I did some digging. A bill was originally introduced by Dem Senator Liz Warren but that one did not move further and instead became a "rider" on another bill known as the "FDA Reauthorization Act of 2017"
Here is the original bill "Over the Counter Hearing Aid Act of 2017" from Liz Warren:
"(Sec. 709) The FDA must categorize certain hearing aids as over-the-counter hearing aids and issue regulations regarding those hearing aids. The regulations for over-the-counter hearing aids must: (1) provide reasonable assurances of safety and efficacy; (2) establish output limits and labeling requirements; and (3) describe requirements for the sale of hearing aids in-person, by mail, or online, without a prescription. The FDA must determine whether premarket notification is required for over-the-counter hearing aids to provide reasonable assurance of safety and effectiveness.
State and local governments may not establish or continue in effect requirements specifically applicable to hearing products that are not identical to FDA requirements and that restrict or interfere with the servicing or sale of over-the-counter hearing aids.
The FDA must update and finalize its draft guidance on hearing products. The guidance must clarify which products are medical devices."
It doesn't directly say that cost should be reduced but assuming it will go OTC, costs should go down ?
It really depends if the barrier to entry for manufacture of hearing aids goes down. If there's still a ton of red tape to bring a hearing aid to market, you might not see very many new entrants and so you wouldn't see prices drop dramatically.
Of course the cost of getting a hearing aid will only include a trip to the pharmacy and the device itself and not doctor visits and all that, so it still benefits people that need them.
Actually, the cost will likely include shipping and handling, as the manufacturers can sell direct to consumers. As I count it, that's at least 2 layers of middlemen that can be removed.
That sounds to me like manufacturers can now capture the profit that two layers of middle men once captured. Call it 1.5 to keep the price lower than going through the doctor
Sure, but hopefully it'll make the barrier of entry easier. I've been noticing that the market does seem to work well when the barrier to entry is low. It seems feasible that simple hearing aids shouldnt be much more expensive than cheap earbuds after a few years.
They could, but each middleman adds a minimum amount of additional cost. Cost which is now easy margin for new entrants to compete with, for very little extra work or profit loss.
Her own supporters seem prone to chants like “Run, Liz, run” ('for president', I assume, not 'away'). So I think the nickname is fair game for everyone else unless she explicitly disapproves.
Funny you ask. I have no idea where I heard but I thought it is easier to type than the whole word. If you google Liz Warren, it auto completes to Elizabeth Warren so its def. a thing.
Wonderful, this market has been out of whack for a while. They've been sold like a medical device instead of a piece of technology, 5-10x markup. Having fittings and prescriptions done in-store induces learned helplessness and is an excuse for cartel pricing, just like with eyeglasses.
Lower price is good but I'm looking forward to the variety of hearing aids and the improvements to them that are bound to happen.
Apple has been interested in getting into the health space. This is a perfect new product for them. The only problem I see is that the market might be too small to make a difference in their profits.
AirPods Pro essentially function as hearing aids already, with their "transparency mode" which routes sound from the microphone to the speakers. It wouldn't surprise me one bit if they'd eventually make a "hearing aid mode" which lets you calibrate the volume and frequency response to more appropriately fit a person's individual hearing issues.
I very highly doubt it: They cannot very well have people's hearing aids fail to work if some sort of doom destroys the phone.
It is probably simply that it isn't so absolutely difficult for Apple to start making these. The company is already experienced in making small electronics, earbuds, and things like this.
They know how to make feedback-based sound equalization via their latest generations of airpods. This bit is very important for adapting the devices to the hearing loss profiles of patients.
This is what made them extremely expensive for a good part of their history. Adaptability and auto-adaptability.
Also, they're very small electronics for what they do.
I love hating on Apple as much as the next guy, but I doubt that would happen. They'd probably have some fancy features that could only be controlled from Apple devices, but surely none of the core functionality.
Not everyone needs to be specially fitted but every hearing aid is priced as such. I know I'd like to try the lower end of the spectrum before I decide I need a specialized hearing aid.
I have a stellar pair of four-driver custom molds from Alclair. Including mild-taking, costs were around $700 all-in. Your $2500 figure seems very high, unless your “good” means “absolute top of the market”.
Fitting is $100-$200. Then you can expend 200-1500 in your in-ear monitors depending on what you want, and the ones that are in the $300 range are already pretty good sounding.
Of course, the same as with headphones, you can spend $5K, 6K or even 10K in some top of the line planar magnetic whatever Audeze, Stax or Hifiman, but really, you don't need them.
Think also about the economy of scale. Hearing aids are more common than hi-fi high end in-ear monitors. If any big player in the electronics field enters this game, prices (and features) could be way better than they are now.
I wonder if non-prescription hearing aid use will become a thing. Especially with active noise canceling/selection tech, it seems like something with broad usecases that would be beneficial even to people without hearing difficulties. I'd love to have smart super-hearing devices, aural AR, noise filtering and speech enhancement, replay/rewind capability etc. There is a lot of potential in this area!
That’s a great point. My hearing is fine but I have some brain thing that make it hard to understand voices in a crowd. My hearing is tested to be plenty sensitive.
A hearing aid would be great in party environments for me.
My father and my daughter have the same condition, so I’m reasonable certain it is inherited.
"Perhaps 5% of children and younger adults (<60 years old) with “clinically normal” audiograms (i.e., tone thresholds better than 20 dB HL from 0.1 to 8 kHz) have difficulties understanding speech, particularly in noisy, reverberant or otherwise challenging listening environments"
“some brain thing that make it hard to understand voices”
Is there a name for this?
When I was 15, something similar started happening to me but even during one on one conversations. Someone would say something, I would hear the sounds, but wasn’t able to really make sense of it (and reply) for a few seconds.
When tested, my hearing was perfect. I never dug too much into it, and eventually it got a lot better. It still happens sometimes in some situations though.
Would be great to learn more about it if you have any additional info.
There's no point in getting formally diagnosed because there's not really any treatment so save the money, but it's sometimes just nice to know it has a name and something to Google.
You might try earplugs. There are nice sets that are made for concerts that preserve the tone, they just reduce the volume (and background noise). Even regular foam ones work pretty well. You can still hear people close to you, as they mainly take care of the background noise.
For loud bar earplugs, you’d probably want ones that would blunt lows and highs pretty aggressively, but preserve a band around 2.5 khz. I attended a presentation from Bob Heil about EQing for understandability on HF, and that was more-or-less his recommendation.
Yup, just filtering out everything except the old-school telephone frequency range will make human voices much more intelligible in a noisy environment.
EQ alone is quite primitive though compared to the computing power that we have available. If you're capturing audio from both ears, it wouldn't be hard to filter out anything other than directly in front of you. If you're sitting across a table from someone in a loud restaurant, you could let all the audio in normally, vibe to the music, but duck the volume on all the background noise when a human voice is detected directly in front of you.
Doppler Labs[0] was getting there with their Here buds. I have a pair that I miss dearly at concerts (they were sadly bricked when the company shut down and yanked their iOS app).
They didn’t do “virtual sidechaining” like you describe, but possibly could have with the DSPs in the earbuds. I’d love to find a replacement for them.
Run it through VirusTotal if you're in sight about the APK's provenance,
Don't let this type of planned obsolescence rule your access to your devices. That is, assuming the app works without some sort of cloudy backing - but then I guess it should of it was to be used in places where network access can be spared or non-existent?
> EQ alone is quite primitive though compared to the computing power that we have available. If you're capturing audio from both ears, it wouldn't be hard to filter out anything other than directly in front of you.
It's not quite a walk in the park, because you only have very small latency budgets.
In my case, I believe it's from operating a stump grinder without ear protection. (Doh!) I've been tested, there is a narrow range where my hearing is impaired. Otherwise, I hear very well.
Put me in a restaurant, I spend about half my time lip-reading and context matching to figure out what the person across from me said.
It may not be the hearing, as such. In my case, at least, it's "Central Auditory Processing Disorder (CAPD)", which is somewhat of a catch all. For me specifically, I have a heck of a time picking out one voice when there are more than one going. Parties are just noise to me.
My hearing itself is well within normal sensitivity when tested (well, it's getting worse, but even that's normal as I age). It's just whatever processing people do to turn sound into parsed language is difficult for me. Even people's houses that have a TV going 24x7 are problematic for me to have a conversation.
Huh, didn’t know this was a thing. You’re pretty much describing me exactly. My hearing is basically normal but parties, or even dinners with more than, say, four people, are hell for me to keep up with.
If I focus on a single person, I can usually have a normal conversation with them and them only, at the expense of blocking out literally everyone and everything else. So, could be worse, but it would be nice to be able to keep up in crowded rooms more easily.
I'm skeptical about this. I also have trouble understanding what people are saying in a noisy environment. Almost every google search result for this type of thing is a business selling hearing aids, all saying that it's a sign of hearing loss. But my hearing itself seems fine. I suspect that it's more of a brain thing. Some people are better than others at understanding (or pretending to understand) what people are saying in a noisy environment.
You can get a hearing test. If everything comes back nominal, you might have a mild form of auditory processing disorder.
It's not too uncommon, and is tremendously common among people with ADHD, dyslexia, and people on the spectrum.
Whatever it is, I definitely have it. One thing that helps me a ton is just focusing directly on people's lips when they're talking in a noisy setting. I can't read lips (at all), but the extra little bit of visual information helps me a great deal with comprehension.
At the moment there is no real reliable procedure to diagnos APD. It is the, we tried everything else but we can't see anything wrong with you type of diagnos.
High frequency hearing loss is associated with decreased intelligibility, and some of the harder situations to discern people is in a group or noisy environment.
I had a fairly rapid decrease in my high frequency hearing (basically my ears aged 20 years in a few months), and the biggest indicator to me was how much harder it was to understand dialogue in loud shows. I was turning on subtitles and/or turning the volume up where before I was fine with a fairly quiet volume.
I have a similar issue which I learned to live with by avoiding very loud environments (lots of people talking in a tight indoor setting). I sometimes mishear dialogue while watching movies and have to rewind here and there. However, when listening using headphones the problem goes away almost entirely. The amplification seems to help in this case. Similarly in semi crowded environments it should help as well. It never bothered me enough to try hearing aids but if barriers to acces dissapear Im willing to give it a try. OTC and prescriptionless should help since I don’t have a medical insurance at the moment.
I think they want a hearing aid that could selectively amplify just one voice. Maybe the loudest voice in the vicinity, for example, while muting the others. Not sure how feasible it would be to do this in real time, though.
Conversation Boost for AirPods Pro helps you better hear conversations in crowded or noisy environments. Through computational audio and beamforming microphones, Conversation Boost focuses AirPods Pro on the voice of the person directly in front of you, making it easier to distinguish speech and follow along in face‑to‑face conversations.
I have AirPods Pro's and they are very disappointing. My pair of $500 hearing aids are far superior. The AirPods provide no gain for external sound, and not nearly enough equalization to compensate for hearing loss. The "beam forming" effect is nearly non-existent. I have a pair of Bose Hearphones (sadly no longer sold), and those really had effective directional capability.
Apple has all the tech needed to get this done, even in their existing product. I'm hopeful they will now feel they can release it. All I need is compression (amplification of soft sounds without over-amplification of loud sounds), equalization, and an app that allows me to make the necessary adjustments - with separate controls for exterior sound and the iOS audio chain.
I'm betting they'll come up with something "good enough" eventually. The pending Pro supposedly has significantly improved audio capabilities so that may help make it happen.
Yeah same this is one thing about Miami that is a bit obnoxious, I'm just minding my own business blowing off steam at happy hour somewhere and like so many normal city bar type spots have like a DJ set up and I wanna be like "hello sir or madam, my phone decibel meter indicates that this is way too loud." ~points to spectrogram on phone screen flashing 97~
I don’t think it needs to selectively amplify just one voice, it just needs to quiet down the background noise.
For reference I had a friend whose hearing aids were doing this 15-20 years ago. He was able to have a conversation just fine in a crowded bar, whereas I couldn’t hear a thing over the din of background conversation.
> Wouldn't that just make the party louder as well, resulting in the same situation?
If everyone was using a naive version of what's described: maybe?
If only a handful of people were using it: probably not.
And I'm sure you could exploit human psychology to engineer some way to keep the party as quiet on average as before.
(Slightly related, I heard of some gadget that projects someone's speech back at them with a slight delay. The effect is said to be so unnerving that untrained people stop talking altogether, or only haltingly. It's apparently been used to shut down protestors.)
> some gadget that projects someone's speech back at them with a slight delay
I wonder if it would be more disconcerting with a varying delay. Long ago I saw a proposal to eliminate "feedback" in a Public Address system by putting in a delay line with variable delay.
I have pretty bad sensoneural hearing loss, and fitted hearing aids didn't help much. Then I found Bose Hearphones[0] that I self adjusted, and they've been great! They were marketed as "conversation enhancing" but they seemed to have been a tip toe into hearing aid systems.
Take good care of them. They worked really well for me.
But, the internal frame is partly plastic, and mine snapped. You have to be careful not to flex it much when taking it off. Now, I'm looking for fine weave carbon fiber cloth to fix it - I got it working once using superglue, but it broke again.
Meanwhile, Bose has completely exited the hearing aid sector.[0]
I imagine a role for being able to select between 3-4 enhancement personalities, just as one might wish to select between different self-driving personalities for different road and traffic conditions.
Also, given what I take to be a high proportion of non-use of hearing aids after a professional "fittting" or "tuning", I wonder what role for "at-home" A/B testing where a wearer can suggest better/worse between two different sets of adjustments.
The might be okay at low level of hearing loss but at higher levels, the noise cancelling/selection tech is still lacking compared to what a human mind can do. Its still difficult in a crowded store trying to focus on what the cashier is saying among others chatting, background music, etc. Typically hearing aids have two mics on each hearing aid so they can focus on the front or omni directional but the intelligent switching is not that good.
One anecdote. Whenever I visit my uncle I go to his church. There's an older guy there who wears something that looks like knockoff airpods. They are his "hearing aids."
I hate this so much. Why can't I buy contact lenses with an expired prescription? I have a prescription, I feel my vision is fine. But I still have to go to an optometrist to get a new prescription, just to be told the power hasn't changed.
Someone Who Isn't Me may have been long buying contacts 'from Canada' online with an expired prescription. They're supposed to check prescription for US customers before shipment, but...
1-800-Contacts will auto-renew your existing prescription in some states via a eye exam you can do on your phone. I think optometrists consistently sue them over that sort of tech to try to keep their useless glasses monopoly in an era where they really don't need to exist anymore.
Else order from Canada or the UK. Still cheaper to get a new exam at Costco in most cases.
Yep. The prescriptions are only good for one year, and it's usually $50-$100 to get tested. Most places won't sell you more than a year's supply of lenses at a time either.
FWIW weekly and biweekly lenses are functionally identical to monthlies (dailies are different). The only difference is FDA rules meant to preserve artificial market segmentation. You can buy a years supply of weekly lenses and wear them longer.
If the land were truly free people wouldn't have to keep shouting it from their EPA regulated lifted trucks while listening to the FTC regulated radio for their favorite country star who uses copyright to keep people from freely playing their music.
You can. I've done it multiple times. Go read how the law is written. Companies have 24 hours to attempt to verify your prescription. If they can't get in contact with the doctor you listed they are allowed to sell you them anyway
My last prescription for contact lens was for a specific brand. Once I realized I wanted to go back to my last brand - I was told my current prescription didn't cover it. Instead of dealing with another appointment or calling up to complain - I just bought them from the a UK site willing to ship.
Even just taking a daily contact out once and immediately popping it back in can sometimes mangle it up enough to noticably fuck up my vision. Biweeklys are much more tough as they're actually designed to be handled.
Not trying to shit on dailies by the way, as they're actually the healthiest for your eyes if you can swing the cost.
>The reason behind the lawsuit? The suit claimed Johnson & Johnson had misled consumers and eye doctors that their Acuvue 1-day lenses had some type of special physical property that limited its use to 1 day when, in fact, they were identical to regular Acuvue lenses, which were bi-weekly contacts.
Sorry I live abroad so buy them infrequently when back in the USA and I can’t find my order receipts in my email to check. I’m sure all the sites work. Funnily enough I’m pretty sure the “Canadian” site I ordered from shipped them to me from a warehouse in Washington.
I would love to be able to punch my audiogram into my phone to get AirPods or similar to do the right amount of amplification.
I can hear almost nothing at many frequencies without amplification in my right ear but have normal hearing in my left. This means I can use a regular headset to hear well with my left ear or use Bluetooth on my one hearing aid to hear with my right ear.
It looks like you can punch in an audiogram. Now I just need to shell out more money for compatible earbuds. I don’t think that will act as a hearing aid yet, so it would leave me switching between AirPods and my hearing aid. The first hearing aid I lost was due to switching between a hearing aid and hearing protection.
They pretty much can right now, unofficially. There's a definitely-not-for-medical-use-wink-wink toggle that uses a paired iPhone's microphone to relay audio at an adjustable level.
It doesn't work very well, because of the latency in the BT chain. An effective solution needs to use the two mics in each AirPod and the internal AirPod DSP.
I've never had issues ordering glasses from Zenni and I think Warby Parker too, you can just put in whatever values you want. Contact lenses on the other hand are regulated, I have to get those from overseas without a prescription.
They won't let you punch in an expired prescription, let alone "whatever you want," but if you've bought a pair of glasses from them in the past, they'll let you buy another pair even if the prescription is now expired.
IIRC they basically try to chase up your eye doctor for you, and if your eye doctor doesn't respond within a certain timeframe, they have a greenlight to proceed with the sale according to a California law that was passed maybe 10 years ago. It's probably different in different states - maybe in some states you can literally just type in whatever you want.
Maybe their policy has changed, but I bought a pair last year and haven't had a prescription in 4 years. It is possible I uploaded that prescription when I first bought glasses from them rather than just entering the values I wanted, but it's for sure years expired.
For contacts the FTC contacts rule requires certain prescription verification rules.
I'm not aware of anything on the federal level that requires a patient have a valid prescription for eyeglasses. (I've looked, but I've not found any such requirement.)
The restrictions appear to be on the state level. Some states prohibit dispensing prescription glasses without a prescription. Other states appear to only regulate what a prescription must contain, and how long it lasts, with no apparent laws around dispensing. (For example South Dakota explicitly does not regulate opticians, so unless there is some federal law I have missed, they can produce and dispense any type of glasses to anyone who asks, but cannot do so for contacts due to the FTC contacts rules.)
My question is how do over the counter hearing aids get adjusted? Currently I go to an audiologist who fine tunes my hearing aids to my specific hearing loss.
Will pharmacists do this now? Or are patients still expected to bring over the counter hearing aids to audiologists for those adjustments?
Oh hey, I'm an auditory scientist who studies hearing loss, hearing aids, and self-fitting and other "alternative-fit" audio devices. I'm going to copy a bit from my latest paper that touches on this (TL;DR at the bottom).
"A central problem of hearing aid fitting is that the space of gain-frequency responses that can be achieved with digital hearing aids is extremely large, but only a subset of those responses could reasonably be audiologically appropriate for any particular ear. Client-based selection of amplification has historically involved some combination of restricting the number of individual gain-frequency responses available (e.g., Humes et al., 2017) and providing efficient methods for navigating the space of gain-frequency responses (e.g., Sabin et al., 2020). The approach of offering a choice between three presets was found to be efficacious in clinical trials of a client-driven delivery model (Humes et al., 2017, 2019). Recent work suggests that as few as four gain-frequency responses can provide audiologically appropriate fits to 60%–75% of adults with mild-to-moderate sensorineural loss (Jensen et al., 2020; Urbanski et al., 2021). Greater coverage can be achieved by expanding the number of gain-frequency responses available to the wearer (Sabin et al., 2021). In a field trial of a self-adjustment tool that provided clients with a large range of gain-frequency responses, participants showed slight preferences for self-adjusted settings over clinician-fit settings, and no group-level differences in clinical measures of amplification benefit were observed (Sabin et al., 2020)."
Perry, T. T., & Nelson, P. B. (2022). Self-Adjustment of Hearing Aid Amplification for Lower Speech Levels: Independent Ratings, Paired Comparisons, and Speech Recognition. American Journal of Audiology, 1-17.
TL;DR: Some products will come with 4 or 5 presets that you can choose between and then tweak slightly. Some products will come with software (such as a smartphone app) that includes simplified (yet effective!) user interfaces for the wearer to self-adjust the amplification. Some products will ask you to engage in a computerized hearing test to set the device to levels prescribed by an audiogram-based fitting prescription formula. We will see many more audiologists and hearing instrument specialists modifying their service delivery models to invite people to bring their already-purchased OTC hearing aids in and have them programmed by a specialist.
You have probably considered this, but just to wonder about an option, might a larger (say 15 or 30 total) preset space be searched by a user, UX-wise, via A/B testing or better/worse responses?
Yes, in fact, there have been scientists investigating the most efficacious algorithms for self-selection of hearing aid amplification since the mid '80s that continues up to today. The modern versions of it are self-adjustment tools like EarMachine ( https://apps.apple.com/us/app/earmachine/id732177210 ) which is the tool I used in my research, or what's called "trainable hearing aids" which have algorithms that observe how you adjust the hearing aid in day-to-day life in different acoustic environments and then try to predict and apply your preferred settings based on the acoustic environment ( https://www.tandfonline.com/doi/full/10.1080/14992027.2016.1... ). These different types of technologies can be (and often are) used together.
Could this be done via smartphone app, where the phone plays a series of sounds and the user responds via the phone's interface? I'm no audiologist, and of course this would depend on the phone's speaker being able to work at a variety of different frequencies.
I don't see why you still wouldnt go to an audiologist if you preferred - but I imagine the tech will get good enough that a) perhaps doing it with a phone app would be sufficient b) maybe pharmacies or grocery stores will have techs to help people.
Ideally, you should be able to do it yourself on your phone. It's not like it takes special training. Pick what frequencies to boost, try it out, make some different settings for loud parties/quiet conversation/whatever.
I'm not an expert here but the small amount of digging I've done suggests the opposite. You can permanently damage your hearing if you tune the hearing aid wrong, and it's extremely fiddly (can take many sessions with a professional audiologist) to get things right.
I think this is still compatible with some adjustments being done on an app, and definitely with some set of "safe parameters" being available without prescriptions. I just want to push back a bit on the idea that what an audiologist is doing is trivial. I expect most people with severe hearing loss will still want to see a specialist. But _as long as the risks are understood_, more choices are better than fewer.
Well yeah, "professional audiologists" would love people to believe turning a 2D volume knob is too complicated and dangerous to do alone. Most people don't want to be obsoleted. I use an EQ plugin for Spotify (https://imgur.com/a/NgdTSd1). Something similar, with safety rails for total volume, would be miles better than going in for adjustments for most people.
Real-time feedback and control goes a long way to turn a (potentially embarrassing or shameful) disability into something simple, empowering, and even fun.
People over 60+ accounts for the majority of people with hearing loss. Sadly this part of the population isn't always that tech savvy.
It should also be noted that a huge problem in countries in Europe where hearing aids are subsidized by the state is getting people to actually use their subscribed hearing aids. Usually the patients needs information and coaching to be motivated. With that in mind I think alot of over the counter hearing aids will just end up in a shelf somewhere if there isn't any good resource for encouragement and technical help.
It seems there are two problems with something in common. Many people don't use their expensive hearing aids after purchase and fitting. And many people might not use inexpensive hearing aids after purchase and whatever fitting. Hmmm.
Older adults of today can be quite tech savvy! In both my research and research from similar labs, the actual programming of a self-fitting hearing aid is completed with a high success rate ( >90% ).
What kind of options are you testing for user controls? Is the core of the tech just frequency boosts or is there fancy stuff in there as well, feedback loops or trying to interpret the sound somehow?
Do you know how people feel about their hearing aids?
Where do you see the industry going in 5-10 years?
What companies in the space look promising/exciting to you?
>What kind of options are you testing for user controls? Is the core of the tech just frequency boosts or is there fancy stuff in there as well, feedback loops or trying to interpret the sound somehow?
I used EarMachine [ https://apps.apple.com/us/app/earmachine/id732177210 ] with custom hardware in my studies. The amplification controls consist of two touchscreen wheels, one which increases the gain (with a higher rate of increase in high frequencies than in the low frequencies) and one which acts as a spectral tilt. There is a complex mapping from the two wheels to the gain, but that's the simplification. It's just traditional non-linear amplification that is applied to the input signal.
Industry labs are privately exploring all sorts of things, but they won't share publicly until their products are ready for market. The NIH has been funding the development of "open master hearing aids/simulators" to promote research into new signal processing strategies, and start-ups are pursuing new delivery models. A lot could change in just the next 2 years.
>Do you know how people feel about their hearing aids?
Every so often some market research data is published under the name MarkeTrak [ https://betterhearing.org/policy-research/marketrak/ ]. This summary is most relevant [ https://www.audiologyonline.com/articles/20q-understanding-t... ]. About 2/3rds of people who could benefit from hearing aids do not own/use them. There are a lot of reasons for that, and actual satisfaction with hearing aids is only a part. In the UK where there's no financial barrier to getting hearing aids for the vast majority of people, hearing aid adoption rates are low. Culture, social stigma, and even personality plays a huge role in how people feel about hearing aids. That's the background for this: Most hearing aid owners are satisfied. People who have hearing aids older than 6 years tend to be less satisfied than people who have new hearing aids.
>Where do you see the industry going in 5-10 years?
Broadly speaking, I expect to see a lot of experimentation and diversity in products and service delivery models. Using the principle of "the more things change, the more things stay the same", I would predict that we will see an increased focus on products and delivery models that feature greater personalization and greater integration with consumer electronics. I think we're gonna see an attempt to leverage more and different sensors on the body to modify and control device output. I think we might see some breakthroughs on noise reduction algorithms, but in the end they won't prove as useful as we'd hoped. I think Zuckerberg wants to sell a VR headset to every grandparent and great-grandparent.
>What companies in the space look promising/exciting to you?
You know I just don't have a good answer for this one. Very sorry!
> The Food and Drug Administration moved to make hearing aids easier to buy over the counter without a prescription or medical exam
But you can already buy hearing aids without a prescription or medical exam. I do mean the United States, and I do mean devices labeled as hearing aids and not personal sound amplification products. See this article from Consumer Reports dated November 11, 2021, where they talk about Direct-to-Consumer Hearing Aids and Self-Fitting Hearing Aids, neither of which require a prescription or medical exam, but are still labeled as Hearing Aids:
An example is the Bose SoundControl Hearing Aid that I know for a fact has been available for purchase without a prescription directly from Bose for many months (in the USA only).
It's true that a lot of people don't know about the Direct-to-Consumer and Self-Fitting Hearing Aids. But I don't understand what benefit comes from the new FDA rules that didn't already exist.
EDIT: It sounds like the FDA could be making it worse. Quoting from the Consumer Reports article above, it says, "FDA-Approved Over-the-Counter Hearing Aids could at first look like some of the Direct-to-Consumer options already available—but they will be subject to additional rules." Why would any manufacturer want to market with additional rules when they're already allowed to sell under the Direct-to-Consumer or Self-Fitting Hearing Aid rules?
Before the new OTC regulations, the situation in the US has indeed been confusing in multiple ways. This has lead to consumers mostly perceiving hearing aids as prescription devices and the industry being able to maintain higher prices because of that.
On the federal level the FDA has required that buyers provide a medical assessment stating their need for a hearing aid. However, buyers older than 18 have been allowed to waive that requirement.
On the state level, many states have had prescription requirements. The FDA has ruled against such state laws several times but many laws have remained on the books. While in theory unenforceable, they have created a lot of FUD for prospective sellers.
The industry (audiologists and hearing aid manufacturers) has continuously reinforced the view that prescriptions are needed and in the buyers' interest.
Personally, I do think the new OTC regulations make the situation clearer and have the potential to improve products (assuming products become easier for users to configure themselves) and lower prices (as it's not only the audiologist's service buyers have paid for, but bundling of examination+device+followups has allowed higher pricing for the devices as well).
The settings are VERY straight-forward for anyone to program a machine, and online stores are already offering 50% off or more on the machines. The pain point is that online stores are required to get a prescription, even though the end user will need to manually configure the machine after receiving it.
I do agree that the accessories are annoying as heck. It really makes competition almost impossible, since trying to price compare medical suppliers is painful to say the least.
>The settings are VERY straight-forward for anyone to program a machine, and online stores are already offering 50% off or more on the machines. The pain point is that online stores are required to get a prescription, even though the end user will need to manually configure the machine after receiving it.
You're right, setting up a CPAP machine is pretty easy. The reason I think a prescription for the machines is worthwhile is for people newly diagnosed with Obstructive Sleep Apnea (OSA).
Because it's useful to actually interact with a medical professional not just to get a "prescription," but to confirm that the issue is actually OSA rather than some other issue that a CPAP sleep regimen won't address, as well as to identify other health issues that can impact overall health and sleep.
What you don't want is someone self-diagnosing themselves and not engaging a health care professional (in this case, a pulmonologist) and deciding they have OSA, buying a machine and its associated accoutrements and not actually having OSA -- rather something else that may be causing the issue -- perhaps something with a higher risk of serious illness or death.
All that said, once you have such a diagnosis, it's stupid to force folks to get new prescriptions to buy a new machine and incredibly stupid to require that for accessories like masks.
>I do agree that the accessories are annoying as heck. It really makes competition almost impossible, since trying to price compare medical suppliers is painful to say the least.
Another good point. I find that, for me, most masks are uncomfortable and leaky. Over the years (almost 20 now), I've found the accessories that work best for me. As such, I know what I want, so price checking is a bit simpler, but it's not something that has a lot of price sensitivity to me -- I'm more concerned with making sure I get what I actually want/need rather than some cheap knockoff.
It's not that hard to learn how to get into the secret "technician-only" settings screens on existing CPAP machines. They can't be that dangerous. I've fiddled with mine (the technician told me how) and the worst I've done is give myself an uncomfortable night's sleep. It's an airhose with a not-particularly-strong seal gently squirting air into your nose, not a chest tube.
They don't need to. You want to set the machine to the lowest pressure limit that ensures you sleep well and are comfortable. This progress can be objectively measured since the machine counts apnea events. Both of these are easily surfaced in the UI.
It's no different than setting the volume on your headphones to a comfortable level. And it is not some fiddly arcane art that requires a medical intervention.
The danger there is that there is more to it than just pressure.
Many of the defaults, at least for me, actually make it much harder. Like, my machine by default ramps up the pressure slowly... which I find quite uncomfortable... I am on the higher end of the pressure range.
I run in APAP mode, with a rather narrow range of 17-20. (20 is the most typical machines can run.. some bipaps can go up to 25). Anything below about 15 feels like I'm breathing through a straw.
Humidity setup is quite important as well, and often paradoxical (lower setting = effectively more humidity, as water capacity is limited and on higher settings pretty much all of the water is used in the first couple of hours).
Now, none of the professional people involved helped or guided me to any of that. My initial sleep stufy (in person, not home, this was ~7 years ago) came up with a static pressure of 13.5. That didn't work well at all, as stated above. That said, if I wasn't a techie, I doubt I'd have figured any of that out.
The market there has mostly eliminated titration in the US. Instead of determining the ideal pressures in a controlled environment, APAP machines are prescribed instead which monitor for events (where you may have stopped breathing) and increase the pressure in turn.
This is why such a large number of sleep studies are home studies now - it is cheaper to spend $200 more for APAP then pay for an overnight sleep study center
I used to work in an office next door to a CPAP place and the few interactions I had with their customers over the years did not suggest that the average person could figure out how to operate one.
Not really, the cartel just wants you to believe that. There just needs to be a limit on the max volume that the OTC devices can put out. The situation is similar to headphones.
What we need is compression and equalization. Now. They can work on the fancy AI stuff later.
From what I understand is that some hearing loss is actually a loss of certain frequencies so you won’t hear things in that frequency anymore. Using a hearing aid that just increases the volume may work but may also damage your hearing farther. What I was told was that is why you need a doctor and a prescription because they determine what frequency is missing and they don’t make the sounds louder but alter the frequencies you don’t hear well into a frequency you do hear.
With that said I have also heard there are apps that could easily determine what you would need for frequency adjustments without the need for a doctor. I think these apps with paired over the counter hearing aids would be the best situation.
I feel like a broken record mentioning that Costco sells high quality hearing aids for $700 each. Exams, fittings, adjustments, cleaning, and many repairs are free so long as you have a Costco membership. No membership is required for the exam.
Most people that need hearing aids that live near a Costco could already be saving thousands of dollars.
It’s only an impressively affordable price after you compare to what they cost almost anywhere else. The cheapest hearing aid from the audiologist affiliated with my ENT was about $3500 for a far inferior device. Other audiologists charge for follow up visits and repairs which can run a couple hundred bucks per year.
I’ve had a hearing aid wire break. I showed up without an appointment at Costco for a regular shopping trip and the repair was done for free by the time I was ready to check out. Similarly when I’ve needed replace ear domes they did the replacement and a cleaning while I shopped or waited.
My previous hearing aid required batteries. They are dirt cheap there too. My current hearing aid is rechargeable so that is no longer an issue.
Everybody I know with hearing aids ends up at Costco. My parents have saved probably more than $15k by this point.
It's a huge racket.
An issue is that hearing aids may still need to be regulated. For instance, it's possible for them to have so much gain and power that they further damage your hearing.
Even ignoring the comparison to existing options. 700$ doesn't sound ridiculous if you consider it includes exam, fitting and so on. It's only 2x the price of airpods, which doesn't come with exam or fitting.
Where do you think you're posting, a socialist forum? This is YC for gods sake, we are here to make an honest to goodness.... absurdly high return on investment by completely monopolizing an industry and spending the rest of your days taking people for all they're worth so they can have a basic life and you can have a third yacht
"Perhaps 5% of children and younger adults (<60 years old) with “clinically normal” audiograms (i.e., tone thresholds better than 20 dB HL from 0.1 to 8 kHz) have difficulties understanding speech, particularly in noisy, reverberant or otherwise challenging listening environments "
Wrong blood glucose monitor readings can have deathly consequences, as you base your insulin intake on it. It makes sense to be more careful there. On the other hand, how OTC monitors can introduce more risks is not exactly clear to me either.
The glucose monitors out on the market right now are **ing terrible anyway. They're regularly off by a huge amount compared to the readings you get from poking a fingertip. Getting really sick of being woken up in the middle of the night because my SO is about to die from low glucose, we check her finger, and it turns out she was completely fine. I'd personally be happy to try out a free market approach at this point
Nearsightedness (myopia) and farsightedness (hyperopia) are both not OTC, presbyopia is. However, the correction for presbyopia (+ lenses) is the same as for farsightedness, provided you don’t have a lot of astigmatism. I won’t explain the intricacies here, but you can look up how accommodation works using the terms above.
Officially yes, but in practice you can buy glasses online if you know the power of the lenses. Contact lenses do have a prescription verification requirement for sellers.
My first thought was how much did Apple (and others) shell out to lobbyists for this to happen ... (There have been rumours that Apple wanted to get into this market - high end hearing aids already come with bluetooth and mic but are quite expensive. Even if Apple charged half of that , they would make a huge profit ... not to mention all the health and other data mining they will be able to do with it).
There's almost no cost that Apple could charge that would be 'worse' than the status quo. A family member just got fitted with hearing aids for her mild hearing loss this week. Had to take out a 5-year loan because she's retired, on fixed income and it's roughly five thousand dollars for her hearing aids. I hope these companies and their executives go bankrupt in as short of a time as humanly possible.
I genuinely consider healthcare to be the biggest legalised scam in the US. An MRI scan for your arm costs $2000 (in NY)? Hell, for that you can fly down to India, get an MRI scan and a personal consultation with a reputed doctor, relax for a week and go back to the US!
AS a hearing aid wearer, I think it would be good if they can bring more competition and innovation. But I prefer if they would make it tiny and invisible like the prescribed ones I wear. It goes over my ears and into my ear canal but nobody can see it unless they look closely. Airpods look much more noticeable.
Good. My grandfather always had a hearing aid. My father needed one. And based on the way I need to go, "huh?" and make everyone repeat what they say to me a second time, I will need one. I don't need a doctor to tell me I can't hear well.
It doesn't feel like it's gotten worse to me. It feels like there's a lot more effort to diagnose kids with hearing trouble and to make hearing aids less stigmatized. More discreet devices make them a compelling option for folks who are self conscious.
But it is the case that headphones _have_ been damaging hearing for a long time. The rise of MP3 players that could blast audio was a known cause of hearing loss even as it occurred.
IIRC the overall prevalence of hearing loss is has not been changing that much. There are a couple of opposing forces at the population level.
Most common hearing loss is age-related and the population is getting older.
Two other common causes are exposure to loud noises at work and infections.
Work-related exposure is decreasing as fewer people work in heavy industry and hearing protection has become almost universal. Infections have also decreased with better hygiene and health care.
I don't know of evidence that loud music is actually causing hearing loss in young people.
I tend to vote mostly conservative, but on this issue I applaud the Biden administration and Senator Warren.
There is great benefit to having strength on both sides of the political aisle. The pendulum swings back and forth, and sometimes we get benefits from the side opposite the one we are on. This appears to be such a case. Thanks to the admin for this.
The FDA has been authorized (and mandated) by Congress to regulate medical devices (including hearing aids, among other things) since the Medical Device Regulation Act was passed in 1976-- this isn't a regulatory agency reaching outside its authorized purview, nor is it the same sort of legal ambiguity that was in question with West Virgina v. EPA.
If you want less regulation in this space, that's a change in the law that needs to go through Congress. Which is exactly what happened here for hearing aids.
> You are suggesting that regulation is both an effective way to combat quackery and perhaps even the most effective way?
Yes. To the extent that there are regulatory gaps today, they're almost exclusively filled with quack medicines.
I'm sure the market might work it out in the long-run, but in the meantime people will suffer from inadequate (or even detrimental) medical care.
You seem to accept this logic for drugs, but quack mechanical devices can cause harm as well. For instance, an inappropriate hearing aid could hasten hearing loss.
> What about costs and benefits, too?
We should definitely work to improve the regulatory process, but just giving up on the whole concept of regulation seems counterproductive.
That's essentially what the FDA is doing with regards to most medical devices. The 'stamp' is allowing you to make certain claims about a device's ability to have some medicinal effect.
As already demonstrated, Bose was able to sell what was effectively a hearing aid in this new category, but without making any claims about assisting with hearing loss.
I guess what you're suggesting is that manufacturers should be able to make any claims they please with the FDA being relegated to a position of endorsing those claims.
Nothing that has happened in the past few years has given me any confidence that such a system would work (see: Ivermectin, Hydroxychloroquine, Bleach, intravenous UV light, Chelation, et al.).
> If we simply went back to pre-1962 law, the FDA could still require proof of safety, but would not be able to require evidence on efficacy. This one change would allow drugs to be developed faster–often as much as 10 years faster. Market success would establish efficacy. Could there be ineffective drugs? Sure. But as doctors and patients learn, such drugs would disappear over time. This is nothing new; doctors and patients regularly evaluate drugs for efficacy. Clinical trials often show that perhaps only 20 percent, 40 percent, or 60 percent of patients benefit. Even when the FDA finally approves the drug as “safe and efficacious,” doctors must still evaluate the drug to find out how efficacious it is for each particular patient. In practice, an FDA certification of efficacy is just a starting point.
Btw Ivermectin is FDA approved. I am not sure why you bring that up?
In the meantime, patients will be switching from drugs with known efficacy to wonder drugs with potentially no clinical evidence of having a medicinal effect.
> Could there be ineffective drugs? Sure. But as doctors and patients learn, such drugs would disappear over time.
Trying to do that piece meal won't work. You need controlled statistical studies to establish such things.
> doctors must still evaluate the drug to find out how efficacious it is for each particular patient.
Generally informed by subsequent clinical trials. They don't just go with their gut.
> Btw Ivermectin is FDA approved. I am not sure why you bring that up?
You know very well why. In fact it kind of makes my point. Patients are attempting to switch from a treatment regime with known efficacy (vaccines) to one with highly questionable efficacy (Ivermectin). If you follow through with your plans to deregulate the pharmaceuticals industry, you'll see a lot more of that.
Because it's the same. A label is a label. Both involve health.
Instead of some fent analogue cooked up in a chinese lab, this knockoff would be cooked up in a chinese lowest cost, cheating encouraged (if you don't get caught), grab parts from wherever, alibaba store room.
We do need to evaluate trade offs between danger, effectiveness, quality control, and price.
IMHO so long as the hearing device won't cause further damage this is a great move and should be treated like OTC glasses.
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As to SCOTUS rulings, see below about this specific mandate by law.
However both parties have ceded massive authority to the executive over the last two decades (accelerating with Cheney).
Feels like that is a big part of the problem here.
Regardless, I don't think SCOTUS is making the right rulings on a ton of things, including EPA specifically per your example. Everything under the sun shouldn't have to be enumerated. we have to look holistically and allow the executive to adapt as dangers and circumstances change.
Executive should be allowed to use the powers Congress has given and often been purposefully ambiguous about (see 9/11 security state).
I'm glad the FDA is finally moving on this - though what President Biden said is somewhat specious.
Biden: "This action makes good on my commitment to lower costs for American families, delivering nearly $3,000 in savings to American families for a pair of hearing aids and giving people more choices to improve their health and well-being."
However, this is really due to the Over-the-Counter Hearing Aid Act that was signed into law in 2017 by President Trump.
There would be no shame in Biden praising an action made by Trump or in Trump praising an action made by Obama.
Congress passed that proposal at the time, but the Trump administration FDA didn't issue the rules that would actually allow for those devices to be sold directly to consumers. It's being implemented now because of the July 2021 "Executive Order on Promoting Competition in the American Economy," in which Biden called on the FDA to take action on over-the-counter hearing aids within 120 days (among a variety of other provisions).
That's my point. The Act specified three years for the implementation, which HHS/FDA ignored. As I wrote, "There would be no shame in Biden praising an action made by Trump or in Trump praising an action made by Obama."
Where's the shame in taking credit for an action that he took himself? Yes, both Trump and Obama did things on this front. But Biden is the one who got it done.
There is no shame. However, this was literally the job of HHS/FDA as directed by law that Warren sponsored and Trump signed. Someone shouldn't be so loud and specious in taking credit when doing their job as ordered by law. As the article says, "The move comes more than four years after Congress ordered the FDA to craft regulations for over-the-counter devices."
Even the FDA in their statement cited the history of the rule, "In 2017, Congress passed bipartisan legislation requiring the FDA to create a category of OTC hearing aids, but it was not fully implemented until now. Consumers could see OTC hearing aids available in traditional retail and drug stores as soon as mid-October when the rule takes effect."
Yes, you are making my point. Biden only took credit for things he did. He didn't take credit for the legislation. Nor did he take credit for what Obama did on this issue.
The only thing Biden cited having doing is the EO. You left that part out of your quote, but that's the only thing he cited having done on this. Thankfully, he got this done finally!
Exactly, and in doing so he attempted to take credit for the years-long work of others, primarily Warren and Trump. That has been my point all along. Thanks for helping me illustrate my point!
Actually, I mentioned Obama in my first two posts... What is related is that you left out Trump when referencing Obama and Warren. Trump signed the law for this. This is the truth, regardless of anything else Trump may have done or said.
In both comments, you spoke only of "Trump praising an action made by Obama." It was not a comment specifically about this issue. I think that's fine. I don't have a problem with you failing to cite everybody who has ever done anything on this issue. It's just the irony of your comments.
I'm not sure signing a bill that did not actually take effect (due to the people put in charge by the signer) should count as an action. I mean, sure, he moved his hand.
We'll have to wait and see if Biden's FDA will take substantive action.
Here is the original bill "Over the Counter Hearing Aid Act of 2017" from Liz Warren:
https://www.congress.gov/bill/115th-congress/senate-bill/670
The bill "FDA Reauthorization Act of 2017" that become the law:
https://www.congress.gov/bill/115th-congress/house-bill/2430
The section for OTC hearing aids says:
"(Sec. 709) The FDA must categorize certain hearing aids as over-the-counter hearing aids and issue regulations regarding those hearing aids. The regulations for over-the-counter hearing aids must: (1) provide reasonable assurances of safety and efficacy; (2) establish output limits and labeling requirements; and (3) describe requirements for the sale of hearing aids in-person, by mail, or online, without a prescription. The FDA must determine whether premarket notification is required for over-the-counter hearing aids to provide reasonable assurance of safety and effectiveness. State and local governments may not establish or continue in effect requirements specifically applicable to hearing products that are not identical to FDA requirements and that restrict or interfere with the servicing or sale of over-the-counter hearing aids. The FDA must update and finalize its draft guidance on hearing products. The guidance must clarify which products are medical devices."
It doesn't directly say that cost should be reduced but assuming it will go OTC, costs should go down ?