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Envoy Medical Receives FDA Approval to Initiate Pivotal Clinical Study for Breakthrough Hearing Device

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https://www.envoymedical.com/news/envoy-medical-recieves-fda-approval-to-initiate-pivotal-clinical-study-for-breakthrough-hearing-device?utm_medium=email&_hsenc=p2ANqtz-978c_-raw7PhHYiXrKOa0HNEPkgBq0VsAs5Fv9g3CDdMQzWz-6svksgJUCn3ihcfWGTB2iOYEwRshE2Odxs_jNnDvHwA&_hsmi=331953280&utm_content=331953280&utm_source=hs_email67

In the previous press release they even talk about a commercialization by 2026: possible?

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Edited

Surgery required, I will stay as far away from Surgery and implants for as long as possible.

Why has this post been largely overlooked? Do you not think a totally invisible implant is possible? Or do you think Envoy Medical is an unreliable company?

Hmmm…I can’t speak for others. My guess is that there are a few factors. Usually implants are considered only by those with a severe loss or worse, so that narrows down the numbers interested. On here, not everybody has a severe loss.

Even if one has a severe loss or beyond, the next issue is cost. This type of implant, being invisible, means it will probably only be available at a premium. My guess is about $40,000 dollars but I am happy to be corrected. Of course there are weaknesses of hearing aids, but I’m thinking most people on here are seeing improvements in technology, that may translate to hearing benefit, such that they would not want to risk taking what effectively is a one way trip into having a device, which, in my view, is not widely publicised and difficult to find indepedent reviews of.

Also, being an invisible device, given the expense, it will not be available on public healthcare systems. No healthcare system will favour such an expensive option if a cheaper functional one will suffice.

It sounds fantastic in theory but not everybody has such deep pockets. Better to stick now with the latest premium hearing aids.

In reply to @glucas

At the moment my loss is severe/profound, but I can still benefit from hearing aids. My concern is for the future, should I get worse.

I am aware that in America medical expenses are not fully covered by the State but you rely on insurance (with all the known difficulties in getting the expenses recognized), but here in Italy cochlear implants, even bilateral ones, are entirely covered by the public health system (for the the contribution is around € 1,300 because it depends on the type of loss).

This is for the current implants, I would not want the contribution to be lower in the case of an invisible implant, you made me doubt.

But I repeat my question: do you think a totally invisible implant will be possible? Or is it pure marketing in this case too?

Edited

It certainly looks possible as they have secured approval to trial the device and studies will be made; if you read the press release it will be put into the hands of cochlear implant providers who will try it on patients. In this respect though we will only know whether it truly works once we see the outcomes of those studies. You will have to watch the press releases of Envoy Medical or search the FDA/publically available lists of clinical study databases to see when those outcomes are expected.

In reply to @lello58

I think there is a few obvious benefits like cosmetic issues or ability to hear for the whole day, and a few potential:

  1. Free ear - possibility to use earbuds, hearing aids (Phonak Infinio Spheric Speech Clarity + - hmmmmm)

  2. Maybe higher-quality input from an oscillating actuator than tiny mics in an ordinary sound processor.

Drawbacks:

  1. No chance to upgrade the sound processor; it’s a lifetime decision, maybe potentially a bit relieved by buying a hearing aid, costly though.

  2. I sometimes like to read about US Air Force planes and I learnt from them a rule which sounds like:

“The more parts an airplane has, the more opportunities there are for any of them to break down, especially the moving parts.”

Envoy CI has more internal parts, thus more sophisticated parts that could potentially break down compared to the solid, relatively simple structure of a CI-only system.
The oscillating actuator attached to the incus bone may be the most failure-prone part.

There are very few moving body implants — artificial joints and cardiac valves. They are rather unlikely to last more than 10–20 years and then requiring new surgery.

  1. @Deaf_piper mentioned in another topic body sounds that can be annoying.

This is my two cents only, but I see more cons than pros.

@Bimodal_user said:

No chance to upgrade the sound processor; it’s a lifetime decision

From the picture on this page

https://hearinghealthmatters.org/hearing-news-watch/2022/first-patient-surgery-acclaim-cochlear-implant/8

it looks like the processor is separate from the implanted cochlear electrodes. The processor contains a rechargeable battery that may need replacing during the patient’s lifetime. Battery replacement may actually involve complete replacement of the processor, and maybe upgrades at that time? In a way this is similar to cardiac pacemakers, where threading of the leads into the heart is hopefully done only once, but the pacemaker itself is right under the skin and can be replaced through minor surgery.

Yes, you’re right. I am not suggesting that upgrading the sound processor part is impossible. I think it is more cumbersome than simply replacing a cardiac pacemaker or implantable cardioverter defibrillator. The latter requires only cutting the skin below the collarbone.

Replacing the sound processor and battery in one procedure is definitely possible, however, more invasive, and patients must be aware of this.

Of course, I don’t want to scare people and say that it is a big, risky operation such as gastrointestinal or aortic surgery. It isn’t. It is simply probably one more skin incision to make.

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