OTC hearing aids in the US

[Carl]

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:
https://www.medtechdive.com/news/fda-targets-late-2019-for-hearing-aid-proposed-rule/540001/.
Enjoy.

--
Regards,
Carl Ijames

 

[Rich S]

On Monday, June 10, 2019 at 4:11:13 PM UTC-4, Carl wrote:

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:
https://www.medtechdive.com/news/fda-targets-late-2019-for-hearing-aid-proposed-rule/540001/.
Enjoy.

--
Regards,
Carl Ijames

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 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 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.
- Rich S.

 

[Jeff Liebermann]

On Mon, 10 Jun 2019 17:28:52 -0700 (PDT), Rich S
<richsulinengineer@gmail.com> wrote:

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 the person with mild-loss needs -- they really are medical
devices.

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 prescribed by an expert IMHO.

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"
<https://www.bbc.com/news/technology-18690973>
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"
<https://www.medtechdive.com/news/bose-self-fitting-hearing-aid-gets-fda-approval/539072/>
...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.

>That's the reason for the high price - long-term expert support.

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.

The training period is lengthy (not the instant gratification
that most people expect).

Training? I read a few web pages and watched some YouTube videos:
<https://forum.hearingtracker.com/t/how-to-program-your-hearing-aids-diy/31749>
<https://forum.hearingtracker.com/c/hearing-aid-self-fitting-and-adjusting>
<https://forum.hearingtracker.com/t/how-to-find-fitting-software-to-program-your-hearing-aids-diy/31753>
I had to learn a few audiology buzzwords and practice on a sacrificial
hearing aid (Learn by Destroying). Not a big deal.

Even with audiological support, the retention rate is already
low (though maybe that's improved over the years?).

What do you mean by retention rate? Retention of what?

Ready access to OTC HAs or PSAs that dissatisfy may lead the
wearer to give up on audiologically-fitted HA.

That might be the plan. Perhaps hearing aid buyers are getting tired
of paying $2,500 for each device and the associated expert support?


--
Jeff Liebermann jeffl@cruzio.com
150 Felker St #D http://www.LearnByDestroying.com
Santa Cruz CA 95060 http://802.11junk.com
Skype: JeffLiebermann AE6KS 831-336-2558

 

[Tom Gardner]

On 11/06/19 01:28, Rich S wrote:

On Monday, June 10, 2019 at 4:11:13 PM UTC-4, Carl wrote:
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:
https://www.medtechdive.com/news/fda-targets-late-2019-for-hearing-aid-proposed-rule/540001/.


Enjoy.

-- Regards, Carl Ijames

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 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
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. - Rich S.

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,
the replacements will cast ÂŁ100.

[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".

 

[Tom Gardner]

On 11/06/19 06:24, Jeff Liebermann wrote:

On Mon, 10 Jun 2019 17:28:52 -0700 (PDT), Rich S
richsulinengineer@gmail.com> wrote:

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 the person with mild-loss needs -- they really are medical
devices.

Yep. However, I really doubt that a person programming a hearing aid
could inflict harm or injury on the hearing aid user.

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*

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).

That's a completely separate (and valid) issue; do
not conflate the two.

They need prescribed by an expert IMHO.

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"
https://www.bbc.com/news/technology-18690973

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.

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"
https://www.medtechdive.com/news/bose-self-fitting-hearing-aid-gets-fda-approval/539072/
...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.

Hearing aids usually come with several "programmes"
that the user can select as the ambient conditions change.

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.

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.

That's the reason for the high price - long-term expert support.

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.

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.

The training period is lengthy (not the instant gratification
that most people expect).

Training? I read a few web pages and watched some YouTube videos:
https://forum.hearingtracker.com/t/how-to-program-your-hearing-aids-diy/31749
https://forum.hearingtracker.com/c/hearing-aid-self-fitting-and-adjusting
https://forum.hearingtracker.com/t/how-to-find-fitting-software-to-program-your-hearing-aids-diy/31753
I had to learn a few audiology buzzwords and practice on a sacrificial
hearing aid (Learn by Destroying). Not a big deal.

You probably have Dunning-Kruger syndrome in this area.

Even with audiological support, the retention rate is already
low (though maybe that's improved over the years?).

What do you mean by retention rate? Retention of what?

Ready access to OTC HAs or PSAs that dissatisfy may lead the
wearer to give up on audiologically-fitted HA.

That might be the plan. Perhaps hearing aid buyers are getting tired
of paying $2,500 for each device and the associated expert support?

I don't pay for them.

You need a humane medical system, not one that is in
the pocket of large corporations.

 

On Tuesday, 11 June 2019 06:24:33 UTC+1, Jeff Liebermann wrote:

On Mon, 10 Jun 2019 17:28:52 -0700 (PDT), Rich S
richsulinengineer@gmail.com> wrote:

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 the person with mild-loss needs -- they really are medical
devices.

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 prescribed by an expert IMHO.

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"
https://www.bbc.com/news/technology-18690973
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"
https://www.medtechdive.com/news/bose-self-fitting-hearing-aid-gets-fda-approval/539072/
...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.

That's the reason for the high price - long-term expert support.

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.

The training period is lengthy (not the instant gratification
that most people expect).

Training? I read a few web pages and watched some YouTube videos:
https://forum.hearingtracker.com/t/how-to-program-your-hearing-aids-diy/31749
https://forum.hearingtracker.com/c/hearing-aid-self-fitting-and-adjusting
https://forum.hearingtracker.com/t/how-to-find-fitting-software-to-program-your-hearing-aids-diy/31753
I had to learn a few audiology buzzwords and practice on a sacrificial
hearing aid (Learn by Destroying). Not a big deal.

Even with audiological support, the retention rate is already
low (though maybe that's improved over the years?).

What do you mean by retention rate? Retention of what?

Ready access to OTC HAs or PSAs that dissatisfy may lead the
wearer to give up on audiologically-fitted HA.

That might be the plan. Perhaps hearing aid buyers are getting tired
of paying $2,500 for each device and the associated expert support?

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?


NT

 

On Tuesday, 11 June 2019 09:42:01 UTC+1, Tom Gardner wrote:

On 11/06/19 06:24, Jeff Liebermann wrote:
On Mon, 10 Jun 2019 17:28:52 -0700 (PDT), Rich S
richsulinengineer@gmail.com> wrote:

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 the person with mild-loss needs -- they really are medical
devices.

Yep. However, I really doubt that a person programming a hearing aid
could inflict harm or injury on the hearing aid user.

There is absolutely no doubt whatsoever that they could
inflict further damage on a user's hearing. **Period*.

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?

They need prescribed by an expert IMHO.

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"
https://www.bbc.com/news/technology-18690973

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.

Of course. There are also treatments outside of the main system that work well & 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 because of that, so I'm never going to buy into the silly idea that only a doctor 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 being an area where mental health issues would normally be a barrier to self treatment.

That's the reason for the high price - long-term expert support.

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.

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.

At the risk of stating the obvious, do you not think some people have simpler conditions that are easily addressed by setting things themselves? I'm sure you're not one of them, obviously that does not put everyone else in the same boat. My hearing is not perfect, and the tweaking required to make it good is trivial. Only a moron would be unable to do it.

The training period is lengthy (not the instant gratification
that most people expect).

Training? I read a few web pages and watched some YouTube videos:
https://forum.hearingtracker.com/t/how-to-program-your-hearing-aids-diy/31749
https://forum.hearingtracker.com/c/hearing-aid-self-fitting-and-adjusting
https://forum.hearingtracker.com/t/how-to-find-fitting-software-to-program-your-hearing-aids-diy/31753
I had to learn a few audiology buzzwords and practice on a sacrificial
hearing aid (Learn by Destroying). Not a big deal.

You probably have Dunning-Kruger syndrome in this area.

Since he has succeeded in his mission, his position is demonstrated to be correct. Not everyone is in your position.

Even with audiological support, the retention rate is already
low (though maybe that's improved over the years?).

What do you mean by retention rate? Retention of what?

Ready access to OTC HAs or PSAs that dissatisfy may lead the
wearer to give up on audiologically-fitted HA.

That might be the plan. Perhaps hearing aid buyers are getting tired
of paying $2,500 for each device and the associated expert support?

I don't pay for them.

You need a humane medical system, not one that is in
the pocket of large corporations.

We all do. We're not there yet. Not even close.


NT

 

[Cursitor Doom]

On Tue, 11 Jun 2019 00:45:47 -0700, tabbypurr wrote:

An attempt to protect people from themselves when there is no harm
involved is just being patronising.

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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On Tuesday, 11 June 2019 19:02:23 UTC+1, Cursitor Doom wrote:

On Tue, 11 Jun 2019 00:45:47 -0700, tabbypurr wrote:

An attempt to protect people from themselves when there is no harm
involved is just being patronising.

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.

that's ever the way.

 

On Monday, June 10, 2019 at 8:28:57 PM UTC-4, Rich S wrote:

On Monday, June 10, 2019 at 4:11:13 PM UTC-4, Carl wrote:
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:
https://www.medtechdive.com/news/fda-targets-late-2019-for-hearing-aid-proposed-rule/540001/.
Enjoy.

--
Regards,
Carl Ijames

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 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 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.
- Rich S.

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.

 

On Tuesday, June 11, 2019 at 1:24:33 AM UTC-4, Jeff Liebermann wrote:

On Mon, 10 Jun 2019 17:28:52 -0700 (PDT), Rich S
richsulinengineer@gmail.com> wrote:

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 the person with mild-loss needs -- they really are medical
devices.

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).

Harm? yes. I am concerned about damaging SPL levels (>85 dB-SPL). I had measured 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 set to the user's upper-comfort level (UCL). Determining the UCL usually requires an audiological exam. The LCL or lowest-comfortable listening level may also be relevant.

They need prescribed by an expert IMHO.

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"
https://www.bbc.com/news/technology-18690973
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.

I admit I'm not up to date on the latest fitting (programming) systems. I recall that each manufacturer had their own to suit their particular digital models (and to adhere the fitter into using their brand). And they required proper training to use. The various parameters would be outside the realm of average patient.

We engineers are NOT the typical patient!

"Bose self-fitting hearing aid gets FDA approval"
https://www.medtechdive.com/news/bose-self-fitting-hearing-aid-gets-fda-approval/539072/
...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.

No doubt the range of audiological expertise varies from state to state. Some states in the U.S. do not require a degreed audiologist to fit HAs. Passing a short training course will do.

That's the reason for the high price - long-term expert support.

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.

HA wearers have an adaptation period; they must get used to simply having an 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 listen to various sounds to assess the benefit of the tweak.

The training period is lengthy (not the instant gratification
that most people expect).

Training? I read a few web pages and watched some YouTube videos:
https://forum.hearingtracker.com/t/how-to-program-your-hearing-aids-diy/31749
https://forum.hearingtracker.com/c/hearing-aid-self-fitting-and-adjusting
https://forum.hearingtracker.com/t/how-to-find-fitting-software-to-program-your-hearing-aids-diy/31753
I had to learn a few audiology buzzwords and practice on a sacrificial
hearing aid (Learn by Destroying). Not a big deal.

Even with audiological support, the retention rate is already
low (though maybe that's improved over the years?).

What do you mean by retention rate? Retention of what?

The wearer retaining the use of the HA -- else, giving up, putting it away in a drawer...

Ready access to OTC HAs or PSAs that dissatisfy may lead the
wearer to give up on audiologically-fitted HA.

That might be the plan. Perhaps hearing aid buyers are getting tired
of paying $2,500 for each device and the associated expert support?


--
Jeff Liebermann jeffl@cruzio.com
150 Felker St #D http://www.LearnByDestroying.com
Santa Cruz CA 95060 http://802.11junk.com
Skype: JeffLiebermann AE6KS 831-336-2558

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On Tuesday, June 11, 2019 at 4:42:01 AM UTC-4, Tom Gardner wrote:

On 11/06/19 06:24, Jeff Liebermann wrote:
On Mon, 10 Jun 2019 17:28:52 -0700 (PDT), Rich S
richsulinengineer@gmail.com> wrote:

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 the person with mild-loss needs -- they really are medical
devices.

Yep. However, I really doubt that a person programming a hearing aid
could inflict harm or injury on the hearing aid user.

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:

So? It would be very easy to regulate the OTC ones so that they
can't produce sound at dangerous levels.

Next!

 

[John Robertson]

On 2019/06/11 5:32 p.m., trader4@optonline.net wrote:

On Monday, June 10, 2019 at 8:28:57 PM UTC-4, Rich S wrote:
On Monday, June 10, 2019 at 4:11:13 PM UTC-4, Carl wrote:
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:
https://www.medtechdive.com/news/fda-targets-late-2019-for-hearing-aid-proposed-rule/540001/.
Enjoy.

--
Regards,
Carl Ijames

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 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 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.
- Rich S.

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.

Pity life, and electronics quality, isn't as simple as some people think:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3876025/

https://www.cnn.com/2016/05/18/politics/hearing-aids-clapper-security-waiver/index.html

https://www.earq.com/blog/can-hearing-aids-cause-hearing-loss

https://canadianaudiology.ca/new-joint-position-statement-direct-to-consumer-sale-of-hearing-aids/

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!

John

 

On Tuesday, June 11, 2019 at 9:11:14 PM UTC-4, John Robertson wrote:

On 2019/06/11 5:32 p.m., trader4@optonline.net wrote:
On Monday, June 10, 2019 at 8:28:57 PM UTC-4, Rich S wrote:
On Monday, June 10, 2019 at 4:11:13 PM UTC-4, Carl wrote:
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:
https://www.medtechdive.com/news/fda-targets-late-2019-for-hearing-aid-proposed-rule/540001/.
Enjoy.

--
Regards,
Carl Ijames

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 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 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.
- Rich S.

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.




Pity life, and electronics quality, isn't as simple as some people think:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3876025/

https://www.cnn.com/2016/05/18/politics/hearing-aids-clapper-security-waiver/index.html

https://www.earq.com/blog/can-hearing-aids-cause-hearing-loss

https://canadianaudiology.ca/new-joint-position-statement-direct-to-consumer-sale-of-hearing-aids/

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?

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.

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!

John

 

[John Robertson]

On 2019/06/11 6:16 p.m., trader4@optonline.net wrote:

On Tuesday, June 11, 2019 at 9:11:14 PM UTC-4, John Robertson wrote:
On 2019/06/11 5:32 p.m., trader4@optonline.net wrote:
On Monday, June 10, 2019 at 8:28:57 PM UTC-4, Rich S wrote:
On Monday, June 10, 2019 at 4:11:13 PM UTC-4, Carl wrote:
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:
https://www.medtechdive.com/news/fda-targets-late-2019-for-hearing-aid-proposed-rule/540001/.
Enjoy.

--
Regards,
Carl Ijames

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 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 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.
- Rich S.

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.




Pity life, and electronics quality, isn't as simple as some people think:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3876025/

https://www.cnn.com/2016/05/18/politics/hearing-aids-clapper-security-waiver/index.html

https://www.earq.com/blog/can-hearing-aids-cause-hearing-loss

https://canadianaudiology.ca/new-joint-position-statement-direct-to-consumer-sale-of-hearing-aids/

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?

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...

John

 

On Tuesday, June 11, 2019 at 8:32:08 PM UTC-4, tra...@optonline.net wrote:

On Monday, June 10, 2019 at 8:28:57 PM UTC-4, Rich S wrote:
On Monday, June 10, 2019 at 4:11:13 PM UTC-4, Carl wrote:
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:
https://www.medtechdive.com/news/fda-targets-late-2019-for-hearing-aid-proposed-rule/540001/.
Enjoy.

--
Regards,
Carl Ijames

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 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 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.
- Rich S.

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.

I wouldn't say "too stupid" but unaware of the potential harm. Hearing damage 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 possible that an "intelligent", sophisticated, hi-tech HA plus smartphone app could be made that carefully evaluates the user needs and programs the HAs. That kind of device wouldn't be as cheap as simple PSA (personal sound amplifiers) - 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.

--
***
This e-mail message is intended only for the designated recipient(s)
named above. The information contained in this e-mail and any attachments
may be confidential or legally privileged. If you are not the intended
recipient, you may not review, retain, copy, redistribute or use this
e-mail or any attachment for any purpose, or disclose all or any part of
its contents. If you have received this e-mail in error, please immediately
notify the sender by reply e-mail and permanently delete this e-mail and
any attachments from your computer system.
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[Martin Brown]

On 12/06/2019 03:26, John Robertson wrote:

On 2019/06/11 6:16 p.m., trader4@optonline.net wrote:
On Tuesday, June 11, 2019 at 9:11:14 PM UTC-4, John Robertson wrote:
On 2019/06/11 5:32 p.m., trader4@optonline.net wrote:
On Monday, June 10, 2019 at 8:28:57 PM UTC-4, Rich S wrote:
On Monday, June 10, 2019 at 4:11:13 PM UTC-4, Carl wrote:
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:
https://www.medtechdive.com/news/fda-targets-late-2019-for-hearing-aid-proposed-rule/540001/.

Enjoy.

--
Regards,
Carl Ijames

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

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.

and smarts (?) to learn 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 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.
- Rich S.

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.

You have to ensure that the device cannot cause harm though. Hearing
damage due to over loud sounds is generally permanent and irreversible.

Pity life, and electronics quality, isn't as simple as some people
think:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3876025/

https://www.cnn.com/2016/05/18/politics/hearing-aids-clapper-security-waiver/index.html


https://www.earq.com/blog/can-hearing-aids-cause-hearing-loss

https://canadianaudiology.ca/new-joint-position-statement-direct-to-consumer-sale-of-hearing-aids/


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?

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.

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).

https://www.businesstelegraph.co.uk/amazon-pledges-to-crack-down-on-toxic-childrens-school-supplies/

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...

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.


--
Regards,
Martin Brown

 

On Tuesday, June 11, 2019 at 10:26:52 PM UTC-4, John Robertson wrote:

On 2019/06/11 6:16 p.m., trader4@optonline.net wrote:
On Tuesday, June 11, 2019 at 9:11:14 PM UTC-4, John Robertson wrote:
On 2019/06/11 5:32 p.m., trader4@optonline.net wrote:
On Monday, June 10, 2019 at 8:28:57 PM UTC-4, Rich S wrote:
On Monday, June 10, 2019 at 4:11:13 PM UTC-4, Carl wrote:
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:
https://www.medtechdive.com/news/fda-targets-late-2019-for-hearing-aid-proposed-rule/540001/.
Enjoy.

--
Regards,
Carl Ijames

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 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 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.
- Rich S.

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.




Pity life, and electronics quality, isn't as simple as some people think:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3876025/

https://www.cnn.com/2016/05/18/politics/hearing-aids-clapper-security-waiver/index.html

https://www.earq.com/blog/can-hearing-aids-cause-hearing-loss

https://canadianaudiology.ca/new-joint-position-statement-direct-to-consumer-sale-of-hearing-aids/

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?

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.

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

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?

Not all of them, no. If someone doesn't want to wear one, that's their
right and it shouldn't be illegal.

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?

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......

 

[Rick C]

On Wednesday, June 12, 2019 at 1:50:42 PM UTC-4, tra...@optonline.net wrote:

On Tuesday, June 11, 2019 at 10:26:52 PM UTC-4, John Robertson wrote:
On 2019/06/11 6:16 p.m., trader4@optonline.net wrote:
On Tuesday, June 11, 2019 at 9:11:14 PM UTC-4, John Robertson wrote:
On 2019/06/11 5:32 p.m., trader4@optonline.net wrote:
On Monday, June 10, 2019 at 8:28:57 PM UTC-4, Rich S wrote:
On Monday, June 10, 2019 at 4:11:13 PM UTC-4, Carl wrote:
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:
https://www.medtechdive.com/news/fda-targets-late-2019-for-hearing-aid-proposed-rule/540001/.
Enjoy.

--
Regards,
Carl Ijames

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 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 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.
- Rich S.

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.




Pity life, and electronics quality, isn't as simple as some people think:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3876025/

https://www.cnn.com/2016/05/18/politics/hearing-aids-clapper-security-waiver/index.html

https://www.earq.com/blog/can-hearing-aids-cause-hearing-loss

https://canadianaudiology.ca/new-joint-position-statement-direct-to-consumer-sale-of-hearing-aids/

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?

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.

Yes and libs LOVE to try to control anything they can. Now it's
hearing aids.

NOW??? Haven't they been considered medical devices for some time now?

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?

Not all of them, no. If someone doesn't want to wear one, that's their
right and it shouldn't be illegal.

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 would it be determined that the injuries were largely because of not wearing a seat belt or would have happened anyway?

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?

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......

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 prevented.

--

Rick C.

- Get 1,000 miles of free Supercharging
- Tesla referral code - https://ts.la/richard11209

 

[Martin Brown]

On 12/06/2019 20:18, Rick C wrote:

On Wednesday, June 12, 2019 at 1:50:42 PM UTC-4, tra...@optonline.net
wrote:
On Tuesday, June 11, 2019 at 10:26:52 PM UTC-4, John Robertson
wrote:
On 2019/06/11 6:16 p.m., trader4@optonline.net wrote:
On Tuesday, June 11, 2019 at 9:11:14 PM UTC-4, John Robertson
wrote:
On 2019/06/11 5:32 p.m., trader4@optonline.net wrote:
On Monday, June 10, 2019 at 8:28:57 PM UTC-4, Rich S
wrote:
On Monday, June 10, 2019 at 4:11:13 PM UTC-4, Carl
wrote:
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:
https://www.medtechdive.com/news/fda-targets-late-2019-for-hearing-aid-proposed-rule/540001/.


Enjoy.

-- Regards, Carl Ijames

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
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
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. - Rich S.

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.




Pity life, and electronics quality, isn't as simple as some
people think:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3876025/

https://www.cnn.com/2016/05/18/politics/hearing-aids-clapper-security-waiver/index.html



https://www.earq.com/blog/can-hearing-aids-cause-hearing-loss

https://canadianaudiology.ca/new-joint-position-statement-direct-to-consumer-sale-of-hearing-aids/



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?

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.

Yes and libs LOVE to try to control anything they can. Now it's
hearing aids.

NOW??? Haven't they been considered medical devices for some time
now?

OTOH there seem to be plenty of them for sale on Amazon:

USA: https://www.amazon.com/s?k=hearing+aid&ref=nb_sb_noss_1

UK: https://www.amazon.co.uk/s?k=hearing+aid&ref=nb_sb_noss_1

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).

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?

Not all of them, no. If someone doesn't want to wear one, that's
their right and it shouldn't be illegal.

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.

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 would it be determined that the injuries were largely
because of not wearing a seat belt or would have happened anyway?

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.

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?

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......

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 prevented.

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.

--
Regards,
Martin Brown