First Look at the Bose Hearing Aid
Hearing Tracker has gotten a first look at the FDA's documentation for the much-anticipated Bose Hearing Aid. The product’s physical form factor looks nearly identical to the consumer-electronic giant's last hearing-assistive product, the Bose “Hearphones”. But the Bose Hearing Aid is the first FDA-approved hearing aid in a newly-minted category of products known as "self-fitting air-conduction hearing aids."
 "Bose Hearing Aid")
Left: Bose Hearing Aid (Source - FDA Filing), Right: Bose Hearphones (Source - Hearphones User Manual)
Clinical findings
The FDA’s summary of the Bose hearing aid is the second shoe to drop following the October approval of the company's fast-track "De Novo" application for the new product. In addition to providing a detailed description of the product, it says clinical findings demonstrate the Bose self-fitting hearing aid "provides performance benefit consistent with that of the same hearing aid fitted by hearing professionals."
The Bose Hearing Aid provides performance benefit consistent with that of the same hearing aid fitted by hearing professionals for individuals ages 18 and older with mild to moderate hearing loss.
FDA Summary
A new category of self-fitting hearing aids
According to the FDA, the Bose self-fitting hearing aid is intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. It is adjusted by the user to meet the user’s hearing needs. No pre-programming or hearing test is necessary. The device is intended for direct-to-consumer sale and use without the assistance of a hearing care professional.
In its summary, the FDA defines a new class of hearing aids:
A self-fitting air-conduction hearing aid is a wearable sound-amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings.
FDA Summary
No clues on release date
Although the latest FDA documentation clears the way for Bose to sell its new Hearing Aid, the company has remained mum about when it plans to go to market. The company was unavailable for comment this evening.
Hearing-aid earbuds slung from a flexible neckband packed with electronics
The Bose Hearing Aid looks like the popular Bose Hearphones, with a flexible neckband housing a rechargeable lithium-ion battery and electronic components with extending cables for the right and left ears. Earbuds are connected to the neckband by flexible wires, with an ear-tip mounted on each earbud. Three sizes of tips are packaged with the product so that the user can choose the optimal size.
The Hearing Aid has two microphones in each earbud that may be configured in omnidirectional or directional modes to enhance understanding of speech in noise. Active noise reduction using “feedback and feedforward control loops” reduces environmental sounds, with power from a rechargeable 3.7 V, 250 mAh lithium-ion battery pack.
Like the Hearphones, the Bose Hearing Aid will feature Bluetooth audio streaming from smartphones, for both music and phone calls.
Self-fitting software with mobile "Bose Hear" smartphone app
The Bose Hear mobile smartphone app works with both iPhones and Android smartphones. Bose Hearphones users will find familiar device configurations including "World Volume" and "Treble/Bass" gain settings. The settings are preserved between use sessions and the settings from the previous session are recalled upon power-up of the device.
 "Bose Hear App")
Screenshots from the Bose Hear App for Bose Hearphones
A set of manual buttons located on one of the cables from the neckband can also be used to adjust both the "World Volume" and directional mode.
Hearing Aid Features
Hearing aid signal processing includes 12-channel wide dynamic range compression amplification with compression thresholds fixed at speech-equivalent 52 decibels (dB) sound pressure level (SPL). Noise reduction is continuously active, lessening environmental noise and decreasing amplification of the user’s own voice.
Additional features include:
- Feedback cancellation
- Steady state noise reduction
- Directionality (three modes controllable by user)
- Impulse noise control
- Left/Right balance
- Bluetooth-compliant 2.4 GHz wireless radio for streaming audio, telephony, and control
- Microphone array to help clarify voices on phone calls
- Volume-optimized audio equalization (selectable high-frequency boost when listening to streamed content)
- Voice prompts
- Battery life of approximately 10 hours
- NFC pairing for compatible Android devices
Clinical tests satisfy FDA that self-fitting software works
A human-factors study, non-clinical bench tests, and two clinical studies satisfied the FDA that the Bose Hearing Aid will be safely deliver on the promise of self-fitting software for people with mild-to-moderate hearing loss.
Among two groups of users, one with a professional fitting and one that used the self-fit software, the studies concluded that:
- Subjects in the self-fit group were satisfied with (or preferred) their own settings to the professionally-selected settings more than were/did subjects in the professionally fit group.
- The subjects in the self-fit group rated themselves significantly happier with the sound quality than did those in the pro-fit group.
- There was no difference in speech intelligibility benefit between the self-fit and pro-fit groups.
The report concludes that the clinical data support the claim that the Bose self-fitting hearing aid "provides performance benefit consistent with that of the same hearing aid fitted by hearing professionals for individuals ages 18 and older with mild to moderate hearing loss."
Hearphones’ kissing cousin
The form factor of the Bose hearing aid, with its neckband and wired earbuds, is unlike other hearing aids. But it’s proven to be popular with consumers in the guise of Bose Hearphones.
With Bluetooth streaming of audio from smartphones and user-adjustable sound, the $499 Bose Hearphones are a logical stepping stone to a product with user-programmable hearing aid capabilities.
But unlike the Hearphones, you can’t buy Bose self-fitting hearing aids in a Bose store, from Amazon, or from your local electronics store. So the most important question that remains to be answered is, “When?”
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There's no reason such a device couldn't be used as a CROS or BiCROS aid*. But I would hesitate to recommend an over-the-counter device for unilateral loss, at least not knowing what the etiology of your hearing loss is.
*CROS (Contra-lateral Routing of Signal) is a hearing aid technology for people with unilateral hearing. A BiCROS implementation is for users with little or no hearing on one side, and with some hearing loss in their better ear.
I’m totally deaf in my left ear. A couple of years ago I bought a pair of Hearphones. They were perfect for me. I’m sorry to say they didn’t pass the crucial test (for me): noisy restaurants. I had lunch at a noisy restaurant, with a table of eight people. I was disappointed . I returned them.
Will the hearing aids solve the noisy restaurant problem? I’m “skeptically optimistic”.
The poor sound quality of many hearing aids seems to be related to the microphones rather than the speaker. I have a new phonak ha and speech and music are truly outstanding via bluetooth.
Using the microphones it's nowhere near as good
I have owned my hearphones for over a year and the sound is close to their best noise cancelling headphones, great quality, full sound. The app works great controlling tone, direction and volume. I am a notary public and am trying to use regular hearing aides at the office but the sacrifice is brutal. Once you try hearphones you won't go back.
Steve
The problem is the "lifetime" of uneeded or unused service paid in advance.
Whose lifetime yours, mine, your business, the device?
What other business charges for lifetime service in advance?
Particularly with older folks lifetime the odds are in your favor.
Hardware sale includes fitting and choice of good , better or best service packages for after sale. Manufacturer warranties the devices.
Have had 2 sets of hearing aids fitted by a hearing professional and tried different hearing aids. Wearing hearing aids for 5 + years. Purchased the bose hearphones over a year ago and I can hear better than with hearing aids at about one tenth of the cost of hearing aids.
You hit the nail on the head, Bose Hearphones are far superior to to my expensive hearing aides and I can actually stream movies and tv like being in the theater!
I sound like an audiologist?! Excellent! I am! Audiologists are actually qualified to make these statements, so I'm very glad you noticed! Allow me to introduce myself: I have my AuD, I have been in the profession for 20 years, I'm a caring, ethical healthcare professional who has helped many patients live a better quality of life and not a week goes by that I don't shed a tear for or with a patient. Not a week goes by that I'm not thanked by a patient for my care and that i'm not thanking that patient for being an awesome person and patient. I've worked for the VA for ten years. Why? Nobody had to pay at the VA. I wear hearing aids myself. Why? I have high frequency hearing loss and terrible, bilateral tinnitus. I've talked MY patients out of suicide. I've turned in hearing aid dispensers/hearing instrument specialists in to the state board for treating patients poorly or unethically. I have paid THOUSANDS of dollars to my national and state organizations to lobby on Capitol Hill for hearing impaired rights and insurance coverage for hearing aids! An audiologist does this because they are in health care to HELP PEOPLE! I'm very passionate about this and I beg of you, implore you, to consider the FDA, insurance companies and many (not all) hearing aid dealers/ hearing instrument specialists are the folks you need to cast blame upon. Audiologists are not hearing aid dealers! We have so much more that we specialize in! I have many days that I don't touch a hearing aid. Why? Vestibular eval, treatment and rehab, pediatrics, neonatal hearing screening, auditory brainstem response, Ecogh, tinnitus eval and management, industrial audoology.... the list is long. Please educate yourself on what audiologist is before you throw the entire profession under the bus. Please. Godspeed.
PS. Also check out our average salary. That will give you an indication of how "rich" you may think audiologist's are getting on hearing aids. It's a doctoral profession, so you would expect six figures, right? Wrong. I drive a used 2016 Honda Civic EX and 2001 F150 in the winter for a reason my friends. :) There is no Mercedes in my driveway.
The device is NOT called "headphones";
It's called "HEARphones"....big difference...important
Way to go!
I'm a speech pathologist, so I know from whence you speak!
I have moderate to severe, bilateral hearing loss...have worn hearing aids since 2012 (I'm 68 years old) and I've struggled with noise, for many years, especially, with my hearing aids (Oticon and then Phonak)...Recently, I bought the Hearphones, after doing lots of research and having dreams about the noise reduction feature..WEll, sorry...although I have also always recommended that HOH people should ONLy visit audiologists, for evaluation, treatment and continued follow up care, I must tell you that I've stopped wearing my hearing aids...(very costly too, I might add) and I'm exclusively using the hearphones...EVERYTHING they promise, they have delivered. I can now go to noisy places with friends and I can hear specific people talking, over the the din of the background noise! And...of course, there's also the savings feature...$499 as opposed to THOUSANDS of dollars for my hearing aids.
My hearing aids are now sitting in their case...I never use them. I exclusively use the Hearphones device, wherever I go.
I still think that audiologists are talented, very highly educated professionals, who really know their equipment and who are so helpful to patients, in terms of education about communication strategies, technology, etc.
But, I'm thrilled with my hearphones and I would buy them over and over again..
The whole way in which congress allowed for OTC aids is totally lame. It is about as anti-innovation as one can imagine, and so typical of the government. Virtually all innovation occurs iteratively, gradually, with micro changes. This approach is the opposite. Bose has to jump through hoops to "prove" the efficacy of their device to aparratchniks at the FDA. The cycle time will be so stretched out as to render the bill meaningless.
With such a huge potential market, a free, unfettered market would generate immense benefit to the consumer. That will not happen as long as the FDA is involved.
Congress finally reacted to the overcharging and price fixing currently existing in the hearing aid market. The market will decide whether or not these are a good product. Why restrict competition (unless you are a traditional audiology practice).
No hearing aid on the market can replicate natural hearing. Any such claim is bull. Also, not everyone wants to be hands off with their hearing aids. I find that current hearing aids are not smart enough to know what I want and need such as when to apply more or less noise suppression or directional patterns for best reception of voices in noisy environments or when I want to tune out everything but streaming audio from my phone or computer.
Also Starkey fell out of favor within the culturally deaf community last year when it was revealed how Starkey percieves the deaf community.
Good! Now another supplier is entering the marketplace.
Phonak has AI as well lol. Already done folks. Also, no hearing aid on this planet replicates normal hearing.
See my comment above about audiologists. WE are your friends, not your foes. There are many audiologists that are hearing impaired and wear hearing aids, so let's go ahead and level that playing field. What the layperson is trying to do here is the exact same thing a patient does when they google their symptoms, diagnose themselves, and then demand a particular prescription for their self-diagnosed illness. This is a problem in all healthcare professiona. MDs have an MD for a reason. AuDs have an AuD for a reason. Do you feel qualified to do what your cardiologist does? If you do, you're going to need to go on back to school for a few years and prepare to be disappointed. You're not picking out a surround sound system for your home theater! You need the full CARE of an audiologist who takes CARE of your healthcare *specific to the ear and psychology, anatomy and physiology of all of that pertains to such*
I don't have the time to type ask the reasons, because I am at work helping people with their dizziness, vertigo, tinnitus, communication, and hearing loss is just a small piece of that pie.
Godspeed
They look identical. Maybe some more "smarts" have been added. NOTE: I'm 75 years old and own TWO PAIR of BOSE HearPhones (so I can charge one while the other charges. I also have STARKEY HALO hearing aids and PHONAK MARVEL.
The BOSE HearPhones are BETTER than my Starkey's, and ALMOST AS GOOD as my Phonak Marvel. I don't like the YOKE AROUND THE NECK, but for "almost as good", and a CONSIDERABLE $ savings, I LOVE the Bose! And for STREAMING, the Bose are head and shoulders ABOVE both the Starkey and Phonak.
Anxious to see the new Bose Hearing Aids!
I have 2 Bose Hearphones that I regularly use and control with the iPhone app. You are correct, there seems to be no way to control the local (or vocal) sound in the app, an appalling oversight. There is a wheel to control ‘World’ or background/environmental sounds, but nothing in the app I’ve found to manage the pickup of vocal or local sounds. To do that you must use the + or - buttons somewhat inconveniently located on the body of the yoke. Also, I’d like to be able to increase the local sound level one or two levels above what’s now allowed.
On the whole, I’m very pleased with my Bose Hearphones and use them routinely in preference to my $6,500 Phonak’s. I do not feel any need for an audiologist’s assistance in fitting or tuning my Hearphones.The key words in the FDA report are ".....with mild to moderate hearing loss." The results for you are entirely dependent on the hearing loss you have. I am not sure how, but you might want to try them before spending the money.
Not enough info from Bose about how it handles MUSIC: Can user adjust compression? At different points in the band? Does the device cover the musical range, at least down to 100 Hz, but hopefully 40 or below as ordinary earbuds certainly can?
The hearing aid industry, and I have to add audiologists and their trainers, at least in UK, have a lot of catching up to do to think beyond mere speech intelligibility between 250 and 4 k. We are still being fitted with aids that kill music because of their feedback suppression and other issues. And not even offered a 'music' option, unless we agitate.
Well the Bose Hearphones broke the code!!
They also broke the financial code at Bose. I have had numerous hearing aids and the original Bose Hearphones were terrific in loud places and noisy restaurants AND HIGHLY REVERBERANT Theaters like the Dorthy Chandler here in LA! I could not get a hold of any of the management at Bose Health. Easy to communicate with their Pro sound system folks. They also abandoned their in canal product but licensed it to Lexie (Powered by Bose)
There are lots of these online now and I think the Asian manufacturer is shipping them now. I have a problem with prescription units shifting the pitch of sound THEN when I play piano without them MY sense of pitch is totally screwed up! A B for example sounds like a B flat! Grrr!!! There are some very advanced In Ear Monitors (7 to 10 transducers in each one!) and if you look at an IEM, A truckers (Blue Parrott) headset, and the Bose Hearphone you just might realize what are the future possibilities!
As they say in the home theater business. No highs , No lows, they must be Bose.
Good luck
Exactly this!!! The professional is the engine that drives the car- without the engine the car wont run. If they had any idea the complexity of what goes on during hearing aid fittings to help a listener feel comfortable and receive benefit in their everyday environments, they would never make the statements above.
side note-Hearing aids are so small and discrete, especially for a patient with a mild to moderate hearing loss. why would someone want to walk around with this thing on them anyway??!
I wear (overpriced) Oticon's, moderate loss both, I also wear cordless (BT) ear buds for gym workouts. The cord behind my head using the BT's is a PITA or PITNeck, not really a pain, but a bother. I cannot imagine wearing this neck collar/choker all day would be fun.
2 cents
I agree with you. I like the look and I LOVE that nothing is going to fall out and get lost! I can see some age groups being more hesitant than others that are used to having sound plugged into their ears anyway
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The benefit a patient/subject receives from a device is determined ALWAYS on several things...
A. the technology in the device
B. the individual who has adjusted it and their skill in doing so
C. the user’s understanding of how to use the device (adjustments, maintenance, proper wear, etc.)
Just because a device has a feature or certain technology (take for example a directional microphone for noise reduction) does NOT mean it is equivalent to another device with the same feature. Technologies are used differently and to different effect in differerent devices. Each manufacturer (and even within a given manufacturer’s product line) applies technology differently. So there are differences between manufacturers and within a given manufacturer’s product line.
PRICE MEANS NOTHING BY THE WAY other than to say what you paid. What I mean by this is that it doesn’t assure you of anything about your benefit. It is relevant, yes, but one could say, “I spent $10,000!”, but that amount does not assure one of better benefit than spending $4000 or $6000. Noting the price of the device is simply a statement about how much you were willing to pay for what was sold to you and sometime is money well spent if your hearing aids work and sometimes money wasted if they don’t!
The individual adjusting the device DOES MATTER. Interesting way Bose/FDA stated (don’t have the exact wording now that I’m commenting-see article above) the device was set equally well for speech understanding by a professional as it was by the consumer and moreover, consumers preferred the way they themselves set it rather than the way the professionals set it for quality of sound. Firstly, I haven’t read the white paper/peer reviewed research where Bose shows their methodology and statistical analysis to prove the statement they claim, but for the sake of argument, I will assume it to be scientifically rigorous opposed to flawed or poorly designed. It is obvious to me that a professional would be equally adept or put at a disadvantage in fitting this device as it isn’t fitted by using traditional HEARING EVALUATION results to adjust the device. Real ear (a verification technique) presumably wasn’t used either to verify the fit as there is no mention of it. Real ear is the most well accepted method of verifying a hearing aid fitting (although not the only method). So I’m wondering how Bose knows the device was “equally well fit” by either consumer vs. professional except by consumers’ subjective report. If so, the methodology was indeed flawed as the consumer will rate the professional adjustment against their own adjustment which is biased as there is no independent rating system. Ultimately, a patient/subject making adjustments will be able to make a device “sound” more pleasant as they are the one perceiving the sound quality while the device is manipulated, so no surprise there. However, the question isn’t really whether the professional and consumer can equally well adjust the device or whether one does so better than the other, the real question is, is the device set to provide the patient/subject with the best ability to hear and communicate! I argue that what is being promoted by Bose as the professional vs. the consumer adjusting the device equally well really means nothing when what they are trying to have the consumer believe is that the device offers the SAME benefit as PROFESSIONALLY FIT HEARING AIDS. This is NOT what Bose tested based on the above article but it is what they want you to take away from what they said. Bose is comparing adjustment of their device only by a consumer vs. professional NOT Bose device vs. professionally fit hearing aid benefit.
Again, the individual who adjusts the device matters! In the comments above, many talk about their brand a, brand b, brand c hearing aids. If the professional adjusting your hearing aids doesn’t adjust them properly. You could spend a million bucks and it doesn’t change the fact you won’t be able to hear well. When buying professionally fit hearing aids, invest with a provider who impresses you that they know what they are doing or your benefit will suffer for it.
Lastly, the consumer and how they maintain and use the device also makes a difference in the benefit achieved. Do you know how to keep the device clean? Do you know when to use your program button most effectively? How should you position your body verses the signal you are trying to hear vs. background noise around you. If you don’t perhaps your provider didn’t explain it, or perhaps you need a refresher course, but again it goes back to having a good provider who can help you when you need it.
The Bose device IS less expensive, but it’s because it has no professional assistance and no scientific verification of benefit. The federal government failed the US public by passing the OTC Act when they should have passed mandatory insurance coverage for professionally fit hearing aids.
The proof is in the pudding. When the new devices are available, simply take them for a test drive and see if you are helped. Furthermore, they will only get better as the technology improves.
Does anyone have an idea as to whether or not the cost will be eligible for an Income Tax deduction?
Ernie
I have the "Bose Hearphones" and I love them! They made conference-calls possible again.
I can't wait for the upgrade. My only complaint are the wires make the device look like grandma glasses.
Right on, I own hearphones, waiting for something smaller and knowing Bose it isn't far away. I hope
From the horse's mouth regarding a future Bose hearing aid
Today I chatted with Steve Rosenthal from Bose. I have his direct number. He says the hearing aid just approved by the FDA will be different to the Hearphones. It will be smaller and look more like a traditional hearing aid. It will not look similar to the Hearphones. He's thinking they'll have something out in, like, a year. He says they don't think of the Hearphones as a hearing aid, per se, but an amplification device. Personally I think they work great and I can hear in noisy environments and what all.
Interesting comments and all helpful.
I agree that Bose/FDA are saying that the Bose device is not compared to hearing aids but to itself . That is compare the Bose when done by a professional to the Bose when done by the purchaser. The Bose May or may not be equal to hearing aid if both done by a professional.
Bose has advantage and disadvantage of greater physical size, so sound is inherently better. More pleasing subjectively of course. Question is at what ranges are hearing aids better. Any objective info out there? Any info on the quality of sound on both systems?
That's very interesting! On the original application Bose made, the new hearing aid was going to look like the hearphone. If, instead, it will be smaller that will please many people who prefer something more discrete. On the other hand, if it makes the receiver smaller then Bose, even with their experience, are going to struggle to replicate the sound quality. Do you have access to any further information you are able to share?
They are great replacement for $5000 hearing aides if you can live with appearance. I work with the public and get looks like I am not paying attention to them.
You're making assumptions reference to design and capacity of an unknown product. Bose has enormous - repeat, enormous - financial and political advantage, in part because Bose supplies to all relevant defense branches and their respective divisions. This results, among other things, in engineered derivatives sold publicly for the benefit of all. Even after particular capabilities of these released products are down-mediated, they are still substantially advanced in the market.