certainly post it on this site and on Facebook/whatdidyousaybook as well as Tweet it @WhatDidYouSay88.

However, before all of this happens, it is worthwhile to do a bit of homework by reading  up on information regarding  FDA Public Comments.

That said, after the public comment period, the FDA has 180 days to review the comments and to formulate a final rules edition.

Advocate for Telecoils in OTC Hearing Aids

The recommendation for telecoils to be included in OTC hearing aids is a must as it speaks to the importance of communication access. Product labeling has to have a Telecoil/hearing loop section to educate the users on this assistive technology system that allows for clearer hearing in loud and sound-confused places and that makes businesses accessible to those with hearing loss.

As the features of OTC hearing aids are discussed in the media, one hopes that telecoils and hearing loops will get much-needed public exposure and that prospective users will see the importance of advocating for this technology.

Best for Hearing Better

And so, It would be tragic to miss the opportunity to speak up on our own behalf. Experts agree that at least for the next 10 to 15 years and maybe longer, hearing loops and telecoils are the best bet for hearing better in background sound – which is where most of life is lived.

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To learn more about topics related to Hearing and Balance, see my website: hearing-loss-talk.com