I saw a little blurb in an AARP magazine about a new law approving over the counter hearing aids, purchasable with no audiologist's prescription. I hadn't heard of this before so after the recent threads on building your own hearing aids I just wanted to pass it on. Apparently in 2017 a law was passed that would eventually make OTC hearing aids legal, once the FDA gets around to creating the appropriate regulations. That article was about the fact that these were once again delayed, (sigh, naturally :-)) with the new FDA target November 2019 (or later). Anyway, for more details here's a link:
I'm concerned about *over-the-counter* hearing aids. While I recognize that prescribed aids are high cost, not covered by health plans, and even less- expensive models might have enough usability and smarts (?) to learn what t he person with mild-loss needs -- they really are medical devices. They nee d prescribed by an expert IMHO. That's the reason for the high price - long
-term expert support. The training period is lengthy (not the instant grati fication that most people expect). Even with audiological support, the rete ntion rate is already low (though maybe that's improved over the years?). Ready access to OTC HAs or PSAs that dissatisfy may lead the wearer to give up on audiologically-fitted HA.
As someone that is profoundly deaf in one ear and severely deaf in the other, I would like to emphasise the validity of those comments.
Fortunately we still have the NHS (or will until a post-brexit trade agreement with Trump destroys it[1]). That means my hearing aids are free, with the exception that if I damage them through negligence,
[1] not an exaggeration. That was an explicit statement from US officials interviewed during the recent state visit.
However, it was noted that true to form Resident Chump said exactly the same one day and the opposite the next. Yet another an illustration that "orange man speaks with forked tongue".
Yep. However, I really doubt that a person programming a hearing aid could inflict harm or injury on the hearing aid user. Whom are you protecting by not allowing hearing aid users to program their own devices? (This is beginning to sound like a version of Right to Repair).
They need *what* prescribed by an expert? Programming? I'm not even close to being an expert, but have programmed a few hearing aids: "Hearing-aid hackers fine-tuning their own devices" One needs are programming cables, adapters, fitting software, some documentation, and a basic knowledge of the process. Hearing tests results are needed to establish a starting point, but the real fine tuning is done by trial and error over a period of time.
"Bose self-fitting hearing aid gets FDA approval" ...an estimated 86% of people who would benefit from hearing aids do not get them, primarily because of cost
Allowing these people to purchase hearing aids at reduced costs is sufficient justification for over the counter hearing aids and user programming: Patients also preferred the hearing aid settings they selected themselves over those chosen by a healthcare professional, FDA said.
That might suggest the experts are not doing an adequate job of programming. However, I suspect they probably are doing an adequate job, but when every subsequent tweak requires a substantial payment to the expert audiologist, it's unlikely that users will use trial and error to optimize the programming. Users will probably accept the first miserable attempt at programming, while the audiologist assumes that the lack of subsequent complaints demonstrates his superior talents at programming.
Do you really think that tweaking an existing hearing aid requires long term support from an expert? I don't. Teach the user how to tweak their own device and the need for long term expert support disappears.
Training? I read a few web pages and watched some YouTube videos: I had to learn a few audiology buzzwords and practice on a sacrificial hearing aid (Learn by Destroying). Not a big deal.
What do you mean by retention rate? Retention of what?
That might be the plan. Perhaps hearing aid buyers are getting tired of paying $2,500 for each device and the associated expert support?
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An attempt to protect people from themselves when there is no harm involved is just being patronising.
I suspect people are getting tired of having to pay $$$$. Surely it should be each person's choice. Freedom where there is no risk of harm is a good thing is it not? Why would someone want to take that away, other than to steam money out of people?
There is absolutely no doubt whatsoever that they could inflict further damage on a user's hearing. **Period*.
The mechanism is simple: with severe deafness the amplification is sufficient to get the sound to dangerous levels: - compression is mandatory, and if the maximum level is set too high then hairs in the cochlea will be knocked off. - if the hearing aid is improperly equalised for the user's canal, then there will be audio feedback that can be heard on the other side of the *room*
That's a completely separate (and valid) issue; do not conflate the two.
It is indeed clear you are not an expert.
That was from 7 years ago. Hearing aid technology is advancing fast; even 4 years makes a noticeable difference.
There are many people that self-treat, sometimes disastrously. Start by looking up "black salve", but there are many other "trearments" used by people who can't afford treatment, are wrongly convinced they have a problem, use phrases such as "MSM", "fake media", "conspiracy", or are just mentally ill.
Hearing aids usually come with several "programmes" that the user can select as the ambient conditions change.
Only in the USA.
That's a fault of the medical industry, not a technical issue. Fortunately I don't have that problem - I can return when I wish. In fact last time I went in to get a part, the audiologists noticed they hadn't tested my hearing for over
3 years, suggested I have a retest, and then issued better aids.
You show your ignorance.
I've watched (and listened!) to the process of measurement and /both/ forms of equalisation - one to attempt to get the bode plots right for varying amplitude (yes), the other to compensate for the shape of my ear canal.
You probably have Dunning-Kruger syndrome in this area.
I don't pay for them.
You need a humane medical system, not one that is in the pocket of large corporations.
Do you not think that over the counter products are legally required to not cause damage? And thus the OTC ones will be limited to prevent damage?
Of course. There are also treatments outside of the main system that work w ell & get used by people to solve their problems. Only someone that hasn't looked into it or is a fool would conclude otherwise. I'm alive today becau se of that, so I'm never going to buy into the silly idea that only a docto r can effectively treat disease.
And fwiw, mentally ill people need healthcare too. And most are capable of self treating in some or many areas. I don't see hearing deficiencies as be ing an area where mental health issues would normally be a barrier to self treatment.
At the risk of stating the obvious, do you not think some people have simpl er conditions that are easily addressed by setting things themselves? I'm s ure you're not one of them, obviously that does not put everyone else in th e same boat. My hearing is not perfect, and the tweaking required to make i t good is trivial. Only a moron would be unable to do it.
Since he has succeeded in his mission, his position is demonstrated to be c orrect. Not everyone is in your position.
I fully agree. I'll wager there's a professional group here lobbying against any relaxation of the laws simply to protect their own self- interest. And if that means thousands of deaf people who can't afford aids have to go without, well that's just their tough shit.
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Harm? yes. I am concerned about damaging SPL levels (>85 dB-SPL). I had mea sured some HAs that could produce 140dB peaks (to suit users with profound loss). An uninformed customer might buy the wrong aid, and crank it up,... A properly-fitted HA should have peak & average level limiting, expertly se t to the user's upper-comfort level (UCL). Determining the UCL usually requ ires an audiological exam. The LCL or lowest-comfortable listening level ma y also be relevant.
I admit I'm not up to date on the latest fitting (programming) systems. I r ecall that each manufacturer had their own to suit their particular digital models (and to adhere the fitter into using their brand). And they require d proper training to use. The various parameters would be outside the realm of average patient.
We engineers are NOT the typical patient! :-)
No doubt the range of audiological expertise varies from state to state. So me states in the U.S. do not require a degreed audiologist to fit HAs. Pass ing a short training course will do.
HA wearers have an adaptation period; they must get used to simply having a n HA. Past that, each further tweak requires time to know if it was better or worse. Usually an audiologist has them sit in a sound-proof booth and li sten to various sounds to assess the benefit of the tweak.
The wearer retaining the use of the HA -- else, giving up, putting it away in a drawer...
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at prescribed aids are high cost, not covered by health plans, and even les s-expensive models might have enough usability and smarts (?) to learn what the person with mild-loss needs -- they really are medical devices. They n eed prescribed by an expert IMHO. That's the reason for the high price - lo ng-term expert support. The training period is lengthy (not the instant gra tification that most people expect). Even with audiological support, the re tention rate is already low (though maybe that's improved over the years?). Ready access to OTC HAs or PSAs that dissatisfy may lead the wearer to gi ve up on audiologically-fitted HA.
Typical lib thinking. People are too stupid to be able to buy a low cost, OTC hearing aid and figure out if it works for them or not. Conservatives believe people should be free to choose and they don't need libs controlling them. Take away their salt shakers too.
that prescribed aids are high cost, not covered by health plans, and even l ess-expensive models might have enough usability and smarts (?) to learn wh at the person with mild-loss needs -- they really are medical devices. They need prescribed by an expert IMHO. That's the reason for the high price - long-term expert support. The training period is lengthy (not the instant g ratification that most people expect). Even with audiological support, the retention rate is already low (though maybe that's improved over the years? ). Ready access to OTC HAs or PSAs that dissatisfy may lead the wearer to give up on audiologically-fitted HA.
I wouldn't say "too stupid" but unaware of the potential harm. Hearing dama ge is generally irreversible. Pickng the wrong HA could be that bad. Unlike picking the wrong eyeglasses, the wrong arch support, etc.
You're right - it's possible an OTC has suitable limiting. It's even possib le that an "intelligent", sophisticated, hi-tech HA plus smartphone app cou ld be made that carefully evaluates the user needs and programs the HAs. Th at kind of device wouldn't be as cheap as simple PSA (personal sound amplif iers) - but maybe cheaper than the full-blown audiologically-fitted pair of HAs. If these high-tech HAs exist, I'd like to see the research to see if that had any better long-term success than human-expert fit.
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Pity life, and electronics quality, isn't as simple as some people think:
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So, sure you can buy hearing aids privately and save money, much like you can buy electronic components and aircraft parts on eBay or Amazon - does that mean you can TRUST them with your hearing or your childrens hearing?
My guess is the people who want to save a buck will do so. They are the deer in the headlights when something goes wrong...and they will want to blame the government for any problems that arise - after asking the government to reduce regulations to save on taxes and costs!
that prescribed aids are high cost, not covered by health plans, and even less-expensive models might have enough usability and smarts (?) to learn w hat the person with mild-loss needs -- they really are medical devices. The y need prescribed by an expert IMHO. That's the reason for the high price - long-term expert support. The training period is lengthy (not the instant gratification that most people expect). Even with audiological support, the retention rate is already low (though maybe that's improved over the years ?). Ready access to OTC HAs or PSAs that dissatisfy may lead the wearer to give up on audiologically-fitted HA.
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If you don't want to trust them, then don't. But what gives you the right to tell the rest of us that we can't try them if we want to? Leave us free to choose.
I don't have the right to tell you to do anything, just like you don't have the right to tell me either. We elect governments to do that sort of thing. Rights are a legal fiction drawn up by humans to (in the best of times) make things work smoother between us. Rights allow us to make assumptions about treatment of people by their government and by other people around them and when those rights are broken people have the right to go to court or speak to their lawmaker about changing things.
Do you agree with seat belt laws? How about food inspection? How about regulations regarding the purity of drugs and alcohol etc that we consume or use? Should they be enforced or should all companies simply decide what is their best practice for producing food your family eats? I'm sure that will turn out well...for the company's shareholders. Unless they eat the same products that the company makes
What about medical devices? Should pacemakers meet some sort of standard? What about hearing aids? If incorrectly installed in children they can lead to permanent deafness? Do you see this as a problem or should parent be free to save a few bucks and harm their children through ignorance? Not everyone researches products they use, as there is a certain assumption in our society that anything sold is safe because the gov. wouldn't let them sell it if it wasn't - would they?
All I'm asking is to consider that regulations may have a bearing on the matter and if over-the-counter hearing aids are sold that they should meet some sort of standard and there should be a way to verify they meet that standard.
I'm sure you are aware of friends who have harmed their hearing through too much loud noise or music, why make things worse by buying a cheaper hearing aid that potentially finishes the job of going deaf if incorrectly used?
I agree that hearing aids appear to be a rip-off, but a bit of research shows me that they simply aren't as simple as adding a microphone to an amplifier and stuffing an earbud in ones ear...
Why are they not covered by US health plans? You pay on average about twice what anyone else in the civilised world pays for healthcare.
You have to ensure that the device cannot cause harm though. Hearing damage due to over loud sounds is generally permanent and irreversible.
In the US? - you have to be kidding. EPA has been totally emasculated by Trump and they have only recently woken up to dodgy heavy metal based pigments on cheap childrens' toys on sale on Amazon (and elsewhere).
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They have to be a bit smarter than that. And I can see that like with reading glasses there are a class of people for whom simple off the shelf devices may be appropriate. The problem is that for optimum behaviour you basically need exact fit ear moulded inserts to avoid howl round and the resulting system fine tuned to the users ear canal frequency response. I expect some of those here could DIY it themselves.
ze that prescribed aids are high cost, not covered by health plans, and eve n less-expensive models might have enough usability and smarts (?) to learn what the person with mild-loss needs -- they really are medical devices. T hey need prescribed by an expert IMHO. That's the reason for the high price - long-term expert support. The training period is lengthy (not the instan t gratification that most people expect). Even with audiological support, t he retention rate is already low (though maybe that's improved over the yea rs?). Ready access to OTC HAs or PSAs that dissatisfy may lead the wearer to give up on audiologically-fitted HA.
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Yes and libs LOVE to try to control anything they can. Now it's hearing aids.
Rights are a legal fiction drawn up by humans to (in the best
Not all of them, no. If someone doesn't want to wear one, that's their right and it shouldn't be illegal.
Like I said, just regulate them so that they can't produce power levels that are HARMFUL. That sure appears the direction we were headed, but here you are objecting......
nize that prescribed aids are high cost, not covered by health plans, and e ven less-expensive models might have enough usability and smarts (?) to lea rn what the person with mild-loss needs -- they really are medical devices. They need prescribed by an expert IMHO. That's the reason for the high pri ce - long-term expert support. The training period is lengthy (not the inst ant gratification that most people expect). Even with audiological support, the retention rate is already low (though maybe that's improved over the y ears?). Ready access to OTC HAs or PSAs that dissatisfy may lead the weare r to give up on audiologically-fitted HA.
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NOW??? Haven't they been considered medical devices for some time now?
If I cause an accident and someone is injured severely because they weren't wearing a seat belt, should I be responsible for their injuries? How woul d it be determined that the injuries were largely because of not wearing a seat belt or would have happened anyway?
d?
I believe that is one of the justifications of making them medical devices. Medical devices have to be designed to not harm people if it can be preve nted.
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So, sure you can buy hearing aids privately and save money, much like
OTOH there seem to be plenty of them for sale on Amazon:
USA:
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UK:
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In a strange quirk of search engines several of the UK images show a US dime for scale (which means nothing to most UK residents).
Fair enough but it should also void their entitlement to anything other than life saving surgery. A guy not wearing a seat belt was garrotted by a laminated windscreen in a high speed crash at the end of our road.
Usually because they go through the windscreen or fall out of a rolling car and get smashed to pieces. It isn't nice for the clean up team.
Also US airbags are designed with enough charge to kill teenagers and women so that they can stop the fat slobs who CBA to wear a seat belt.
There are plenty available to buy in the US and UK. They use other phrases to get around the law apparently judging by the adverts.
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