October 12, 2018, 01:16 PM
ZSMICHAELFDA Allows Sales of First Self-Fitting Hearing Aid
Perhaps the costs will come down.....
The FDA on Friday approved the sale of the first hearing aid that users can buy, fit, and use themselves, without the sometimes expensive expert help.
The Bose Hearing Aid is for anyone 18 and older with mild to moderate hearing loss.
"Today’s marketing authorization provides certain patients with access to a new hearing aid that provides them with direct control over the fit and functionality of the device," says Malvina Eydelman, MD, director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA's Center for Devices and Radiological Health. "The FDA is committed to ensuring that individuals with hearing loss have options for taking an active role in their health care."
More than 37 million adults have some level of hearing loss.
The wireless Bose Hearing Aid is what’s known as an "air conduction" hearing aid. These devices capture sound vibrations through one or more microphones. The signal is then processed, amplified, and played back through an earphone placed in the ear canal. Patients can adjust the hearing aid through an app on their phone. This technology lets users choose the hearing aid settings themselves.
In a statement, Bose says the FDA approval "validates that Bose technologies can be applied to help people with mild to moderate hearing impairment take control of their hearing. We look forward to bringing affordable, accessible and great sounding solutions to the millions of people who could benefit from hearing aids, but don’t use them."
Some state laws may still require the hearing aid to be purchased from a licensed dealer.
The FDA's decision is part of a move toward greater consumer freedom when it comes to hearing aids. The FDA Reauthorization Act of 2017 requires the agency to write new regulations for over-the-counter hearing aids.
The FDA says it reviewed data from clinical studies of 125 patients that showed the Bose device is comparable to a professionally fitted hearing aid.
WebMD Health News © 2018
LINK:https://www.medscape.com/viewarticle/903102?nlid=125494_381&src=WNL_mdplsnews_181012_mscpedit_wir&uac=65325SY&spon=17&impID=1767491&faf=1
October 12, 2018, 01:19 PM
dusty3030Great news.
October 12, 2018, 01:19 PM
HRKI hadn't heard about it...
October 12, 2018, 01:28 PM
PHPaulquote:
Originally posted by HRK:
I hadn't heard about it...
October 12, 2018, 02:51 PM
cparktdJust curious, I have some high frequency loss, but not enough to warrant hearing aids.
I know aids can be tuned to amplify only the range you have problems with but can any simply shift high frequency sounds to a slightly lower frequency that you can hear? Sort of like auto tune? Superficially it seems like a good idea but it might sound really weird...
I think I could hear just fine it this damn ringing would stop!
October 12, 2018, 03:00 PM
ensigmaticI wonder how it'll compare to
EarGo?
October 12, 2018, 04:40 PM
Hamden106I have $7000 aids. They work pretty good.
October 12, 2018, 04:48 PM
rduckworquote:
Originally posted by Hamden106:
I have $7000 aids. They work pretty good.
Yeah, for that price they damn sure should. That's the problem with hearing aids, closed market secondary to the FDA. Maybe things will get better now.
RMD
October 12, 2018, 05:18 PM
Elk Hunterquote:
Originally posted by rduckwor:
quote:
Originally posted by Hamden106:
I have $7000 aids. They work pretty good.
Yeah, for that price they damn sure should. That's the problem with hearing aids, closed market secondary to the FDA. Maybe things will get better now.
RMD
I have the best Phonak hearing aids on the market. Bought them at Costco. Free supplies, tune ups, etc. Spent about $3000 for them. They now have "house brand" aids, too. The technician told me that they were very good. They cost about $1600.
October 12, 2018, 05:49 PM
wreckdiverI recently got the Lucid hearing aids sold by a hearing specialist at Sam's Club. Tuned across the board to help in both highs and lows as needed. I had no idea what I couldn't hear, they are awesome. The nearly $4K price tag stung, but well worth it. 90 days to return will NOT be needed

October 12, 2018, 05:55 PM
DakorBose heading aids are not self fitting at all. Simply a wide-band amplifier.