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