FDA to allow Americans to buy hearing aids over the counter
The U.S. Food and Drug Administration (FDA) finalized a rule that would allow Americans with mild to moderate hearing loss to buy hearing aids without a prescription beginning in the middle of October.
The New York Times said this means people will be able to buy hearing aids online and in retail stores without being required to see a doctor for an exam to get a prescription. The Times said this could lead to new hearing aid technology that is cheaper and more innovative.
The FDA said the OTC category does not apply to those who have “severe hearing impairment” or users younger than 18 because these hearing aids are prescription devices.
The FDA said in its rule making document that it has received comments that the FDA should do more to encourage health insurers, including Medicare, to help with payments for hearing aids. The FDA said it doesn’t have authority to do this.
The FDA made their rule making document available online in a PDF file. It includes many comments from the public and the FDA’s responses. The document is 200 pages long and the link is in the transcript.
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The Hearing Loss Association of America (HLAA) said the FDA’s step is a “win.” The HLAA said OTC hearing aids may not help if you have a hearing loss at a level where you have trouble hearing loud sounds like power tools or motor vehicles — and recommended that you see a hearing care professional.
I read several deaf people’s comments on Twitter that recommended deaf people to go and see an audiologist to get the best devices that fit what they needed.
FDA Press Release: https://www.fda.gov/news-events/press-announcements/fda-finalizes-historic-rule-enabling-access-over-counter-hearing-aids-millions-americans
Rule making document: https://public-inspection.federalregister.gov/2022-17230.pdf
https://www.nytimes.com/2022/08/16/health/fda-hearing-aids.html
https://twitter.com/US_FDA/status/1559527860221739008
https://www.axios.com/2022/08/16/hearing-aids-over-the-counter-fda
https://www.hearingloss.org/hearing-help/technology/otc-hearing-devices/otc-hearing-aids/
https://www.hearingloss.org/new-class-of-hearing-aids-available-without-perscription/
https://www.hearingloss.org/proposed-rules-for-otc-hearing-aids/
https://www.nbcnews.com/health/health-news/fda-says-hearing-aids-may-sold-prescription-rcna43306