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Comment by echelon | Hacker News Reader

> Cost of entry is immense. As with anything medical or food and drug related, there are large (and expensive) obstacles to hurdle before any product can enter the market.

What about not using the US as the launch market?

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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.

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-fina...

https://www.federalregister.gov/documents/2022/08/17/2022-17...

Does 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.

On the other hand, there's probably no country with as large a population as ready to spend as much money on medical devices.

Any market that doesn't have the equivalent of the FDA probably has very little money in it.

Not that I'm particularly knowledgable on the subject but I find this a little hard to believe. I'd expect any first-world country around the world to have a reasonable demand and means to afford a product of this nature. The US obviously isn't the only country with access to 21st century medical devices of this sort?

And they have regulatory agencies.

Mexico and Australia are the two markets I've heard to start with for healthcare devices. The US market shouldn't be your first for that.

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