Bose Hearing Aid FDA Approval

Bose Hearing Aid FDA Approval

Dr. Clifford R. Olson

Dr. Olson is a Board Certified Audiologist and holds his doctoral degree from the University of Illinois at Urbana-Champaign. Dr. Olson is a member of the Academy of Doctors of Audiology, a Fellow of the American Academy of Audiology, and holds his Certificate of Clinical Competency from the American Speech-Language-Hearing Association. He is also an adjunct lecturer for the Department of Speech & Hearing Science at his alma mater.
Dr. Clifford R. Olson

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On October 5, 2018, the Food and Drug Administration issued a press release announcing that Bose now had approval to market a new hearing aid that could actually be self-adjusted without the help of a hearing care professional. This really shouldn’t come as much of a surprise, because Bose was one of the main supporters of the FDA Reauthorization Act of 2017, which would establish a new category of over-the-counter hearing aids for individuals with a mild to moderate hearing loss.

Over the Counter Hearing Aids

As of right now, we still don’t know what an over-the-counter hearing aid is, since the FDA has three years from the time this was signed into law in 2017 to actually establish the criteria for what an over-the-counter hearing aid is and what the regulations will be on those particular devices.

Basically, this means that over-the-counter hearing aids don’t even exist yet because there are no criteria to define what an over-the-counter hearing aid is. That being said, direct-to-consumer hearing aids have been around for a while, and there are even ones out there that you can buy, have them sent directly to your house, and program them yourself. This is basically what the Bose hearing aids will be like. We don’t know exactly what these devices are going to be yet, but I can promise you this – when these devices get released, I will do a review.

FDA Press Release

According to the FDA press release, “Patients can adjust the hearing aid through a mobile application on their phone. This technology enables users to fit 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.”

For the sake of making something clear: just because someone prefers the way something sounds when they’re self-programming does not mean that that hearing device is programmed correctly to that patient’s hearing loss prescription.

Will the Bose Hearing Aids Work?

If these Bose hearing aids truly work as well as they claim, then they could be a capable option

for individuals with a mild to moderate hearing loss. There are a number of things that we still don’t know about these Bose hearing aids, number one being we don’t know what they’re going to look like. Some speculate that they’ll probably look like a consumer electronic rather than a hearing aid, but at the end of the day we don’t really know until they release it.

Another thing is, we don’t know how much they’re going to cost. These could be really expensive. They could be really cheap on the spectrum of hearing aids. We don’t know the answer to that, either. Bose doesn’t really make cheap products, so I don’t expect them to be extremely cheap, but they’ll probably still be cheaper than hearing aids that require the fitting from a hearing care professional.

Another thing we don’t know is how well these devices will work in real world situations. It is one thing to test these devices in a controlled environment. It is a completely different thing to take these things out into the real world and test them in those environments. Now these devices will likely be able to be adjusted, of course, in a noisy setting, so perhaps the user could find the perfect settings in that noisy situation, but at the end of the day, that really comes down to if the user is actually capable of doing that.

Bose Will Build on Hearphone Technology

Bose has already dabbled in the world of hearing loss with their Hearphones, which are designed to increase the volume of speech that’s around you, and to stream audio directly from a smart device. That being said, Bose is really going to have to step it up from the Hearphones going to the hearing aids, because there’s some serious drawbacks of the Hearphones when it comes to a daily wear device. You can check out my review of the Bose Hearphones as well (

Overall, it’s hard to speculate just how good the Bose hearing aids will be, but they are getting a massive head start on the competition with this FDA marketing approval ahead of the OTC Hearing Aid Act guidelines going into effect. Of course, Bose is going to start marketing and selling these hearing aids before the OTC Hearing Aid Act guidelines come into effect, but until they do, they’re actually going to have to comply with local regulations for hearing aid dispensing. However, I suspect with your ability to purchase virtually any hearing aid online at the current moment, I don’t think you’re going to run into very much red tape with buying these Bose hearing aids really soon.