FDA moves to make over-the-counter hearing aids available
washingtonpost.com
washingtonpost.com
Here is the original bill "Over the Counter Hearing Aid Act of 2017" from Liz Warren:
https://www.congress.gov/bill/115th-congress/senate-bill/670
The bill "FDA Reauthorization Act of 2017" that become the law:
https://www.congress.gov/bill/115th-congress/house-bill/2430
The section for OTC hearing aids says:
"(Sec. 709) The FDA must categorize certain hearing aids as over-the-counter hearing aids and issue regulations regarding those hearing aids. The regulations for over-the-counter hearing aids must: (1) provide reasonable assurances of safety and efficacy; (2) establish output limits and labeling requirements; and (3) describe requirements for the sale of hearing aids in-person, by mail, or online, without a prescription. The FDA must determine whether premarket notification is required for over-the-counter hearing aids to provide reasonable assurance of safety and effectiveness. State and local governments may not establish or continue in effect requirements specifically applicable to hearing products that are not identical to FDA requirements and that restrict or interfere with the servicing or sale of over-the-counter hearing aids. The FDA must update and finalize its draft guidance on hearing products. The guidance must clarify which products are medical devices."
It doesn't directly say that cost should be reduced but assuming it will go OTC, costs should go down ?
It's been common in politics for a century, even among supporters.
Of course the cost of getting a hearing aid will only include a trip to the pharmacy and the device itself and not doctor visits and all that, so it still benefits people that need them.
I'm not seeing where "markup" is coming into this.
In the spot where a couple hundred bucks worth of services and a couple hundred bucks worth of electronics becomes $2,500.
Of course, the same as with headphones, you can spend $5K, 6K or even 10K in some top of the line planar magnetic whatever Audeze, Stax or Hifiman, but really, you don't need them.
Think also about the economy of scale. Hearing aids are more common than hi-fi high end in-ear monitors. If any big player in the electronics field enters this game, prices (and features) could be way better than they are now.
Apple has been interested in getting into the health space. This is a perfect new product for them. The only problem I see is that the market might be too small to make a difference in their profits.
It is probably simply that it isn't so absolutely difficult for Apple to start making these. The company is already experienced in making small electronics, earbuds, and things like this.
This is what made them extremely expensive for a good part of their history. Adaptability and auto-adaptability.
Also, they're very small electronics for what they do.
A hearing aid would be great in party environments for me.
My father and my daughter have the same condition, so I’m reasonable certain it is inherited.
Or am I just being really dumb?
Conversation Boost for AirPods Pro helps you better hear conversations in crowded or noisy environments. Through computational audio and beamforming microphones, Conversation Boost focuses AirPods Pro on the voice of the person directly in front of you, making it easier to distinguish speech and follow along in face‑to‑face conversations.
Apple has all the tech needed to get this done, even in their existing product. I'm hopeful they will now feel they can release it. All I need is compression (amplification of soft sounds without over-amplification of loud sounds), equalization, and an app that allows me to make the necessary adjustments - with separate controls for exterior sound and the iOS audio chain.
For reference I had a friend whose hearing aids were doing this 15-20 years ago. He was able to have a conversation just fine in a crowded bar, whereas I couldn’t hear a thing over the din of background conversation.
If everyone was using a naive version of what's described: maybe?
If only a handful of people were using it: probably not.
And I'm sure you could exploit human psychology to engineer some way to keep the party as quiet on average as before.
(Slightly related, I heard of some gadget that projects someone's speech back at them with a slight delay. The effect is said to be so unnerving that untrained people stop talking altogether, or only haltingly. It's apparently been used to shut down protestors.)
I wonder if it would be more disconcerting with a varying delay. Long ago I saw a proposal to eliminate "feedback" in a Public Address system by putting in a delay line with variable delay.
EQ alone is quite primitive though compared to the computing power that we have available. If you're capturing audio from both ears, it wouldn't be hard to filter out anything other than directly in front of you. If you're sitting across a table from someone in a loud restaurant, you could let all the audio in normally, vibe to the music, but duck the volume on all the background noise when a human voice is detected directly in front of you.
They didn’t do “virtual sidechaining” like you describe, but possibly could have with the DSPs in the earbuds. I’d love to find a replacement for them.
https://m.apkpure.com/here-one/com.dopplerlabs.hereone
Run it through VirusTotal if you're in sight about the APK's provenance,
Don't let this type of planned obsolescence rule your access to your devices. That is, assuming the app works without some sort of cloudy backing - but then I guess it should of it was to be used in places where network access can be spared or non-existent?
It's not quite a walk in the park, because you only have very small latency budgets.
My hearing itself is well within normal sensitivity when tested (well, it's getting worse, but even that's normal as I age). It's just whatever processing people do to turn sound into parsed language is difficult for me. Even people's houses that have a TV going 24x7 are problematic for me to have a conversation.
If I focus on a single person, I can usually have a normal conversation with them and them only, at the expense of blocking out literally everyone and everything else. So, could be worse, but it would be nice to be able to keep up in crowded rooms more easily.
I had a fairly rapid decrease in my high frequency hearing (basically my ears aged 20 years in a few months), and the biggest indicator to me was how much harder it was to understand dialogue in loud shows. I was turning on subtitles and/or turning the volume up where before I was fine with a fairly quiet volume.
It's not too uncommon, and is tremendously common among people with ADHD, dyslexia, and people on the spectrum.
Whatever it is, I definitely have it. One thing that helps me a ton is just focusing directly on people's lips when they're talking in a noisy setting. I can't read lips (at all), but the extra little bit of visual information helps me a great deal with comprehension.
Is there a name for this?
When I was 15, something similar started happening to me but even during one on one conversations. Someone would say something, I would hear the sounds, but wasn’t able to really make sense of it (and reply) for a few seconds.
When tested, my hearing was perfect. I never dug too much into it, and eventually it got a lot better. It still happens sometimes in some situations though.
Would be great to learn more about it if you have any additional info.
There's no point in getting formally diagnosed because there's not really any treatment so save the money, but it's sometimes just nice to know it has a name and something to Google.
You may have ADP/KKS:
https://en.wikipedia.org/wiki/Auditory_processing_disorder
Learning about this helped me immensely deal with my own struggles of hearing voices with background noise.
In my case, I believe it's from operating a stump grinder without ear protection. (Doh!) I've been tested, there is a narrow range where my hearing is impaired. Otherwise, I hear very well.
Put me in a restaurant, I spend about half my time lip-reading and context matching to figure out what the person across from me said.
But, the internal frame is partly plastic, and mine snapped. You have to be careful not to flex it much when taking it off. Now, I'm looking for fine weave carbon fiber cloth to fix it - I got it working once using superglue, but it broke again.
Meanwhile, Bose has completely exited the hearing aid sector.[0]
[0] https://www.hearingtracker.com/news/bose-cease-hearing-aid-s...
> Meanwhile, Bose has completely exited the hearing aid sector.
Sounds like they sold or partnered with Lexie, so some hope: https://lexiehearing.com/us/lexie-powered-by-bose-hearing-ai...
I imagine a role for being able to select between 3-4 enhancement personalities, just as one might wish to select between different self-driving personalities for different road and traffic conditions.
Also, given what I take to be a high proportion of non-use of hearing aids after a professional "fittting" or "tuning", I wonder what role for "at-home" A/B testing where a wearer can suggest better/worse between two different sets of adjustments.
/rant
However — I have ordered and received such items from out of state vendors with home delivery without incident.
Wait until you hear that Kinder Surprise are banned there, too.
Else order from Canada or the UK. Still cheaper to get a new exam at Costco in most cases.
Even just taking a daily contact out once and immediately popping it back in can sometimes mangle it up enough to noticably fuck up my vision. Biweeklys are much more tough as they're actually designed to be handled.
Not trying to shit on dailies by the way, as they're actually the healthiest for your eyes if you can swing the cost.
https://www.bvoptometry.com/daily-contacts-vs-monthly-contac...
So silly.
I was more pointing out that other countries handle this better.
https://en.wikibooks.org/wiki/Muggles'_Guide_to_Harry_Potter...
I can hear almost nothing at many frequencies without amplification in my right ear but have normal hearing in my left. This means I can use a regular headset to hear well with my left ear or use Bluetooth on my one hearing aid to hear with my right ear.
Not sure if you can punch in a custom audiogram, but there are apps (like Apple’s built-in one or Mimi) that will generate one for you.
IIRC they basically try to chase up your eye doctor for you, and if your eye doctor doesn't respond within a certain timeframe, they have a greenlight to proceed with the sale according to a California law that was passed maybe 10 years ago. It's probably different in different states - maybe in some states you can literally just type in whatever you want.
Zenni does let you buy "whatever you want".
I'm not aware of anything on the federal level that requires a patient have a valid prescription for eyeglasses. (I've looked, but I've not found any such requirement.)
The restrictions appear to be on the state level. Some states prohibit dispensing prescription glasses without a prescription. Other states appear to only regulate what a prescription must contain, and how long it lasts, with no apparent laws around dispensing. (For example South Dakota explicitly does not regulate opticians, so unless there is some federal law I have missed, they can produce and dispense any type of glasses to anyone who asks, but cannot do so for contacts due to the FTC contacts rules.)
Will pharmacists do this now? Or are patients still expected to bring over the counter hearing aids to audiologists for those adjustments?
I'm not an expert here but the small amount of digging I've done suggests the opposite. You can permanently damage your hearing if you tune the hearing aid wrong, and it's extremely fiddly (can take many sessions with a professional audiologist) to get things right.
I think this is still compatible with some adjustments being done on an app, and definitely with some set of "safe parameters" being available without prescriptions. I just want to push back a bit on the idea that what an audiologist is doing is trivial. I expect most people with severe hearing loss will still want to see a specialist. But _as long as the risks are understood_, more choices are better than fewer.
Real-time feedback and control goes a long way to turn a (potentially embarrassing or shameful) disability into something simple, empowering, and even fun.
It should also be noted that a huge problem in countries in Europe where hearing aids are subsidized by the state is getting people to actually use their subscribed hearing aids. Usually the patients needs information and coaching to be motivated. With that in mind I think alot of over the counter hearing aids will just end up in a shelf somewhere if there isn't any good resource for encouragement and technical help.
Do you know how people feel about their hearing aids?
Where do you see the industry going in 5-10 years?
What companies in the space look promising/exciting to you?
I used EarMachine [ https://apps.apple.com/us/app/earmachine/id732177210 ] with custom hardware in my studies. The amplification controls consist of two touchscreen wheels, one which increases the gain (with a higher rate of increase in high frequencies than in the low frequencies) and one which acts as a spectral tilt. There is a complex mapping from the two wheels to the gain, but that's the simplification. It's just traditional non-linear amplification that is applied to the input signal.
Industry labs are privately exploring all sorts of things, but they won't share publicly until their products are ready for market. The NIH has been funding the development of "open master hearing aids/simulators" to promote research into new signal processing strategies, and start-ups are pursuing new delivery models. A lot could change in just the next 2 years.
>Do you know how people feel about their hearing aids?
Every so often some market research data is published under the name MarkeTrak [ https://betterhearing.org/policy-research/marketrak/ ]. This summary is most relevant [ https://www.audiologyonline.com/articles/20q-understanding-t... ]. About 2/3rds of people who could benefit from hearing aids do not own/use them. There are a lot of reasons for that, and actual satisfaction with hearing aids is only a part. In the UK where there's no financial barrier to getting hearing aids for the vast majority of people, hearing aid adoption rates are low. Culture, social stigma, and even personality plays a huge role in how people feel about hearing aids. That's the background for this: Most hearing aid owners are satisfied. People who have hearing aids older than 6 years tend to be less satisfied than people who have new hearing aids.
>Where do you see the industry going in 5-10 years?
Broadly speaking, I expect to see a lot of experimentation and diversity in products and service delivery models. Using the principle of "the more things change, the more things stay the same", I would predict that we will see an increased focus on products and delivery models that feature greater personalization and greater integration with consumer electronics. I think we're gonna see an attempt to leverage more and different sensors on the body to modify and control device output. I think we might see some breakthroughs on noise reduction algorithms, but in the end they won't prove as useful as we'd hoped. I think Zuckerberg wants to sell a VR headset to every grandparent and great-grandparent.
>What companies in the space look promising/exciting to you?
You know I just don't have a good answer for this one. Very sorry!
"A central problem of hearing aid fitting is that the space of gain-frequency responses that can be achieved with digital hearing aids is extremely large, but only a subset of those responses could reasonably be audiologically appropriate for any particular ear. Client-based selection of amplification has historically involved some combination of restricting the number of individual gain-frequency responses available (e.g., Humes et al., 2017) and providing efficient methods for navigating the space of gain-frequency responses (e.g., Sabin et al., 2020). The approach of offering a choice between three presets was found to be efficacious in clinical trials of a client-driven delivery model (Humes et al., 2017, 2019). Recent work suggests that as few as four gain-frequency responses can provide audiologically appropriate fits to 60%–75% of adults with mild-to-moderate sensorineural loss (Jensen et al., 2020; Urbanski et al., 2021). Greater coverage can be achieved by expanding the number of gain-frequency responses available to the wearer (Sabin et al., 2021). In a field trial of a self-adjustment tool that provided clients with a large range of gain-frequency responses, participants showed slight preferences for self-adjusted settings over clinician-fit settings, and no group-level differences in clinical measures of amplification benefit were observed (Sabin et al., 2020)."
Perry, T. T., & Nelson, P. B. (2022). Self-Adjustment of Hearing Aid Amplification for Lower Speech Levels: Independent Ratings, Paired Comparisons, and Speech Recognition. American Journal of Audiology, 1-17.
TL;DR: Some products will come with 4 or 5 presets that you can choose between and then tweak slightly. Some products will come with software (such as a smartphone app) that includes simplified (yet effective!) user interfaces for the wearer to self-adjust the amplification. Some products will ask you to engage in a computerized hearing test to set the device to levels prescribed by an audiogram-based fitting prescription formula. We will see many more audiologists and hearing instrument specialists modifying their service delivery models to invite people to bring their already-purchased OTC hearing aids in and have them programmed by a specialist.
But you can already buy hearing aids without a prescription or medical exam. I do mean the United States, and I do mean devices labeled as hearing aids and not personal sound amplification products. See this article from Consumer Reports dated November 11, 2021, where they talk about Direct-to-Consumer Hearing Aids and Self-Fitting Hearing Aids, neither of which require a prescription or medical exam, but are still labeled as Hearing Aids:
https://www.consumerreports.org/hearing-aids/your-guide-to-h...
An example is the Bose SoundControl Hearing Aid that I know for a fact has been available for purchase without a prescription directly from Bose for many months (in the USA only).
It's true that a lot of people don't know about the Direct-to-Consumer and Self-Fitting Hearing Aids. But I don't understand what benefit comes from the new FDA rules that didn't already exist.
EDIT: It sounds like the FDA could be making it worse. Quoting from the Consumer Reports article above, it says, "FDA-Approved Over-the-Counter Hearing Aids could at first look like some of the Direct-to-Consumer options already available—but they will be subject to additional rules." Why would any manufacturer want to market with additional rules when they're already allowed to sell under the Direct-to-Consumer or Self-Fitting Hearing Aid rules?
On the federal level the FDA has required that buyers provide a medical assessment stating their need for a hearing aid. However, buyers older than 18 have been allowed to waive that requirement.
On the state level, many states have had prescription requirements. The FDA has ruled against such state laws several times but many laws have remained on the books. While in theory unenforceable, they have created a lot of FUD for prospective sellers.
The industry (audiologists and hearing aid manufacturers) has continuously reinforced the view that prescriptions are needed and in the buyers' interest.
Personally, I do think the new OTC regulations make the situation clearer and have the potential to improve products (assuming products become easier for users to configure themselves) and lower prices (as it's not only the audiologist's service buyers have paid for, but bundling of examination+device+followups has allowed higher pricing for the devices as well).
(See https://www.audiologypractices.org/state-laws-and-hearing-ai... and https://fda.report/media/75418/Regulatory-Requirements-for-H...)
https://www.bose.com/en_us/products/headphones/earbuds/sound...
The current expensive and very slow process getting a machine has some, but very little, to do with safety.
I don’t think the average layperson can be easily taught to understand airway pressures.
If the resolution to a steep learning curve is automation and I, then I posit an at-home suturing machine.
It's no different than setting the volume on your headphones to a comfortable level. And it is not some fiddly arcane art that requires a medical intervention.
Many of the defaults, at least for me, actually make it much harder. Like, my machine by default ramps up the pressure slowly... which I find quite uncomfortable... I am on the higher end of the pressure range.
I run in APAP mode, with a rather narrow range of 17-20. (20 is the most typical machines can run.. some bipaps can go up to 25). Anything below about 15 feels like I'm breathing through a straw.
Humidity setup is quite important as well, and often paradoxical (lower setting = effectively more humidity, as water capacity is limited and on higher settings pretty much all of the water is used in the first couple of hours).
Now, none of the professional people involved helped or guided me to any of that. My initial sleep stufy (in person, not home, this was ~7 years ago) came up with a static pressure of 13.5. That didn't work well at all, as stated above. That said, if I wasn't a techie, I doubt I'd have figured any of that out.
This is why such a large number of sleep studies are home studies now - it is cheaper to spend $200 more for APAP then pay for an overnight sleep study center
What we need is compression and equalization. Now. They can work on the fancy AI stuff later.
As a long time CPAP user, I'm fine with prescription requirements for the machines themselves.
What really annoys me is that accessories (like masks) also require a prescription.
Which is ridiculous on its face.
The settings are VERY straight-forward for anyone to program a machine, and online stores are already offering 50% off or more on the machines. The pain point is that online stores are required to get a prescription, even though the end user will need to manually configure the machine after receiving it.
I do agree that the accessories are annoying as heck. It really makes competition almost impossible, since trying to price compare medical suppliers is painful to say the least.
You're right, setting up a CPAP machine is pretty easy. The reason I think a prescription for the machines is worthwhile is for people newly diagnosed with Obstructive Sleep Apnea (OSA).
Because it's useful to actually interact with a medical professional not just to get a "prescription," but to confirm that the issue is actually OSA rather than some other issue that a CPAP sleep regimen won't address, as well as to identify other health issues that can impact overall health and sleep.
What you don't want is someone self-diagnosing themselves and not engaging a health care professional (in this case, a pulmonologist) and deciding they have OSA, buying a machine and its associated accoutrements and not actually having OSA -- rather something else that may be causing the issue -- perhaps something with a higher risk of serious illness or death.
All that said, once you have such a diagnosis, it's stupid to force folks to get new prescriptions to buy a new machine and incredibly stupid to require that for accessories like masks.
>I do agree that the accessories are annoying as heck. It really makes competition almost impossible, since trying to price compare medical suppliers is painful to say the least.
Another good point. I find that, for me, most masks are uncomfortable and leaky. Over the years (almost 20 now), I've found the accessories that work best for me. As such, I know what I want, so price checking is a bit simpler, but it's not something that has a lot of price sensitivity to me -- I'm more concerned with making sure I get what I actually want/need rather than some cheap knockoff.
Most people that need hearing aids that live near a Costco could already be saving thousands of dollars.
Are you expecting people to read this and think $700 sounds impressively affordable?
It's a huge racket.
An issue is that hearing aids may still need to be regulated. For instance, it's possible for them to have so much gain and power that they further damage your hearing.
I’ve had a hearing aid wire break. I showed up without an appointment at Costco for a regular shopping trip and the repair was done for free by the time I was ready to check out. Similarly when I’ve needed replace ear domes they did the replacement and a cleaning while I shopped or waited.
My previous hearing aid required batteries. They are dirt cheap there too. My current hearing aid is rechargeable so that is no longer an issue.
Not starving is also worth a lot, but that doesn't mean that a hamburger should cost $10,000.
/s
My issues seem to be cognitive in nature...I wonder how many people will encounter the same thing?
FDA Clears Path for Hearing Aids to Be Sold over the Counter - https://news.ycombinator.com/item?id=32482714 - Aug 2022 (15 comments)
Also:
Ask HN: Hearing Aid Industry Disruption - https://news.ycombinator.com/item?id=30536064 - March 2022 (3 comments)
Silencing the Competition: Inside the Fight Against the Hearing Aid Cartel - https://news.ycombinator.com/item?id=28946158 - Oct 2021 (4 comments)
The FDA wants you to be able to buy a hearing aid without a prescription - https://news.ycombinator.com/item?id=28921244 - Oct 2021 (448 comments)
Why Are Hearing Aids So Expensive? - https://news.ycombinator.com/item?id=15537513 - Oct 2017 (251 comments)
It's not clear what would happen if someone made drugs or devices and sold them with no claims whatsoever.
But it is the case that headphones _have_ been damaging hearing for a long time. The rise of MP3 players that could blast audio was a known cause of hearing loss even as it occurred.
Hearing loss is cumulative and the statistics are mind boggling. ~20% of people in their 20’s have hearing loss.
Most common hearing loss is age-related and the population is getting older.
Two other common causes are exposure to loud noises at work and infections. Work-related exposure is decreasing as fewer people work in heavy industry and hearing protection has become almost universal. Infections have also decreased with better hygiene and health care.
I don't know of evidence that loud music is actually causing hearing loss in young people.
There is great benefit to having strength on both sides of the political aisle. The pendulum swings back and forth, and sometimes we get benefits from the side opposite the one we are on. This appears to be such a case. Thanks to the admin for this.
They are a labeling agency. Ie they confirm and enforce something is what the manufacturer says it is.
That’s the level of consumer protections I want. If it says it’s heroine that’s good, don’t want fentanyl laced heroine.
Why did the FOOD AND DRUG ADMINISTRATION ever keep HEARING aids off the open market?
Im so happy SCOTUS started using the major questions doctrine. Hopefully this can fix some of this stuff
https://eelp.law.harvard.edu/2022/07/supreme-court-embraces-...
Remove the executive authority to regulate hearing devices, eye glasses, prosthetics, etc. I’m fine with a stamp of approval, but not banning sales.
Companies can already sell what is effectively a hearing aid[1] without FDA approval. They just can't market it as such.
There's already too much quackery in the world today, we shouldn't be inviting more of it.
[1] https://www.amazon.co.uk/Bose-Hearphones-Conversation-Enhanc...
What about costs and benefits, too?
Yes. To the extent that there are regulatory gaps today, they're almost exclusively filled with quack medicines.
I'm sure the market might work it out in the long-run, but in the meantime people will suffer from inadequate (or even detrimental) medical care.
You seem to accept this logic for drugs, but quack mechanical devices can cause harm as well. For instance, an inappropriate hearing aid could hasten hearing loss.
> What about costs and benefits, too?
We should definitely work to improve the regulatory process, but just giving up on the whole concept of regulation seems counterproductive.
Who suggested that?
The original comments suggestion was to improve the regulatory process to the following ideal:
> They are a labeling agency. Ie they confirm and enforce something is what the manufacturer says it is.
> That’s the level of consumer protections I want. If it says it’s heroine that’s good, don’t want fentanyl laced heroine.
As already demonstrated, Bose was able to sell what was effectively a hearing aid in this new category, but without making any claims about assisting with hearing loss.
I guess what you're suggesting is that manufacturers should be able to make any claims they please with the FDA being relegated to a position of endorsing those claims.
Nothing that has happened in the past few years has given me any confidence that such a system would work (see: Ivermectin, Hydroxychloroquine, Bleach, intravenous UV light, Chelation, et al.).
> If we simply went back to pre-1962 law, the FDA could still require proof of safety, but would not be able to require evidence on efficacy. This one change would allow drugs to be developed faster–often as much as 10 years faster. Market success would establish efficacy. Could there be ineffective drugs? Sure. But as doctors and patients learn, such drugs would disappear over time. This is nothing new; doctors and patients regularly evaluate drugs for efficacy. Clinical trials often show that perhaps only 20 percent, 40 percent, or 60 percent of patients benefit. Even when the FDA finally approves the drug as “safe and efficacious,” doctors must still evaluate the drug to find out how efficacious it is for each particular patient. In practice, an FDA certification of efficacy is just a starting point.
Btw Ivermectin is FDA approved. I am not sure why you bring that up?
In the meantime, patients will be switching from drugs with known efficacy to wonder drugs with potentially no clinical evidence of having a medicinal effect.
> Could there be ineffective drugs? Sure. But as doctors and patients learn, such drugs would disappear over time.
Trying to do that piece meal won't work. You need controlled statistical studies to establish such things.
> doctors must still evaluate the drug to find out how efficacious it is for each particular patient.
Generally informed by subsequent clinical trials. They don't just go with their gut.
> Btw Ivermectin is FDA approved. I am not sure why you bring that up?
You know very well why. In fact it kind of makes my point. Patients are attempting to switch from a treatment regime with known efficacy (vaccines) to one with highly questionable efficacy (Ivermectin). If you follow through with your plans to deregulate the pharmaceuticals industry, you'll see a lot more of that.
If you want less regulation in this space, that's a change in the law that needs to go through Congress. Which is exactly what happened here for hearing aids.
Instead of some fent analogue cooked up in a chinese lab, this knockoff would be cooked up in a chinese lowest cost, cheating encouraged (if you don't get caught), grab parts from wherever, alibaba store room.
We do need to evaluate trade offs between danger, effectiveness, quality control, and price.
IMHO so long as the hearing device won't cause further damage this is a great move and should be treated like OTC glasses.
--
As to SCOTUS rulings, see below about this specific mandate by law.
However both parties have ceded massive authority to the executive over the last two decades (accelerating with Cheney).
Feels like that is a big part of the problem here.
Regardless, I don't think SCOTUS is making the right rulings on a ton of things, including EPA specifically per your example. Everything under the sun shouldn't have to be enumerated. we have to look holistically and allow the executive to adapt as dangers and circumstances change.
Executive should be allowed to use the powers Congress has given and often been purposefully ambiguous about (see 9/11 security state).
Biden: "This action makes good on my commitment to lower costs for American families, delivering nearly $3,000 in savings to American families for a pair of hearing aids and giving people more choices to improve their health and well-being."
However, this is really due to the Over-the-Counter Hearing Aid Act that was signed into law in 2017 by President Trump.
There would be no shame in Biden praising an action made by Trump or in Trump praising an action made by Obama.
Congress passed that proposal at the time, but the Trump administration FDA didn't issue the rules that would actually allow for those devices to be sold directly to consumers. It's being implemented now because of the July 2021 "Executive Order on Promoting Competition in the American Economy," in which Biden called on the FDA to take action on over-the-counter hearing aids within 120 days (among a variety of other provisions).
https://obamawhitehouse.archives.gov/blog/2016/12/07/fda-tak...
We'll have to wait and see if Biden's FDA will take substantive action.
If he had cited what Obama did and took credit for that, or what Warren did and took credit for that, you'd have a point.
The only thing Biden cited having doing is the EO. You left that part out of your quote, but that's the only thing he cited having done on this. Thankfully, he got this done finally!
Obviously, it was about this issue. I was commenting and discussing on this very issue.