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?
It is curious that (from the
Owner’s Guide) doesn’t show up in a search of the FCC database.
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.
This has potential to help a lot of people who might not get treated for hearing loss due to cost. I will be interested in seeing how the technology develops over time or will it fade away like its predecessor.
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?
Thanks, kjp111, for your review. Do you live in one of the 5 states they’re selling to right now, or did you find a workaround for that. I’d really like to get a pair, but they’re not available in Michigan right now.
I wonder, if they get taken seriously as a hearing aid manufacturer, if Bose will come up with a more-consumer and less-medical looking device. I don’t know why all the manufacturers aren’t offering some kind of ear bud form factor by now. And I’m still pissed at Bose for thinking Bass and Treble are mutually exclusive. If they have a good money back guarantee I think a lot of fence sitters will try these simply to skip the audiologist (which would cement the idea they really do have certified bad hearing).
We will see they have a history of devices coming and going. I like this idea and it has potential. I will want to see where they go from here.
just got mine today. At this point I’m impressed, but will know more in a few weeks. I have slight hearing loss in low frequency’s but moderate in highs. First HA’s other than some cheap amplifiers off of Amazon I’ve used for a year. Had a conversation with a neighbor tonight, and was the first time I understood everything she said. This in spite of 3 dogs barking the whole time. I’m surprised how good they work so far.
I like that they don’t have rechargeable batteries, and are very small and comfortable. We will see what I think of them this time next week.