6 ms·
The US is probably the worst launch market. The FDA regulates hearing aids so any new product would have to go through the FDA validation process, which is expe
by methodical 3y ago
The US is probably the worst launch market. The FDA regulates hearing aids so any new product would have to go through the FDA validation process, which is expensive.
Edit: I may have misread your comment, my apologies! I'm only loosely familiar with the US regulation on this matter and completely unfamiliar with other countries' regulations but I'd find it hard to believe there's any country more expensive to launch in for a medical device than the US, so for the OP I'd agree with you that the US should probably be a later market to target.
- thfuran 3y agoOn the other hand, there's probably no country with as large a population as ready to spend as much money on medical devices.
- ksherlock 3y agoIn 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.