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Bose Hearing Aid FDA Approval | Self-Fitting Hearing Aid

By: Dr Cliff Olson
October 9, 2018
Video Transcript

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/6Rbf87bmPNQIt 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.

Dr Cliff's Thoughts

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 (https://youtu.be/6Rbf87bmPNQ).

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.

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