Bose self-fitting hearing aids are finally here (Bose SoundControl™)

Approved under new self fit pathway, trailblazed by Bose in 2018.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K21100823

Looks bulky. Also, no active noise cancellation?

saw people comparing bose hearing aids against the olive pro & BeHear… starting to wonder what really is the difference here in terms of sound quality. Paying $800 for a non-rechargeable hearing aid doesn’t seem to make much sense to me

Thank you for the post. These look promising considering they are from Bose. Bose was the first to the market with aviation noise cancelling and reduction headphones. I still have a pair from back then.

For me, lack of streaming and battery recharging are a plus not a reduction.

Jeff

Is there any indication that these have noise cancelling ability? I didn’t see it. All I saw was something that suggested directional microphones (like Bose Earphones had)

Well, olive pro and behear are completely different form factors. I would compare these more to the newsound products which offer rechargeability but no streaming, around the same price point from various vendors.

Interesting. Would be curious to know how it works. I know the Hearphones had it for streaming, but only had directional microphones for speech. I remember being quite disappointed about this when I tried out Hearphones and called Bose to make sure I wasn’t missing something.

So they designed it to look as much like a standard HA the public thinks of as possible. Including the putty type of color and air zinc battery associated with HAs the average person is aware of (including me until I got involved in fixing my own hearing loss). It’s a safe strategy for design, trying to look boring, corporate, mainstream appearance, even if dated compared to HAs generally sold today.

Bose always took that approach with their designs (outside of the original Bose speakers back in the 70’s that represented a major break from stereo speakers of that period). Bose also, IMHO, overprices their products. Bose noise cancellation headphones have excellent ANC, but the actual sound is middle of the road at best. Sony offers superb BT wireless ANC headphones for less. They might not look all that fancy, for comparison look at the new Apple over the ear headphones for ~$500, which is gorgeous and a great example of excellent industrial design. But they’re also not $500.

They should have brought this in under $750. That makes it attractive to HAs for several thousand dollars, and almost half of what Costco can offer for their KS aids. This is pushing the price up to where it’s not an impulse buy for most, and maybe doesn’t seem like a super good deal when for what, $500 more, you can get a KS10 professionally fitted by a hearing aid specialist, adjusted by accepted medical audiometry testing, and is rechargeable and streams music and phone calls. And Bose doesn’t get discounted, so you’re not going to shop it out for a lower price.

Personally, having recently run the gauntlet for HAs, I’d be hesitant to have gone this route if it had been released a few months earlier. But that’s a dataset of 1, me, so I wouldn’t put much faith in generalizing it.

It is interesting it’s FSA qualified, so it is fully recognized as a medically acceptable solution, at least by the FDA, which influences the policies of the IRS. It’s like buying an extra pair of glasses before the end of the year to use up your HSA/FSA if it won’t carry over to the next year. Just a lot more money than an average pair of extra glasses (although I’ve seen how expensive those can get with designer frames and cutting edge thin lenses that do everything except wipe themselves clean).

Honestly, this Gizmodo author doesn’t really understand the FDA process Bose went through.

I will humbly beg to differ. IF they received approval based on a “predicate equivalence “ 520(k) approval process I’m quite familiar with the process. No, it’s not fun, but medical devices, in general, do not receive anything close to the scrutiny applied to their drug approval process. I’ll take new drugs out, but to get approval for a generic version of a branded medication which require you to show you can meet the standard of therapeutic equivalence, along with evidence of following GMP, good manufacturing practice, is a nightmare. Sadly, been there, done that (twice) and am glad I’ll never have to through it ever again.

While you do not have to repeat all the clinical trials done for the original NDA, new drug application (you can at least rely on that data for efficacy), the process is beyond painful. Your submission ends up several thousands pages long, showing each step and independent validation of each step, for a successful submission. The water purification system, already approved for the manufacture of other products was some 200 pages long. Then comes labeling requirements where if your artwork was off in text size by 1 pt, you have to complete that all over again. The language is identical to the branded approved text, yet has to be reviewed for approval of the language used. That can tie you up for a month or two (and have them return 6 months later, after your final approval, to say the packaging text color is no longer acceptable). It typically can take 12-18 months for it to be considered complete and subject to approval or denial within 180 days of submission, another 6 months waiting for comments so you can start all over again.

Whereas for a substantially equivalent device, the hurdle is nowhere close to that. Devices from hip replacement joints to pacemakers have gone through that process, usually (ok almost always) based on a prior device that already completed the approval process. In fact you can pull up patents for products that are decades old, yet are acceptable to show substantial equivalence.

I’m not saying Bose did not put a great deal of time, effort, and plenty of money, to get this product to the point of sales and distribution. Bose is also a respected company with a long history of excellent attention to the functionality of their products. I bet this turns out to be a modest success. But the price point is still high, and the objective evidence in performance for the intended use isn’t as developed as what any prescribed and fitted HA could use some help as they seemed to take the subjective opinion of the study participants.

I have not read that article. Maybe I should dig it up. But when you’re claiming it works as well as a professionally fitted HA you should face a higher hurdle to achieve that recognition.

I also reviewed the Bose web pages on the product. From what I read, their use of the term “fitting” refers to the different domes and adjusting the wire length. It is not a fitting in the manner we use it here. It all comes down to their app, and relying on simple controls to “dial in” the perfect settings.

I am truly not knocking the product or the company. But I believe healthy skepticism is useful in deciding if these are worth $850, and if the consumer really gets the hearing correction they need. If it does help a whole bunch of people who would otherwise not have access to a prescribed aid, then it’s a good thing. Hearing loss treatment is so misbalanced with what is the figure, 75% of those with hearing loss never address that issue. Helping even a fraction of that group would be a huge step forward and I applaud any company that takes the design and development of their product seriously, aiming for the best result within the inherent limitations of such DTC products.

On a slight tangent, is it your opinion or knowledge if the RIC they chose was designed and manufactured exclusively for them, or is it a generic RIC with whatever plug design Bose chose to place on the processing/mic/battery compartment?

This is something I’ve meant to ask for some time but felt weird starting a thread about it. Why do we call the speaker of an RIC a receiver? Wouldn’t the mic be the receiver of the sound, and the speaker in your canal is just that, a speaker. So how or where did the label receiver come from?

@eskie227 said:

I will humbly beg to differ. IF they received approval based on a “predicate equivalence “ 520(k) approval process I’m quite familiar with the process.

Assume that was a typo and you meant 510k. Let me address the specifics of the problems with the gizmodo article:

This all sounds great, and truly, the tech involved is impressive. However, health tech is still a sort of wild, loosely regulated frontier, and it pays to be skeptical if you’re thinking about investing in a pair of these. For starters, FDA clearance is not the same as FDA approval, even though many consumers assume that to be the case. This particular product—like most medical devices—was cleared via the 510(k) process. That means the FDA cleared a device because it was “substantially equivalent” to a device that already has FDA approval or clearance—or what’s referred to as a predicate. This makes it easier to fast-track new devices, but critics say the system needs an overhaul as gadgets cleared this way often skip testing and clinical trials—meaning many have had the bare minimum of government scrutiny. There have been cases of safety issues with 510(k)-cleared devices based on outdated predicates. In this case, although Bose has a validation study, one study with a small sample size of 75 participants is not a guarantee that the device is bulletproof. To confuse things further, federal law states that getting 510(k) clearance “does not in any way denote official approval of the device. Any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding.”

The author fails to mention that Bose’s 510k1 was filed against the Self-Fitting Air-Conduction Hearing Aid1 class of hearing aids that was established by Bose in 2018, with a prototype version of the Bose hearing aid. Could there be a clearer case for a 510k?

While I do have some problems with the 510k process, the author should probably save her ire for companies like Eargo and Olive, who have essentially skipped the 510k process entirely and registered as traditional hearing aids (the traditional classes do not accommodate self-fitting or DTC hearing aids). To be clear, I’m not bashing either company, but if you’re looking for holes in the FDA’s process… look no further.

Here’s a snippet from Eargo’s recent SEC filing:

Hearing aids are considered medical devices subject to regulation by the FDA. We currently market our products pursuant to the FDA regulatory framework for air-conduction hearing aids, which are classified as Class I devices exempt from premarket review procedures […] The regulatory landscape for hearing aid devices has been subject to recent changes that may alter or increase our requirements for regulatory compliance. The FDA Reauthorization Act of 2017, or FDARA, created a new category of over-the-counter, or OTC, hearing aids that are intended to be available through in-person transactions, by mail or online without the involvement of a licensed practitioner. Under the statute, the FDA is required to issue regulations to implement the new framework. As part of its rulemaking process, the FDA is required to evaluate whether OTC hearing aids should be subject to premarket review and clearance under Section 510(k) of the Federal Food, Drug, and Cosmetic Act, or FDCA, and it is unclear whether the FDA will subject OTC hearing aids to this requirement or other more onerous requirements. The language in FDARA is not self-implementing, which means that the OTC hearing aid category does not exist until the effective date of a published final regulation. Despite the deadline in FDARA for the FDA to issue proposed regulations by August 18, 2020, the FDA has not yet issued a notice of proposed rulemaking or indicated how it will implement the new OTC hearing aid pathway. We market the Eargo system devices as Class I exempt air-conduction hearing aids under existing regulations and are not dependent on the FDA’s issuance of OTC hearing aid regulations for the marketing of our products. However, our devices may become subject to additional requirements in connection with such regulations in the future.

In addition, in May 2018, the FDA granted a de novo classification request from Bose for a direct-to-consumer “self-fitting air-conduction hearing aid,” which is classified as Class II and subject to 510(k) premarket review. We do not consider our devices to be “self-fitting” hearing aids similar to the recently cleared Bose device, but the FDA could disagree. While we expect our products to continue to be regulated as Class I exempt devices, our products could in the future be deemed to fall under the definition of a “self-fitting air-conduction hearing aid” or an OTC hearing aid, in which case we could be required to seek 510(k) clearance for our products or otherwise comply with additional regulatory requirements associated with these new pathways. In such case, the FDA may require us to remove our devices from the market while we seek FDA clearance. In addition, even if our current products remain Class I exempt devices, it is possible that any future products we may develop could fail to meet the requisite criteria for similar regulation and could be subject to more stringent requirements and premarket review, increasing our costs for regulatory compliance.

I guess what I’m saying is Bose did things by the book and went above and beyond to prove that their products work. This is more than can be said for a lot of the products on the market.

@eskie227 said:

I have not read that article. Maybe I should dig it up. But when you’re claiming it works as well as a professionally fitted HA you should face a higher hurdle to achieve that recognition.

Yes, you should. It’s very good.

https://journals.sagepub.com/doi/10.1177/23312165199005898

@eskie227 said:

On a slight tangent, is it your opinion or knowledge if the RIC they chose was designed and manufactured exclusively for them, or is it a generic RIC with whatever plug design Bose chose to place on the processing/mic/battery compartment?

I do not know. If I learn more, I will let you know.

Why do we call the speaker of an RIC a receiver?

It receives the output signal from the amplifier. Yes, it’s confusing to me too.