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In 2017, congress ordered the FDA to allow over-the-counter hearing aids. In late 2022, they finally got around to it, so it should be easier now than it was.
by ksherlock 3y ago
In 2017, congress ordered the FDA to allow over-the-counter hearing aids. In late 2022, they finally got around to it, so it should be easier now than it was.
https://www.fda.gov/news-events/press-announcements/fda-finalizes-historic-rule-enabling-access-over-counter-hearing-aids-millions-americans https://www.fda.gov/news-events/press-announcements/fda-fina...
https://www.federalregister.gov/documents/2022/08/17/2022-17230/medical-devices-ear-nose-and-throat-devices-establishing-over-the-counter-hearing-aids https://www.federalregister.gov/documents/2022/08/17/2022-17...
- methodical 3y agoDoes OTC status affect the process by which a product gets approved by the FDA, or only dictate the means by which it can be distributed? I'm unfamiliar with the distinction, but if it means these types of products are easier for consumers to get access to then it's certainly great news. Certainly, non-implant hearing aids shouldn't have to jump through the same number of hoops as more conventional medical devices.