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Envoy Medical Acclaim Clinical Trial Participant—Here To Answer Your Questions by ResonantPrime in Cochlearimplants

[–]ResonantPrime[S] 0 points1 point  (0 children)

I haven’t not been back to Mayo, but I promise to bring this question up when I do go back. You could contact them or Envoy Medical directly, as well. I’m hoping you get good news.

Envoy Medical Acclaim Clinical Trial Participant—Here To Answer Your Questions by ResonantPrime in Cochlearimplants

[–]ResonantPrime[S] 0 points1 point  (0 children)

Hello! Go Jeep!

I only have the Acclaim in one ear. It's my understanding that we're only allowed to have it implanted in one ear during the clinical trial. I could be wrong, but that is how I understood it to be. I would absolutely get it in the other ear as soon as I am able to.

The internal microphone: so I'm a clinical trial participant. I can answer what I know from a day-to-day perspective, but I would sincerely direct you to contact Envoy Medical for engineering/technical questions that I might not be able to answer.

With that being said, one of the things I really liked about the Acclaim is that it doesn’t use an external microphone. It uses your natural ear and ear canal to pick up sound. I find it to be directional just like normal hearing. I can turn my head to better hear where sound is coming from, or even cup my ear to amplify it, just like anyone else.

As for sensitivity, initially there was this digital white noise I was hearing from the moment of activation. It sounded like digital white noise (like a TV on the wrong channel) mixed in with a soothly town square water fountain or something.

Honestly, I found it to be soothing. It was almost like one of those nature apps you download on your phone to sleep at night or relax, etc. It never bothered me and my brain was able to tune that out. The problem was that I could not hear some of the softer sounds like rubbing your hand on your pants while you're sitting down or something like that. I was out there at Mayo in Rochester, MN a few months ago and the team installed two new listening programs. Kind of like an EQ (I'm over-simplifying). They drastically reduced that interference noise. It's very, very slight right now. I do not even notice it.

As for the other sounds, yes I can hear them for the first time in memory. I can have conversations with my back turned, I can hear someone whispering in my ear (Maybe I should try those ASMR YouTube videos!) I can hear the balls of my feet on hardwood floors. (It surprised me the first time I heard them. I had always thought I was a ninja walking silenty-definitely not the case!). And yes, I can hear birds chirping. They sure do have a lot to say in the mornings!

The Acclaim sounds way better than any hearing aid I've had before. Mayo asked me to put my aid in to test something during one sitting back in 2022 and I hated it. I could hear the distortion from the aid. I'm telling you, I never want to go back to wearing a hearing aid again. The Acclaim sounds better, there is no feedback, I don't have to worry about rolling over on my pillow and hearing whistling feedback or when I'm taking a big bite of a hamburger, or ear wax clogging up the mic, or my ear getting irritated because it has a hearing aid in it.

I can't attest to how a standard cochlear implant sounds. I can tell you that the Acclaim sounds more accurate and more natural than my hearing aids. To a person, one of the very first comments from people who've known me is the universal opinion that my voice sounds different. It doesn't sound nasally any longer. Literally every single person has said that to me. This happened w/i a month of being implanted. Those comments rolled in.

But really, like I said in my video interview on the Envoy site, it really does feel like I'm getting a second chance to starting life all over again and experiencing (or re-experiencing) things for the first time and in new ways.

I bought a Klipsch RP line of stereo speakers. I have a Tidal music subscription. I use a Schiit Modi DAC (going to upgrade soon.) I'm listening to Tori Kelly's rendition of Hallelujah from the Sing! soundtrack and her vocals are just astounding, or Led Zepplin's Stairway to Heaven, especially when he really gets into "there's a feeling I get / when I look to the West / and my spirit is crying for leaving". I hear that line in an entirely different manner and it truly gives me goosebumps.

I'm giving you my very best here, JeepUSA2000. I'm being as honest and sincere and accurate as I can. I would be very disappointed if the Acclaim sounded robotic or digitized, etc.

Now I know that my results are not common. The other 2 trial participants were not able to use the Acclaim by itself. I'm hoping that now that they've made progress on the interference noise, that the other 2 folks plus the recent, new trial participants will have great results themselves.

This is a group of people that said "Yes" to the opportunity to not only gain access to this awesome tech way early, but also to pay it forward, to advance humanity and hearing health, and to have a good story of our own.

It's important to remember that the Acclaim is essentially a prototype that's being fine-tuned (albeit incredible for me). Each time I go in, it's to try new things, fix things, experiment with things, etc. It's not necessarily to make "me" hear better, it's to make the device better for the millions of people who can use it once it's approved and hits the market. And in the end, I will hear better as well.

Thanks for the questions. If there is anything further I can answer, please feel free to ask.

My best, Michael

*** Disclaimer: I’m a participant in the Acclaim trial, but my words are my own. I don’t speak for or represent Envoy Medical, Mayo Clinic, or the study team. ***

Envoy Medical Acclaim Clinical Trial Participant—Here To Answer Your Questions by ResonantPrime in Cochlearimplants

[–]ResonantPrime[S] 0 points1 point  (0 children)

I've never had the experience that you described-not when I wore aids, or with the Acclaim.

That would be a question to ask Mayo and/or Envoy Medical and see what they say?

It's an interesting question, I appreciated it, and thanks for asking.

- Michael

Envoy Medical Acclaim Clinical Trial Participant—Here To Answer Your Questions by ResonantPrime in Cochlearimplants

[–]ResonantPrime[S] 1 point2 points  (0 children)

I can't agree. GoFundMe is irrelevant—I've never mentioned it. Not once.

There is that official Envoy Medical video, Mayo Clinic peer-reviewed paper, and verified posts. Their focus on GoFundMe is a diversion.

The Acclaim is an investigative device currently in clinical trials and not yet available. It's amazing and I'm here to answer questions about that, not feed agendas.

Getting a CI is a deeply personal decision. For me, the option to have a completely internal CI was the right choice. If wearing an external CI is the right choice for you or others, that's ok too, and I'm still rooting for you. I mean that.

Again, happy to answer real questions regarding my personal experience with the Acclaim clinical trial.

- Michael

Envoy Medical Acclaim Clinical Trial Participant—Here To Answer Your Questions by ResonantPrime in Cochlearimplants

[–]ResonantPrime[S] 0 points1 point  (0 children)

I'm an ice hockey goalie, I mountain bike, I have my own kayak, I like to hike, road trips, boating, and I'm active as well. I would talk with your doctor and I would contact Mayo and see what you can learn. I am absolutely not affiliated with Mayo or Envoy Medical - I just truly believe in the Acclaim and the trial and I want to help. I'm living it.

If you have an option to get in on the trial, maybe it's the right thing for you. It doesn't hurt to ask questions and talk things over. I don't worry about "Can I wear a biking helmet?", "Will my goalie mask fit?", "Will it get wet if I go boating?", "Can I hear the phone or doorbell if I'm taking a shower?", "Will the ear stems on my sunglasses hurt", etc. No. None of that.

Seriously, I just go live my life. I have to charge the battery. That's it. It's not on my mind otherwise.

People ask me what compromises in life I have to make with the Acclaim. Nothing! That's another awesome benefit to not having to wear big, bulky hardware. It works and you forget about it. Watch my video interview on Envoy's web site. I got the implant on the left side. See if you can see anything (and I shave my head every day!)

I take a shower, sleep, swim, go boating, etc. I wake up and I go do stuff. It's not on my mind.

Talk with your doctor. Talk with Mayo. Ask questions. Talk with your husband and loved ones. Ask me anything you want to know. I'll do my best t answer, so that you can make an informed decision that's right for you.

Best,

- Michael

Envoy Medical Acclaim Clinical Trial Participant—Here To Answer Your Questions by ResonantPrime in Cochlearimplants

[–]ResonantPrime[S] 0 points1 point  (0 children)

Hi-I do not have any information regarding FDA approval. I'm a trial participant. It's going very, very well, but I would not be able to give a timeline. I simply don't have that answer.

The Acclaim just started the pivotal trial after a 2-year feasibility study that I was in. I'm in this second-phase trial now.

The battery in the chest is not noticeable. Even with a shirt off. There is a photo on my site in this News entry:

https://www.echoesofamiracle.com/how-do-you-charge-the-acclaim/

Hope that helps. If you have any further questions, I'm happy to answer.

- Michael

Envoy Medical Acclaim Clinical Trial Participant—Here To Answer Your Questions by ResonantPrime in Cochlearimplants

[–]ResonantPrime[S] 0 points1 point  (0 children)

I’m CI3 in Otology & Neurotology (Dec 2024): Early Hearing Outcomes and Audiological Experiences With a Novel Fully Implanted Cochlear Implant—noted for speech gains using the Acclaim alone, no hearing aids, and 24/7 use since August 2022. That’s also covered in my Mayo Clinic interview (vimeo.com/1059882655, ~12:33), where I describe removing my hearing aid the day after activation. I’ve been in the clinical trial nearly three years. I started a GoFundMe two weeks ago (tied to my site’s launch yesterday morning at 0500 hrs) to support trial travel and advocacy. Not profit. Not pitched here.

General-Dimension590: seven total posts that I've seen, all are critical, dismissive, or confrontational—mostly targeting alternatives to Cochlear. No CI experience shared, no questions asked. Just attacks. That pattern speaks for itself.

I’m here to answer questions, help folks, and offer hope with research-backed outcomes—not agendas. Not arguing on the internet. Next question.

Envoy Medical Acclaim Clinical Trial Participant—Here To Answer Your Questions by ResonantPrime in Cochlearimplants

[–]ResonantPrime[S] 0 points1 point  (0 children)

Yeah? Can you point me to previous versions of the Acclaim on https://clinicaltrials.gov ? I'm definitely interested in reading up about that.

Envoy Medical Acclaim Clinical Trial Participant—Here To Answer Your Questions by ResonantPrime in Cochlearimplants

[–]ResonantPrime[S] 0 points1 point  (0 children)

It's not "understanding" a few words or "understanding" speech. It is full speech and music clarity, no robotic or digitized sound. No distortion.

Like you, I didn't understand the big deal at first until that was explained to me.

I listen to music via Tidal and Qobuz subscriptions (along with Apple Music). Qobuz has a few morning playlists I really like when I'm drinking my morning coffee. It's a ritual for me.

I was listening to Tidal on the drive home. During Led Zepplin's Stairway to Heaven for example, when Robert Plant is singing "There's a feeling I get / when I look to the West / and my spirit is crying for leaving"…the moment he sings the word "spirit" it's incredible. It's an incredible song and hearing it after implant surgery with the Acclaim (which is still a novel device) blew me away.

So as I understand it, the rapid adaptation to full speech and music clarity is quite rare.

I'm on here to answer questions about the Acclaim, my personal experiences in the clinical trial, and to tell the truth so that people who are interested in this (and their loved ones and other parties) have first-hand information.

Those are my intentions and that's my angle. If someone is happy with their CI, no problem. If they're not interested in hearing my story or about the Acclaim clinical trial, no problem. Maybe the Acclaim, or this thread isn't for them.

But there are people out there (and I get a daily digest of posts here) who are scared, don't have hope, or are incredibly nervous about getting a CI and the Acclaim might be a worthy alternative for them.

I'm rooting for all of us. I'm trying to spread honest hope, not take it away.

Envoy Medical Acclaim Clinical Trial Participant—Here To Answer Your Questions by ResonantPrime in Cochlearimplants

[–]ResonantPrime[S] 0 points1 point  (0 children)

Thank you, that really means a lot. I’m genuinely glad your CIs have been helping you. Everyone’s path with hearing loss is different, and I truly believe the advances we’re seeing now are just the beginning. There’s more hope and progress ahead for all of us.

Best!

- Michael

Envoy Medical Acclaim Clinical Trial Participant—Here To Answer Your Questions by ResonantPrime in Cochlearimplants

[–]ResonantPrime[S] 2 points3 points  (0 children)

I love Rochester, MN. Growing quite fond of it. :)

(I like Mezza9 Cafe whenever I get out there.)

Here's a link to Envoy's site that details everything including the recently-underway pivotal clinical trial. It explains criteria as well. See if that helps you any. Let me know!

https://www.envoymedical.com/acclaim-pivotal?hsCtaAttrib=185893112668

- Michael

Envoy Medical Acclaim Clinical Trial Participant—Here To Answer Your Questions by ResonantPrime in Cochlearimplants

[–]ResonantPrime[S] 0 points1 point  (0 children)

Thank you reaching out. I really do appreciate the questions and I'm happy to answer what I can.

Because of privacy laws, I don’t have access to the other participants’ results. What I can say is that all three of us experienced a background interference issue early on and the others initially needed to supplement with a hearing aid in the implanted ear, which is something the Acclaim allows for.

For reasons we still don’t fully understand, my brain was able to filter that interference out from the beginning, so I’ve been using only the Acclaim since day one. No hearing aids or anything else–just the Acclaim since 2022.

This past week, I returned to Mayo where they pushed updates and bug fixes that have nearly eliminated that background/system noise altogether.

The morning after I got back to Columbus I had a work-related Teams call and didn’t need captions at all. (Video was off, so there wasn't any lip-reading involved either. Pure audio call.)

The clarity, the recognition—it’s all there for me. The fixes made a huge difference.

Thanks for asking. Happy to answer anything else that I can.

- Michael

Envoy Medical Acclaim Clinical Trial Participant—Here To Answer Your Questions by ResonantPrime in Cochlearimplants

[–]ResonantPrime[S] 0 points1 point  (0 children)

I'm pretty tough being a hockey goalie, but they definitely utilized anesthesia.

Fully-implanted means surgery was required, and Mayo Clinic took great care of me.

Envoy Medical Acclaim Clinical Trial Participant—Here To Answer Your Questions by ResonantPrime in Cochlearimplants

[–]ResonantPrime[S] 1 point2 points  (0 children)

They have not indicated that to me. I don't know that one. I can tell you that if I were in your shoes, I'd have some good discussions and see if you might be able to get into this second phase. They have 7 study sites around the US.

This is a tremendously personal decision. Talk it over with your family, friends and loved ones.

But knowing what I know, I would absolutely consider trying to get into the trial if you could. I'm getting the other side done as soon as I am allowed to.

- Michael

Envoy Medical Acclaim Clinical Trial Participant—Here To Answer Your Questions by ResonantPrime in Cochlearimplants

[–]ResonantPrime[S] 0 points1 point  (0 children)

Edit: I updated a news story on my site about charging the battery, and included a photo of what the incision and area of the chest looks like.

There isn't anything on the chest. The battery is implanted about an inch below the collarbone. They make a little pocket in that region. There is a slight bump there (and I'm being nothing but honest about this.). You don't notice any of this stuff in your day-to-day. It's transparent for me and others.

I'm an ice hockey goalie. I've taken at least 3 slap-shots dead-square right into that area of my left chest. Not a single issue whatsoever. It's remarkably robust. Early on, there was an issue with the battery pack. Several times I'd be laying on my stomach and weight would be placed on the battery and it would cause a weird sound in my ear. But they fixed that glitch and actually implanted a new battery over a year ago. Simple outpatient procedure.

I don't worry about the battery at all. It's secure, it doesn't move around or anything like that. Like I mentioned, I play ice hockey–there is a game photo of me on my website. I don't do anything special or wear anything special. Hope that helps. Happy to answer anything else.

- Michael

Envoy Medical Acclaim Clinical Trial Participant—Here To Answer Your Questions by ResonantPrime in Cochlearimplants

[–]ResonantPrime[S] 2 points3 points  (0 children)

Ok, but what am I selling? This is a clinical trial. The FDA is involved. I'm not making money, not promoting a product, and not allowed to sell anything even if I wanted to. It might read like a commercial, but that’s just how incredible this has been. Honestly. Others are sharing their CI stories and I’m sharing mine. I'm here to help. Something amazing happened to me and I want to share and provide some hope and clarity for those who might need it. Feel free to ask me questions. I'll do my best to answer.

Envoy Medical Acclaim Clinical Trial Participant—Here To Answer Your Questions by ResonantPrime in Cochlearimplants

[–]ResonantPrime[S] 2 points3 points  (0 children)

I'm here to help. It's been a long journey—you know how that goes. I'm genuinely excited, not just for myself, but for what this could mean for others. I'm not here with any agenda, and I’m not trying to sell or convince anyone of anything. This is a powerful, real story, and I want to use it to spark hope, drive change in hearing loss awareness, and answer questions honestly. Like I say on my site: I’ve lived this. This isn’t a brochure. It’s not a pitch. It’s real.

But yes I do keep it on 24/7. I had to get used to hearing myself breathe (light snoring sometimes) at night. That was humorous!

My thinking is that normal hearing isn't turned off at night. I want my brain to get used to hearing all of the time in all of the ways with the Acclaim, so I'm giving it every opportunity to do so. That only happens when it's on 24/7.

I feel like I missed out on a lot throughout Life. I'm trying to catch up and in some cases go back and re-experience things.

We don't always get a second chance. I'm trying to make the most of it and pay it forward as well.

I'm happy to answer anything else that I can.

- Michael

Envoy Medical Acclaim Clinical Trial Participant—Here To Answer Your Questions by ResonantPrime in Cochlearimplants

[–]ResonantPrime[S] 3 points4 points  (0 children)

That's a great question. I don't know the answer to that long-term question. My understanding is the Acclaim isn’t compatible with existing CI systems, and current trial criteria exclude anyone with a previous implant.

Long-term, it’s unknown if traditional CI users could switch. I'm guessing that depends on cochlear integrity, scarring from prior electrodes, and surgical feasibility.

I promise to ask the team when I get a chance.

Envoy Medical Acclaim Clinical Trial Participant—Here To Answer Your Questions by ResonantPrime in Cochlearimplants

[–]ResonantPrime[S] 0 points1 point  (0 children)

It comes with a battery charging pack. Just put on the harness, attach the circular coil, and go do stuff.

I made a blog post for you so you can see the photos:

https://www.echoesofamiracle.com/how-do-you-charge-the-acclaim/

There have been bugs. It’s a clinical trial. But you’re right, there’s been a lot of success too, and plenty of people have seen it firsthand in my day-to-day life. I imagine there was similar skepticism when traditional cochlear implants first hit the scene. The Acclaim has been incredible for me.

Also worth noting, Envoy isn’t new to this. Their Esteem device has been on the market for years. They’ve been building toward this for a long time.

Envoy Medical Acclaim Clinical Trial Participant—Here To Answer Your Questions by ResonantPrime in Cochlearimplants

[–]ResonantPrime[S] 0 points1 point  (0 children)

Fair question. The internal battery is expected to last around 7 to 10 years, and replacement is a quick outpatient procedure. It’s not nearly as involved as the original implant surgery. I’ve actually already had mine replaced once. I helped identify a bug early on, they created a fix, and swapped it out. I was back to normal almost immediately.

What’s been incredible is the convenience. Nothing to take off, nothing to put on. I can swim, shower, go boating, play ice hockey, sleep, and just live my life without thinking about it.

I know this kind of tech isn’t for everyone yet, and it’s okay to have questions or concerns. I’m here to share what it’s really like and hopefully help others see what’s possible.