Michelle Gross, HLAA Rochester
To qualify as an OTC Hearing Aid certain guidelines have to be followed such as limiting gain to avoid over amplification, limiting the depth that the "ear mold" or ear piece can be inserted into the ear, and must have a user controlled audio control (unlike the "automatic" control feature with some prescription hearing aids). They also have to meet some standards regarding sound distortion and a few other "must haves". The OTCs also have to have certain labeling information for health and safety.
PSAP are not "medical devices" and because of that are not regulated and are more likely to pose a danger to the user.
Having said all of that there needs to be oversight to be sure the guidelines are followed, so it remains to be seen how users feel about the ability to have OTC aids, most are kind of "bare bones" but for those who otherwise would need to go without, they may have a place. Time will tell.
Michelle Gross
On Wednesday, November 30, 2022, 03:35:05 PM EST, Barbara Cooledge <cooledgebb@...> wrote:
You are right. We will only know in five years.
toggle quoted message
Show quoted text
On Wed, Nov 30, 2022 at 12:57 PM John Woodgate < jmw@...> wrote:
If you search on-line, you will
find that everything is deemed unsafe by someone.
======================================================================================
Best wishes
John Woodgate OOO-Own Opinions Only
www.woodjohn.uk
Rayleigh, Essex UK
I hear, and I forget.
I see, and I remember.
I do, and I understand.
Xunzi (340 - 245 BC)
On 2022-11-27 00:41, Barbara Cooledge
wrote:
I’ve heard it may not be safe from two sources
on-line. Sounds like it is just a problem if they are turned up
too loud. And, supporters believe that the risk is worth it if
it wards off diabetes, dementia, heart problems, etc. ?
On Sat, Nov 26, 2022 at 2:37
PM John Woodgate < jmw@...>
wrote:
It is deeply disturbing to learn that
an audiologist says that 'OTC hearing aids are not
safe'. It is a totally unscientific generalization.
It is possible that ANY hearing aid could cause
additional hearing loss. This is if it delivers a
too loud sound, causing 'ringing in the ears' and that warning sign is
ignored. Dispensed hearing aids should be set
so that is cannot occur, but certainly my dispensed
hearing aids can be set to 'play too loud for
comfort'. Just don't do it! If you hear sound 'in
your ear' rather than 'out in the room', the sound
is too loud, so turn it down.
======================================================================================
Best wishes John Woodgate OOO-Own Opinions Only
www.woodjohn.uk
Rayleigh, Essex UK
I hear, and I forget. I see, and I remember. I do, and I
understand. Xunzi (340 - 245 BC)
On 2022-11-18 04:23, Barbara Cooledge wrote:
What is the $2,500.00? My husband’s aids
were under $1,800.00 at Costco and they had the booth
and technician and custom hearing exam. Not
over-the-counter and not covered by insurance e except
for initial examination. So, I am wondering, do over
the counter just amplify? Or do you test yourself and
customize your custom over-the-counter devices using
your computer?
I’m just curious probably because my
husband is losing his hearing. Does not have minor
hearing loss.
An audiologist said on her site that
over-the-counter are not safe. So is HLAA in the
proper position on this? Could be a disaster?
Barbara
|
|
You are right. We will only know in five years.
toggle quoted message
Show quoted text
On Wed, Nov 30, 2022 at 12:57 PM John Woodgate < jmw@...> wrote:
If you search on-line, you will
find that everything is deemed unsafe by someone.
======================================================================================
Best wishes
John Woodgate OOO-Own Opinions Only
www.woodjohn.uk
Rayleigh, Essex UK
I hear, and I forget.
I see, and I remember.
I do, and I understand.
Xunzi (340 - 245 BC)
On 2022-11-27 00:41, Barbara Cooledge
wrote:
I’ve heard it may not be safe from two sources
on-line. Sounds like it is just a problem if they are turned up
too loud. And, supporters believe that the risk is worth it if
it wards off diabetes, dementia, heart problems, etc. ?
On Sat, Nov 26, 2022 at 2:37
PM John Woodgate < jmw@...>
wrote:
It is deeply disturbing to learn that
an audiologist says that 'OTC hearing aids are not
safe'. It is a totally unscientific generalization.
It is possible that ANY hearing aid could cause
additional hearing loss. This is if it delivers a
too loud sound, causing 'ringing in the ears' and that warning sign is
ignored. Dispensed hearing aids should be set
so that is cannot occur, but certainly my dispensed
hearing aids can be set to 'play too loud for
comfort'. Just don't do it! If you hear sound 'in
your ear' rather than 'out in the room', the sound
is too loud, so turn it down.
======================================================================================
Best wishes John Woodgate OOO-Own Opinions Only
www.woodjohn.uk
Rayleigh, Essex UK
I hear, and I forget. I see, and I remember. I do, and I
understand. Xunzi (340 - 245 BC)
On 2022-11-18 04:23, Barbara Cooledge wrote:
What is the $2,500.00? My husband’s aids
were under $1,800.00 at Costco and they had the booth
and technician and custom hearing exam. Not
over-the-counter and not covered by insurance e except
for initial examination. So, I am wondering, do over
the counter just amplify? Or do you test yourself and
customize your custom over-the-counter devices using
your computer?
I’m just curious probably because my
husband is losing his hearing. Does not have minor
hearing loss.
An audiologist said on her site that
over-the-counter are not safe. So is HLAA in the
proper position on this? Could be a disaster?
Barbara
|
|

John Woodgate
If you search on-line, you will
find that everything is deemed unsafe by someone.
======================================================================================
Best wishes
John Woodgate OOO-Own Opinions Only
www.woodjohn.uk
Rayleigh, Essex UK
I hear, and I forget.
I see, and I remember.
I do, and I understand.
Xunzi (340 - 245 BC)
On 2022-11-27 00:41, Barbara Cooledge
wrote:
toggle quoted message
Show quoted text
I’ve heard it may not be safe from two sources
on-line. Sounds like it is just a problem if they are turned up
too loud. And, supporters believe that the risk is worth it if
it wards off diabetes, dementia, heart problems, etc. ?
On Sat, Nov 26, 2022 at 2:37
PM John Woodgate < jmw@...>
wrote:
It is deeply disturbing to learn that
an audiologist says that 'OTC hearing aids are not
safe'. It is a totally unscientific generalization.
It is possible that ANY hearing aid could cause
additional hearing loss. This is if it delivers a
too loud sound, causing 'ringing in the ears' and that warning sign is
ignored. Dispensed hearing aids should be set
so that is cannot occur, but certainly my dispensed
hearing aids can be set to 'play too loud for
comfort'. Just don't do it! If you hear sound 'in
your ear' rather than 'out in the room', the sound
is too loud, so turn it down.
======================================================================================
Best wishes John Woodgate OOO-Own Opinions Only
www.woodjohn.uk
Rayleigh, Essex UK
I hear, and I forget. I see, and I remember. I do, and I
understand. Xunzi (340 - 245 BC)
On 2022-11-18 04:23, Barbara Cooledge wrote:
What is the $2,500.00? My husband’s aids
were under $1,800.00 at Costco and they had the booth
and technician and custom hearing exam. Not
over-the-counter and not covered by insurance e except
for initial examination. So, I am wondering, do over
the counter just amplify? Or do you test yourself and
customize your custom over-the-counter devices using
your computer?
I’m just curious probably because my
husband is losing his hearing. Does not have minor
hearing loss.
An audiologist said on her site that
over-the-counter are not safe. So is HLAA in the
proper position on this? Could be a disaster?
Barbara
|
|
I’ve heard it may not be safe from two sources on-line. Sounds like it is just a problem if they are turned up too loud. And, supporters believe that the risk is worth it if it wards off diabetes, dementia, heart problems, etc. ?
toggle quoted message
Show quoted text
On Sat, Nov 26, 2022 at 2:37 PM John Woodgate < jmw@...> wrote:
It is deeply disturbing to
learn that an audiologist says that 'OTC hearing aids are not
safe'. It is a totally unscientific generalization. It is
possible that ANY hearing aid could cause additional hearing
loss. This is if it delivers a too loud sound, causing
'ringing in the ears' and that warning sign is ignored.
Dispensed hearing aids should be set so that is cannot occur,
but certainly my dispensed hearing aids can be set to 'play
too loud for comfort'. Just don't do it! If you hear sound 'in
your ear' rather than 'out in the room', the sound is too
loud, so turn it down.
======================================================================================
Best wishes
John Woodgate OOO-Own Opinions Only
www.woodjohn.uk
Rayleigh, Essex UK
I hear, and I forget.
I see, and I remember.
I do, and I understand.
Xunzi (340 - 245 BC)
On 2022-11-18 04:23, Barbara Cooledge
wrote:
What is the $2,500.00? My husband’s aids were
under $1,800.00 at Costco and they had the booth and technician
and custom hearing exam. Not over-the-counter and not covered by
insurance e except for initial examination. So, I am wondering,
do over the counter just amplify? Or do you test yourself and
customize your custom over-the-counter devices using your
computer?
I’m just curious probably because my husband is
losing his hearing. Does not have minor hearing loss.
An audiologist said on her site that
over-the-counter are not safe. So is HLAA in the proper position
on this? Could be a disaster?
Barbara
|
|

John Woodgate
It is deeply disturbing to
learn that an audiologist says that 'OTC hearing aids are not
safe'. It is a totally unscientific generalization. It is
possible that ANY hearing aid could cause additional hearing
loss. This is if it delivers a too loud sound, causing
'ringing in the ears' and that warning sign is ignored.
Dispensed hearing aids should be set so that is cannot occur,
but certainly my dispensed hearing aids can be set to 'play
too loud for comfort'. Just don't do it! If you hear sound 'in
your ear' rather than 'out in the room', the sound is too
loud, so turn it down.
======================================================================================
Best wishes
John Woodgate OOO-Own Opinions Only
www.woodjohn.uk
Rayleigh, Essex UK
I hear, and I forget.
I see, and I remember.
I do, and I understand.
Xunzi (340 - 245 BC)
On 2022-11-18 04:23, Barbara Cooledge
wrote:
toggle quoted message
Show quoted text
What is the $2,500.00? My husband’s aids were
under $1,800.00 at Costco and they had the booth and technician
and custom hearing exam. Not over-the-counter and not covered by
insurance e except for initial examination. So, I am wondering,
do over the counter just amplify? Or do you test yourself and
customize your custom over-the-counter devices using your
computer?
I’m just curious probably because my husband is
losing his hearing. Does not have minor hearing loss.
An audiologist said on her site that
over-the-counter are not safe. So is HLAA in the proper position
on this? Could be a disaster?
Barbara
|
|
What is the $2,500.00? My husband’s aids were under $1,800.00 at Costco and they had the booth and technician and custom hearing exam. Not over-the-counter and not covered by insurance e except for initial examination. So, I am wondering, do over the counter just amplify? Or do you test yourself and customize your custom over-the-counter devices using your computer? I’m just curious probably because my husband is losing his hearing. Does not have minor hearing loss. An audiologist said on her site that over-the-counter are not safe. So is HLAA in the proper position on this? Could be a disaster? Barbara
toggle quoted message
Show quoted text
On Thu, Nov 17, 2022 at 8:04 PM Stephen O. Frazier < hlaanm@...> wrote:
Hi All - It appears I left out some critically important words in the earlier post on this matter. The Lexie Lumen hearing aids referred to in it are not the only OTC hearing aids available in stores - Best Buy alone carries 10 different models plus a $2,500 PSAP..
The Lexie Lumen, though, is the only one that has telecoils. When you add the OTC models sold at Best Buy, Verizon, Walgreens, and even at the Hy-Vee supermarkets in some states, plus models available from a number of websites like CVS Cructfield etc., there's a plethora of OTC hearing aids to pick from BUT, still, only the Lexie Lumen has telecoils.
If this news disturbs your, please click on the link below and share your comments re the absence of telecoils in the comment box available by scrolling down to the bottom of the screen...
Photo of Best Buy OTC hearing aid display located in the cellular phone area. Contrary to Best Buy publicity, the "Blue Shirt" who helped me has had no training on the devices. When asked about it his response was, "There's a training video course but it's not mandatory so I haven't taken it."
Stephen O. Frazier, Hearing Loss Support Specialist
Please support the
GET IN THE HEARING LOOP
campaign of the
Hearing Loss Association of America
Hi All - It appears that Lexie Lumen hearing aids are the only OTC FDA approved hearing aids (at Walgreen's) that are actually currently available over-the-counter in retail stores. I have commented on this on the Hearing Health and Technology Matters blog.
Comments on the blog from advocates of hearing loops like you would help to make the OTC hearing aid industry aware of the need to address this this issue. You can visit the blog at:
Stephen O. Frazier, Hearing Loss Support Specialist
Please support the
GET IN THE HEARING LOOP
campaign of the
Hearing Loss Association of America
|
|

Stephen O. Frazier
Hi All - It appears I left out some critically important words in the earlier post on this matter. The Lexie Lumen hearing aids referred to in it are not the only OTC hearing aids available in stores - Best Buy alone carries 10 different models plus a $2,500 PSAP..
The Lexie Lumen, though, is the only one that has telecoils. When you add the OTC models sold at Best Buy, Verizon, Walgreens, and even at the Hy-Vee supermarkets in some states, plus models available from a number of websites like CVS Cructfield etc., there's a plethora of OTC hearing aids to pick from BUT, still, only the Lexie Lumen has telecoils.
If this news disturbs your, please click on the link below and share your comments re the absence of telecoils in the comment box available by scrolling down to the bottom of the screen...
Photo of Best Buy OTC hearing aid display located in the cellular phone area. Contrary to Best Buy publicity, the "Blue Shirt" who helped me has had no training on the devices. When asked about it his response was, "There's a training video course but it's not mandatory so I haven't taken it."
Stephen O. Frazier, Hearing Loss Support Specialist
Please support the
GET IN THE HEARING LOOP
campaign of the
Hearing Loss Association of America
---------- Forwarded Message ---------- From: "Stephen O. Frazier" <hlaanm@...> To: HLAATech@groups.io, HLAAGITHL@..., HLAAGITHL@groups.io, HLAALeaders@... Subject: [HLAATech] OTC Hearing Aids and Telecoils Date: Tue, 15 Nov 2022 15:52:38 GMT
Hi All - It appears that Lexie Lumen hearing aids are the only OTC FDA approved hearing aids (at Walgreen's) that are actually currently available over-the-counter in retail stores. I have commented on this on the Hearing Health and Technology Matters blog.
Comments on the blog from advocates of hearing loops like you would help to make the OTC hearing aid industry aware of the need to address this this issue. You can visit the blog at:
Stephen O. Frazier, Hearing Loss Support Specialist
Please support the
GET IN THE HEARING LOOP
campaign of the
Hearing Loss Association of America
|
|