FDA allows marketing of first self-fitting hearing aid controlled by the user


#1

FDA allows marketing of first self-fitting hearing aid controlled by the user

FDA News Release
October 5, 2018

The U.S. Food and Drug Administration today allowed marketing of a new device, the Bose Hearing Aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment (hearing loss). This is the first hearing aid authorized for marketing by the FDA that enables users to fit, program and control the hearing aid on their own, without assistance from a health care provider.

“Hearing loss is a significant public health issue, especially as individuals age,” said Malvina Eydelman, M.D., director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA’s Center for Devices and Radiological Health. “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. The FDA is committed to ensuring that individuals with hearing loss have options for taking an active role in their health care.”

Approximately 37.5 million adults aged 18 and over report having some trouble hearing without a hearing aid, ranging from “a little trouble” to “deaf.” Hearing loss can be caused by aging, exposure to loud noises, certain medical conditions and other factors. Hearing loss may be permanent or temporary. Individuals with permanent hearing loss can use hearing aids to help them hear the speech and sounds around them better, enabling them to communicate more effectively with others.

The Bose Hearing Aid is a user-fitted wireless air conduction hearing aid. Air conduction hearing aids work by capturing sound vibrations through one or more microphones. The signal is processed, amplified, and played back through an earphone placed in the ear canal. 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.

While users may fit, program and control the Bose Hearing Aid on their own, the device must comply with applicable federal and state laws regarding the sale of hearing aids, including state laws that might require hearing aids to be purchased from or dispensed by a licensed hearing aid dispenser. The FDA is in the process of drafting proposed regulations for a new category of over-the-counter hearing aids as required by the FDA Reauthorization Act of 2017.

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. The Bose Hearing Aid has been labeled to inform the consumer when to consult a hearing health care professional.

The Bose Hearing Aid was reviewed under the FDA’s De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no prior legally marketed device.

The FDA granted marketing authorization of the Bose Hearing Aid device to Bose Corporation.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


#2

Is this the same as Bose Hearphones?


#3

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm622692.htm


#4

Any idea when it might become available or about pricing? I am newly diagnosed with hearing loss and looking at my options.


#5

This is wonderful news. It will benefit so many people. While Bose products tend to be quite expensive, this will be the beginning of many such products from other companies, and the market will make prices competitive. This is the beginning of the end of current hearing aid providers stronghold on hearing aids.


#6

Bose? You gotta be kidding me. I sure hope they bought another company to do this.


#7

The Bose Hearphones are no joke. I’m sure these will be comparable or better.


#8

This is going to be a game changer in the HA industry. Dare we say Adios to $5,000 + hearing aids. The industry has had it too good for too long. They’ve taken advantage of tens of thousands of people with their overpriced, underperforming products.


#9

What fraction of HA users would be capable of self programming?


#10

they are big and clunky, cost around 500 bucks, and battery life is short, not something you can wear all day


#11

Understand that a perscription is necessary, correct?


#12

Sounds intersting…where did you get a chance to see them? Thanks


#13

Well I’m hopeful since they certainly have done well in the noise canceling headphone arena. First impression (of the web page) is “ugh”. A tone control. That century old bastard child of EQ. Where treble is opposite bass. If you don’t follow, a tone control dials up for treble and down for bass. The preferred route is separate bass and treble controls because they are NOT mutually exclusive. You can see it in the app screen shot on the web page. I sure hope that isn’t for real.


#14

What blows me away about this announcement from the FDA is the high percentage of people you tried these Bose aids and tuned it themselves actually preferred the way they did it over that of the audiologist.
Not for a second would i think this could be universal, but for ‘some’ people, certainly plenty I know, this would be the difference between being able to afford and not afford something to improve their hearing.

I’m super happy with my new Rexton CICs, and would not consider these Bose devices as being anywhere in the same class, but gee I’d love to have a spare pair to lend to friends to show them how they could improve their situation for minimal cost before perhaps a later migration upward.


#15

I will be trying them out, at the very least for when I am at home watching TV. I have never felt like any audiologist (and I’ve had about four) can understand what I’m trying to tell them about how the fitting is, and I always wanted the ability to tinker with it myself. I’m a techie, so it has driven me crazy to have to sit there and try to explain to a person who can’t hear what I’m hearing “no, that crinkling of the paper you’re doing doesn’t really tell me anything.”

My current HAs are six years old, but my latest audiogram is unchanged (eight years running now), and I’m an Android person and am not making any moves until HAs start working with my phone.

It’s also always driven me nuts that I can enjoy pure clear sound when listening to music or tv with headphones, but my HAs make the world sound like it’s all coming through via AM radio. I might tip the scales toward a company like Bose to pay a bit more attention to the quality of the sound.


#16

Depends on what the FDA decides. In my state, MN, you do not need a prescription to get hearing aids since Jan. 2017.This is definitely something I would have considered getting, but when I threw it past my ENT yesterday, he said my hearing in one ear is too poor for it. The Bose technology, at this point, won’t address severe hearing loss. :frowning: I wish I could have put off hearing aids for just another couple of years - would save a lot of money, I think.


#17

Interesting blog on this topic. I’m not sure if hearingreview is a competitor site to hearingtracker, but I’ll assume that posting this is ok (until told otherwise).

http://www.hearingreview.com/2018/10/blog-observations-fda-granting-de-novo-status-bose-hearing-aid/?ref=fr-title


#18

There was an article about the entry of consumer electronic companies into the HA market in SciAm a couple months ago.

I’d be interested in how different this is from the AmericaHears aids + computer adapter & software. I tried this back in 2010, but wasn’t thrilled. I’m a computer guy through & through, but found that I was inept when it came to know what adjustments to make.


#19

I don’t think anyone’s actually seen it yet, so nobody knows. I used a self-fit hearing aid for about 6 years (Blamey & Saunders) which was a lot better than my previous audiologist-fitted aids but not as good as my current audiologist-fitted aids.

2Pi is one company that seem to be working on self-fitting apps. Nuheara already have one for their IQ Boost product. Mimi are trying to claim part of that space too perhaps?

My impression is that fitting aids is an algorithmic thing anyway (assuming straightforward vanilla sn hearing loss). There are steps to follow in a particular sequence. At some point, you might have to go back a few steps and repeat until some condition is met before moving on. I’d love to try an evidenced-based and creatively designed interface for self-fitting.