FDA Finalizes Rule to Deregulate Hearing Aids
fda.gov
fda.gov
https://en.wikipedia.org/wiki/Over-the-Counter_Hearing_Aid_A...
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.
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.
And he did. He got Roe overturned (with an assist from Mitch McConnell).
The stuff Trump wanted to do himself he had much less success with.
Also, he did free a lot of federal inmates https://thehill.com/homenews/administration/589600-thousands...
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.
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.
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 worry about politicians who think about things in an excessively ideological eye, because the ideologues are immune compromising.
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?
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.
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.
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.
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...
What did everybody expect was going to happen? That companies were magically going to sterilize their production lines?
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.
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.
> 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.
There's no government compulsion to make sesame free products and should not be in a free Society.
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 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.
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.
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.
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.
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.
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.
they've added sesame where there was none before
If it was obvious it was none there wouldn't be an issue.
we don't know specifically which cases there was no sesame before but we do know there were a lot of them
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.
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.
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.
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...
I wonder if they will legislate on that soon.
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.
This is FDA starting to go with the flow.
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.
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.
IF there actually is a consensus by economists that bureaucrats won't regulate well then I'd believe them
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.
There is always a stock story available to explain whatever we currently don't like, but who knows what the facts are.
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.
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.
> Congress actually passed a law in 2017 ordering them to sell them over the counter.
There is no credit here, whatsoever, for FDA.
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
Here's a website that lets you compare over-the-counter hearing aids:
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 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.
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 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.
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!
That is comparable to a pair of glasses.
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.
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!
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.
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.
A lot of safety related legislation and regulation seems made with the middle class in mind, ignoring that the poor exist.
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.
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.
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.
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...
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 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.)
…and if they could act as hearing aids for folks who need that, then awesome.
https://www.bose.com/en_us/products/headphones/earbuds/sound...
Some other online glasses sales places will make you show them a sufficiently-recent prescription.
I'm I secretly checking a box that says I pinky swear I have a valid prescription?
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.
Edit: appointment is required for the hearing test. They will insist on doing their own test even if you show up with an audiogram.
Hugh end hearing aids are just ridiculously expensive.
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.
The FDA only approved the first closed loop pump last year which did not need to take this long.
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!
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.
https://support.apple.com/en-nz/guide/iphone/iphb80ab7516/io...
He was sorely disappointed. I tried that feature out before returning them, and agree.
Also, the concerns about not having safe ear canal protrusion limits, and not having volume controls are not things I (or the regulators) invented.