Envoy Medical Receives FDA Breakthrough Device Designation for Fully Implanted Acclaim Cochlear Implant

https://hearinghealthmatters.org/hearingnewswatch/2020/envoy-medical-fda-acclaim-cochlear-implant/

Just so everyone isn’t confused, this doesn’t mean this thing has FDA approval. Not even close.

Here’s their patent, it was only awarded on my birthday this year: United States Patent: 10646709

It uses the middle ear as the microphone rather than an implantable microphone like Cochlear’s fully implantable devices.

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Interesting but also very confusing. FDA did not approve device, so the game is still in the first or second inning. A so called “break through device designation” doesn’t mean much these days. And though I did not read article thoroughly I don’t see anything mention as far as power source? As in what type of power to drive implanted cochlear implant and how long will that power (battery I suppose) last?

Until there is a proven way to power an internal implanted CI, all the other stuff really doesn’t mean anything.

Ive been following this company for over 15 years dating back to when they were going through clinical trials for their middle ear implant device. If finally came to market about 10 years ago and patients seem very satisfied with so it appears they have the infrastructure in place for a fully implantable cochlear implant.

I know it’s not even close but that might be worth a look for the deaf wrestler on this message board!
@dwolenik

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@spectrumplay I believe it’s battery operated, similar to that of a pacemaker. If this is fact it means the battery compartment will need changing every so often.

I think I’ll stick to my CI and rechargeable battery.

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Some day we will see a completely implantable CI but that day is probably ten years off. Medical Science can’t figure out how to power the CI behind someone’s skin or skull. An implantable CI has been on the drawing board for probably twenty years and the “chalk” is fading badly. What was really impressive six/seven years ago was M.I.T, Harvard Medical Clinic and Massachusetts Eye and Ear Clinic all working together (within eye sight of each other) to try and manufacture the first successful implantable CI. The deal was three years of research and testing and then two, three years of FDA review before approval. I thought for sure these “impressive” instiutions with their wealth of engineering and medical knowledge would pull it off and implanted CI would be worn by now.

Well what sounded like a wonderful idea back in 2014 is still on the drawing board or shall we say in the “does not work” file. Again I think the problem was how to power a CI internally. There was even discussion of using a pillow as a charging pad so as you slept your implantable CI recharged. In any event some day someone will figure things out but I don’t see it around the corner. Probably 2028 and beyond.

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@spectrumplay here in Melbourne they are up to trials of the fully implantable CI. They have struck a few issues with it also. Still the battery needs to be changed ever so often. As well as that all the recipients complained of an awful lot of intolerable very loud “body sounds” . They could hear the whooshing of the blood pumping around your body. As well as all the numerous gut noises the body has in any given normal day. And just eating food was very loud also.
So they have a lot of issues that need to be improved upon.

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Yea, one hurdle after another, but I was not aware that internal body sounds could be detected by a implantable CI. Strange and I’m no medical expert but the M.I.T. implantable CI study supposedly used human cadavers to judge testing results. Not sure how that works exactly , but I won’t be volunteering for any future tests.

You should checkout Cochlear’s patents: Patent Database Search Results: AANM/cochlear in US Patent Collection

For example, this one: United States Patent: 10516953

Nothing new here in “link” except Envoy Medical claims the FDA is now “fast tracking” fully implantable CI. What I find very interesting and some what odd is - Envoy Medical invisible CI is getting very little attention on the internet. With that said - there must be some serious benefits to the CI device - since the FDA is not only reviewing it, but also fast tracking. I can’t think of any other U.S. company (or foreign company - other then in U.K.) that has gotten as far as producing an invisible CI and pushed it through for FDA fast track approval.

At some point there’s going to be other outside medical sources giving their opinions (pro or con) regarding what Envoy Medical has achieved. But if I’m correct we will get an answer from the FDA within 12 to 18 months if this device is a go or not.

It’s sort of weird that this is an article on a local newspaper website and not a press release from the company. There’s no news on their website from more recently than 2015, and all the “news” is reposts of articles or YouTube videos, many of which are defunct. Their “Sounding Board” link, which from the URL is a blog, goes to a website with a 403 Forbidden error. It’s pretty weird…

EDIT Nevermind when I searched Envoy Medical I came up with the Esteem middle ear implant website and that’s the one that hasn’t been updated in ages. Their actual Envoy Medical website has more information on it, but it’s odd that it doesn’t come up higher in search results.

This is an investigational device and it will be in clinical trials for several years. In addition, there is no guarantee that it will ever receive regulatory approval. If you have been told you need a cochlear implant, it is important that you listen to your healthcare providers and get one sooner than later.

https://www.envoymedical.com/cochlear-implants

No daily battery changes. Implanted rechargeable battery expected to last several days between charges

Totally agree with your comments. Either Envoy Medical has the “worst” P.R. department ever or they seem to be very comfortable with local small newspapers as as their marketing department. Envoy website as you pointed out is “outdated” and rather bare bones regarding new invisible CI device.

Though I did not click on your “power link”, if they are using a implanted rechargeable battery that has to be replaced after several days, who actually removes the battery? The user, a Audi, a doctor? Its not like the battery is hanging outside your ear with a BTE aid or a regular canal aid. To make this “legit” I’d really like to read what the FDA expects or is testing and how its all ends up in one very neat small package? The CEO mentions about how some big investors took a chance investing in Envoy back in 1995 or 2005 (not sure exact date) but if this "invisible CI roll out gets any “quieter” those investors might be in trouble.

I bet they have some kind of external charger. Maybe an inductive charger built-in to your pillow; maybe they have some kind of BTE device you wear for an hour to charge the battery. The battery is supposed to last a couple years if it’s the same kind they have for their Esteem implant (the Esteem website says 4-6 years, and I’m sure they’d leverage that). They can also maybe derive some energy recovery from the sensor mounted to the middle ear bones that they use as a microphone to extend the lifecycle (like an electric car using regenerative breaking). Though I didn’t see anything like that in their patents.

We can speculate all we want - but really why should we. The company clearly should come out with all the details, especially how CI is powered. That has been the big hurdle or should I say “grave yard” for other invisible CI that never made it off the drawing board. Obviously Envoy Medical is keeping things under wraps, but if they’ve handed the “ball” to the FDA to review/approve - they should spell out exactly how everything works.

Sorry but people are being way too negative. This is a big thing. The misinformation is part of the situation where there have been many false dawns with a fully internal cochlea implant. I get it. But it’s clouding people’s judgement. This is using the infrastructure of their fully internal hearing aid (for the record one visit to the doctor and year and a battery replacement which is a small operation every 5-6 years. They are also spelling on Recharging like the iPhone 11). This product, called esteem, has been verified in clinical trials as having better word recognition score than external hearing aids. TheAcclaim® Cochlear Implant is piggybacking off this research and that is why it’s fast tracked. Most of the research has been done. Cochleae in Australia are also in clinical trials but with a different process. Be negative if you wish but don’t be negative on good news !

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I probably know more about an internal cochlear implant than maybe 100 people on the planet. If you have any questions please just ask.

The esteem has been around for ten years. They have made improvements. Rest of what you say is true.

I for one am all for medical advances and eventual replacement of current cochlear implants. I believe CI started out way back in the late 70’s and over time has (slowly) advanced over the years. But during that time span I honestly can’t say there’s been a serious medical advancement or breakthrough in CI devices nor surgery required. Improvements over the years - yes but no major advancements. Maybe others will disagree but we are talking 42 years which is a long time - in medical years.

If Envoy Medical is on to something new or providing an alternative to current CI’s, that to me is a major step forward. If they can pull it off, get FDA approval and then show over time there is definite improvement in overall hearing versus current cochlear implants. Adamdeen - thanks for explaining the reason for the “fast track” status.

Several years ago I was aware of several very small hearing aids that were medically inserted deep into the ear canal. As I understand it these small aids had to be removed by a Audi or a doctor on a routine basis to replace batteries. I honestly don’t know if they are still in use but my assumption is that most users got tired having batteriers replaced every few weeks by someone else, other then themselves.

Maybe some one here can speculate the time frame of fast track review and approval/rejection but I’m still sticking with my 12 month to 18 month time frame. It would also be interesting if FDA approved if someone had the Envoy Medical device implanted (and it didn’t work out) if that same person would still be a candidate for a cochlear implant.

Lots of issues there…

May i direct your to the Australian company web site. Cochlear. October 2018 they re-started trials for a fully internal cochlea implant. Different method to envoy.

Two approaches working to beat each other. My kind of competition.

Yeah 12-18 months is about right. But the key point is it’s more positive than people think because of the slow But steady evolution in the fully internal hearing aid which is now ten years old.

I am 44 and need a cochlea implant. I am waiting. If you need one today I strongly advise you to NOT get external cochlear implants. WAIT.!

It is coming and coming quickly.

24-36 months from today. More likely lower end of that range. Fast track does mean what it says!

I think you are referring to a mild to moderate (loss) hearing aid that Surgically put into the ear not a fully internal hearing aid. CI’s are for profound to severe hearing loss. It is called lyric invisible hearing aid. Things have moved on since.