I’ve worked in the industry, and try to remember that people’s hearing can change rapidly and customers are finicky so your novel tech will need to be adjusted by someone who isn’t about to learn a tech stack for one line of products. We had patients that would come in every couple of weeks for years, asking for slight changes to their frequency range.

The hearing aids themselves will be physically abused. Worn in saunas, get packed with ear wax, be left in freezing temps, get chewed up by pets, stepped on, dropped into sinks and toilets. It’s actually incredible that most are repairable despite all of that, without even needing to return to the manufacturer.

They also need to be usable by those with limited mobility and no ability to use tech, and relatives with no idea what to do except replace the battery and put them in the ears.

That was a uniquely satisfying and comprehensive answer. You answered about 10 questions I’ve had on my mind for a good 50 years.

Hardware 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.

I was an early employee at Whisper so I got to see many of the challenges in this space first hand. I can't speak to the specifics of Whisper leaving the market, but I can say generally that bringing a new piece of medical hardware to market is very hard for a startup to pull off.

In the early days you need to bring together a group of people with a diverse set of skills --- mechanical engineers, electrical engineers, firmware engineers, audio engineers, regulatory specialists, people with experience working with factories, along with ML engineers in our case. You need a lot more people to bring a product to market than if you're building another SaaS company. (And, of course, all your code is running on a chip that has to be small enough to fit behind their ear.) Then hardware startups also have a problem that they tend to have slower growth and lower margins than successful software startups. So later stage VCs are more inclined to invest in software startups.

Hearing aids are also unique in that they require a lot of tuning to get the audio to sound as natural as possible. There are dozens of algorithms that process different features of the audio, things like wind noise reduction and feedback cancellation, and some of them can be a bit finicky. Companies like Oticon or Widex have hundreds of engineers who have been tuning these algorithms for decades. (Another advantage the big guys have is that they can make custom silicon So if you want a top of the line hearing aid the bar is very high. Then until recently there were big barriers to entry on the sales side --- you weren't selling just to the customer, you were also selling to the audiologist, and many audiologists have incentives to (mostly) sell a single brand. This is less of a barrier now with the recent changes to allow hearing aids to be sold over-the-counter.

I do hope to see another startup give it a go because I still think there's room for disruption --- the big companies move a lot slower than a startup can, and the ODML space is developing very, very quickly. But it's not a project for the faint of heart.

Hello, 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)

It would be good to work with musicians on having ways to adjust hearing aids for better-sounding music, both recorded and live.

Most hearing aid vendors and audiologists don't seem to make much of an effort on this, so I usually switch to Airpods for better sound.

Hypothetically could one go to Taiwan and buy a pair while on vacation? Asking for a friend…

You could probably find a company or a person in Taiwan to ship them to you from Taiwan.

Looking at their website though there's a lot of showing up at their retail location to do hearing tests, so that might not work quite as well.

they are a Taiwanese founders and company. the US is not the axis of the world :)

Odd that your curiosity wouldn't just take you to the website they linked which would have told you the answer.

Not sure but can mention some challenges:

- The power budget of a traditional HA is ~1mW and operate on ~1V. Existing vendors use custom silicon with sub-threshold designs to hit this. I see this as one of their largest moats. Lipo rechargeable wearables work around this problem.

- Customers for your product want their hearing back, and that's not something HAs realistically provide. So selling them is pretty weird as your customer isn't going to be completely satisfied and newer HAs won't improve much along this dimension. On the other hand you can sell "comfort" via noise reduction, bluetooth streaming, and whatever technology buzzwords you can fit on a brochure.

- But can my fancier DSP algorithms improve speech understanding in noise? Maybe, but you've got a 10ms latency budget in which to do so. Hard to compete with the human brain which can cheat and backdate perceptions into the past.

- FM systems, on the other hand, can dramatically improve speech understanding by eliminating noise and echoes. Right now it's only a fit for situations where you can mic the speaker. Traditional HA companies have a hand in making these.

Not to mention that there's a wide range of hearing issues that you will have to decided on tackling. There are several, inexpensive over-the-counter aids that can help with moderate loss, but if you have clinically profound hearing loss, there's no avoiding more expensive gear.

Let's not forget the rigor it must stand up to (water, wax, sweat, heat, temp differentials, dead skin buildup, etc.).

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. It's a rather difficult market to get into without a large amount of capital at your disposal.

You can presumably now sell OTC hearing aids in the US. Also, I see quite a few kickstarters/indigostarters in this space [1]. So it isn't that difficult.

[1] https://www.indiegogo.com/explore/tech-innovation?project_ti...

> 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 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.

Most startups are not technical problems. Hearing aids are no different.

There is a stigma with hearing aids. You have to get over both the internal ego and the external stigma. For many people, that means admitting they're aging and "need help".

Frankly, it really doesn't matter how amazing the hardware is. That's just an incredibly challenging problem to overcome.

The one person in my family with these issues is quite the opposite. "I don't care if the aid is visible, I don't care if I have to charge it daily, I just want to hear properly."

The example they cite is people with vision problem. Very few people hide their glasses. If anything, at this point, glasses are often considered as enhancing a person's beauty.

Nobody cares when I wear AirPods all over the place, they actually (almost) work like hearing aids and definitely could with some software tweaks alone, even more so with minor hardware tweaks.

Get somebody to design hearing aids that are meant to be noticed instead of badly hidden.

When you talk to people, do you take your AirPods out?

Or do people just talk more loudly at you since they don’t know how well you can hear.

I don't mean to say I leave my airpods in when I'm having a conversation with a person, but for example walking to the grocery store and checking out. People don't seem to notice, or if they do they don't act in any way other than normal.

Yea, but nobody cares about people walking around with hearing aids.

The stigma is in conversations...

You can get over-the-ear hearing aids in plenty of colors. This is not where the gap lies.

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.

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.

https://www.relajet.com/ - started by a friend with hearing loss

Thank you clkao :) Relajet is our company name, otoadd is our hearing aid brand.

I have been working in the hearing aid industry for over two decades and it’s quite a specific niche. It’s where Medical Model meets Consumer Electronics. So on the medical side you need proper diagnostics by an Audiologist and then very demanding ongoing support and patient hand-holding. Here one uses the expensive medical grade devices R&D’d by the Big5 global majors who have consolidated the whole market. It’s high margin and clinicians like it. On the the other hand there is very common presbycusis or age related high frequency loss or noise induced loss which almost everyone ends up getting (with marginal frustration) - this is the market the new OTC class of ‘starter products’ is aiming for and they are DTC sold online. They are low margin and quite hit and miss at this stage, but can potentially grow the market (create awareness). Competition will be fierce (soon Apple/Android pods will do the same)and the Big5 are all scrambling to buy up potential OTC device companies eg. Sonova Group Switzerland (Phonak, Unitron) has bough Sennheiser consumer division, Sony is working with Signia/Siemens etc (they want to own the whole escalator to high margin medical grade devices). I have it directly from the co-founder of hear.com the worlds largest online h/a marketer and networked referral source that they blew several million euro on a DTC/onlinetest/delivery model which was a total fail (“not interested!!)Then there’s the unit economics: only a small percentage of humanity has moderate to severe hearing loss (MUST act) so the R&D to sales ratio is terrible compared to eg Samsung that makes a billion TV or fridges. And then you must plug that device into the medical supply chain where each degreed professional ads their margin. So, because of the monopolistic tendency with high barriers to entry in a niche market with intensive personal service under a medical umbrella, I think it calls for disruption but it’s tough. My sense it that the cheap OTC market grows rapidly but there’s not a killing to be made, and the Big5 get more concentrated and smarter as real-time AI (liked to a smartphone-hearing aid) solves speech to noise ratios with advances algorithms.The hearing impaired consumer will always pay top dollar for this as ‘to be human is to communicate’. HM

It 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.

I am very ignorant about this, but couldn’t this be solved with a config where you specify “hearing loss at these frequencies at these levels” and then the headphones increase/decrease this frequencies in response? Obviously, there needs to be a standard, and hw that listens to the standard.

It could. Apple AirPods actually support this (using a real "Audiogram") but annoyingly they currently "average" your two ears and don't apply an ear-specific correction. Which for someone like me with perfect hearing on one side and supposedly "Mild" but realistically quite significant hearing loss on the other side is a real pain.

There are already quite a few products in this space: Bose HearPhones Nuheara .. and many more.

Awesome to discover this, a necessary but not sufficient step to improving competition and choice.

Frequency response is similar to an EQ, but there are lots of other problems. There is feedback, which is worse at higher amplification, which people with more severe hearing loss need. There is wind noise.

It’s not only that, the hearing loss may be very different in each ear. I don’t need a hearing aid for my left ear. If I lie with my left ear on a pillow, I will hear almost nothing. My yappy ankle biter dog a 3ft is audible. This means that if I use an OK headset, shift the balance as far right as possible while keeping the left speaker on, then turn my iPhone all the way up, I hear stereo at a comfortable but not loud level. Surely that amplifies some frequencies way higher than they should be amplified.

which is quite similar to the challenge of active noise cancellation. It's not a technology issue per se. Just adapting current tech to this domain.

Dunno.

TI has a useful page though:

https://www.ti.com/solution/hearing-aid

That page basically says use an all in one "MSP430F5510" MPU with "CC2640R2F" Bluetooth.

Here’s a Swedish one https://ondemove.eu/products/

Auricle (W21) and AudioFocus (S19) were two YC startups around hearing, I'm not sure what the status of them is though.

The concentration of power and wealth dis-incentives competition in the market.

Not sure, have yet to hear from one

Am I the only one who is surprised AirPods aren’t doing this (yet) ?

I have healthcare and if you need a hearing aid you get one so who the hell cares how expensive it is?