Here’s an article from Gizmodo. Interesting take from a tech site on the product and the approval process that was actually followed (this method has been used for devices in the past and it doesn’t guarantee a perfect outcome), and the size of their test group which they’re basing their claims on (sorry, but in my book, 75 isn’t a lot to feel secure with).
https://gizmodo.com/boses-fda-cleared-hearing-aids-are-cool-but-you-should-1846870216
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?
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 510k was filed against the Self-Fitting Air-Conduction Hearing Aid 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.
Yes, you should. It’s very good.
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.
Some suggest that the original origin of the term “receiver” is with the telephone and Alexander Graham Bell’s view of how sound was transmitted over a wire. Harvey Dillon on page 11 of his 2nd Edition of Hearing Aids simply notes that, “Microphones used to be called transmitters, which explains why something that emits sound should be called a receiver,” PRR provides more details on Bell’s thinking and mentions that original analog electronic hearing aids used to incorporate some telephone parts: Why is a hearing aid speaker called a receiver?
First, yes that is a typo. Between using my phone to post and the idiotic autocorrect that still hates my use of HA when I type, my posts are rift with typos. However, autocorrect is not responsible for that one. I did it all on my own.
The predicate is based on their 2018 De Novo application for a self fitting hearing assist device. The product approved at that time (if I’m not mistaken, the form factor they used were headphones) was not marketed to the public (in which case I totally missed the boat).
I imagine much of what is in the current product such as the sound amplification circuitry and software are close enough to support the approval, despite the new RIC design. So yes, I do recognize the time and commitment made by Bose was quite significant. But it still falls outside the OTC hearing aid classification legislation that thr FDA has still not come up with final guidance on.
While the eventual “true” approved OTC devices will likely take a similar form factor and the principle of self fitting design, I really want to see how the FDA approved products actually work and the retail cost of those products compared to prescription HAs. As these were approved as DTC with limited claims and instructions regarding the target audience and push to referral to a HA specialist with certain symptoms, and the offered phone support (they leave it a bit nebulous if those are licensed hearing aid specialists or just a product support line with CS agents who run off a prompted script designed to provide more detailed guidance) they may represent what the final rule looks like as a standard to be met. But the may or could or whatever is far from certain until issued. No doubt it does represent a shot across the bow for the prescription HA industry to get on board pretty quick to be ready for the wide OTC market that’s heading towards them.
Oh, and thanks on some info on the terminology. It initially struck me as one of those “why do we park on a driveway and drive on a parkway?” things. 
My guess is the FDA will look for a quick win and just borrow the language from the de novo class and write “OTC Class” on the top. Watch and see 
Yes, in my article I explained that the De Novo was done on a set of earbuds that resembled the Bose Hearphones… but my understanding is that Bose was able to replicate the performance of the hearphones with the new soundcontrol aids with the exception of matching low pitch output. But that’s to be expected and in line with the performance of every other RIC aid.
Might I just say that while Bose self-fit hearing aids seem to have some limitations and functionality at their recent launch…
…does this mark the way of the future for hearing assistance for those of us who are audio-challenged?
This launch represents a true milestone for the industry in the sense that the SoundControl is the first truly legitimate self-fitting hearing aid, and the self-fitting process was rigorously validated. The background technology for self fitting has been around for at least a decade with the Ear Machine app, and this new RIC merely represents a fully legal RIC vessel to deliver this robust self fitting approach in a consumer friendly form factor. I suspect this is just the beginning and that wireless connectivity / rechargeability will be in the next iterations.
Next up if they do use this as an outline fir the OTC crowd will be FDA approved, which sounds strong, although the general public likely thinks cleared and approved are the same thing.
Even if this doesn’t motivate the final rule guidelines, it does open the door for other companies to now use this device as a predicate for “clearance “ by the FDA under the same rules Bose used, so long as they can show a self fitting process that’s appropriate for the intended market. That can let them make the same claims, provide a support system similar to Bose (still wish I knew who trained their phone support staff and how much help they can actually provide), and not have to sit around another year before establishing themselves in the marketplace. Hopefully at a lower retail price than Bose went.
Does anyone know why they’re initially being sold in only 5 states? And why those 5?
How do the specs on this new product compare with the now-discontinued HearPhones from BOSE?
They’re probably too busy to enter it while they’re trying to figure out what and if they can do anything about Facebook.
I bought a pair and so far I’m impressed. I’ve had a pair of Signia Cellion 5 which I paid about $4K for and have been using for about 4 years. The right one stopped working and by accident I saw that the Bose were on sale on the first day they offered them. I received them last night and set them up and I’m on my first full day using them. I think they’re at least as good and at a quarter of the price. I had an online meeting this morning and it’s the first time in years, with or without hearing aids that I’ve actually been able to hear it. I imagine that these are going to upset the applecart in the hearing aid industry. These are too good to dismiss or discredit. I’m guessing that each generation is going to get even better. This is going to be good for people that can’t afford 3-4-5 K for hearing aids.
Congratulations, glad to hear you are happy with the Bose Sound Controls.
Would You mind sharing your audiogram. This is very important for others interested in these hearing devices.
I don’t think it will fade away. There are way more people with hearing loss over the fraction that get professionally fitted HAs. The need is too great and with more positive endorsements, will only get more popular.
ok, but what kind of loss do you have?
(from the