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FDA Finalizes Rule to Deregulate Hearing Aids
- skybrian 3y agoThis is from a year ago. Here's a website that lets you compare over-the-counter hearing aids: https://www.soundly.com/shop https://www.soundly.com/shop
- rektide 3y agoMostly around $5000. Seen a $1000 and a $2000. I wonder how long prices will stay up there. I wonder what mind of hardware is packed in here. Bigger battery, bigger microphone, how miniatiruzes are the chips, how much DSP processing is there... Interesting times.
- skybrian 3y agoThe website covers all kinds of hearing aids. You can filter it to see the OTC hearing aids, which are lower cost. The reviews on that website don't say much about the mobile apps, though. Even for the high-end hearing aids I bought, the app was finicky and difficult to even get connected, and the controls are dumbed down. If you check the Play Store, you'll see lots of bad reviews. Fortunately the app isn't needed day-to-day. I'm a bit surprised Apple hasn't done something; they could really clean up here.
- joecool1029 3y ago> I'm a bit surprised Apple hasn't done something; they could really clean up here. https://www.cell.com/iscience/fulltext/S2589-0042(22)01708-4 https://www.cell.com/iscience/fulltext/S2589-0042(22)01708-4 (their current devices are almost there) My guess is they do enter the OTC space within the next year or so or in true Tim Cook fashion just sell a higher binned version of airpod with OTC hearing aid capability. Their watch series 4 already has FDA medical device certifications. As for the rest of the market, the amount of margin has been insane for hearing aids. I say look at IEM market which uses same balanced armature technology: They charge at a minimum 20x what Knowles charges for the drivers. Chinese sellers figured it out and sell IEM's with the same drivers and only 3-4x markup. It's killed all but the highest custom end of IEM markets (most of the companies merged). Hearing aids once again have the same balanced armature drivers and mark up at least 200-500x the driver cost. There is of course some cost to the DSP and paying someone to customize it but most of it is pure regulatory capture to get the FDA approval.
- radicalbyte 3y agoMy small bluetooth DAC/amp with mic cost $120 and I have IEMS ranging from $20-$300. With the top combination you're looking at $300 for a single ear for the quality option. That is comparable to a pair of glasses.
- skybrian 3y agoI use AirPods for music. The battery life isn't long enough to wear all day, so they'd have to do something different for hearing aids. I can also play music using the bluetooth support on my hearing aids, but the sound isn't as good, since they're optimized for voice and have little bass. (They let some sound through, so that's normally not a problem.) Also, hearing aid algorithms are tuned to maximize voice comprehension rather than to make music sound good. The default setting on mine makes a piano sound like a toy piano due to boosting the treble so much. I have another setting for live music.
- an_d_rew 3y agoYou can import your audiogram into your iphone and it will program your airpods to match. https://support.apple.com/en-us/HT211218 https://support.apple.com/en-us/HT211218 It’s bloody amazing. A thousand blessings, health, and happiness to EVERYONE at Apple’s accessibility team for this!
- skybrian 3y agoI can’t do that using only an iPod, unfortunately, because the Apple Health app isn’t available. But there is a basic hearing test and that adjusts it pretty well.
- Spivak 3y agoI think prices will be in free fall once Apple launches their hearing aids as just a model of AirPods and every other phone OEM makes their own hearing aid to keep up. Audiologists will loudly complain that they're not as effective as once custom fitted and tuned but for literally 1/10 the price and no expensive tuning sessions it will be a no brainer.
- zamnos 3y agoTwo things. First you can get custom tips made for airpods (not exactly cheap, but custom isn't cheap). Second, you can actually use a training app, and then import that profile into the airpods for even better, personalized performance.
- funkdified 3y agoEasy sound comparisons here https://www.hearingtracker.com/hearing-aids/compare https://www.hearingtracker.com/hearing-aids/compare
- mperham 3y agoWhat are the odds Apple moves the AirPods Pro into this space?
- noipv4 3y agoand Bose too. I liked the ambient sound feature of the QC20 wired earplugs.
- red_trumpet 3y agoLooks like Bose is already there: https://www.soundly.com/product/lexie-b2-powered-by-bose https://www.soundly.com/product/lexie-b2-powered-by-bose
- slindsey 3y ago"While Bose is no longer manufacturing and selling SoundControl™ Hearing Aids, we are continuing to offer our complimentary technical support for those who have already purchased SoundControl™ Hearing Aids." https://www.bose.com/en_us/products/headphones/earbuds/soundcontrol-hearing-aids.html https://www.bose.com/en_us/products/headphones/earbuds/sound...
- porkbeer 3y agoBose has to be the most overrated audio brand ever.
- aaronbrethorst 3y agoHigh I hope. My hearing is somewhere between fine and great, but I’d love a pair of AirPods I could comfortably and discreetly wear all day without them getting in the way of engaging in normal conversations. …and if they could act as hearing aids for folks who need that, then awesome.
- drifkin 3y agoThe AirPods Pro already have a bunch of features that overlap quite a bit with hearing aids (e.g., importing audiograms), but it'll be interesting to how it evolves: https://support.apple.com/en-us/HT211218 https://support.apple.com/en-us/HT211218
- civilized 3y agoI'm seeing this amidst a lot of pundit complaints that the FDA and similar regulatory organizations are hopelessly restrictionist. Because of their incentives, because they only add new regulations and never remove old and ill-suited ones, etc. I'm not saying the pundits are wrong in general, but this seems to be an exception. What went right here and why? Is there anything to learn?
- Tuna-Fish 3y agoThere has been very significant pushback against such restrictionism for more than a decade, and it has steadily won over support especially among doctors. This is FDA starting to go with the flow.
- civilized 3y agoBy this do you mean that doctors are changing their minds, and since doctors do things like run advisory boards at the FDA, that causes the FDA to behave less restrictively? In other words, why would the FDA bother to go with any flow? On the view of some economists, bureaucrats should never deregulate because there's no incentive for them to, and mere cultural pressure shouldn't really be an incentive.
- brundolf 3y agoCultural pressure means political pressure and eventually that works its way through the system. It may be blunt and slow, but it gets there eventually.
- civilized 3y agoI'm realizing that you can always spin a story either way. If regulation is restrictionist, you talk about the ratchet and the overriding aversion of the regulator to being blamed for anything. If regulation is lax and ineffective, you talk about the revolving door with industry and the reluctance of regulators to piss off companies they could later get lucrative consulting jobs at. There is always a stock story available to explain whatever we currently don't like, but who knows what the facts are.
- bigsmiles01 3y agoMr. Beast lobby w
- s5300 3y agoCPAP should be next.
- Spivak 3y agoAnd insulin pumps. Half the diabetics I know are DIY in some capacity. The FDA only approved the first closed loop pump last year which did not need to take this long.
- Someone1234 3y agoThis cannot be stressed enough. You need to go to an expert and have a sleep study done for your initial settings, but it is no different from going to your eye doctor then buying glasses off of Zenni Optical. The whole medical equipment industry is just very expensive rent seeking, offering little support or expertise. This is particularly nasty for simple accessories like hoses, masks, filters, etc wherein the markup and insurance overhead is massively outpacing the raw cost of these goods (and if you know where to look you can buy them 75% off without those things). This is a true story: With insurance, my PERSONAL cost, was $1K though a medical equipment company. Then I had to have a modem in it and had my insurance spy on me for six months. Alternatively, for $900 I could have gone onto an online CPAP store, supplied by script, and been handed an identical machine (with included mask). Done.
- Multicomp 3y agoI use some oticon opn s series hearing aids as open hearing headphones. We need this to become cheaper and more ubiquitous as hearing aids provide open hearing and quiet sound without people necessarily even being aware that you have electronic music going on
- hinkley 3y agoThe hearing deficient kid I know is paranoid about getting his head wet. His parents, who are pretty well off, sent him the wrong messages about protecting his extremely expensive hearing aids when he was young and he developed a complex about it. If they were as cheap as retainers I think he’d enjoy swimming, but as things stand he’d rather eat bugs.
- joshe 3y agoCongress actually passed a law in 2017 ordering them to sell them over the counter. https://en.wikipedia.org/wiki/Over-the-Counter_Hearing_Aid_Act_of_2017 https://en.wikipedia.org/wiki/Over-the-Counter_Hearing_Aid_A...
- agar 3y agoCredit where credit is due. It was bipartisan legislation that was signed into law by Trump. Rollout and re-regulation was very slow, with additional hearing aids being made available over the next few years but with the FDA seemingly maintaining a fairly strong regulatory hand. The Biden administration pushed the FDA to fully implement the law and gave a 120-day deadline. I'm sure work was already in progress, but the FDA pushed and met the deadline which brings us to today. IMO this is a case where politics worked. Biden gets a "win" by touting this as more affordable healthcare and helping the middle class. Trump will I'm sure take credit for signing it into law, and republicans will highlight it as a win for deregulation. In the end though, this should be an unvarnished good for millions with hearing impairment that can't afford hearing aids, but also for many companies who can now innovate without onerous FDA testing requirements.
- deleted 3y ago[deleted]
- scarface74 3y ago> Credit where credit is due. It was bipartisan legislation that was signed into law by Trump. I was never a Trump supporter for reasons. But I was disappointed in him nonetheless. I thought Trump, not being beholden to the traditional powers that be and having followers that would literally get arrested for him, would be able to bully his way into getting things done that he supported that no other Republican could. He spoke out publicly against the drug companies and their prices and wanted up front pricing from the medical industry, believed in criminal justice reform (along with Rand Paul and the Koch brothers), and a few other measures I agree with. But he let his petty grievances get in the way. Yes I am well aware that the architects of the mess that criminal Justice is on the federal level was spearheaded by Clinton and Biden back in the day.
- sneak 3y agoCan we do contact lenses next please?
- stocknoob 3y agoGlasses and contact lenses have extreme potential for abuse, and should only be used with a recent (1 year) prescription from a licensed optometrist.
- ntonozzi 3y agoAnd toothbrushes too, did you know in some countries it is legal to brush your teeth and buy a toothbrush even if you didn’t see a dentist in the last year?
- sneak 3y agoI became addicted to mine after only a few days of use! Now I use them every day without fail and I think I would have a very hard time stopping.
- trillic 3y agoMy readers from 3 years ago are not dangerous I promise you, absolutely no chance of “abuse” from my Costco glasses. If you could please clarify?
- stocknoob 3y agoMedical regulations exist for the good of the public, and I wouldn’t risk treating a condition that a medical professional’s diagnosis is required for. The FDA would only block self-treatment if it were dangerous.
- bbarn 3y agoI'd love to see some facts backing this up. It might be true that wearing slightly off prescriptions could train eyes slightly worse over time, but for most people going without them is a far worse option. Also, the skillset required to prescribe glasses and contacts is something that can be (and is in some countries) effectively on the job training, not necessarily something that requires a specialist doctor with years of education. In most of Europe your average glasses shop can put you in a machine for a few minutes, and spit out an accurate prescription.
- hinkley 3y agoI’m looking forward to what Etymotic and Shure field in this market. Bose currently has the product that most closely approaches a hearing aid but isn’t. Hugh end hearing aids are just ridiculously expensive.
- hedora 3y ago> In response to public comments and to assure the safety and effectiveness of OTC hearing aids, the final rule incorporates several changes from the proposed rule, including lowering the maximum sound output to reduce the risk to hearing from over-amplification of sound, revising the insertion depth limit in the ear canal, requiring that all OTC hearing aids have a user-adjustable volume control, and simplifying the phrasing throughout the required device labeling to ensure it is easily understood. The final rule also includes performance specifications and device design requirements specific to OTC hearing aids. The previous version of this rule sounds pretty bad! Imagine the OTC hearing aids all being instantly permanently deafening with no volume control, and, on top of that, they puncture your eardrum and only produce feedback whine!
- joshe 3y agoNormal earphones don't have these restrictions. No one is making eardrum piercing earphones. It would have been much better if they had just deregulated them right when congress told them to in 2017. Or even better the FDA could have allowed OTC 30 years ago. Airpods are not regulated this way and they are much better engineered and more effective then even the best hearing aids. We have squandered so many years of hearing for fantasy harms. For millions of people.
- wgm 3y agoThis is a pretty uninformed take. The tech in AirPods is great, but people using a normal earphone as a hearing aid will be disappointed. The vast majority of people with hearing loss have a degree of loss that varies by sound frequency. If you boost everything 40 dB so the high pitches are back to normal, the low pitches will be extremely uncomfortable. The programming of a hearing aid is in many ways more important than the "engineering" that makes an AirPod Pro a great listening device.
- hedora 3y agoYeah. Also, I got a pair for my father in law (who has expensive hearing aids) for the remote listen accessibility feature (which uses the iPhone mic on the table next to the speaker instead of an in ear mic). He was sorely disappointed. I tried that feature out before returning them, and agree.
- TaylorAlexander 3y agoLiterally just spoke to my mom who is considering buying hearing aids. Does anyone have any informed outlook on when we can see lower prices? I’m assuming we will know more in 3-6 months but any more information would be appreciated. Thank you!
- mgerdts 3y agoGo to Costco. Free exams, no membership required for the exam. Hearing aids are about $700 each with free cleanings and adjustments, at least as long as the warranty. Membership is required for purchase and service. I have had cleanings and repairs at no charge with no appointment while doing my regular shopping. Edit: appointment is required for the hearing test. They will insist on doing their own test even if you show up with an audiogram.
- kevin_thibedeau 3y agoYou can buy them on Amazon now at various price points depending on desired features. They've been available for years, just under euphemistic names to avoid regulatory action.
- pkaye 3y agoI have hearing aids. Costco is probably the best deal on prescription hearing aids. It kind of depends on how bad her hearing is. At higher level of hearing loss sound needs so much amplification that you need good signal processing to reject background noise. Even with the good ones I have I struggle in noisy rooms to focus on a voice. Whatever she tries make sure the return policy is good.
- solatic 3y ago> In response to public comments and to assure the safety and effectiveness of OTC hearing aids, the final rule incorporates several changes from the proposed rule, including lowering the maximum sound output to reduce the risk to hearing from over-amplification of sound, revising the insertion depth limit in the ear canal Translation: people with severe hearing loss don't have the same right to purchase OTC hearing aids. Are they trying to get Fourteenth Amendment (equal protection of the laws) lawsuits?? Further translation: we'll let you buy OTC hearing aids, but only ones that are easily knocked out of the ear canal. Forget about participating in team or contact sports, or going to dances, etc. As someone with a moderate-severe hearing loss all my life, this is bullshit!
- gibolt 3y agoI feel for you, but in this case it sounds reasonable, at least as a first step. OTC medicines tend to be less potent than their prescribed counterparts. This is to protect people who don't know what they need from themselves (and many other reasons). You are going to have tons of new low quality new options, and setting hard limits on their potential damage to new users (either due to misuse or poor design) seems like a good approach until the dust settles.
- concordDance 3y agoSo if you can't afford to go to the specialist to get the prescription you're screwed... A lot of safety related legislation and regulation seems made with the middle class in mind, ignoring that the poor exist.
- Johnny555 3y agoBut also it's protection to prevent you from further damaging your hearing, just like most drugs require a prescription. The real problem isn't the regulation requiring professional oversight of potentially damaging devices (or medications), but the fact that medical care is affordable for many.
- gibolt 3y ago
- tommieb 3y agoAs a user of hearing aids, profoundly deaf from birth, I am against the philosophy of purchasing hearing aids over the counter, unencumbered from audiology prescription fittings and diagnostics. There is absolutely no come-back on this. Sure, hearing aids have come on in leaps and bounds since the digitization of the chip, and it was not so long ago either, two decades ago there was a switch over from analog to digital, well, in Europe that is. This is just opening up potential lawsuits against hearing aid manufacturers - "I bought this hearing aid from place X for Y dollars and now my hearing has detoriarated, am going to sue for damages", this could be unprecedented and sustained damage to the manufacturer's reputation. Each and everyone who does endevour to purchase over the counter, it does take at least a few weeks for the brain to adapt to the new sounds and could raise false hope "I bought this hearing aid X days ago and not noticing any improvement". Not to mention, that audiologists have spent years to study and how to fit/diagnose/troubleshoot hearing aids based off manufacturers specifications. The human side of getting a skilled opinion from a qualified audiologist on the diagnosis for loss of hearing will be effectively lost. Just no, this is just a recipe for disaster.
- trappist 3y agoThis change doesn't prohibit hearing-impaired patients from seeing an audiologist to get set up with a hearing aid. It's just no longer compulsory. I can't imagine understanding that this requirement is an encumbrance, and being "against the philosophy" of unencumbering access to hearing aids.
- nimish 3y agoNext up: glasses. Glasses are crazy overpriced and optometry is a peculiar US impediment to buying glasses.