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The FDA wants you to be able to buy a hearing aid without a prescription

744 points by cf100clunk 5y ago

annoyingnoob 5y ago
Can we free vision correction next? The US is behind the times.
fallingknife 5y ago
Can't we just get rid of the prescription system in general, and make doctors advisors like lawyers are? I don't need all these gatekeepers "keeping me safe." In Mexico you can just walk into a pharmacy and buy anything. Even pain killers. And it works fine. The only drugs that seem to cause societal problems are the ones that the government tries to keep you from getting.
oneplane 5y ago
Wouldn't it make more sense if the FDA just wanted everyone to be able to hear properly? I get that they are a policy institution and "hear better, implement it however you like" isn't much of a policy, but an almost-directive (buy whatever you want) seems to be rather decoupled from any health related issue which is what an hearing aid is for.
moistrobot 5y ago
Good, now let's do this for everything
joshsyn 5y ago
Anything regulated just becomes pricey.
cf100clunk 5y ago
"People with mild or moderate hearing loss" should be free to purchase these sort of generic hearing aids in much the same way that buying non-prescription reading glasses is common. If problems persist, it is time to consult a professional.
- causi 5y ago
  Heck, imagine if prescription glasses were only available from government-certified vendors. We'd be back to paying $700 a pair like the bad old days.
  - kfprt 5y ago
    Glasses are a huge ripoff due to the industry being a monopoly with no help from the government.
    - Turing_Machine 5y ago
      There are some online retailers that have pretty good prices.
      - kfprt 5y ago
        Spare a link or two?
        wmeredith 5y ago
        I like these: https://eyeglassfactoryoutlet.com https://eyeglassfactoryoutlet.com
        mixmastamyk 5y ago
        https://www.zennioptical.com/ https://www.zennioptical.com/
        yboris 5y ago
        https://www.eyebuydirect.com/ https://www.eyebuydirect.com/
  - jleyank 5y ago
    Buy lightweight frames and lenses, have progressives and get anti-glare coating and "we'd be back to paying $700/pair" is like, last year if I miss a sale. Lenscrafters, not a small shop. They're all owned by the same site, and I work on the 50% off of lenses sale. Frames are 150-300 as I avoid big-name style. These are way more than +2.5 diopter reading glasses, and you might imagine that astigmatism and progressives does wonders for straight lines...
cf100clunk 5y ago
What about building one's own hearing aid? This DIY project came to mind: https://hackaday.com/2013/12/15/diy-hearing-aid/ https://hackaday.com/2013/12/15/diy-hearing-aid/ No mention of DIY hearing aids from the FDA.
- ghostly_s 5y ago
  Because there aren't any FDA regulations preventing you from building a DIY hearing aid?
  - cf100clunk 5y ago
    But there are batteries (pun intended) of lawyers from the hearing aid manufacturers who would act against DIY kit vendors if asked. I wonder who/what is the best entity to help shield DIYers from patents...
    - spicybright 5y ago
      Source? I've seen a myrid of kits that overlap heavily with different products like a DIY hearing aid would.
kiba 5y ago
Some feature requests for hearing aid: Can we get hearing aids that are bigger? These small hearing aids make it easier to lose, and I do not mind looking "disabled" to people. Also would like to use bluetooth to both locate the hearing aids, and to connect to devices as needed. Would be cool if the battery can be recharged as needed, maybe through usb-c if possible, but magnetic charging would be acceptable.
- elliekelly 5y ago
  Do most elderly people even have the dexterity to use the teeny hearing aids on the market today?
  - pugworthy 5y ago
    You may not have meant to, but your question just reinforces the fallacy that hearing aids are for old people. Yes, hearing loss does occur with age for many, but it's not as uncommon as you might think for those not deemed "elderly". I've personally worn them since my mid 20's. I'm glad that I ignored the perceived stigma of wearing hearing aids and got them. They are like glasses for my ears.
  - cf100clunk 5y ago
    Not just elderly people. Rechargable devices would be a boon.
    - braum 5y ago
      I wear hearing aides every day. SMALLER would be better and mine have BT5 and rechargeable. they are NOT cheap about $6k pair with 3 year complete warranty included. Again having options is the best thing, making them larger for me would mean they are more easily dislodged when I bend over to pick something up or are wearing them when working in shop. Having some that have better weather or fully waterproof would be great. I normal take them off when working outside or in the shop. The sweat makes them mostly useless because of the "noise" the sweat makes against the mics. Then the sweat also makes them slick and they will not stay in place. Having options is ideal and affordable options would be great. I don't know why these things are $6k pair when they share a lot of tech with modern in ear options from bose/apple/ect.
kristofferR 5y ago
Contact lenses next? It's amazingly stupid that I, as a tourist, who knows exactly what types of contacts I need, may need to get a US prescription for contacts.
- bastardoperator 5y ago
  How are optometrists supposed to make money if they don't sell you services and glasses from their showroom?
  - DaveExeter 5y ago
    They charge for the eye exam.
    - bastardoperator 5y ago
      That's the break even, those optometrist tools aren't cheap and that's to get you in the door. The real money comes from frames and contact sales.
      - RHSeeger 5y ago
        Then their business model is broken and they need to charge more for exam.
  - adam_arthur 5y ago
    How are people supposed to make money when we have machines producing all these goods! Maybe your post was sarcasm though :) That's the economic progress of humanity. We automate, and jobs that were once valued are no longer needed. Easy to look at a specific instance and fight against the change, but in the long run it's better for everybody. Glasses/Vision in particular costs hundreds more than it needs to. Glasses could be produced and sold at $10-20 bucks if regulations were eased. What is the material cost to produce these? You can get reading glasses in grocery stores for a few dollars. I'm fairly well off and even I feel bad paying over a hundred dollars for some of this stuff. Imagine all the lower earners/poor that pay hundreds of dollars for glasses for no reason other than protectionism. The entire eye exam can be automated very easily (and I believe already has). Would be easy to have machine learning algorithms that can diagnose problems from the image of your retina scan. I really don't think it'd be that difficult, if it doesn't exist already.
the__alchemist 5y ago
Great news. I've been learning about and implementing real-time DSP algorithms for audio enhancement. (Cortex-M7) I started this hoping to make scifi headphone that enhance hearing for normal people with different presets, but realized what I'm essentially building is more like a hearing aid. Didn't even realize the regularly issue. (Although using the article's terminology, could probably already market this as a PSAP and be fine. (?)).
- ygjb 5y ago
  Check out nuraphones; I don't know enough about hearing and audio to know what voodoo they are doing, but as a person with significant hearing loss, the hearing customization they perform during set up allows the device to emit the right frequencies at the right volume that I can hear a significant portion of the left audio channel (which is impressive, given that I am "profoundly deaf" in that ear).
  - the__alchemist 5y ago
    Awesome. Looks outstanding from their site. Seems to be marketed at music listening, especially in noisy environments, although I can't tell for sure.
- Vecr 5y ago
  I'm pretty sure That's what 3M Peltor Comtac headsets do, they have microphones on the outside and speakers on the inside, without passing through gunshots or explosions, so you can maintain situational awareness in a combat situation.
  - the__alchemist 5y ago
    Sounds badass!
Ginden 5y ago
BUT WHAT IF PEOPLE ABUSE HEARING AID?????? To be serious: amount of things that are "prescription only", even if they can cause only minimal harm, is astounding.
- onemoresoop 5y ago
  What if they do end up with a better hearing though? Think about the consequences.. Or what if the ENTs haven't lobbied lately but instead the device makers did this time?
  - jrace 5y ago
    Perhaps you do not realize, or are just trying to be funny, but most audiology professionals do this to help people hear better.
- deleted 5y ago
  [deleted]
- jrace 5y ago
  You can cause more than "minimal" harm. Both hearing loss and comprehension can be changed by an improper hearing aid.
  - Ginden 5y ago
    Can you estimate that harm in term of DALYs?
Spivak 5y ago
As some with a mild APD this would be fantastic! It has never been worth the cost and effort to get "real" hearing aids but I would probably live in the oct version.
throwawaysea 5y ago
Middlemen and gatekeepers are all over our medical industry. When I travel I am always surprised at how much easier it is to get drugs outside the US. Many prescription drugs here are over the counter elsewhere and much cheaper. I hope we start removing prescription gatekeeping more broadly, so I can stop paying hundreds for performative office visits that offer no value. It’s also a big time sink just to get some mundane antibiotic or skincare cream or whatever, when all that happens is that an FNP runs through the most basic Q&A script that can be self discovered online.
- LocalH 5y ago
  Capitalism (as a life goal, rather than one of many tools in a toolkit) is what makes all that possible. If can insert yourself in the middle of a transaction, and do that long enough, then you can get pretty entrenched to the point where people just expect it to be that way. I maintain that, if automobiles were invented today, the horse-and-buggy industry would be able to successfully fend them off, based on the path regulatory capture has taken in the last 150 years.
  - tpmx 5y ago
    There's plenty of capitalism happening in the countries where these things are readily available. Cronyism is the word should have been looking for.
    - LocalH 5y ago
      Perhaps I should have said "societal goal". The stark contrast between those countries, and the US, is that the US collectively has this unwavering dedication to capitalism above all else, it seems in practice.
JCM9 5y ago
There are a number of healthcare areas in the US that have been protected by regulation, but it’s increasingly unclear if this is good for patients, consumers, or public health at large. The increasing sentiment seems to be probably not. Vision care is another area I’d expect to see more changes and disruption coming down the pipeline. Vision care is very important and advanced cases require special skills, but it’s also unclear why many routine checks couldn’t just be done by a family doctor. The US requires one to see a “doctor of optometry” to get a basic single vision prescription. That industry used to make its money turning around and selling you glasses from the same office but that whole industry has been turned upside down by online retailers like Warby Parker and such. Why the US can’t follow the models followed most elsewhere in the world is unclear, but it would remove a lot of extra steps and costs in getting a basic care of glasses. Ophthalmology (medical doctors) are still very much a thing but most countries don’t have this model of needed a “prescription” from an optometrist for a basic pair of single vision specs.
- lisper 5y ago
  > Why the US can’t follow the models followed most elsewhere in the world is unclear To the contrary, it is very clear: regulatory capture. https://en.wikipedia.org/wiki/Regulatory_capture https://en.wikipedia.org/wiki/Regulatory_capture
  - JCM9 5y ago
    Yes… didn’t know what the technical term was but that’s it
  - BurningFrog 5y ago
    Still unclear why Regulatory Capture only happens in the US?
    - lisper 5y ago
      It happens outside the U.S. as well, but the U.S. has a particularly weak form of democracy which makes it more prone to regulatory capture. In particular, money is a more powerful policial level in the U.S. than in most other democracies, and that creates a positive feedback loop that tends to encourage and reinforce regulatory capture (you use RC to make money, which you then turn around and use to pursue more RC in order to make more money...)
jleyank 5y ago
Having worn hearing aids a long time (don't turn sh*t up to 11), I should point out that they require setting per-ear and one can have multiple programs (voice, music, ...). My fear of rechargeable aids is that with serious+ loss they'd burn through batteries in a (very) short time and if they're not replaceable it makes the aids disposable. Fitting is helpful as it's also done for mid-high earphones. This will have to be paid for somehow, and somebody has to do the tests to know what to set. Same as glasses. So we should be able to get the raw aids at a lower cost and then deal with the extras. Costco sells reduced priced aids, so there's a little flexibility in the industry. For my last set pre-covid, there were behind-ear (big), in ear (small) and in ear canal (very small). If you saw True Lies, their "radios" were probably dummy in-ear-canal aids. As I'm not blessed with a 15+ dex and like other posters I don't mind being see so the behind ears are ok. They can be hidden as dangly earrings with a sheath to make it interesting if you'd like. Otherwise, it's a bloody conservative industry re: colors. I wanted blue and red so it matched stereo wires :-). And my attempt at bluetooth connectivity for phone calls failed as the things could not stay sync'd during conversations. Better to just use a headset.
- jrace 5y ago
  "And my attempt at bluetooth connectivity for phone calls failed as the things could not stay sync'd during conversations. Better to just use a headset. " And that is what you should use the money you paid for....getting proper follow up and adjustments, including making your BT work. BT and hearing aids have been used for over 10 years.
  - ricardobeat 5y ago
    What exactly is the audiologist going to adjust to improve BT reliability?
    - jrace 5y ago
      Apply new firmware to the hearing aids. help you set your phone to work properly. Return them and use a different make/model that works with your phone.
frabcus 5y ago
Does this relate in any way to us getting cheaper hearing aids? A pair of bluetooth streaming rechargable ones is about $3000. With Transparency mode and the latest software for AirPod pros, you can adjust the frequency distribution, and get what seem to be servicable hearing aids for $250. What I'd like is proper (medical) assessment and fitting, but of cheaper commodity aids that are much much better made with better apps than most of those on the market now.
- jrace 5y ago
  The tech in the hearing aids is cheap. it is the fitting and follow up where the money you spend should be going. -- that and repairs and regular maintenance.
  - ricardobeat 5y ago
    In my experience with a family member, the fitting and tuning done by the audiologist is as good as a random guess. Constant noise and screeching even after multiple, expensive tuning sessions. As a result the hearing aids get tossed away unused most of the time. The adjustment offered by something like the AirPods Pro seem much more effective.
    - jrace 5y ago
      Then you need to go to a different audiologist. Most of my rejected fittings were from people who had far too high expectations. that did not stop me from trying, and when unable to get success provide a 100% refund, and refer to a different AUD.
nickthemagicman 5y ago
how about the FDA lets us buy whatever we want without a prescription because we're adults?
gumby 5y ago
I just ordered some AirPods Pro to see if they will be adequate. I’m not sure hearing aids can really replace headphones for phone calls etc until both HAs and phones support BT 5.2, and I don’t really want buy several $K of hearing aids that only work some of the time.
busymom0 5y ago
I understand why things like drugs we inject in our body need to be regulated. But I don't understand why hearing aids need to be regulated this way and even need a prescription. It's either "hey I can hear well and it fits my ears well" or it's "it doesn't help me hear well".
- jrace 5y ago
  Because improper use can cause significant hearing loss.
gigatexal 5y ago
This is going to murder companies like audibene.com / hear.com
jrace 5y ago
How much would you pay for: *Hearing test * Hearing aid fitting * Usage counselling * Follow up adjustments * Annual retest of your hearing * Replacement of lost hearing aids * Unlimited repair for 3 years ?? ====== I got out of the Audiology field in 2015. At that time all the above was included for every hearing aid we sold (Prices varied from $750 / ear - $3600 / ear. When I was in that field many companies tried "pay as you go" models, instead of bundles. You know what happened? People paid the minimum (test, and fit) the never returned for repairs or re-tunings. And then complained to everyone that "hearing aids don't work". Buy a hearing aid today from any major provider in Canada and you get: Initial test Initial fitting Follow up tests Follow up re tunes Counselling repairs - including full replacement in case of loss Batteries In-clinic repairs and cleanings. 100% return, and in some cases $0.00 3 month trial period. There is far more to fixing your hearing issues that just amplifying sound. Sadly, most people wait too long before trying a hearing aid, and give up because they hear too much noise. Imagine returning your eye glasses because you still see ugly people. I truly wish hearing aids were far cheaper, and that was a very hard part of my job and one of the reasons why I changed careers.
- brutus1213 5y ago
  Any insights on tuning process for little kids? (2-3 year olds?) These guys don't really have the ability to provide feedback for retuning.
  - jrace 5y ago
    Tuning for them is more about slowly increasing the sound levels overtime than adjusting for understanding. As well you may want to work with a Speech Language Pathologist.
- chairmanwow1 5y ago
  Correct me if I’m wrong, but isn’t this something people could do on their own at home if the hardware had a decent setup UX / tuning instructions? This doesn’t necessarily seem like something that couldn’t be done pretty automatically.
AlbertCory 5y ago
Almost half the comments relate to eye exams & glasses, not hearing aids. There's almost no one defending the present system, and I suspect if you took a poll of the US population, at least 90% would favor deregulating hearing aids. Probably glasses, too. So why hasn't it happened? Those people who said "regulatory capture" get a gold star. A small group who will suffer a lot manage to defeat a much bigger group who will benefit by a much smaller amount.
Damogran6 5y ago
So do I…oddly, I went and got my hearing tested and my issues are with processing, not hearing. The guy said “I actually can’t prescribe you a hearing aid, even if I wanted to.” So, there should be some barrier to entry. Just not at $3500 an ear.
- jrace 5y ago
  That is a very realy situation for most people. A hearing aid - AIDS you in hearing, but your brain does the processing and speech comprehension. if you start wearing a hearing aid now you will just get lazier with your "hearing". Just like if your knees are sore, and you get a knee brace - when you should have done exercises to improve your muscles supporting your knee - the brace will do more harm than good.
  - bserge 5y ago
    I am in pain every fucking second of walking.
    - jrace 5y ago
      So you should be treated differently than someone who "doesn't walk much because my knees are sore.
ChuckMcM 5y ago
It has always seemed broken to me that hearing aids were not covered by healthcare, nor was there some sort of VSP like plan for hearing aids. I've worked with folks who had hearing aids from childhood and it is a big expense to bear while their glasses are subsidized. Of course, the vision folks turned it into a racket for extracting cash. So ideally we'd want to avoid that and perhaps fix the vision racket while we are at it.
paxys 5y ago
Similar frustration – I need a prescription to buy contact lenses every year. So I have to go get an annual eye checkup, which is still fine because it is preventive care and (mostly) covered by insurance. However, optometrists around me refuse to give a prescription for contact lenses without an additional $70 "contact lens fitting" fee which is not covered by insurance. The whole thing is a scam.
bserge 5y ago
Jesus, why were they prescription only in the first place? Same shit as levothyroxine, a basic medication used by millions, being prescription only. And many other drugs.
- jrace 5y ago
  Asprin is not rx...and has killed millions. https://pubmed.ncbi.nlm.nih.gov/16086703/#:~:text=Death%20rate%20attributed%20to%20NSAID,to%20low%2Ddose%20aspirin%20use https://pubmed.ncbi.nlm.nih.gov/16086703/#:~:text=Death%20ra....
inglor_cz 5y ago
On a similar topic: I find it rather weird that contact lenses need a prescription in the U.S. You will buy them over-the-counter here, and I have seen even a vending machine full of them. (That was in Lithuania, IIRC.)
slownews45 5y ago
Fantastic news. If you can afford the $5,000 - great! The current system works for you. 80% of people cannot and so are stuck. For folks with mild/moderate loss (where a LOT of people don't get help) something as simple as letting Apple tweak noise cancellation to be voice enhancing and providing a tuning and hearing test app in the iphone would be a godsend. The elderly miss out on a lot of family life because of hearing issues - people stop talking to them even if they are fully sound of mind because of this issue. I've seen this personally. And for all those who say apple is just a consumer products company and there is no way their $180 - $250 airpods can provide any benefit I think you might be surprised.
- kristofferR 5y ago
  Yeah, the AirPods Pro's are amazing as hearing aids. The only issue is that they are very visible and only last 4 hours each charge (I suppose you could get two pairs and switch between them every four hours).
  - slownews45 5y ago
    Airpods 3's should be 6 hours without spatial audio. And yes, I do use one at a time! The charge time is pretty quick.
    - kristofferR 5y ago
      The things that makes it work good as a hearing aid are the microphones and other Pro-only features though, so the non-Pro can't be used.
- falcolas 5y ago
  FWIW, there is a nuanced difference between hearing aids and iPods. Hearing aids basically apply a hearing-capability matched EQ to the incoming sound. Why this matters: Hearing loss is not uniform across frequencies, and we use huge portions of the spectrum for different functions (truck backup beepers vs. car engine noises, both used to identify what's coming your way).
aurizon 5y ago
A hearing test measures how sensitive your hearing is in each ear at a range of frequencies - they send a beep at a certain frequency and ask you if you can hear it, and lower the volume until you can not hear it, raise it to confirm you can hear it. This is repeated in each ear over the normal range of hearing, nominally 20- Hz to 20,000 Hz, most older people have lost at the low and high end. The detailed frequency/volume curve allows the hearing aid to be programmed to bring hearing to the 'normal' curve. Some people may have lost hearing at certain frequencies, it may be an irrevocable loss? That said, an iphone with headphones can easily create and administer a tone to each ear that can be varies in frequency and intensity - with the customer pushing a button when he loses the tone, repeat to confirm, then on to the next frequency until the audio range is covered. They the customer is given test results and he sets an on the phone equalizer at the values needed for each frequency and he is good to go. It needs to be made to limit the intensity to a maximum, and some gaps might remain where he has lost hair cells and will have a permanent frequency gap that can not be cured unless we learn how to grow new hair cells in the right place of the right length. A huge market will open up, there will be a wailing and gnashing of teeth in the old FDA shielded crooks, who must adapt or fold. If they adapt, they will do well.
- jrace 5y ago
  And the test is done in a controlled environment with calibrated equipment. A "iphone hearing test' is a useful screening tool, and no more sadly.
  - aurizon 5y ago
    Well, a subjective test, in a quiet room, with test tones for references is satisfactory for most purposes - if the system determines that it is unable to assess the situation, it can be escalated to an MD.
    - jrace 5y ago
      Exactly, just useful for a screening, but not for determining actual settings. And there is more that is taken in to account when setting the hearing aids, such as: Age Speech comprehension issues Loudness thresholds cognitive issues As well there are a handfull of "red flags" that are looked for, some of which can only be done with a visual examination, and others by more involved audiometric testing.
jjk166 5y ago
> Prescription device means a device that, because of its potential for harm, the method of its use or the collateral measures necessary to its use, is not safe except under the supervision of a practitioner licensed in this state to direct the use of such device and for which "adequate directions for use" cannot be prepared How were these ever prescription devices to begin with?
- falcolas 5y ago
  Improperly tuned, they will damage your hearing - a permanent effect.
  - GaylordTuring 5y ago
    How? Because you simply amplify the sound too much?
    - jrace 5y ago
      yes. Hearing aids can exceed 120dB. As well improper mid-long term use can cause comprehension and "hearing in difficult situations" issues.
  - jjk166 5y ago
    That doesn't make them unsafe. Plenty of devices can damage your hearing but are still perfectly safe to operate. I fail to see how adequate directions for use could not be prepared.
    - falcolas 5y ago
      How do you know when something is too loud without measuring it? If your answer is "ringing ears", you've already incurred at least some hearing damage. Do you have the tools to measure how loud your headphones are? I don't. And so I keep them as low as I can. Is there a limiter in amplifying headphones to keep them from going above a certain threshold (like 80Db)?
tpmx 5y ago
Next do CPAP, please!
jrm4 5y ago
NOW DO CPAP MACHINES
gpt5 5y ago
We are seeing a long term consolidation between hearing devices and headphones. On the headphones side, we are getting smaller, truly-wireless headphones with some ambient sound features (such as noise cancellation, and iOS hearing features). New trends like AR would just accelerate the change due to the need to solve all day worn audio devices. On the hearing aids side, almost every hearing aid today acts as an always connected set of headphones for your mobile phone (and has been like that for years on iOS). Deregulating this could bring the tech industry innovation to hearing aids through natural progression of headphones technology. This trend would make hearing aids not just target hearing impaired people, but also individual with normal hearing. For example, features such as protecting your ears against a sudden loud noise, silencing a loud restaurant so you can have a quiet conversation or improving the audio of a soft speaker could be useful for everyone.
- wrycoder 5y ago
  And yet Bose discontinued their very helpful Hearphone product and has introduced a much more expensive and less capable conventional aid, which they are marketing to older people. Very disappointing!
- themodelplumber 5y ago
  Long live the consolidation. May it work out better than the consolidation between tuna cans and more expensive hearing aids. (I have a friend who's an audiologist...watch Starkey, they are very proactive about industry changes and headwinds.)
  - justinph 5y ago
    Starkey is not exactly a quality company and I would be more than happy to see them put out of business. They tried to shaft their employees out of retirement money, they inflated their donation numbers, and a former executive was sent to prison for all kids of fraud.
    - encryptluks2 5y ago
      Kids of fraud are no joke. I'm pretty sure I'm a kid of fraud.
luckydata 5y ago
Do glasses first.
pessimizer 5y ago
The headline is deceptive. It's more like "Congress ordered the FDA to let you buy a hearing aid without a prescription, and the FDA refused for half a decade afterwards."
Ansil849 5y ago
> For decades, the FDA has regulated hearing aids as a prescription medical device — an arrangement that adds to the cost and effort people must expend to get them. What is the rationale for this?
- jrace 5y ago
  Same rational for an eye exam and Rx. it is more complicated than just "do you see or not?" And medical issues can, and are, discovered with a comprehensive hearing evaluation. As well improper use can cause permanent damage.
- akira2501 5y ago
  It's a treatment for a specific medical condition. Those devices and claims about them are universally regulated. I also don't believe deregulating the market is going to work. The reason prices are so high is because there is a small monopoly of manufacturers that control global supply and a small cadre of middle-men that are allowed to create whatever markup they like. Deregulating the middle men doesn't really solve the fundamental problem. I would expect a lot of patent lawsuits to be filed against small manufacturers and distributors if the government gets it's way here. It's an attempt to solve an endemic lack of regulation with even less regulation.
lifeisstillgood 5y ago
Cautionary tale: Opticians I went for an eyetest. A woman with 3 years post-grad training sat down for 45 minutes, ran a battery of tests, detected a bacterial infection in my eye, sent me for a hospital appointment the next day, and gave me a prescription that I filled out online. My payment to her - 25 quid. I did get her some chocolates to say thank you. Now name another (para-)medical area where the medical part is a loss leader for the rest? (I am worried i will hear a lot of Americans ...)
- jrace 5y ago
  In Canada I did the very same, but for free. Free hearing evaluation, discovered ear infections, referred back to GP. At no time was I compensated by the client or the government.
  - Underphil 5y ago
    Interesting that you said client instead of patient. Is that just a thing that differs between countries?
    - jrace 5y ago
      In the industry (at least in Canada) outside of the medical system customers are "clients" and not "patients".
spaetzleesser 5y ago
It's always funny to see how the land of the "free" and free market" is not very "free market" when it comes to protecting the profits of favored industries like medical even from its own citizens. Things like being required to go to a doctor and pay big $$$ to get a hearing aid or not being allowed to import drugs from countries where they are cheaper are absolutely not "free market". Even during COVID the country could not deploy cheap rapid tests but only super expensive PCR tests.
- Rapzid 5y ago
  Well, the USA is a land of laws too. Everyone is also crying that the USA wasn't giving enough vaccines to the rest of the world and is now moving on to boosters. Gotta put your mask on first.
spicybright 5y ago
Even if you disagree with this, the competition will bring prices down to non inflated levels for everyone, and your insurance premiums will likely reduce as an effect.
m0zg 5y ago
I heard Apple is working on hearing aid software for AirPods. This is excellent news all around. My hearing is pretty decent (save for very mild tinnitus caused by being an "invincible" idiot when I was younger and listening to music at max volume), but I'd love to be able to use vaguely AirPod shaped, reasonably priced hearing aids which would, for example, boost speech and attenuate noise in noisy environments, especially if they are able to do so directionally, for the source in front of me.
jollybean 5y ago
I think a better option might be to ensure that easy and affordable access to all the 'other things' that go along with hearing aids is available. I'm not sure if it's just as simple as 'throw in a device'. I'm wary that inappropriate use and maintenance could have negative health effects. Sometimes even the most very basic counselling has quite an effect. Perhaps we should create a nursing/paramedic level specialization for this and allow those people to offer such services.
worik 5y ago
I tread that article, hoping it would explain why, in the giddy universe, would it ever have been a good idea to require prescriptions for hearing aids? Perhaps I missed it....
- sonicggg 5y ago
  Health insurance coverage is a good one. Don't know any insurance that covers OTC equipment.
ineedasername 5y ago
This is part of an interesting trend in technological & human development. Massively expensive & highly specialized tech is being made common place & cheap more & more often, and perhaps more quickly. So, yesterday's "treatments" for people with problems are becoming today's augmentations for otherwise healthy people. --In years past, you might have a cardiologist prescribe the use of a constant heart monitor for a few days to track & diagnose issues. Now, you can get a cheap device that does that-- among other things-- for yourself. (Yes, the expensive specialized versions are still better) --Glasses were for people with vision problems (or simple fashion) but now are in the early stages of AR, and (relatively) mainstream use for simple augmentations like music listening and personal assistants. I'm sure I'm missing lots of other examples.
kumarvvr 5y ago
I don't get what prescription is required for a hearing aid? Are there different types? Like with equalizers or volume controls? Why can't a person, who is hard of hearing, go to a store, pick one and start using it? Granted, let FDA approve them and mandate using only FDA approved ones.
Consultant32452 5y ago
How did we ever get to a place where you needed a prescription to buy hearing aids in the first place? Was there a bunch of hearing aid junkies knocking over liquor stores to get another hearing aid fix? We need a ground-up reassessment of the whole concept of prescriptions. If it doesn't present a systemic risk it should be over the counter. If everyone over-uses antibiotics we might all die. Fine. But if some goober misuses blood pressure medicine, they can only hurt themself. Let people buy albuterol inhalers without permission. It's going to be fine.
known 5y ago
"If it moves tax it. If it keeps moving regulate it. And if it stops moving subsidize it" --Ronald Reagan (b. 1911)
silexia 5y ago
Monopolies granted by the government lead to disasters for consumers. Even when such monopolies were originally granted with good intentions.
solatic 5y ago
Any real attempt at hearing aid reform cannot skip in-person hearing tests. You need somebody to look inside the ear to verify that the hearing loss is not due to earwax buildup or infection, and to run a tympanogram test to check for mid-to-inner-ear issues. Maybe the rest of a hearing test could be done with current headphone technology in a quiet environment, I don't know. But until somebody makes a take-home, ML-powered widget with both a camera and a tympanogram-capable widget, people will need to show up in person to get a dependable hearing test result. The biggest thing the FDA could do would be to standardize a digital format for hearing tests and require new hearing aids to be programmed on the basis of the standard format. This would allow people to go in-person to get their hearing checked by a technician, get a test result, and then program that test result into any hearing aid of their choice bought on the open market.
jerkstate 5y ago
Please, do glasses next
OOvsuOO 5y ago
Audiology industry is filled with profit seeking corporations and they a have a HUGE political hand. They lobby. I would not be surprised to see the Audiology industry fight back this. They make huge profits and Audiologists are licensed workers.. Like doctors they're required to go though hoops and loops to get a license. The cochlear implant industry is the same it's all about profit and pushing the CI into babies and taking advantage of the early technology by using them on deaf people where in the future it will be more like cyborg tech way more advanced and they're just testing and pushing this huge industry. It's full of people that think a hearing aid or CI is a solution to the problem where it's really not. I would put neuro link tech into the same pool as CI tech. They're testing it on disabled people and touting the benefits while hiding the negatives.
sharmin123 5y ago
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ameasure 5y ago
What is the rationale in making something like a hearing aid require a prescription? I can understand addictive drugs, you don't want them misused. What about the million other things that require a prescription?
sprainedankles 5y ago
As someone with moderate hearing loss in both ears since ~1st grade, I'm all for expanding access to hearing aids. It took changing doctors in high school to finally get a prescription, and it was life-changing. Not cheap, but entirely worth it - I'm grateful to have had access at that point. Cost is still a challenge, of course. But I'd like to point out that my current set of aids ($2800 pair) just hit the 5-year mark of usage, and they are still working perfectly. For devices that I use ~16 hours a day, everyday, it's amazing. However, it took 3 visits to the audiologist to get the tuning/fitting just right. For the first month of use, these hearing aids were "garbage" (I was really frustrated). But once we hit the mark, I have had zero complaints ever since. So, that all said, there is tremendous value to initiatives like the Bose SoundControl Hearing Aids (~$900 pair off-the-shelf hearing aids), but the biggest hurdle they face is the fitting/tuning portion. I've tried them, but they don't fit my ears well, so I can't use them effectively (yet - I want to try adjusting the receiver cables). I'm hopeful this is just the turbulent beginning of a new hearing aid market that expands access to as many people as possible, because it is far from a solved problem.
bookofjoe 5y ago
Not a good time to be in audiology school accruing massive student loan debt...
throwawaymanbot 5y ago
Goodbye private coversations. Anecdotal evidence from people using hearing aid type devices to eavesdrop is ...well...disgusting. A medical need at least prevented those with no need from having.

744 points by cf100clunk 5y ago

Can we free vision correction next? The US is behind the times.

Can't we just get rid of the prescription system in general, and make doctors advisors like lawyers are? I don't need all these gatekeepers "keeping me safe." In Mexico you can just walk into a pharmacy and buy anything. Even pain killers. And it works fine. The only drugs that seem to cause societal problems are the ones that the government tries to keep you from getting.

oneplane 5y ago

Wouldn't it make more sense if the FDA just wanted everyone to be able to hear properly? I get that they are a policy institution and "hear better, implement it however you like" isn't much of a policy, but an almost-directive (buy whatever you want) seems to be rather decoupled from any health related issue which is what an hearing aid is for.

moistrobot 5y ago

Good, now let's do this for everything

joshsyn 5y ago

Anything regulated just becomes pricey.

cf100clunk 5y ago

"People with mild or moderate hearing loss" should be free to purchase these sort of generic hearing aids in much the same way that buying non-prescription reading glasses is common. If problems persist, it is time to consult a professional.

causi 5y ago
Heck, imagine if prescription glasses were only available from government-certified vendors. We'd be back to paying $700 a pair like the bad old days.
- kfprt 5y ago
  Glasses are a huge ripoff due to the industry being a monopoly with no help from the government.
  - Turing_Machine 5y ago
    There are some online retailers that have pretty good prices.
    - kfprt 5y ago
      Spare a link or two?
      - wmeredith 5y ago
        I like these: https://eyeglassfactoryoutlet.com https://eyeglassfactoryoutlet.com
      - mixmastamyk 5y ago
        https://www.zennioptical.com/ https://www.zennioptical.com/
      - yboris 5y ago
        https://www.eyebuydirect.com/ https://www.eyebuydirect.com/
- jleyank 5y ago
  Buy lightweight frames and lenses, have progressives and get anti-glare coating and "we'd be back to paying $700/pair" is like, last year if I miss a sale. Lenscrafters, not a small shop. They're all owned by the same site, and I work on the 50% off of lenses sale. Frames are 150-300 as I avoid big-name style. These are way more than +2.5 diopter reading glasses, and you might imagine that astigmatism and progressives does wonders for straight lines...

cf100clunk 5y ago

What about building one's own hearing aid? This DIY project came to mind: https://hackaday.com/2013/12/15/diy-hearing-aid/ https://hackaday.com/2013/12/15/diy-hearing-aid/ No mention of DIY hearing aids from the FDA.

ghostly_s 5y ago
Because there aren't any FDA regulations preventing you from building a DIY hearing aid?
- cf100clunk 5y ago
  But there are batteries (pun intended) of lawyers from the hearing aid manufacturers who would act against DIY kit vendors if asked. I wonder who/what is the best entity to help shield DIYers from patents...
  - spicybright 5y ago
    Source? I've seen a myrid of kits that overlap heavily with different products like a DIY hearing aid would.

kiba 5y ago

Some feature requests for hearing aid: Can we get hearing aids that are bigger? These small hearing aids make it easier to lose, and I do not mind looking "disabled" to people. Also would like to use bluetooth to both locate the hearing aids, and to connect to devices as needed. Would be cool if the battery can be recharged as needed, maybe through usb-c if possible, but magnetic charging would be acceptable.

elliekelly 5y ago
Do most elderly people even have the dexterity to use the teeny hearing aids on the market today?
- pugworthy 5y ago
  You may not have meant to, but your question just reinforces the fallacy that hearing aids are for old people. Yes, hearing loss does occur with age for many, but it's not as uncommon as you might think for those not deemed "elderly". I've personally worn them since my mid 20's. I'm glad that I ignored the perceived stigma of wearing hearing aids and got them. They are like glasses for my ears.
- cf100clunk 5y ago
  Not just elderly people. Rechargable devices would be a boon.
  - braum 5y ago
    I wear hearing aides every day. SMALLER would be better and mine have BT5 and rechargeable. they are NOT cheap about $6k pair with 3 year complete warranty included. Again having options is the best thing, making them larger for me would mean they are more easily dislodged when I bend over to pick something up or are wearing them when working in shop. Having some that have better weather or fully waterproof would be great. I normal take them off when working outside or in the shop. The sweat makes them mostly useless because of the "noise" the sweat makes against the mics. Then the sweat also makes them slick and they will not stay in place. Having options is ideal and affordable options would be great. I don't know why these things are $6k pair when they share a lot of tech with modern in ear options from bose/apple/ect.

kristofferR 5y ago

Contact lenses next? It's amazingly stupid that I, as a tourist, who knows exactly what types of contacts I need, may need to get a US prescription for contacts.

bastardoperator 5y ago
How are optometrists supposed to make money if they don't sell you services and glasses from their showroom?
- DaveExeter 5y ago
  They charge for the eye exam.
  - bastardoperator 5y ago
    That's the break even, those optometrist tools aren't cheap and that's to get you in the door. The real money comes from frames and contact sales.
    - RHSeeger 5y ago
      Then their business model is broken and they need to charge more for exam.
- adam_arthur 5y ago
  How are people supposed to make money when we have machines producing all these goods! Maybe your post was sarcasm though :) That's the economic progress of humanity. We automate, and jobs that were once valued are no longer needed. Easy to look at a specific instance and fight against the change, but in the long run it's better for everybody. Glasses/Vision in particular costs hundreds more than it needs to. Glasses could be produced and sold at $10-20 bucks if regulations were eased. What is the material cost to produce these? You can get reading glasses in grocery stores for a few dollars. I'm fairly well off and even I feel bad paying over a hundred dollars for some of this stuff. Imagine all the lower earners/poor that pay hundreds of dollars for glasses for no reason other than protectionism. The entire eye exam can be automated very easily (and I believe already has). Would be easy to have machine learning algorithms that can diagnose problems from the image of your retina scan. I really don't think it'd be that difficult, if it doesn't exist already.

the__alchemist 5y ago

Great news. I've been learning about and implementing real-time DSP algorithms for audio enhancement. (Cortex-M7) I started this hoping to make scifi headphone that enhance hearing for normal people with different presets, but realized what I'm essentially building is more like a hearing aid. Didn't even realize the regularly issue. (Although using the article's terminology, could probably already market this as a PSAP and be fine. (?)).

ygjb 5y ago
Check out nuraphones; I don't know enough about hearing and audio to know what voodoo they are doing, but as a person with significant hearing loss, the hearing customization they perform during set up allows the device to emit the right frequencies at the right volume that I can hear a significant portion of the left audio channel (which is impressive, given that I am "profoundly deaf" in that ear).
- the__alchemist 5y ago
  Awesome. Looks outstanding from their site. Seems to be marketed at music listening, especially in noisy environments, although I can't tell for sure.
Vecr 5y ago
I'm pretty sure That's what 3M Peltor Comtac headsets do, they have microphones on the outside and speakers on the inside, without passing through gunshots or explosions, so you can maintain situational awareness in a combat situation.
- the__alchemist 5y ago
  Sounds badass!

Ginden 5y ago

BUT WHAT IF PEOPLE ABUSE HEARING AID?????? To be serious: amount of things that are "prescription only", even if they can cause only minimal harm, is astounding.

onemoresoop 5y ago
What if they do end up with a better hearing though? Think about the consequences.. Or what if the ENTs haven't lobbied lately but instead the device makers did this time?
- jrace 5y ago
  Perhaps you do not realize, or are just trying to be funny, but most audiology professionals do this to help people hear better.
deleted 5y ago
[deleted]
jrace 5y ago
You can cause more than "minimal" harm. Both hearing loss and comprehension can be changed by an improper hearing aid.
- Ginden 5y ago
  Can you estimate that harm in term of DALYs?

Spivak 5y ago

As some with a mild APD this would be fantastic! It has never been worth the cost and effort to get "real" hearing aids but I would probably live in the oct version.

throwawaysea 5y ago

Middlemen and gatekeepers are all over our medical industry. When I travel I am always surprised at how much easier it is to get drugs outside the US. Many prescription drugs here are over the counter elsewhere and much cheaper. I hope we start removing prescription gatekeeping more broadly, so I can stop paying hundreds for performative office visits that offer no value. It’s also a big time sink just to get some mundane antibiotic or skincare cream or whatever, when all that happens is that an FNP runs through the most basic Q&A script that can be self discovered online.

LocalH 5y ago
Capitalism (as a life goal, rather than one of many tools in a toolkit) is what makes all that possible. If can insert yourself in the middle of a transaction, and do that long enough, then you can get pretty entrenched to the point where people just expect it to be that way. I maintain that, if automobiles were invented today, the horse-and-buggy industry would be able to successfully fend them off, based on the path regulatory capture has taken in the last 150 years.
- tpmx 5y ago
  There's plenty of capitalism happening in the countries where these things are readily available. Cronyism is the word should have been looking for.
  - LocalH 5y ago
    Perhaps I should have said "societal goal". The stark contrast between those countries, and the US, is that the US collectively has this unwavering dedication to capitalism above all else, it seems in practice.

JCM9 5y ago

There are a number of healthcare areas in the US that have been protected by regulation, but it’s increasingly unclear if this is good for patients, consumers, or public health at large. The increasing sentiment seems to be probably not. Vision care is another area I’d expect to see more changes and disruption coming down the pipeline. Vision care is very important and advanced cases require special skills, but it’s also unclear why many routine checks couldn’t just be done by a family doctor. The US requires one to see a “doctor of optometry” to get a basic single vision prescription. That industry used to make its money turning around and selling you glasses from the same office but that whole industry has been turned upside down by online retailers like Warby Parker and such. Why the US can’t follow the models followed most elsewhere in the world is unclear, but it would remove a lot of extra steps and costs in getting a basic care of glasses. Ophthalmology (medical doctors) are still very much a thing but most countries don’t have this model of needed a “prescription” from an optometrist for a basic pair of single vision specs.

lisper 5y ago
> Why the US can’t follow the models followed most elsewhere in the world is unclear To the contrary, it is very clear: regulatory capture. https://en.wikipedia.org/wiki/Regulatory_capture https://en.wikipedia.org/wiki/Regulatory_capture
- JCM9 5y ago
  Yes… didn’t know what the technical term was but that’s it
- BurningFrog 5y ago
  Still unclear why Regulatory Capture only happens in the US?
  - lisper 5y ago
    It happens outside the U.S. as well, but the U.S. has a particularly weak form of democracy which makes it more prone to regulatory capture. In particular, money is a more powerful policial level in the U.S. than in most other democracies, and that creates a positive feedback loop that tends to encourage and reinforce regulatory capture (you use RC to make money, which you then turn around and use to pursue more RC in order to make more money...)

jleyank 5y ago

Having worn hearing aids a long time (don't turn sh*t up to 11), I should point out that they require setting per-ear and one can have multiple programs (voice, music, ...). My fear of rechargeable aids is that with serious+ loss they'd burn through batteries in a (very) short time and if they're not replaceable it makes the aids disposable. Fitting is helpful as it's also done for mid-high earphones. This will have to be paid for somehow, and somebody has to do the tests to know what to set. Same as glasses. So we should be able to get the raw aids at a lower cost and then deal with the extras. Costco sells reduced priced aids, so there's a little flexibility in the industry. For my last set pre-covid, there were behind-ear (big), in ear (small) and in ear canal (very small). If you saw True Lies, their "radios" were probably dummy in-ear-canal aids. As I'm not blessed with a 15+ dex and like other posters I don't mind being see so the behind ears are ok. They can be hidden as dangly earrings with a sheath to make it interesting if you'd like. Otherwise, it's a bloody conservative industry re: colors. I wanted blue and red so it matched stereo wires :-). And my attempt at bluetooth connectivity for phone calls failed as the things could not stay sync'd during conversations. Better to just use a headset.

jrace 5y ago
"And my attempt at bluetooth connectivity for phone calls failed as the things could not stay sync'd during conversations. Better to just use a headset. " And that is what you should use the money you paid for....getting proper follow up and adjustments, including making your BT work. BT and hearing aids have been used for over 10 years.
- ricardobeat 5y ago
  What exactly is the audiologist going to adjust to improve BT reliability?
  - jrace 5y ago
    Apply new firmware to the hearing aids. help you set your phone to work properly. Return them and use a different make/model that works with your phone.

frabcus 5y ago

Does this relate in any way to us getting cheaper hearing aids? A pair of bluetooth streaming rechargable ones is about $3000. With Transparency mode and the latest software for AirPod pros, you can adjust the frequency distribution, and get what seem to be servicable hearing aids for $250. What I'd like is proper (medical) assessment and fitting, but of cheaper commodity aids that are much much better made with better apps than most of those on the market now.

jrace 5y ago
The tech in the hearing aids is cheap. it is the fitting and follow up where the money you spend should be going. -- that and repairs and regular maintenance.
- ricardobeat 5y ago
  In my experience with a family member, the fitting and tuning done by the audiologist is as good as a random guess. Constant noise and screeching even after multiple, expensive tuning sessions. As a result the hearing aids get tossed away unused most of the time. The adjustment offered by something like the AirPods Pro seem much more effective.
  - jrace 5y ago
    Then you need to go to a different audiologist. Most of my rejected fittings were from people who had far too high expectations. that did not stop me from trying, and when unable to get success provide a 100% refund, and refer to a different AUD.

nickthemagicman 5y ago

how about the FDA lets us buy whatever we want without a prescription because we're adults?

gumby 5y ago

I just ordered some AirPods Pro to see if they will be adequate. I’m not sure hearing aids can really replace headphones for phone calls etc until both HAs and phones support BT 5.2, and I don’t really want buy several $K of hearing aids that only work some of the time.

busymom0 5y ago

I understand why things like drugs we inject in our body need to be regulated. But I don't understand why hearing aids need to be regulated this way and even need a prescription. It's either "hey I can hear well and it fits my ears well" or it's "it doesn't help me hear well".

jrace 5y ago
Because improper use can cause significant hearing loss.

gigatexal 5y ago

This is going to murder companies like audibene.com / hear.com

jrace 5y ago

How much would you pay for: *Hearing test * Hearing aid fitting * Usage counselling * Follow up adjustments * Annual retest of your hearing * Replacement of lost hearing aids * Unlimited repair for 3 years ?? ====== I got out of the Audiology field in 2015. At that time all the above was included for every hearing aid we sold (Prices varied from $750 / ear - $3600 / ear. When I was in that field many companies tried "pay as you go" models, instead of bundles. You know what happened? People paid the minimum (test, and fit) the never returned for repairs or re-tunings. And then complained to everyone that "hearing aids don't work". Buy a hearing aid today from any major provider in Canada and you get: Initial test Initial fitting Follow up tests Follow up re tunes Counselling repairs - including full replacement in case of loss Batteries In-clinic repairs and cleanings. 100% return, and in some cases $0.00 3 month trial period. There is far more to fixing your hearing issues that just amplifying sound. Sadly, most people wait too long before trying a hearing aid, and give up because they hear too much noise. Imagine returning your eye glasses because you still see ugly people. I truly wish hearing aids were far cheaper, and that was a very hard part of my job and one of the reasons why I changed careers.

brutus1213 5y ago
Any insights on tuning process for little kids? (2-3 year olds?) These guys don't really have the ability to provide feedback for retuning.
- jrace 5y ago
  Tuning for them is more about slowly increasing the sound levels overtime than adjusting for understanding. As well you may want to work with a Speech Language Pathologist.
chairmanwow1 5y ago
Correct me if I’m wrong, but isn’t this something people could do on their own at home if the hardware had a decent setup UX / tuning instructions? This doesn’t necessarily seem like something that couldn’t be done pretty automatically.

AlbertCory 5y ago

Almost half the comments relate to eye exams & glasses, not hearing aids. There's almost no one defending the present system, and I suspect if you took a poll of the US population, at least 90% would favor deregulating hearing aids. Probably glasses, too. So why hasn't it happened? Those people who said "regulatory capture" get a gold star. A small group who will suffer a lot manage to defeat a much bigger group who will benefit by a much smaller amount.

Damogran6 5y ago

So do I…oddly, I went and got my hearing tested and my issues are with processing, not hearing. The guy said “I actually can’t prescribe you a hearing aid, even if I wanted to.” So, there should be some barrier to entry. Just not at $3500 an ear.

jrace 5y ago
That is a very realy situation for most people. A hearing aid - AIDS you in hearing, but your brain does the processing and speech comprehension. if you start wearing a hearing aid now you will just get lazier with your "hearing". Just like if your knees are sore, and you get a knee brace - when you should have done exercises to improve your muscles supporting your knee - the brace will do more harm than good.
- bserge 5y ago
  I am in pain every fucking second of walking.
  - jrace 5y ago
    So you should be treated differently than someone who "doesn't walk much because my knees are sore.

ChuckMcM 5y ago

It has always seemed broken to me that hearing aids were not covered by healthcare, nor was there some sort of VSP like plan for hearing aids. I've worked with folks who had hearing aids from childhood and it is a big expense to bear while their glasses are subsidized. Of course, the vision folks turned it into a racket for extracting cash. So ideally we'd want to avoid that and perhaps fix the vision racket while we are at it.

paxys 5y ago

Similar frustration – I need a prescription to buy contact lenses every year. So I have to go get an annual eye checkup, which is still fine because it is preventive care and (mostly) covered by insurance. However, optometrists around me refuse to give a prescription for contact lenses without an additional $70 "contact lens fitting" fee which is not covered by insurance. The whole thing is a scam.

bserge 5y ago

Jesus, why were they prescription only in the first place? Same shit as levothyroxine, a basic medication used by millions, being prescription only. And many other drugs.

jrace 5y ago
Asprin is not rx...and has killed millions. https://pubmed.ncbi.nlm.nih.gov/16086703/#:~:text=Death%20rate%20attributed%20to%20NSAID,to%20low%2Ddose%20aspirin%20use https://pubmed.ncbi.nlm.nih.gov/16086703/#:~:text=Death%20ra....

inglor_cz 5y ago

On a similar topic: I find it rather weird that contact lenses need a prescription in the U.S. You will buy them over-the-counter here, and I have seen even a vending machine full of them. (That was in Lithuania, IIRC.)

slownews45 5y ago

Fantastic news. If you can afford the $5,000 - great! The current system works for you. 80% of people cannot and so are stuck. For folks with mild/moderate loss (where a LOT of people don't get help) something as simple as letting Apple tweak noise cancellation to be voice enhancing and providing a tuning and hearing test app in the iphone would be a godsend. The elderly miss out on a lot of family life because of hearing issues - people stop talking to them even if they are fully sound of mind because of this issue. I've seen this personally. And for all those who say apple is just a consumer products company and there is no way their $180 - $250 airpods can provide any benefit I think you might be surprised.

kristofferR 5y ago
Yeah, the AirPods Pro's are amazing as hearing aids. The only issue is that they are very visible and only last 4 hours each charge (I suppose you could get two pairs and switch between them every four hours).
- slownews45 5y ago
  Airpods 3's should be 6 hours without spatial audio. And yes, I do use one at a time! The charge time is pretty quick.
  - kristofferR 5y ago
    The things that makes it work good as a hearing aid are the microphones and other Pro-only features though, so the non-Pro can't be used.
falcolas 5y ago
FWIW, there is a nuanced difference between hearing aids and iPods. Hearing aids basically apply a hearing-capability matched EQ to the incoming sound. Why this matters: Hearing loss is not uniform across frequencies, and we use huge portions of the spectrum for different functions (truck backup beepers vs. car engine noises, both used to identify what's coming your way).

aurizon 5y ago

A hearing test measures how sensitive your hearing is in each ear at a range of frequencies - they send a beep at a certain frequency and ask you if you can hear it, and lower the volume until you can not hear it, raise it to confirm you can hear it. This is repeated in each ear over the normal range of hearing, nominally 20- Hz to 20,000 Hz, most older people have lost at the low and high end. The detailed frequency/volume curve allows the hearing aid to be programmed to bring hearing to the 'normal' curve. Some people may have lost hearing at certain frequencies, it may be an irrevocable loss? That said, an iphone with headphones can easily create and administer a tone to each ear that can be varies in frequency and intensity - with the customer pushing a button when he loses the tone, repeat to confirm, then on to the next frequency until the audio range is covered. They the customer is given test results and he sets an on the phone equalizer at the values needed for each frequency and he is good to go. It needs to be made to limit the intensity to a maximum, and some gaps might remain where he has lost hair cells and will have a permanent frequency gap that can not be cured unless we learn how to grow new hair cells in the right place of the right length. A huge market will open up, there will be a wailing and gnashing of teeth in the old FDA shielded crooks, who must adapt or fold. If they adapt, they will do well.

jrace 5y ago
And the test is done in a controlled environment with calibrated equipment. A "iphone hearing test' is a useful screening tool, and no more sadly.
- aurizon 5y ago
  Well, a subjective test, in a quiet room, with test tones for references is satisfactory for most purposes - if the system determines that it is unable to assess the situation, it can be escalated to an MD.
  - jrace 5y ago
    Exactly, just useful for a screening, but not for determining actual settings. And there is more that is taken in to account when setting the hearing aids, such as: Age Speech comprehension issues Loudness thresholds cognitive issues As well there are a handfull of "red flags" that are looked for, some of which can only be done with a visual examination, and others by more involved audiometric testing.

jjk166 5y ago

> Prescription device means a device that, because of its potential for harm, the method of its use or the collateral measures necessary to its use, is not safe except under the supervision of a practitioner licensed in this state to direct the use of such device and for which "adequate directions for use" cannot be prepared How were these ever prescription devices to begin with?

falcolas 5y ago
Improperly tuned, they will damage your hearing - a permanent effect.
- GaylordTuring 5y ago
  How? Because you simply amplify the sound too much?
  - jrace 5y ago
    yes. Hearing aids can exceed 120dB. As well improper mid-long term use can cause comprehension and "hearing in difficult situations" issues.
- jjk166 5y ago
  That doesn't make them unsafe. Plenty of devices can damage your hearing but are still perfectly safe to operate. I fail to see how adequate directions for use could not be prepared.
  - falcolas 5y ago
    How do you know when something is too loud without measuring it? If your answer is "ringing ears", you've already incurred at least some hearing damage. Do you have the tools to measure how loud your headphones are? I don't. And so I keep them as low as I can. Is there a limiter in amplifying headphones to keep them from going above a certain threshold (like 80Db)?

tpmx 5y ago

Next do CPAP, please!

jrm4 5y ago

NOW DO CPAP MACHINES

gpt5 5y ago

We are seeing a long term consolidation between hearing devices and headphones. On the headphones side, we are getting smaller, truly-wireless headphones with some ambient sound features (such as noise cancellation, and iOS hearing features). New trends like AR would just accelerate the change due to the need to solve all day worn audio devices. On the hearing aids side, almost every hearing aid today acts as an always connected set of headphones for your mobile phone (and has been like that for years on iOS). Deregulating this could bring the tech industry innovation to hearing aids through natural progression of headphones technology. This trend would make hearing aids not just target hearing impaired people, but also individual with normal hearing. For example, features such as protecting your ears against a sudden loud noise, silencing a loud restaurant so you can have a quiet conversation or improving the audio of a soft speaker could be useful for everyone.

wrycoder 5y ago
And yet Bose discontinued their very helpful Hearphone product and has introduced a much more expensive and less capable conventional aid, which they are marketing to older people. Very disappointing!
themodelplumber 5y ago
Long live the consolidation. May it work out better than the consolidation between tuna cans and more expensive hearing aids. (I have a friend who's an audiologist...watch Starkey, they are very proactive about industry changes and headwinds.)
- justinph 5y ago
  Starkey is not exactly a quality company and I would be more than happy to see them put out of business. They tried to shaft their employees out of retirement money, they inflated their donation numbers, and a former executive was sent to prison for all kids of fraud.
  - encryptluks2 5y ago
    Kids of fraud are no joke. I'm pretty sure I'm a kid of fraud.

luckydata 5y ago

Do glasses first.

pessimizer 5y ago

The headline is deceptive. It's more like "Congress ordered the FDA to let you buy a hearing aid without a prescription, and the FDA refused for half a decade afterwards."

Ansil849 5y ago

> For decades, the FDA has regulated hearing aids as a prescription medical device — an arrangement that adds to the cost and effort people must expend to get them. What is the rationale for this?

jrace 5y ago
Same rational for an eye exam and Rx. it is more complicated than just "do you see or not?" And medical issues can, and are, discovered with a comprehensive hearing evaluation. As well improper use can cause permanent damage.
akira2501 5y ago
It's a treatment for a specific medical condition. Those devices and claims about them are universally regulated. I also don't believe deregulating the market is going to work. The reason prices are so high is because there is a small monopoly of manufacturers that control global supply and a small cadre of middle-men that are allowed to create whatever markup they like. Deregulating the middle men doesn't really solve the fundamental problem. I would expect a lot of patent lawsuits to be filed against small manufacturers and distributors if the government gets it's way here. It's an attempt to solve an endemic lack of regulation with even less regulation.

lifeisstillgood 5y ago

Cautionary tale: Opticians I went for an eyetest. A woman with 3 years post-grad training sat down for 45 minutes, ran a battery of tests, detected a bacterial infection in my eye, sent me for a hospital appointment the next day, and gave me a prescription that I filled out online. My payment to her - 25 quid. I did get her some chocolates to say thank you. Now name another (para-)medical area where the medical part is a loss leader for the rest? (I am worried i will hear a lot of Americans ...)

jrace 5y ago
In Canada I did the very same, but for free. Free hearing evaluation, discovered ear infections, referred back to GP. At no time was I compensated by the client or the government.
- Underphil 5y ago
  Interesting that you said client instead of patient. Is that just a thing that differs between countries?
  - jrace 5y ago
    In the industry (at least in Canada) outside of the medical system customers are "clients" and not "patients".

spaetzleesser 5y ago

It's always funny to see how the land of the "free" and free market" is not very "free market" when it comes to protecting the profits of favored industries like medical even from its own citizens. Things like being required to go to a doctor and pay big $$$ to get a hearing aid or not being allowed to import drugs from countries where they are cheaper are absolutely not "free market". Even during COVID the country could not deploy cheap rapid tests but only super expensive PCR tests.

Rapzid 5y ago
Well, the USA is a land of laws too. Everyone is also crying that the USA wasn't giving enough vaccines to the rest of the world and is now moving on to boosters. Gotta put your mask on first.

spicybright 5y ago

Even if you disagree with this, the competition will bring prices down to non inflated levels for everyone, and your insurance premiums will likely reduce as an effect.

m0zg 5y ago

I heard Apple is working on hearing aid software for AirPods. This is excellent news all around. My hearing is pretty decent (save for very mild tinnitus caused by being an "invincible" idiot when I was younger and listening to music at max volume), but I'd love to be able to use vaguely AirPod shaped, reasonably priced hearing aids which would, for example, boost speech and attenuate noise in noisy environments, especially if they are able to do so directionally, for the source in front of me.

jollybean 5y ago

I think a better option might be to ensure that easy and affordable access to all the 'other things' that go along with hearing aids is available. I'm not sure if it's just as simple as 'throw in a device'. I'm wary that inappropriate use and maintenance could have negative health effects. Sometimes even the most very basic counselling has quite an effect. Perhaps we should create a nursing/paramedic level specialization for this and allow those people to offer such services.

worik 5y ago

I tread that article, hoping it would explain why, in the giddy universe, would it ever have been a good idea to require prescriptions for hearing aids? Perhaps I missed it....

sonicggg 5y ago
Health insurance coverage is a good one. Don't know any insurance that covers OTC equipment.

ineedasername 5y ago

This is part of an interesting trend in technological & human development. Massively expensive & highly specialized tech is being made common place & cheap more & more often, and perhaps more quickly. So, yesterday's "treatments" for people with problems are becoming today's augmentations for otherwise healthy people. --In years past, you might have a cardiologist prescribe the use of a constant heart monitor for a few days to track & diagnose issues. Now, you can get a cheap device that does that-- among other things-- for yourself. (Yes, the expensive specialized versions are still better) --Glasses were for people with vision problems (or simple fashion) but now are in the early stages of AR, and (relatively) mainstream use for simple augmentations like music listening and personal assistants. I'm sure I'm missing lots of other examples.

kumarvvr 5y ago

I don't get what prescription is required for a hearing aid? Are there different types? Like with equalizers or volume controls? Why can't a person, who is hard of hearing, go to a store, pick one and start using it? Granted, let FDA approve them and mandate using only FDA approved ones.

Consultant32452 5y ago

How did we ever get to a place where you needed a prescription to buy hearing aids in the first place? Was there a bunch of hearing aid junkies knocking over liquor stores to get another hearing aid fix? We need a ground-up reassessment of the whole concept of prescriptions. If it doesn't present a systemic risk it should be over the counter. If everyone over-uses antibiotics we might all die. Fine. But if some goober misuses blood pressure medicine, they can only hurt themself. Let people buy albuterol inhalers without permission. It's going to be fine.

known 5y ago

"If it moves tax it. If it keeps moving regulate it. And if it stops moving subsidize it" --Ronald Reagan (b. 1911)

silexia 5y ago

Monopolies granted by the government lead to disasters for consumers. Even when such monopolies were originally granted with good intentions.

solatic 5y ago

Any real attempt at hearing aid reform cannot skip in-person hearing tests. You need somebody to look inside the ear to verify that the hearing loss is not due to earwax buildup or infection, and to run a tympanogram test to check for mid-to-inner-ear issues. Maybe the rest of a hearing test could be done with current headphone technology in a quiet environment, I don't know. But until somebody makes a take-home, ML-powered widget with both a camera and a tympanogram-capable widget, people will need to show up in person to get a dependable hearing test result. The biggest thing the FDA could do would be to standardize a digital format for hearing tests and require new hearing aids to be programmed on the basis of the standard format. This would allow people to go in-person to get their hearing checked by a technician, get a test result, and then program that test result into any hearing aid of their choice bought on the open market.

jerkstate 5y ago

Please, do glasses next

OOvsuOO 5y ago

Audiology industry is filled with profit seeking corporations and they a have a HUGE political hand. They lobby. I would not be surprised to see the Audiology industry fight back this. They make huge profits and Audiologists are licensed workers.. Like doctors they're required to go though hoops and loops to get a license. The cochlear implant industry is the same it's all about profit and pushing the CI into babies and taking advantage of the early technology by using them on deaf people where in the future it will be more like cyborg tech way more advanced and they're just testing and pushing this huge industry. It's full of people that think a hearing aid or CI is a solution to the problem where it's really not. I would put neuro link tech into the same pool as CI tech. They're testing it on disabled people and touting the benefits while hiding the negatives.

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ameasure 5y ago

What is the rationale in making something like a hearing aid require a prescription? I can understand addictive drugs, you don't want them misused. What about the million other things that require a prescription?

sprainedankles 5y ago

As someone with moderate hearing loss in both ears since ~1st grade, I'm all for expanding access to hearing aids. It took changing doctors in high school to finally get a prescription, and it was life-changing. Not cheap, but entirely worth it - I'm grateful to have had access at that point. Cost is still a challenge, of course. But I'd like to point out that my current set of aids ($2800 pair) just hit the 5-year mark of usage, and they are still working perfectly. For devices that I use ~16 hours a day, everyday, it's amazing. However, it took 3 visits to the audiologist to get the tuning/fitting just right. For the first month of use, these hearing aids were "garbage" (I was really frustrated). But once we hit the mark, I have had zero complaints ever since. So, that all said, there is tremendous value to initiatives like the Bose SoundControl Hearing Aids (~$900 pair off-the-shelf hearing aids), but the biggest hurdle they face is the fitting/tuning portion. I've tried them, but they don't fit my ears well, so I can't use them effectively (yet - I want to try adjusting the receiver cables). I'm hopeful this is just the turbulent beginning of a new hearing aid market that expands access to as many people as possible, because it is far from a solved problem.

bookofjoe 5y ago

Not a good time to be in audiology school accruing massive student loan debt...

throwawaymanbot 5y ago

Goodbye private coversations. Anecdotal evidence from people using hearing aid type devices to eavesdrop is ...well...disgusting. A medical need at least prevented those with no need from having.