I don’t know about hearing aid startups, but if someone can make an aid with decent Bluetooth I would love to hear about it. I recently got a pair of Otacon
Real 1s and the Bluetooth has a range of about 1 foot. If I pair my iPhone and stream music it will cut out if I put it in my front pocket. They were basically a $3000 mistake, after insurance.
Ask HN: Why aren't there more hearing aid startups?
11–20 of 53 posts
Re: Ask HN: Why aren't there more hearing aid startups?
#12Cost 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. It's a rather difficult market to get into without a large amount of capital at your disposal.
> 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?
Any market that doesn't have the equivalent of the FDA probably has very little money in it.
Re: Ask HN: Why aren't there more hearing aid startups?
#13Hardware is tough. Medical hardware doubly (triply?) so. Also realtime audio processing in a power and space limited, heavily patented and proprietary industry isn't for the faint of heart.
That said with the recent changes allowing OTC hearing aids as of 2022 and companies like rewind.ai chasing always-on audio recording I imagine we'll see some interesting innovations in this space over the next few years.
Re: Ask HN: Why aren't there more hearing aid startups?
#14Earlier quoted context omitted.
> 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?
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?
Re: Ask HN: Why aren't there more hearing aid startups?
#15It doesn't even need to be a startup: hearing aids are techically inferior to mid-range earbuds, yet cost more than 10x more. I'm guessing it's a certification+distribution issue, like for smartphones in the US. I've heard Bose has something in test though ?
It’s not quite the same, many people with hearing loss only lose hearing on part of the spectrum, so it’s not just about making things louder, it’s about making the specific frequencies louder in ratio to the loudness of the noise.
Re: Ask HN: Why aren't there more hearing aid startups?
#16Earlier quoted context omitted.
> 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?
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 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...
Re: Ask HN: Why aren't there more hearing aid startups?
#17Earlier quoted context omitted.
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 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.
Re: Ask HN: Why aren't there more hearing aid startups?
#18Hello, my name is Blue. I am also severely hearing loss. We have developed hearing aids, but we are currently only sold in Taiwan. Other countries will start selling them this year(FDA approved). If you are interested, you can follow otoadd ( https://otoadd.com/index-en.html )
Hypothetically could one go to Taiwan and buy a pair while on vacation? Asking for a friend…
Re: Ask HN: Why aren't there more hearing aid startups?
#19I don’t know about hearing aid startups, but if someone can make an aid with decent Bluetooth I would love to hear about it. I recently got a pair of Otacon Real 1s and the Bluetooth has a range of about 1 foot. If I pair my iPhone and stream music it will cut out if I put it in my front pocket. They were basically a $3000 mistake, after insurance.
I have a Kirkland KS9 that supports Bluetooth. It cuts out at about 30 to 40 feet with a wall or two in between. It cost $700 retail, the hearing test, fitting, follow-up, and repairs are free with a Costco membership.
The Bluetooth audio quality is not as good as the normal amplification or a decent headset, but it is functional for listening and calls. If I had two aids I would probably care more about getting it tuned for better music listening.
Re: Ask HN: Why aren't there more hearing aid startups?
#20Earlier quoted context omitted.
> 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?
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…
On the other hand, there's probably no country with as large a population as ready to spend as much money on medical devices.