Over the Counter Hearing Aids #Government #hlaa
HLAA will be filing comments to the Food and Drug Administration on its proposed rule establishing over-the counter hearing aids due January 18, 2022. Once finalized by the FDA, consumers 18 and older with mild to moderate hearing loss will be able to purchase hearing aids at retail and online outlets.
In our comments, HLAA told the FDA that the labeling both outside and inside the package needs to inform consumers whether a smartphone or other technology is needed to set up and use the OTC hearing aid. The comment letter also asks the FDA to require labeling that informs consumers about OTC hearing aid compatibility with wireless phones and audio connectivity options such as telecoil or Bluetooth. HLAA also asks FDA to require a free 45-day trial period for purchasers to receive a full refund if the OTC hearing aid does not meet their needs.
Other issues in the comment letter address the classification of self-fitting hearing aids and the importance of usability without professional intervention. It also notes the need to pay particular attention to the needs of two populations that stand to gain from OTC hearing aids: underrepresented minorities (low income and people of color) and older Americans.
Anyone can file comments with the FDA in this proceeding. If you would like to file your own comments, go to Regulations.gov. If you would like an advance copy of HLAA’s draft comments to help you draft your own comments, contact LHamlin@...
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