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BumRushDaShow

(129,064 posts)
Tue Aug 16, 2022, 10:14 AM Aug 2022

F.D.A. Clears Path for Hearing Aids to be Sold Over the Counter

Source: New York Times

The Food and Drug Administration moved on Tuesday to make hearing aids available over the counter and without a prescription to adults, a long-sought wish of consumers frustrated by expensive exams and devices. As soon as mid-October, people with mild to moderate hearing loss should be able to buy hearing aids online and in retail stores, without being required to see a doctor for an exam to get a prescription.

The F.D.A. cited studies estimating that about 30 million Americans experience hearing loss, but only about one-fifth of them get help. The changes could upend the market, which is dominated by a relatively small number of manufacturers, and make it a broader field with less costly, and perhaps, more innovative designs. Current costs for hearing aids, which tend to include visits with an audiologist, range from about $1,400 at Costco to roughly $4,700 elsewhere.

“This could fundamentally change technology,” said Nicholas Reed, an audiologist at the Department of Epidemiology at Johns Hopkins Bloomberg School of Public Health. “We don’t know what these companies might come up with. We may literally see new ways hearing aids work, how they look.” The F.D.A.’s final rule takes effect in 60 days. Industry representatives say device makers are largely ready to launch new products, though some may need time to update labeling and packaging or to comply with technical details in the rule.

Dr. Robert Califf, the F.D.A. commissioner, tweeted Tuesday that the rule tackles a “critical public health issue” that affects millions. Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective and affordable hearing aids from their neighborhood store or online,” he said. Hearing loss is associated with cognitive decline, depression, isolation and other health problems in older adults. Yet the barriers to getting hearing help have included costs that are not covered by Medicare. There is also stigma — such as appearing “old” — that comes with use.

Read more: https://www.nytimes.com/2022/08/16/health/fda-hearing-aids.html



No paywall link

If you already have people using "ear buds" then.... Just have to be very careful with the schlock manufacturers.
45 replies = new reply since forum marked as read
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F.D.A. Clears Path for Hearing Aids to be Sold Over the Counter (Original Post) BumRushDaShow Aug 2022 OP
Celebrate good times come on! Ponietz Aug 2022 #1
I see what you did there!!! hamsterjill Aug 2022 #36
Thanks! So much good news in the past several weeks Ponietz Aug 2022 #38
This message was self-deleted by its author Ponietz Aug 2022 #37
eh, what you say? JohnSJ Aug 2022 #2
🤣 Heather MC Aug 2022 #20
Excellent news. Now allow birth control pills to be sold over the counter as well. Lonestarblue Aug 2022 #3
I have Rebl2 Aug 2022 #9
Birth Control pills can be very dangerous forthemiddle Aug 2022 #13
I see nothing in any copy of the Constitution saying that The Mouth Aug 2022 #26
the tech is already out there. my youngest mopinko Aug 2022 #4
Hopefully I will be able to mail order one from Australia. Aussie105 Aug 2022 #5
This is good. Getting tired of being accused by my husband Wingus Dingus Aug 2022 #6
Awesome news, now let's get it for CPAP-type devices Hugh_Lebowski Aug 2022 #7
rent a $300 machine for $800/month Kali Aug 2022 #11
The VA gave me a ResMed AirCurve 10 bilevel CPAP. Dysfunctional Aug 2022 #30
There are machines that can self-calibrate via sensors and don't require outside monitoring Hugh_Lebowski Aug 2022 #32
It is indeed inspiring to learn that humans have finally learned to amplify sound electronically Otto_Harper Aug 2022 #8
+1 well said ... from a fellow ironic/sarcastic SOB ;) (nt) Hugh_Lebowski Aug 2022 #33
A big Thank You to Elizabeth Warren! rurallib Aug 2022 #10
Not many cases of prescription hearing aid abuse IronLionZion Aug 2022 #12
Interesting, but.. k0rs Aug 2022 #14
Well the ENT doctors and audiologists have fought this move with that reasoning BumRushDaShow Aug 2022 #17
+1 Auggie Aug 2022 #22
The tech is here; it's been a medical/legal problem. BadgerKid Aug 2022 #23
My $150 apple air pods pro far surpasses my $4,500 Resounds. LiberalArkie Aug 2022 #24
I have one hearing aid and a cochlear implant. Old Crank Aug 2022 #27
The iPhone accepts an audiogram for the air pods pro so it has a good frequency response. LiberalArkie Aug 2022 #28
I've just been tested. Quite deaf in right ear, a little in left duhneece Aug 2022 #39
I was quite surprised at the air pods pro. I was using them for music in the gym instead of the LiberalArkie Aug 2022 #40
I'm going to give them a try duhneece Aug 2022 #42
I recall getting my hearing aids. She put some reading material into a paper sac for me to riversedge Aug 2022 #41
It is those little things that I had never heard even as a child. LiberalArkie Aug 2022 #44
New ones on order now Bayard Aug 2022 #15
With an iPhone and the air pods pro, you can install an audiologists chart into the iPhone LiberalArkie Aug 2022 #25
I'm all for this Jilly_in_VA Aug 2022 #16
Elizabeth Warren and the Democratic party, getting things done. sarcasmo Aug 2022 #18
Been waiting for this ever since I had to get my own hearing-aids. sdfernando Aug 2022 #19
People have all kinds of tech hanging from their ears. TeamProg Aug 2022 #21
The relationship between hearing loss and dementia... littlemissmartypants Aug 2022 #29
THIS is my biggest motivation duhneece Aug 2022 #43
Over the counter aides will be legal very soon with the IRA. I'd wait a bit longer. ❤ littlemissmartypants Aug 2022 #45
Without a hearing test, how can the hearing aids be set to the right frequencies? Dysfunctional Aug 2022 #31
I blew out my left eardrum at a young age Aussie105 Aug 2022 #34
Heard this on the radio yesterday as I was driving and I think it's great news luv2fly Aug 2022 #35

Ponietz

(2,974 posts)
38. Thanks! So much good news in the past several weeks
Wed Aug 17, 2022, 09:11 AM
Aug 2022

after such a long drought is making me hopeful. Even spam calls are are almost gone. I’m very surprised and impressed with what the President and Congress have accomplished in an era of unprecedented threat. We can’t fully celebrate until he’s arrested.

Response to Ponietz (Reply #1)

Lonestarblue

(10,010 posts)
3. Excellent news. Now allow birth control pills to be sold over the counter as well.
Tue Aug 16, 2022, 10:18 AM
Aug 2022

There is only one reason for such a safe product to be prescription only—religious objections. The FDA should not be ruled by religion.

Rebl2

(13,516 posts)
9. I have
Tue Aug 16, 2022, 10:42 AM
Aug 2022

to disagree. There are women who should not be taking them, in particular those with uncontrolled high blood pressure. Those with a history of blood clots are another group that comes to mind.

forthemiddle

(1,379 posts)
13. Birth Control pills can be very dangerous
Tue Aug 16, 2022, 11:20 AM
Aug 2022

A major problem with BC pills is that they are associated with blood clots. Without a very detailed history they should not be used.
I am in favor of giving Pharmacists the ability to prescribe them, but they should never be put over the counter.

The Mouth

(3,150 posts)
26. I see nothing in any copy of the Constitution saying that
Tue Aug 16, 2022, 03:04 PM
Aug 2022

the government has any say over what goes in, or on, my body.

mopinko

(70,113 posts)
4. the tech is already out there. my youngest
Tue Aug 16, 2022, 10:20 AM
Aug 2022

has sensory overload issues, and she has buds that filter out certain frequencies and high volumes. they're weird, a series of little concentric cones.
you can adjust volume and control what you hear. hearing aids in all but name.

i dont remember what they cost, but i think about $200.

Aussie105

(5,401 posts)
5. Hopefully I will be able to mail order one from Australia.
Tue Aug 16, 2022, 10:21 AM
Aug 2022

Local prices for testing and buying a good device are horrendous.

Wingus Dingus

(8,054 posts)
6. This is good. Getting tired of being accused by my husband
Tue Aug 16, 2022, 10:30 AM
Aug 2022

of "mumbling". The fact that he spent nearly four decades surrounded by guitars, drums and amplifiers loud enough to blow your hair back doesn't seem to occur to him.

 

Hugh_Lebowski

(33,643 posts)
7. Awesome news, now let's get it for CPAP-type devices
Tue Aug 16, 2022, 10:32 AM
Aug 2022

Another ridiculous scam requiring expensive, non-covered (or mostly non-covered) assessments and sleep tests and other BS like locked-down machines set to the pressure the people who did the sleep test 'say is right'. And the machines cost way more than they should for what they are.

The machines can basically self-calibrate these days and there's not really any harm to using one even if you don't technically need it.

The whole system (which I just went through, again) is a racket, big-time.

Kali

(55,011 posts)
11. rent a $300 machine for $800/month
Tue Aug 16, 2022, 10:57 AM
Aug 2022

it was covered, but I was shocked by the scamming. I don't want to do the insurance companies' job for them but holy shit.

 

Dysfunctional

(452 posts)
30. The VA gave me a ResMed AirCurve 10 bilevel CPAP.
Tue Aug 16, 2022, 07:43 PM
Aug 2022

They monitor it and make adjustments to it as needed. I would not want to have one without the sleep test and the monitoring of the system. If not monitored and levels changed, the machine can cause more harm than not using it.

 

Hugh_Lebowski

(33,643 posts)
32. There are machines that can self-calibrate via sensors and don't require outside monitoring
Tue Aug 16, 2022, 07:51 PM
Aug 2022

And what exactly is this harm you speak of?

Let me also add ... if your machine suddenly dies, and you've been using it for YEARS (as I had happen to me), if you're NOT in something like the VA, you can literally end up going WEEKS without able to sleep properly (they are, admittedly, addictive in a certain sense) while you go through all the insurance company BS (unless you have a $800+ laying around, which I fortunately did, and hence bought my new one using my old Rx from cpap.com ... after dealing with all kinds of crap with UHC, and flaky-ass providers).

If you're in the 'right system', like the VA, it's probably not that big a deal.

Private insurance, esp. for low-income folks, though? It can be a HUGE hassle if your equipment fails on you, esp. if it's been a long while since your last sleep test.

Otto_Harper

(509 posts)
8. It is indeed inspiring to learn that humans have finally learned to amplify sound electronically
Tue Aug 16, 2022, 10:39 AM
Aug 2022

Why, I will bet you that now that the Gubmint says its OK to buy a device capable of amplifying sound and conveying it to the ear, there are myriad new and marvelous devices that we may see. Such as a little box which stores music and plays it on demand through tiny earphones worn by the user. Or, perhaps, some sort of long range communication devices, perhaps also including a camera, clock and supercomputer which would allow the wearer to reach out and communicate to anyone around the world.

Or, greater still, using that supercomputer to perform better processing and delivery of sound to the wearer than the $4000 rip-offs were ever capable of.

This is not some benificent easing of procrustean restrictions for the good of all, but rather, an attempt to somehow get ahead of the obsoleting of the phony-baloney technology which could no longer be kept in the possession of the anointed few corporations with a government permit to dispense sound amplification to the masses.


(Full disclosure: Have been using, building and designing devices that can electronically amplify sound for the past 50+ years)

IronLionZion

(45,447 posts)
12. Not many cases of prescription hearing aid abuse
Tue Aug 16, 2022, 10:59 AM
Aug 2022

I don't know anyone who is robbing people to support a hearing aid addiction.

k0rs

(72 posts)
14. Interesting, but..
Tue Aug 16, 2022, 11:42 AM
Aug 2022

..I wonder how user acquired hearing aids will be programmed correctly? Modern hearing aids can be adjusted to boost frequencies in which the user is deficient. This requires an accurate hearing test to determine how the hearing aids can best be programmed to suit the individual user. Newer models can be adjusted by Bluetooth link to a cell phone, which is convenient, but still requires knowledge to do correctly. Good hearing aids aren't simply audio amplifiers that boost all sounds equally. They are very sophisticated devices which can even block unwanted noises. These concerns may be able to be addressed by manufacturers and new regulation could conceivably bring costs down considerably. It will be be interesting to watch the technology develop. As a hearing aid user, I'm excited at the possibilities.

BumRushDaShow

(129,064 posts)
17. Well the ENT doctors and audiologists have fought this move with that reasoning
Tue Aug 16, 2022, 12:11 PM
Aug 2022

But I think that it ends up becoming a risk/benefit/cost factor for those who don't have any known disease-caused hearing loss. I.e., their loss may have been due to their work environment (notably construction/manufacturing/landscape maintenance when there was a lack of protection or lack of use of it or for certain concert musicians/staff who had extended exposure to speaker systems run at excessive volume, etc).

For many, just simple "amplification" is enough to make a quality of life improvement, particularly if one is a senior who doesn't have the funds to shell out for specialists and exotic hearing devices when they are rarely if ever covered by insurance.

The same type of thing is already in place for "reading glasses", which are basically just magnifying lenses in eyeglass frames.

If you had people "making due" with stuff like this for centuries -



then why not?

BadgerKid

(4,553 posts)
23. The tech is here; it's been a medical/legal problem.
Tue Aug 16, 2022, 01:09 PM
Aug 2022

Software equalization is a known technology, as well as noise cancellation with headphones and earbuds.

We need equalization in all contexts, not just music playback.

LiberalArkie

(15,716 posts)
24. My $150 apple air pods pro far surpasses my $4,500 Resounds.
Tue Aug 16, 2022, 01:25 PM
Aug 2022

That is really all I have to say as someone who needed hearing aids when I was 5, back in the 1950's. But being from a working class family, it was very far out of reach. We could not afford glasses until I was in the 1st grade when the school said I had to have them.

I bought the Resounds when I retired at 65 and cashes my little 401K to get them. They were fantastic. But I never realized how much noise my dog made walking across the floor. tap tap tap of his toe nails. Never heard that before. Never heard squirrels moving through the trees. Never heard tree frogs.

Batteries cost a lot though.

The air pos pro in just "transparency mode" Are so much better than my Resounds.

A lot of people are going to enjoy life a lot more.

PS: After I put my Resounds in my ear, I brushed my hand across my jeans and there was a swooshing sound. I asked the audiologist if she heard that and she smiled and said yes.

Old Crank

(3,589 posts)
27. I have one hearing aid and a cochlear implant.
Tue Aug 16, 2022, 04:05 PM
Aug 2022

The hearing aid seems to be transparent but when the battery goes dead it is worse because I have a plug molded to by ear canal.
Having it tuned to my frequency needs really helps. I would imagine that some smart phone people could set up a program that would allow you to boost different frequency ranges through Wifi to the aid.

The implant is a whole different animal. Since to get hearing on that side from a hearing aid I needed to hit bone conductive sound levels. That ear is 80-100 db down.

Some times I like not hearing the world around me though. I like the peace and quiet without the appliances.

Good luck with yours.


LiberalArkie

(15,716 posts)
28. The iPhone accepts an audiogram for the air pods pro so it has a good frequency response.
Tue Aug 16, 2022, 04:27 PM
Aug 2022

The Resound does not do bass at all only the upper mid and high frequencies. It relies on bass to just pass through.

At my age I like to hear the bass also, I guess that is why the Apples work better as they seal the ear.. The noise cancellation works great also like that.

duhneece

(4,113 posts)
39. I've just been tested. Quite deaf in right ear, a little in left
Wed Aug 17, 2022, 09:23 AM
Aug 2022

But we’re going-in-the-hole broke so I haven’t gone back for recommendations.
I’ll be checking out your suggestion

LiberalArkie

(15,716 posts)
40. I was quite surprised at the air pods pro. I was using them for music in the gym instead of the
Wed Aug 17, 2022, 09:49 AM
Aug 2022

Resounds as the price of the batteries in the hearing aide were getting expensive. I read on a tech site about this thing called "transparency mode". The place on the iPhone settings even had a place where I could input the audiogram from the audiologist.

The sweet thing is that when I take off the face mask, my Resound hearing aides go flying, the Air Pods do not. They just stay put.

The hearing aides will stream from the phone, but only the hearing part. You have to hold the phone up to your mouth to talek to someone on the phone. The air pod pros are all in one.

I have several friends who just have one in their ear and later in the day when the battery gets low, they take it out and put it in the case to recharge and put the one in the other ear.

It is a very good system. The case will charge the air pods in your pocket so there is no reason to run out of charge in a day.

The Hearing aides will go several days on a cell running as just hearing aids, but run out of juice in a day if you stream audio to it.

Amazon has the air pods pro for $179 right now.. Only the pro models have the transparency mode

riversedge

(70,239 posts)
41. I recall getting my hearing aids. She put some reading material into a paper sac for me to
Wed Aug 17, 2022, 10:52 AM
Aug 2022

read when I got home. I was somewhat taken back by the rustle of the paper sac. I told her--I can hear you put those papers in the sack. She said--well good. and smiled. Then when I was in the car, I moved out into the road and put by blinkers on--my god, I had not heard my blinkers in years.



I am quite happy with mine at this time.

LiberalArkie

(15,716 posts)
44. It is those little things that I had never heard even as a child.
Wed Aug 17, 2022, 04:10 PM
Aug 2022

I am what I call "neurologically spicy". Aspergers, pretty hard of hearing since birth - First hearing aides at 65 (or so). Pretty near sighted and first glasses in or before 1st grade. Dyslexic - But read and spell correctly on a keyboard and computer. Just fail at reading and writing on paper. Go figure.

Bayard

(22,075 posts)
15. New ones on order now
Tue Aug 16, 2022, 11:50 AM
Aug 2022

5K+, not covered by insurance, from the most well-known company in the biz. That's the trick--is getting ones that don't just amplify all sound.

LiberalArkie

(15,716 posts)
25. With an iPhone and the air pods pro, you can install an audiologists chart into the iPhone
Tue Aug 16, 2022, 01:29 PM
Aug 2022

and it will tailor the air pods for it

Jilly_in_VA

(9,979 posts)
16. I'm all for this
Tue Aug 16, 2022, 12:10 PM
Aug 2022

I have tinnitus and probably some slight hearing loss. I may need some eventually and Medicare doesn't cover anything. I refuse to use Medicare Advantage and many of those plans don't cover them either, so screw that.

sdfernando

(4,935 posts)
19. Been waiting for this ever since I had to get my own hearing-aids.
Tue Aug 16, 2022, 12:28 PM
Aug 2022

Still paying for them too! This will be a game changer for so many people. I never understood why Medicare and most insurance policies wouldn't cover them....Corporate greed I guess.

littlemissmartypants

(22,691 posts)
29. The relationship between hearing loss and dementia...
Tue Aug 16, 2022, 05:31 PM
Aug 2022

Scholarly articles...

https://pubs.asha.org/doi/10.1044/persp3.SIG6.18

https://academic.oup.com/brain/article/144/2/391/6044086

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8053549/

https://bjgp.org/content/67/663/444.1

Excerpt...

Recent research has suggested that use of hearing aids may reduce or prevent the increased prevalence of dementia seen in adults with hearing loss.3,4 This needs confirmation, as current evidence is weak due to the large number of confounding factors. General practice is ideally suited to carry out this research thanks to our large-scale and long-duration databases. In the meanwhile, GPs are likely to see increasing numbers of patients asking for referral for hearing aids, as some in the commercial sector are stating this benefit of hearing aids as fact. Such referral should be expedited; GPs are sometimes accused of minimising hearing loss and delaying referral, but early users of hearing aids are more likely to use aids successfully over a longer timescale as they can be difficult to use. Hearing loss is associated with depression and social isolation;5 denial of the disability is common, as is irritability and interference with relationships. By the age of 70 years, 70% of GP patients have hearing loss. If in doubt, or if the patient is reluctant, a simple validated screening test is available over the phone or online.6


https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2740068

Excerpt...

July 31, 2019
Association of Hearing Loss With Dementia
Chin-Mei Liu, PhD1,2; Charles Tzu-Chi Lee, PhD1
Author Affiliations Article Information
JAMA Netw Open. 2019;2(7):e198112. doi:10.1001/jamanetworkopen.2019.8112
Key Points Español 中文 (Chinese)

Question
What is the association of hearing loss with future incident dementia in the general population of Taiwan?

Findings
In this population-based matched cohort study of 16 270 participants, hearing loss was positively associated with incident dementia, especially in patients aged 45 to 64 years.

Meaning
Hearing loss is associated with a higher risk of dementia, and findings suggest that hearing protection, screening, and treatment may be used as strategies to mitigate this potential risk factor.

Abstract...at the link.

Snip...

Conclusions and Relevance
In this study, hearing loss was positively associated with a risk of dementia, especially in patients aged 45 to 64 years. Hearing protection, screening, and treatment may be used as strategies for mitigating this potential risk factor.


https://pubmed.ncbi.nlm.nih.gov/24662628/

Excerpt...

Relationship of hearing loss and dementia: a prospective, population-based study
Richard Klaus Gurgel et al. Otol Neurotol. 2014 Jun.

Snip...

Conclusion: Elderly individuals with HL have an increased rate of developing dementia and more rapid decline on 3MS-R scores than their nonhearing impaired counterparts. These findings suggest that hearing impairment may be a marker for cognitive dysfunction in adults age 65 years and older.



❤ pants





duhneece

(4,113 posts)
43. THIS is my biggest motivation
Wed Aug 17, 2022, 01:05 PM
Aug 2022

I, too, read the science… but money is too tight to gamble several thousand I don’t have. I’m going to try the Air Pod Pro suggested above.

Aussie105

(5,401 posts)
34. I blew out my left eardrum at a young age
Wed Aug 17, 2022, 06:46 AM
Aug 2022

when a .22 rifle went stupid.

It was repaired, but as I age, left ear hearing has worsened.

I'm hoping that:

1. I can mail order one from the US to Australia when they become available.

2. Software is available to tune frequencies to the point where your hearing is balanced.

You can currently get Android phone software that picks up surrounding audio on it's microphone, amplifies it and delivers it to an earbud.
Tuneable frequency boost/cut to adjust the audio.

Unfortunately the delay involved is too long to be a real solution.

luv2fly

(2,475 posts)
35. Heard this on the radio yesterday as I was driving and I think it's great news
Wed Aug 17, 2022, 08:12 AM
Aug 2022

Kind of like being able to run by the local store and pick up some 10 dollar reading glasses, rather than paying $300 for a set of prescription glasses.

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