Hearing aids may become cheaper and easier to get

[MillCreek]

http://www.seattletimes.com/business/hearing-aid-makers-hear-techs-footsteps-coming-closer/

Speaking as someone who pays several thousand dollars out of pocket every few years for a new set of hearing aids, I say bring on the market disruption.

[brimic]

What sets them apart legally is their intended use. They cannot be marketed for hearing loss, a medical condition. Rather, according to draft guidance issued by the FDA in 2013, PSAPs are for people with normal hearing who need an extra boost in certain situations, like bird-watching, hunting or listening to a lecture from a distant speaker.

But it is almost farcical to pretend that PSAPs are being used only by bird-watchers. The FDA is now re-evaluating the guidance.

Just watch as the FDA screws this up.

[Hawkmoon]

But the opportunity in hearing aids appears striking. Nearly 30 million Americans, including two-thirds of those over 70, are said to have hearing loss. But only 15 to 30 percent of those who could benefit from hearing aids use them.

According to the VA, I am among those who could benefit. I have a service-connected disability for hearing loss, and the VA provides me with hearing aids.

Which I can't use. The [bleep]ing audiologist adjusted them so loud that they're painful to wear because EVERY sound becomes excruciatingly loud -- and she expects ME to adjust them by using some app on a cell phone. Why a VA audiologist would expect a grumpy 70+ year old curmudgeon to have apps on a cell phone is incomprehensible to me.

So my shiny now-not-so-new hearing aids sit in the box on top of the dresser in my bedroom, and I live life saying to certain people "Wha-ja-say?" on a regular basis. I'd probably do better with Game Ears from Cabela's

[Hawkmoon]

Just watch as the FDA screws this up.

Why should the FDA have anything to say about it? Hearing aids are neither food nor drugs. Another example of a government agency overstepping its bounds.

[MillCreek]

^^^The FDA also regulates medical devices, such as hearing aids.

[230RN]

Why should the FDA have anything to say about it? Hearing aids are neither food nor drugs. Another example of a government agency overstepping its bounds.

Well, they also regulate lasers, like the laser sight on your gun.

Terry

[Hawkmoon]

^^^The FDA also regulates medical devices, such as hearing aids.

I know.

That's my point. And I'm sure the government answer to any question is, "Well, somebody has to do it."

So what about the Consumer Product Safety Commission? Are they safe? Yes? Okay, sell them.

[Ben]

We went through two iterations of expensive hearing aids for my dad. He hated them. Last year just for kicks, I bought him $35 over the ear "hearing amplifiers" on Amazon, and he likes those way better. Still won't wear them 99% of the time though, which seems to be a commonality with a lot of guys in the 70+ year range. My dad's biggest complaint on all hearing aids is background noise and also multiple people speaking at once.

[grampster]

Huh?

[brimic]

Too bad suppressors couldn't be obtained easily via doctor's prescription and covered by most health insurance plans as 'preventative medicine.'

[230RN]

Huh?

Are you referring to the laser sights?

If so, to answer in advance, I wondered if we had to keep those little laser warning stickers on one's guns, considering that normal cleaning solvents, oils, and manipulation would readily destroy the adhesive and they'd fall off.  In addition it specifically said, in the Crimsom Trace instructions, that they had to be stuck on the gun.

After due diligence, I discovered that lasers were regulated by the Food and Drug Administration (FDA).  So I wrote to them twice for clarification on this question with no reply from them.  I got a response on the third try.

Upshot:  There is no federal requirement for the end user to affix them to the gun:

Unless the end-user is also a manufacturer the CDRH standards in 21 CFR 1040.10(a) do not apply.  That is to say, the end user may remove the labels.  

(Extracted from an official letter to me from the FDA 30 Sep 2008.)

Terry, 230RN

[Jocassee]

Are you referring to the laser sights?

If so, to answer in advance, I wondered if we had to keep those little laser warning stickers on one's guns, considering that normal cleaning solvents, oils, and manipulation would readily destroy the adhesive and they'd fall off.  In addition it specifically said, in the Crimsom Trace instructions, that they had to be stuck on the gun.

After due diligence, I discovered that lasers were regulated by the Food and Drug Administration (FDA).  So I wrote to them twice for clarification on this question with no reply from them.  I got a response on the third try.

Upshot:  There is no federal requirement for the end user to affix them to the gun:

Terry, 230RN

Grampsters comment was a punny response to this thread topic...I think.

[Pb]

I wear sound generators for hyperacusis treatment.  They are over 3k a pair.  It is outrageous that we can't buy these sorts of devices over the counter.

[RevDisk]

Why should the FDA have anything to say about it? Hearing aids are neither food nor drugs. Another example of a government agency overstepping its bounds.

As MillCreek said, medical devices. This has come up before. Hearing aid manufacturers claim diagnosing and treating hearing loss is too complex for consumers using consumer devices, specially without the aid of a professional. Plus federal and state law say must be provided by an audiologist, a licensed dispenser or a doctor. Combined with FDA approval process and liability costs, they run $2k to $5k. Ten or twenty years ago, probably justified because fitting DSPs into that tiny of a package was expensive.

Now, your average $40 Bluetooth headset has better technology. It just lacks the certs or calibration. IMHO, and MillCreek could chime in, but it'd be unwise for the manufacturer to have a calibration app specifically claiming for hearing loss. A 'normal' calibration app might be fine. Aftermarket apps might be able to skirt the law or law suits.

Under the law, you can use your $40-$100 Bluetooth headset as a hearing aid. The manufacturer cannot be marketed for a medical condition (ie hearing loss) without the device being certified as a medical device. The other issue is audio amplification across the spectrum can be bad for hearing loss. A hearing aid is supposed to only amplify the frequencies to the point matching the amount of hearing loss. Another reason for their cost. As end users can testify, a lot or most hearing aids are not so calibrated. They also have crap ambient noise filtering.

It is entirely possible to build a consumer device and a smartphone app to calibrate it to probably within 95% accuracy of a professional audiologist. In practice, probably better than a lot of professional audiologists. For probably one tenth the cost of a hearing aid.

[MillCreek]

http://www.nytimes.com/2016/07/19/health/hearing-aid-alternatives.html

More companies are looking at the market for hearing aid alternatives.

[Firethorn]

That's my point. And I'm sure the government answer to any question is, "Well, somebody has to do it."

So what about the Consumer Product Safety Commission? Are they safe? Yes? Okay, sell them.

Some days I think that the FDA needs to be broken up and reshifted between the USDA and CDC.

That being said, the reason that the FDA regulates hearing aids, same with other medical devices, is that they claim that they treat medical illness(deafness or whatever).  It's a consequence of all the "snake oil" sold in the bad old days, and is still an issue seeing as how there are people advocating injecting bleach up kid's butts in order to cure autism.

That being said, there's a bit of difference between a piece of equipment you expect to be actually inserted into the body and used for extended periods - though hearing aids are probably on the edge, and things like toasters, where you pretty much only have to ensure that it doesn't explode or electrocute it's users.

That doesn't mean that the FDA hasn't become a bloated obstructionist mess though.

[cassandra and sara's daddy]

I have a DARIO meter to test blood sugar. Cheap effective.
The fda has not certified the android version of the dario app. I can't download it here. In theory  I am not supposed to use it on I pad but I do. In other countries I would not have this issue

Sent from my SAMSUNG-SM-G890A using Tapatalk

[just Warren]

“We are willing to evolve and change, if that is appropriate,” Dr. William H. Maisel, acting director of the Office of Device Evaluation at the FDA, said in an interview.

Gee thanks, pal. You're awesome!