Bose Hearing Aid FDA Approval | Self-Fitting Hearing Aid. Cliff Olson, Doctor of Audiology and founder of Applied Hearing Solutions in Anthem Arizona, discusses the recent FDA Marketing Approval for Bose’s new hearing aids.
The FDA recently issued a press release announcing that Bose’s self-fitting hearing aid has been given marketing approval before the Over The Counter hearing aid guidelines are established. This is no surprise since Bose was a leading supporter for the FDA reauthorization act of 2017 which will give birth to a new category of Over The Counter Hearing Aids.
As of right now, there is no such thing as an Over The Counter hearing aid because the regulations will not be established until sometime in 2020. However, direct to consumer hearing aids have been available for some time. This includes devices that you can order and program yourself from the comfort of your own home.
It is unknown how good Bose’s NEW Hearing Aid will actually be, but as soon as it is released I will conduct a complete review of the device.
The FDA press release states:
“Patients can adjust the hearing aid through a mobile application on their phone. This technology enables users to fit the hearing aid settings themselves, in real-time and in real-world environments without the assistance of a health care professional.”
It goes on to read…
“In authorizing marketing of the Bose device, the FDA reviewed data from clinical studies of 125 patients, which demonstrated that outcomes with self-fitting of the Bose Hearing Aid are comparable on average to those with professional fitting of the same device with respect to the amount of amplification selected, speech in noise testing and overall benefit. In addition, when participants self-fit the Bose Hearing Aid, they generally preferred those hearing aid settings over the professionally-selected settings.”
Just to be clear, preferred settings of hearing aids has nothing to do if the hearing aids are programmed properly to a person’s hearing loss prescription. However, if the Bose Hearing Aids are as good as the FDA states, the will be a very capable option for individuals with a mild to moderate hearing loss.
We still don’t know what the Bose Hearing Aids will look like or how much they will cost. We also don’t know how well they will work in the real-world.
Currently Bose has a product called the Hearphones that are specifically designed to amplify speech. Bose Hearing Aids will need to improve upon these devices significantly if they are going to be a suitable daily wear device. Bose Hearphones Review: https://youtu.be/6Rbf87bmPNQ
It is hard to speculate how good the Bose Hearing Aids will be, but they are getting a huge head start on other OTC companies. They will however, need to comply with state hearing aid dispensing laws before the OTC regulations are announced. That being said, since you can virtually buy any hearing aid online, you shouldn’t have a problem getting yourself a pair really soon.