FDA Finalizes Rule to Deregulate Hearing Aids
fda.govCongress actually passed a law in 2017 ordering them to sell them over the counter.
https://en.wikipedia.org/wiki/Over-the-Counter_Hearing_Aid_A...
Credit 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.
Interesting that the two oldest presidents are united on hearing aids.
I wouldn't read too much into this considering they have enough money to even commission themselves a one-off, fully-custom design if they wanted to.
> 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.
> would be able to bully his way into getting things done that he supported that no other Republican could.
And he did. He got Roe overturned (with an assist from Mitch McConnell).
He didn’t care about abortion. He was pro choice most of his life. That was clearly a pandering move and now he is being criticized by the anti abortion crowd because he said he doesn’t think there should be a federal ban.
Republicans used Trump to overturn Roe. Trump himself didn't care at all about abortion and was nominally pro-choice until he decided to run for president
The stuff Trump wanted to do himself he had much less success with.
Trump forced hospital to publish prices, no? https://www.cnbc.com/2019/11/15/trump-releases-rule-requirin...
Also, he did free a lot of federal inmates https://thehill.com/homenews/administration/589600-thousands...
It looks like I was wrong. He never really embraced criminal Justice reform sincerely. He thought it would make inroads with minorities and he had to be convinced by his son in law (https://www.politico.com/news/2022/05/01/trump-republicans-f...).
That isn’t by itself meant to be a criticism. But politically, he couldn’t even fight the rhetoric from the right.
And I didn’t know the transparency rule ever made it through.
But, he didn’t get a law passed. It was administrative meaning it would be easier to fight in court (which is happening) and another administration could overturn it.
Again, with his political clout over his base, he could have brow beat enough Republicans and the Democrats wouldn’t dare oppose it. He didn’t focus his energy on getting laws passed in support of the parts of his agenda that’s traditionally not conservative.
Everything with Trump is a transaction, literally everything - so in that process some good things happen, because most of the people in the process - everyone but Trump are at least by some amount of measure, rational actors.
He didnt spend time getting laws passed because he couldn't figure out how to wrap his transactional thinking into a larger program designed to accomplish things - in his mind every deal is a one off, and it cant really merge deals into a larger direction.
I always thought that Trump is not a good builder, I just couldn't put my finger on it. I think this is it, the thinking of everything as transactions with immediate effects.
Let's be honest, all politicians think at transactions, but he might be lacking a strong internal belief, to help him tie some not so great transactions for "the greater good".
I dont think most politicians are all transactional, but I do think that willing to think about certain issues in a transactional way or willing to use transactions in certain deals helps you achieve your agenda. But you need to be willing to call that favor chit back in later, and able to think about the issues in a longer term way.
I worry about politicians who think about things in an excessively ideological eye, because the ideologues are immune compromising.
dude, he was and is batsh*t insane. you are listing things he would / could do like he was a rational actor that really cared about anything.
You cannot be disappointed in this system which you know is blatantly just a "win voters by any means necessary" reward system. The laws that matter (and the laws that take away your freedom) will get passed with no publicity since there is no political divide, but you'll only remember the laws that the X political party sees as important to winning over/taking voters since these always get the most news coverage.
I'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?
Plans for open-source hearing aids have also been developed and released, like happened on HN a few years ago (amazing work by the gentleman @zdw) https://news.ycombinator.com/item?id=20604566. So, I think like someone else said, this is gov't catching up to the fact that market alternatives exist and are undercutting an industry that has celebrated regulatory shielding for a long time. Really, the hardware is less complex as time goes on, right? It makes sense that low-cost alternatives will bring quality up for consumers and prices down for consumers. Question, Hearing aids are considered medical gear and therefore the regulation?
I always was told that the heating aids need to match the user. By that it means heating is tested and what frequency loss the patient has the hearing aid will then take that frequency and alter it to one the client can hear. It’s not a matter of higher volume. It seems now however a simple app on a phone could do the hearing test and then match up what the patient needs with an open sourced hearing aid.
>It seems now however a simple app on a phone could do the hearing test and then match up what the patient needs with an open sourced hearing aid.
I would bet a lot of things could be done by regular people with proper software support. Having licensed gatekeepers raises prices for the service. Since you're excluding a lot of supplierd from the market.
The question is then why gatekeep at all?
With antibiotics for example, abuse and misuse can cause a lot of harm, so having someone gatekeep them, even if this raises the price of service makes sense.
But with a lot of licensed professions we're merely creating an artificial moat that increases prices in a market economy.
>I'm not saying the pundits are wrong in general
The pundits are wrong. The FDA follows the instructions given to them by Congress.
What went right is that there was broad bipartisan support for the 2017 FDA reauthorization act which permitted them to do this.
What went wrong was that covid delayed the rule making process by about 18 months.
Every single rule/regulation in the Code of Federal Regulations can be traced back to a law that originated in Congress with the words "the Secretary shall..." in it, with the secretary being the head of a government agency.
Prior to 2017 the Congress said "the Secretary shall regulate medical devices" and under the definition created by Congress hearing aids were medical devices, so the FDA did.
After 2017 the Congress said "the Secretary shall regulate medical devices but also make a category for OTC hearing aids" so the FDA did.
Also, rule changes take a long time either because of changes in the laws telling federal agencies what to do or laws already in 5 U.S. Code that define the rule-making process.
There are many federal agencies that would like to wave their hands and create or eliminate rules but for better or worse (I think mainly better) they can't.
Many, though not all, pundits don't realize what the process is.
Some things need to be over-regulated, like food (making sure companies don't put bad things in it or lie about what they're selling), or anything common for the matter. Some things ehh...like experimental drugs, which some argue need to be well-tested, but the alternative for some is dying or living in constant pain (personally, I think people should be able to sign up for anything as long as its, beyond doubt, under their own choice and they're fully aware of potential consequences)
I just don't see the reason to regulate hearing aids. It's not like they'll blow up in your ear or translate people's everyday conversations into conspiracy theories, and hearing aids which don't work well are better than none at all.
As a counter example, sesame was recently made a major food allergen by the FDA, which caused many food makers to add sesame to their food.
Adding sesame was easier than following the regulations to assert their foods were sesame free, so now food that used to be safe is now dangerous for anyone with a sesame allergy.
https://www.fastcompany.com/90830854/sesame-seed-allergen-fd...
And for those with a mild sesame allergy, things improved dramatically as they don't have to play roulette with how much "undetectable" sesame is in their food anymore. The amount of sesame is known, quantified, and reliable. Once they establish that a food is "safe", they can buy it going forward.
What did everybody expect was going to happen? That companies were magically going to sterilize their production lines?
My heart truly bleeds for companies who face the insurmountable task of printing "may contain sesame" next to the rest of their allergen information.
Wheat was already on the major allergens list, the regulatory burden of keeping aerosolised flour from contaminating other products doesn't seem to have been much of an issue.
The article also seems to make the case that sesame allergens were making their way into foods, with presumably disastrous effects but that was fine because companies didn't have to think about it.
The preferred solution to the intentional adulteration of products should be to fine the companies and throw their executives in jail. It might make them more amenable to complying with the spirit of the law. In fact, society would be better off in general if executives went to jail more often.
> My heart truly bleeds for companies who face the insurmountable task of printing "may contain sesame"
The reason the regulation, and the commercial response to it, is controversial is that companies cannot simply print "may contain sesame" and be done with it.
"Statements such as 'may contain [allergen]' ... can be used to address unavoidable 'cross-contact,' only if manufacturers ... have taken every precaution to avoid cross-contact"
https://www.fda.gov/food/food-labeling-nutrition/food-allerg...
This is a counter-intuitive, and presumably unintended consequence of the regulation that sucks if you're allergic, but fining or jailing executives for complying with it is silly. Hopefully, enough other companies will see a competitive advantage in retooling their processes to deliver sesame-free products.
My mistake. They're simply required to do the same thing the do to ensure their enriched breads do not cross contaminate unenriched breads with milk and eggs, or that gluten free breads aren't contaminated with wheat flour.
> This is a counter-intuitive, and presumably unintended consequence of the regulation that sucks if you're allergic, but fining or jailing executives for complying with it is silly.
They're not complying, they're skirting. People who play these kinds of games are a weight around society's neck. The purposefulness and agency over their actions is what should see them in jail. See the attempts of past Uber executives to obstruct the investigation of their illegal activities for an egregious, and relatively well known example of people who need a stern lesson on how to behave in society.
I think you need to take a step back and get some perspective if you are calling for Bakers who add Sesame to their ingredients to be jailed.
There's no government compulsion to make sesame free products and should not be in a free Society.
My understanding is that the recent law does not allow for compliance by simply labeling possible contaminants. If the recipe does not intentionally include seseme, the product must not list seseme as an ingredient, and must not contain any seseme.
So, the insurmountable task is either maintaining completely seseme free manufacturing lines, or cleaning manufacturing lines between recipes to the point of guaranteeing no seseme cross-contamination.
Does it really follow that executives should be jailed for adding seseme to their company recipes? I imagine many of the companies that made this change were previously voluntarily listing seseme as a possible contaminant, but had to stop because of the law.
> My understanding is that the recent law does not allow for compliance by simply labeling possible contaminants. If the recipe does not intentionally include seseme, the product must not list seseme as an ingredient
My mistake. Since 2004, Major food allergens have come with a requirement that manufacturers take steps to avoid cross contamination. The addition of sesame to the list requires it to be treated in the same way.
> and must not contain any seseme.
The manufacturer must follow "current good manufacturing practices (cGMPs)"[0] as described by the FDA. These should already be in place to prevent cross contamination of the existing major allergens.
> So, the insurmountable task is either maintaining completely seseme free manufacturing lines, or cleaning manufacturing lines between recipes to the point of guaranteeing no seseme cross-contamination.
The insurmountable task is to do the same thing they're already required to do to make sure enriched breads, containing milk and eggs, were not cross contaminating merely leavened products or to make sure that wheat flour doesn't contaminate non-wheat products.
> Does it really follow that executives should be jailed for adding seseme to their company recipes?
Yes. Any executive that added sesame to their product in response to this law should be in jail. I'm tired of executives facing no consequences when they intentionally cause harm in their pursuit of profit.
> I imagine many of the companies that made this change were previously voluntarily listing seseme as a possible contaminant, but had to stop because of the law.
Presumably part of the reason sesame was added as a major allergen was because companies weren't doing a great job disclosing it as an ingredient.
No one is perfect. They sought to amend the rules after it became clear that would be an issue.
You can go to places where food is essentially unregulated, as even if there are laws, they aren't enforced. I guarantee people will warn you against eating the local food, and those warnings will be from experience.
Your ‘counter example’ is exactly what we want to happen.
It’s not that they’ve added sesame where there was none before, it’s that they’re having to declare that sesame might be there. It’s great news for people with sesame allergies and has no effect on those that don’t.
That was my first thought, but look at other well-documented comments here. It sure looks like "may contain" is a certification that every possible avenue to avoid "contamination" had been pursued. Which is an open-ended liability. Easier to just add 1% and definitively say it does contain sesame.
No, they added sesame where there was none before.
The law requires you either have no sesame contact at all (as in not even having sesame based products travel on the same belts), or you list sesame as an ingredient.
But you can't just list ingredients that aren't in your food: "travelled on the same belt as sesame" isn't enough. So they actually went and added sesame.
Yes. Before there may have been sesame, it was a lottery. Now there definitely is or is not sesame, which is what's important to people with allergies.
Though it's weird that the FDA don't just allow a 'may contain traces' warning, many countries do.
> Though it's weird that the FDA don't just allow a 'may contain traces' warning, many countries do.
The reason is that such information is useless. If someone has a sesame allergy, they can not eat the food that "may contain traces" anyway. So actually having a definitive boolean _hasSesame is far more useful information, and will lead to less accounts of confusion.
Just as an example, my son's friend is allergic. Can I, as a parent of a friend, give to this child food with the "may contain traces" label? Will every parent of a friend make the same decision? With the new labeling, the answer is much clearer.
Manufacturers going on a sesame flour adding spree to foods that were previously perfectly safe for those kids is going to cause a lot more pain than people irresponsible enough to treat "May contain" as worth risking for kids they don't know well enough to make that call on.
> It’s not that they’ve added sesame where there was none before, it’s that they’re having to declare that sesame might be there
They added it where there was none before. People with allergies to sesame were eating bread at Olive Garden and Chick-Fil-A just fine before this legislation and now they can't.
> Though it's weird that the FDA don't just allow a 'may contain traces' warning, many countries do
The FDA always allowed that. But by naming it a major allergen the "Contain" statement becomes mandatory, and the "May Contain" statement doesn't satisfy that.
this is incorrect
they've added sesame where there was none before
The thing driving the regulation is that there is an (small or trace but) unknown amount of sesame.
If it was obvious it was none there wouldn't be an issue.
So the solution to comply is to intentionally add Sesame to the manufacturing process has the most effective way to meet the regulation. This means that products that previously may have had occasionally low PPM levels of sesame now have a much greater amount intentionally added in larger but known quantities
in some cases there were trace amounts, and in others there weren't, but the absence of sesame couldn't be guaranteed
we don't know specifically which cases there was no sesame before but we do know there were a lot of them
Poorly calibrated hearing aids actually can damage your hearing (even worse than it was). It’s sending highly amplified noise directly into your ear drum.
Hearing aids are generally calibrated for an individual’s specific frequency loss (usually done by a medical professional). We’re already seeing devices that simply amplify all frequencies, and while I’m no doctor, I can imagine boosting all frequencies for prolonged periods of time could lead to additional hearing loss.
Given the current state of common food I don't think I would agree that it's currently over-regulated.
The opposite is true. Most Americans are eating food that isn't what the label says it is (eg. fish). This sort of scam is completely legal and the FDA allows it to happen. More regulation needed.
Then you have dietary supplements which is a complete wild west. There's a 3 billion dollar kratom industry, for example. You can buy this dangerously addictive drug at your nearest 7-11 or gas station.
So how many people have been seriously harmed by this 3 billion dollar industry? I'm particularly interested to know how many people who weren't taking the drug but were harmed by someone who was?
I don't have figures because nobody has done the studies. Like I said... Completely unregulated.
R/quittingkratom has tens of thousands of members. So hundreds of thousands of people have had their lives seriously affected by it (every addict ruins multiple lives... Family and friends). That's to say nothing of the many dead from kratom.
If there are no studies and you're implying that kratom is a big problem, so what are you basing that on?
There are many subreddits related to quitting various things. If that's your metric for “lives ruined" there are dozens of other things that have ruined dozens of times more lives.
I mean, if there are hundreds of thousands of posts from Americans talking about how it's ruined them, how the hell are you going to respond with "show me the studies"?
1. Most of the posts on they sub have nothing to do with people's lives being "ruined".
2. Yeah its may be unhealthy but people do all kinds of unhealthy things to themselves.
3. 35k subs on a subreddit that seen around 12 years is TINY. There's a sub about quitting porn that has over a million.
4. Even though you claim there are "no studies", here's a study from the WHO. Where they concluded that no action beyond "monitoring" was warranted based on current evidence.
https://www.who.int/publications/m/item/kratom-mitragynine-7...
Fully informed people doing unhealthy things to themselves by choice is fine. That’s not how the kratom industry operates though. Instead, they cover up the dangers of the drug with “it’s in the coffee family”, straight up hiding it in “herbal teas”, and even covering up entire operations behind “kava bars”. It’s all slow sleazy, with the goal of creating addicts before they even realize what they’re addicted to.
Count the obese people you see, that is your answer.
Kratom users make other people obese? Now that’s a novel theory. (I think you misread the post you replied to.)
The US baby food contains so much heavy metal, that's not even funny anymore.
I wonder if they will legislate on that soon.
>It's not like they'll blow up in your ear
I mean there is still product safety laws for this, which I would hope are enforced. But they should be just as strict as for your earphones.
There 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.
By 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.
> On the view of some economists, bureaucrats should never deregulate because there’s no incentive for them to
Well, so economists models of things outside their notional specialty aren’t any more connected to reality than those inside. That’s…to be expected, I guess.
Economists model incentive structures, I'd expect them to actually model things that aren't traditional economics quite well.
IF there actually is a consensus by economists that bureaucrats won't regulate well then I'd believe them
Traditional economists model traditional economic incentives. Behavioral economists try to understand all the gaps in traditional economic models such as why people don't steal as much as they can when there is 0% chance of getting caught or why people who choose In-and-Out when given an option between McDonalds and In-and-Out suddenly choose McDonalds when just asked to pick a restaurant for lunch.
Humans are motivated by emotional incentives at least as much as economic incentives, and humans also have cognitive and memory constraints that aren't considered by traditional economists.
All of which is to say that while there may not be an economic incentive for government regulators to de-regulate, that conclusion fails to consider that many government regulators actually have an emotional desire to feel like they are doing good in the world and that emotional incentive can sometimes be stronger than the traditional economic incentive to keep regulations in place.
Cultural pressure means political pressure and eventually that works its way through the system. It may be blunt and slow, but it gets there eventually.
I'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.
I feel like there are a lot of similar examples they just don’t get a lot of press. Naloxone was recently approved for OTC and they also recently approved allowing Mifepristone prescriptions by mail. They’re considering allowing a new birth control to be sold over the counter. Maybe a decade or so ago Plan B was prescription only but they allow that to be sold over the counter now, too.
And a lot of other drugs have made the jump in my adult memory: allergy drugs like Claritin and Flonase used to be prescription only as did just about every major antacid like Prilosec and Nexium. There’s a new topical NSAID for arthritis that recently made the switch to OTC too, I think.
> There’s a new topical NSAID for arthritis that recently made the switch to OTC too, I think.
Diclofenac did, if that's the one you're thinking of. I was prescribed it for joint pain a few years ago and was pleasantly surprised when I was able to buy it OTC after a while.
I think only in topical cream form vs as a pill right?
https://news.ycombinator.com/item?id=35846202
> Congress actually passed a law in 2017 ordering them to sell them over the counter.
FDA was pushed for, I think, over six years by laws to allow over-the-counter hearing aids. I don't know why they even started regulating them.
There is no credit here, whatsoever, for FDA.
Congress passed a law that made them do this - in 2017! The FDA has been going slow on implementation till the Biden admin gave them another kick in the pants.
federal bureaucracy is slow to move, definitely
afaik older hearing aids actually posed some harm to folks if they got the wrong kind
new models basically make this kind of problem non-existent
This is from a year ago.
Here's a website that lets you compare over-the-counter hearing aids:
Mostly 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.
The 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.
> 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 (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.
I 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.
You can import your audiogram into your iphone and it will program your airpods to match.
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!
I 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.
My 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.
I 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.
Two 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.
What training app? Could benefit from this
Easy sound comparisons here https://www.hearingtracker.com/hearing-aids/compare
> 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!
I 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.
This is such a cop-out. It basically sounds like they're just going to be ordinary earphones then. Even ordinary earphones will damage your hearing at the highest outputs; damage comes long before "ear-splitting" / painful levels. If the regulations permit levels that are sufficient for moderate hearing loss, some mild users will program the levels too high and make things worse.
There are reasonable limitations to be made here: requiring initial settings to be low, restricting how quickly volume can be increased while they're being programmed, having different drivers for different levels of hearing loss (which is already the case for prescription hearing aids), etc. But individual responsibility is fundamentally both a requirement and reasonable presumption. We don't let people who commit suicide by swallowing a bottle full of sleeping pills prevent the rest of society from having access to sleeping pills, nor would we presume that a prescription magically stops people from getting suicidal. Yet the consequences for misprogramming OTC hearing aids are much lower than the consequences for not taking sleeping pills as directed.
So 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.
Hearing and vision are both very sensitive senses, that are easy to permanently damage.
Everyone should have access to treatment they need, but having a licensed doctor review severe cases to find the right fit and prevent further degradation or full deafness, especially if their hearing is already weak, is a reasonable safeguard.
You can use an app to check which frequencies are missing. The man with the bit of paper will be doing the same thing.
I may be biased as I work on a medical device and at least for the device I work on the doctors signing off are contributing nothing more than their license.
Where are you getting your clinical data then?
But 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.
What are the odds Apple moves the AirPods Pro into this space?
The 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
100%.
On a related note, I could see Apple improving the AirPod Pro's ability to protect hearing through improved isolation combined with a modified Transparent mode. Such a "concert mode" device would effectively moderate the volume to a reasonable decibel rating but keep the audio sounding pure and unmuffled, improving over even concert earplugs. Current devices are almost, but not quite there[1].
Making health or safety claims often risks running afoul of FDA regulations; I don't know if that's the case here, but the more open hearing aid FDA rules may allow such use cases with lower risk. IMO this, plus hearing aids, make an "AirPad Pro+"'s market too large for them to ignore.
[1] https://www.nytimes.com/wirecutter/blog/can-airpods-pro-prot...
Diaphragm earplugs already work much better than the technology you describe will, and are about $20:
https://www.gomumba.com/products/mumba-high-fidelity-concert...
This brand is ranked well on Amazon. I’ve never used them, but can’t remember the brand name of the name brand ones I had in the 1990’s. There are also ones optimized for hunting, or you like using power tools during casual conversations.
I have a hearing deficit and am looking forward to more options in this space. But I will be surprised if Apple ever sells anything that can be discreetly worn. They seem to enjoy making products serve as advertisements.
(I use my iPhone and Apple Watch and AirPods Pro daily. It seems that one still cannot buy a version of the Apple Watch with a cell modem without a red ring on it.)
I really don’t want discreet hearing aids. My first set were a color designed to match my (brown) hair. Good luck finding one if it got knocked out by my kids. Plus, they don’t restore normal hearing, so I’d rather have them be something that alerts someone talking to me that my hearing is defective. I generally get white or silver now (depending on what’s available). If fluorescent blue were an option, I would go with that.
Good point. I just don't want them to look like my AirPods or people near me might think that I am ignoring them. I would rather they look like hearing aids.
High 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.
and Bose too. I liked the ambient sound feature of the QC20 wired earplugs.
Looks like Bose is already there: https://www.soundly.com/product/lexie-b2-powered-by-bose
"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/sound...
Bose has to be the most overrated audio brand ever.
Can we do contact lenses next please?
Might as well do ordinary glasses, too.
Zenni is effectively this, although you do need at least a one-time measure of your prescription and pupillary distance.
Though they don't, in my experience, ask for any indication that this comes from a prescription, that it's up to date, etc. You're free to use numbers from an ancient prescription, just guess at your refraction, whatever.
Some other online glasses sales places will make you show them a sufficiently-recent prescription.
Any store will sell me clothes that don't fit, food I'm allergic to, and chemicals that are dangerous if used incorrectly. It's not unreasonable to expect the buyer to take some basic responsibility.
I don't dislike that Zenni does this.
They have their limits to this laissez fair policy though, for whatever reason...I tried buying multiple pairs of glasses at slightly different strengths from Zenni (stronger rx for it for outdoor distance views and weaker for inside and they freaked out and they called and asked if it was a mistake. When I explained what I was doing, they said nope and cancelled the order on me.
Are they not already? I just put in my Rx numbers on the website and get my contacts shipped to me.
I'm I secretly checking a box that says I pinky swear I have a valid prescription?
When I do this they make me upload a scan/picture of the prescription. Sure, I guess you could fake it.
Glasses and contact lenses have extreme potential for abuse, and should only be used with a recent (1 year) prescription from a licensed optometrist.
And 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?
I'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.
It's sarcasm, I'm fairly sure.
I 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.
My 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?
Medical 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.
Even if this is sarcasm, you may want to be careful as people may actually believe this ludicrous take.
I 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
The 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.
Literally 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!
Go 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.
You 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.
I 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.
I’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.
As 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.
This 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.
Next up: glasses. Glasses are crazy overpriced and optometry is a peculiar US impediment to buying glasses.
CPAP should be next.
This 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.
And 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.
Mr. Beast lobby w
> 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!
Normal 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.
This 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.
That’s why apple supports importing an audiogram so you can selectively boost certain ranges of sound.
https://support.apple.com/en-nz/guide/iphone/iphb80ab7516/io...
Yeah. 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.
Hearing aid manufacturers are currently making things loud enough to cause hearing loss in normal ears. According to the quote I pasted in, the comment period is the reason they are still prescription-only.
Also, the concerns about not having safe ear canal protrusion limits, and not having volume controls are not things I (or the regulators) invented.