Bose Hearing Aid FDA Approval | Self-Fitting Hearing Aid

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:

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.


Joshua Guerra says:

This is going to hurt the retail hearing aid industry. I have been fitting hearing aids for 11 years and I believe that the OTC will not only hurt the providers but confuse the consumer in general.

ALaughaday1 says:

@Doctor Cliff, Aud: I’ve been watching you videos to help me in researching hearing aids to help with my Acoustic Neuroma post-surgery hearing loss. My left ear is now “dead”–no hearing in it. Today I went to my audiologist to try out BICROS hearing aids. She recommended the Phonak CROS B in my “dead” ear and the Phonak Audeo B-312 (30 level). I tried a pair out in her office and using the noisy simulation, I noticed a positive benefit in hearing and clarity. Here is my issue. I asked her if she did Real Ear Measurements (because you always mention this practice) and she said that she doesn’t do this because it’s an outdated process. She said when needed, she does put the patients in the audiology booth and test them out with an audiogram (not sure if that’s the right term. She said she can do a hearing test in the booth with the hearing aids in place). Would this still accurate? The hearing in my good ear is relatively normal. Now I’m confused and wondering if it’s still OK to work with this audiologist.

Dennis Neira says:

Hello Dr. Cliff, my name is Dennis and I am a hearing instruments specialist. I watch your videos religiously! Do you have a recommendation as to what REM product to use?
The ENT clinic I work for says most of it is too expensive. I would love to implement this into our practice.
I know that your videos are geared toward patients however I love watching them and you really help me stay informed on the latest technology.

Kareem Khan says:

I think this would be good and help make the consumer pricing more level across the playing field I do feel this route wouldn’t have been needed if insurance companies would have stepped up to cover more in hearing aids if you have profound hearing loss without aids you are pretty much deaf and many insurance companies only cover low end aids which are not normally suitable to those with profound loss whatsoever Medicare advantage plans really need to step up the game and although coverage has gotten better for this year due to new regulation hearing aid coverage still weren’t really upped into plans this year a $400 coverage isn’t really all that helpful especially when the majority of those with hearing loss need 2 aids

ikungfuyou2 says:

What do you predict in 2020 the end of the practice practice? Everyone says unbundling, but i don’t see Miracle Whip (I mean ear) or Beltone staying around with the 12k plus hearing aids. What is your thinking? I see Aud’s like you going to hospitals for the kids and more profound losses and everything going online (mild/Mod losses) and people like me (BC-HIS) looking for new job. Fun while it lasted I guess.

Michael Fiola says:

Thank you for the info. I saw the press release the other day and have not been able to find any real information about it. Presumably Bose already has the device in or near production since this would have been needed for testing and FDA review. Hopefully we will not need to wait too long to see the launch. I agree, Bose does not make cheap products… I’ll offer a pure guess of $599 (you heard it here first people!) …cheaper than Rx options, enough to make a profit, and not prohibitive for the target consumer.

unbogosse says:

I’m very pleased that OTC hearing devices are becoming available. More than twenty years ago my elderly mother spent over $3,000 a piece on custom fitted hearing aids and they frequently needed to be sent back to the manufacturer for adjustment/over hauling/retuning and other reasons that I forget. These repair trips cost many hundreds of dollars each time for each device. She was a frail old lady and never abused or mistreated her hearing devices. I became convinced after making her change to a different group of audiologists that the hearing aid business is mostly a racket that preys upon the elderly. If I need hearing devices I hope I will be spared being robbed and cheated and I’ll gladly pay for an OTC device.

Really ? says:

I hope Apple, Samsung, Sony and several other big electronic players get involved in this industry. The demographics alone should attract them as millions of baby boomers age.

Steven Wang says:

are there options that are not miniaturized high cost focused for hearing aids? 30+years and still waiting (edit out rant)

holdmybeer says:

well at least the [CC] on youtube is so much better than a few years ago.

Kathy Attwood says:

Would you say that these pose a risk to users’ hearing if they are used at a volume which is too loud for their hearing loss?

Suja Raj says:

Is it for one side or both side problems

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