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.
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?
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...
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.
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.
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.
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.
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.
Also, the concerns about not having safe ear canal protrusion limits, and not having volume controls are not things I (or the regulators) invented.
