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Unread 05-29-2008, 03:56 PM   #1
alreadygone78
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Smile Envoy Esteem middle ear implant

Hi everyone!

I'm in the Envoy Esteem clinical study, and I will be implanted on June 18th. Any members still around who have had the implant? I've been following this study for quite some time, and I am very excited. I was a part of the study back in 2005, but I failed my baseline testing two days before surgery and was forced to drop out. At that particular point of testing, I had to listen to a cd and repeat the words requested, but I had a very hard time understanding this particular man's voice. I was really devastated.

Yesterday, I managed to pass all the testing, so everything's looking great. I'm always up for meeting fellow patients!

By the way, for those of you who have/are interested in cochlear implants...Envoy is set to begin studies on a fully implantable cochlear implant with NO outer components! I've heard this study will begin sometime in 2009. It's amazing how much technology has been advancing over the years!
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Unread 05-29-2008, 06:28 PM   #2
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Hi everyone!

I'm in the Envoy Esteem clinical study, and I will be implanted on June 18th. Any members still around who have had the implant? I've been following this study for quite some time, and I am very excited. I was a part of the study back in 2005, but I failed my baseline testing two days before surgery and was forced to drop out. At that particular point of testing, I had to listen to a cd and repeat the words requested, but I had a very hard time understanding this particular man's voice. I was really devastated.

Yesterday, I managed to pass all the testing, so everything's looking great. I'm always up for meeting fellow patients!

By the way, for those of you who have/are interested in cochlear implants...Envoy is set to begin studies on a fully implantable cochlear implant with NO outer components! I've heard this study will begin sometime in 2009. It's amazing how much technology has been advancing over the years!

well good luck. Is this the next phase? My daughter has had the implant for almost 2 yrs now and is still working on getting it adjusted. Hopefully they've worked out all the anchoring issues. it's cool that you want to be one of the pioneers to.
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Unread 05-29-2008, 09:13 PM   #3
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Originally Posted by alreadygone78 View Post
Hi everyone!

I'm in the Envoy Esteem clinical study, and I will be implanted on June 18th. Any members still around who have had the implant? I've been following this study for quite some time, and I am very excited. I was a part of the study back in 2005, but I failed my baseline testing two days before surgery and was forced to drop out. At that particular point of testing, I had to listen to a cd and repeat the words requested, but I had a very hard time understanding this particular man's voice. I was really devastated.

Yesterday, I managed to pass all the testing, so everything's looking great. I'm always up for meeting fellow patients!
Good luck! Let us know how the surgery goes and your recovery.

I've just started hearing recently about this. My googling found:

Hearing Aids, Sensorineural Hearing Loss, Hearing Impaired - Envoy Medical

Seems to be good information but I don't know anyone either who's been part of the trial. I'd be curious to find out if I'd be a candidate.

You failed the initial test because you weren't able to understand the words requested, am I understanding that right? Why? Wouldn't that have made you the right kind of candidate for the Envoy implant? Maybe I don't understand ...
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Unread 05-29-2008, 09:17 PM   #4
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Very interesting. From the website, it seems that you need to have functional cochlear hair cells, which majority of the deaf people don't have. I sorely lack cochlear nerve hair cells, which is why CI works.

However, there has been some talk about fully implantable CIs as well. The problem I have with that is it may not be "upgradeable" processors, and I don't think I want to have a "battery" in my head, regardless. It still need maintainace. After a few years (maybe 10-15) of having the fully implantable CI on the market, it will be as much as an improvement as the CIs now compared to 15 years ago. Make sense?


I do wish you best of luck and hope you keep us updated on your progress!
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Unread 05-30-2008, 06:55 AM   #5
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Good luck! Let us know how the surgery goes and your recovery.

I've just started hearing recently about this. My googling found:

Hearing Aids, Sensorineural Hearing Loss, Hearing Impaired - Envoy Medical

Seems to be good information but I don't know anyone either who's been part of the trial. I'd be curious to find out if I'd be a candidate.

You failed the initial test because you weren't able to understand the words requested, am I understanding that right? Why? Wouldn't that have made you the right kind of candidate for the Envoy implant? Maybe I don't understand ...

Hi! You can visit my journal ( Building My Self Esteem ) to find out a lot more about the surgery and the requirements, but I can tell you the basic requirements: you must have a sensorineural hearing loss, a healthy middle ear, and have a speech discrimination score of 60% or better. They have allowed a group of patients to have a sd score between 40 and 60%, which is how I got in.

Because the implant is still under study for full FDA approval, the study MUST stay under strict guidelines approved by the FDA, meaning right now they can only accept patients who pass the current requirements. Back in 2005, my sd scores were great, but I had trouble understanding that voice on the cd, and I fell out of the requirements. The purpose of that particular cd test is to test your hearing with and without your hearing aids, to use as a comparison to your future results with the implant. Even though it was just that particular voice I had trouble with, they could not make a change just for me. I wasn't the only one who failed because of it.

As the study advances, the requirements to participate will become less strict. Right now, I have a moderate loss in my left ear, and a moderate/profoud loss in my right ear, yet both qualify. So who knows? If it's something you have an interest in, research it thoroughly and request the literature on it. Many people perfer to wait and see what happens with FDA approval and future testing. To each his own, right? =)
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Unread 05-30-2008, 07:04 AM   #6
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Very interesting. From the website, it seems that you need to have functional cochlear hair cells, which majority of the deaf people don't have. I sorely lack cochlear nerve hair cells, which is why CI works.

However, there has been some talk about fully implantable CIs as well. The problem I have with that is it may not be "upgradeable" processors, and I don't think I want to have a "battery" in my head, regardless. It still need maintainace. After a few years (maybe 10-15) of having the fully implantable CI on the market, it will be as much as an improvement as the CIs now compared to 15 years ago. Make sense?


I do wish you best of luck and hope you keep us updated on your progress!

Yes, you are right - the middle ear implant and CI are a bit different. Currently, people who qualify to be a CI patient have a hearing loss too severe for the MEI.

I'd like to point one thing out though...assuming the fully implantable CI is successful, both it and the MEI will be be able to benefit from the newest and updated processors when it's time to change the "battery." First generation MEI patients had theirs last about 3 to 5 years, and these new second generation processors are said to last 8 to 10 years. Who knows what the next generation will bring?

Believe me..I completely understand anyone's hesitation to become a guinea pig of sorts and take such a risk to be in this kind of study. It was a very hard decision for me, but I'm personally at a place in my life where I can really benefit from this. Plus, I hope this study will help open doors for my own HoH children years from now.

Thank you all for your good luck wishes, it's gonna be a long three weeks!!
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Unread 05-30-2008, 07:07 AM   #7
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well good luck. Is this the next phase? My daughter has had the implant for almost 2 yrs now and is still working on getting it adjusted. Hopefully they've worked out all the anchoring issues. it's cool that you want to be one of the pioneers to.
Yep, Generation 2 is underway and I think they are getting ready to close it by mid June, I'm not sure. I think I remember reading a bit about your daughter having problems, what kind of issues is sh having? My sister has had the implant and absolutely loves hers. She's anxious for the second implant now. I know of a couple of people who havehad problems, but they are surprisingly understanding and optimistic. Not so sure I could be. :S
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Unread 05-30-2008, 01:45 PM   #8
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...you must have a sensorineural hearing loss, a healthy middle ear, and have a speech discrimination score of 60% or better. They have allowed a group of patients to have a sd score between 40 and 60%, which is how I got in.

...I had trouble understanding that voice on the cd, and I fell out of the requirements. The purpose of that particular cd test is to test your hearing with and without your hearing aids, to use as a comparison to your future results with the implant.

... I have a moderate loss in my left ear, and a moderate/profoud loss in my right ear, yet both qualify. So who knows? If it's something you have an interest in, research it thoroughly and request the literature on it. Many people perfer to wait and see what happens with FDA approval and future testing. To each his own, right? =)
Gotcha! Sounds like at this point I wouldn't qualify -- I have a profound hearing loss. I don't think I could do 60% or better (or even the 40-60%) on a speech discrimination test. Congratulations on passing it the second time, and again, good luck with the surgery! I'll check your blog for updates.
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Unread 05-31-2008, 03:07 AM   #9
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Yep, Generation 2 is underway and I think they are getting ready to close it by mid June, I'm not sure. I think I remember reading a bit about your daughter having problems, what kind of issues is sh having? My sister has had the implant and absolutely loves hers. She's anxious for the second implant now. I know of a couple of people who havehad problems, but they are surprisingly understanding and optimistic. Not so sure I could be. :S
The anchoring issue is finally fixed. Now programming is going on. I think that is going ok now. Her problem is the audiologist only works a couple of half days during the week and only those days so she's the one who has to accommodate that audi. When I participated in the freedom trials for their new programming my audi actually worked to accommodate me.
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Unread 05-31-2008, 08:19 AM   #10
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Interesting on how much pre-requirements you need in order to get that. I do have sensoneural loss, but my sentence discrimination falls way below that level. I was actually VERY surprised on how low it actually was. I could hear pretty well with my hearing aids, but I used a lot of other visual information in order to understand. My left was 6% - now it's 25%, my right was 26% - I'm eager to see my sentence discrimination after I get activated.

Wish you best of luck!
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Unread 06-11-2008, 03:06 PM   #11
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I received some great news today, they will be implanting my worse ear after all. I am very relieved, and I'm starting to get a little nervous. To those of you with cochlear implants, how was your recovery after surgery? It will be my first time under anesthesia. :S Still looking for other Envoy patients!
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Unread 06-11-2008, 03:25 PM   #12
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AlreadyGone -

Everyone kind of react differently to anesthesia. For my case, I found that I get nausous. For my second surgery, I made sure that I put on the nausea patch (Tresderma Scoop).

Most of these people has nausea or vomiting. So, if you have a bit of a sensitive stomach, ask your surgeon if you can put on a nausea patch before surgery. That way, the drug will remain in your system for a while.

My first surgery, it took me a little less than 2 hours to recover, and had a bit of groggy feeling for quite a while. My second surgery took me 30 mins to recover, and I was walking around and feeling great. This was pretty weird.

So, like I said, people react differently. It also depends what the doctors will do to "knock you out". The first time I had Propofol (white stuff, used very often to anethesize animals). The second time I had the mask.

Hugs, and I'm looking forward on reading about your journey! PICTURES PICTURES!! :-)
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Unread 06-27-2008, 11:50 AM   #13
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AlreadyGone -

Everyone kind of react differently to anesthesia. For my case, I found that I get nausous. For my second surgery, I made sure that I put on the nausea patch (Tresderma Scoop).

Most of these people has nausea or vomiting. So, if you have a bit of a sensitive stomach, ask your surgeon if you can put on a nausea patch before surgery. That way, the drug will remain in your system for a while.

My first surgery, it took me a little less than 2 hours to recover, and had a bit of groggy feeling for quite a while. My second surgery took me 30 mins to recover, and I was walking around and feeling great. This was pretty weird.

So, like I said, people react differently. It also depends what the doctors will do to "knock you out". The first time I had Propofol (white stuff, used very often to anethesize animals). The second time I had the mask.

Hugs, and I'm looking forward on reading about your journey! PICTURES PICTURES!! :-)
Whoops, I missed your post! I had my surgery last week, and it went really well. They did put a patch on my neck before knocking me out. I only had one side effect from the patch, and that was an extremely dry mouth. Well, I guess it wasn't so much a dry mouth as a dry taste. Nothing tasted very good at all - even the chicken noodle soup tasted dry! Recovery was great, though I quickly discovered that trying to fight off the anesthesia was a losing battle.

The worst part of the whole thing was really just the nausea from taking a Percocet or two, bleh. My stitches camne out yesterday, and my activation day is August 15th.

I'm very curious - did you implant your worse ear first, and what was it like suddenly having that ear become the better ear? Did it take a while to adjust to having one good/implanted ear? Was it overwhelming at first? Are you glad you implanted both ears now?

Sorry about all the questions. I'm just really fascinated with the idea that my worst ear will soon become the better of the two. For instance, I cannot use the phone with my right ear at all, so I cannot imagine suddenly relying on that ear for this and other things. You know, it's just a little hard to imagine.
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Unread 06-29-2008, 10:13 AM   #14
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I'm very curious - did you implant your worse ear first, and what was it like suddenly having that ear become the better ear? Did it take a while to adjust to having one good/implanted ear? Was it overwhelming at first? Are you glad you implanted both ears now?

Sorry about all the questions. I'm just really fascinated with the idea that my worst ear will soon become the better of the two. For instance, I cannot use the phone with my right ear at all, so I cannot imagine suddenly relying on that ear for this and other things. You know, it's just a little hard to imagine.
No biggie! I saved your blog as my Bloglines, so I've been updated on your progress!

Yes, I implanted my worse ear first. Majority of the surgeons and audiologists prefer to do that mainly because they want the patient to be able to "save" the better ear JUST in a so slight chance that the patient won't like it. I *WISHED* I did my better ear first, but you know what, I probably would have gone bilateral anyways.

Yes, it felt a little WEIRD to have my left hear better. When I had hearing aids on, I would wear both all the time. I can't really wear one without the other. I can hear music vocals a little bit better if I have my left aid on, instead of just my right. So, there's certain sounds that my left had that my right didn't and the other way around. I used my right hearing aid for phone, I could never hear too well out of my left. After getting implanted in my left, I realized that I was missing quite a lot of the high frequencies. It pretty much felt like I was hearing Left and Right through the left ear...with the high frequencies that I didn't have in the first place. When I wore my hearing aids, I could only hear 80 db at high frequencies areas. So, that's pretty bad. With my CI now, it's straight across the board at 10-15 db line. So yeah. :-) Oddly enough - with both CI, I'm hearing MORE out of my right than my left.

Now that I have both - it took a while to get used to it for my left. I think it took about 2 or 3 weeks to really understand what I was hearing, and picking up a lot more sounds. My right, it took the next day. :-) I haven't even have my first "real" map yet! It's always crude at first to allow adjustments...then about 3 to 4 weeks later, it's mapped with programmings and higher DR, and whatnot. I have tried just wearing one CI. Left first. Whoa...everything is soft. Right next - every thing is soft. Both - Perfect (for now...Right still needs a much better map than I have now!).
So, yes, I'm SO glad I had two done.

Hugs!
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Unread 11-03-2010, 06:33 AM   #15
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does this work for profound loss?
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Unread 11-03-2010, 08:32 AM   #16
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Probably not.

"Esteem® is designed to help improve the hearing of many adults with moderate to severe sensorineural hearing loss"

How Esteem® Improves Hearing
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Unread 11-26-2010, 05:12 PM   #17
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send your audiogram to audiograms@envoymedical.com and they'll tell you if you are eligible
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Unread 12-17-2010, 07:18 PM   #18
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decided to look into this new-fangled hearing appaaratus.

Guess it won't work for me either, since I too have middle-ear nerve damage.

Oh well, eh?

-charles
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Unread 12-31-2011, 01:53 AM   #19
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how is it ?
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Unread 01-02-2012, 05:51 PM   #20
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Ten bucks says that this is going to sink like a stone. They were hyping this device on the HLAA site awhile back. But the thing is, with sky high insurance premuiums (sp?) very few insurance companies will be covering this....they don't even cover HAs,so why would they cover THIS?!?!
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Unread 01-02-2012, 09:40 PM   #21
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Ten bucks says that this is going to sink like a stone. They were hyping this device on the HLAA site awhile back. But the thing is, with sky high insurance premuiums (sp?) very few insurance companies will be covering this....they don't even cover HAs,so why would they cover THIS?!?!
Actually, the Esteem Envoy business is doing very well because there are enough people who can afford it. As for insurance...
https://www.facebook.com/topic.php?u...00&topic=19889
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Unread 01-02-2012, 09:59 PM   #22
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Actually, the Esteem Envoy business is doing very well because there are enough people who can afford it. As for insurance...
https://www.facebook.com/topic.php?u...00&topic=19889
CIs and implants are covered by health insurance but, practically speaking, hearing aids are not.

Conclusion: Surgeons are much better at business negotiations and lobbying than audiologists and us, the D/d/hh.
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Unread 03-31-2012, 08:33 PM   #23
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I'm a unilateral cochlear implant user who's very interested in a Completely Implantable Cochlear Implant.


I found a recent article discussing about the Totally Implantable C.I.



Cochlear's sound outlook dampened by debate over rival

by: Richard Gluyas
From:The Australian
August 15, 2011 12:00AM


By continually investing heavily in research and development (expenditure in this area was up 15 per cent to $109m, or almost 14 per cent of sales), Cochlear minimises the risk of disadvantage from a technological breakthrough by a rival.

The risk, however, will never be completely neutralised.

The prevailing wisdom is that the company's competitive advantage is protected for at least five to 10 years, with threat such as stem cell regeneration likely to take years to negotiate the regulatory system.

More immediate disruption could come from success in the industry's quest for a fully implantable device, including battery, processor and microphone, which would have obvious cosmetic appeal.

UBS's Goodsall discounts the view that Cochlear lags its rivals in the search for this "gold-standard" implant.

"We believe it is now only a matter of time before (the company) has a totally implantable cochlear implant hearing system. It may well be targeting launch within three years," he says.

Cochlear, he says, is moving towards trials, with key hurdles, such as a battery that is recharged through the skin and a problematic implanted microphone, already overcome.


The article said that the Totally Implantable cochlear implant may well be targeting launch within three years, in 2011. It is NOW 2012... so, the Totally Implantable C.I. may well be targeting launch within two years. I have an important question. When the article says that the totally implantable cochlear implant may well be targeting launch within two years... does it REALLY mean commercial availability within two year??? or just mere clinical trials????
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Unread 04-01-2012, 05:15 PM   #24
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It does mean a target launch date into post trials, however targets are extraordinarily rarely reached, and part of the approval process can only take place when a device exits clinical trials and becomes commercially available, so even after something is launched it's still hard to get. Then you have to get the training and experience out there to all the potential surgeons who might offer it, and not everyone will want to for various reasons. All of which diminishes the pool of people who will be able to access it even once it's technically available. If the medical community really embraces it and drives for it then it will work. If it doesn't then it will fall flat and roll out slowly.
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Unread 04-03-2012, 10:23 AM   #25
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Anyone implanted with the Envoy Esteem still have a high chance of more hearing loss and it will lead to either deafness or the cochlear implant.
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Unread 04-03-2012, 01:59 PM   #26
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It does mean a target launch date into post trials, however targets are extraordinarily rarely reached, and part of the approval process can only take place when a device exits clinical trials and becomes commercially available, so even after something is launched it's still hard to get.

That's great news!!!


I really do think that it'll happen. A Totally Implantable cochlear implant (with a wireless remote that can turn it on/off adjust volume et cetera) is going to be commercially available in Australia! In a year or two.

I'm saving tons of money (hundreds thousands of dollars for this technology). Once it's commercially available in Australia, am I allowed to travel from the US and pay for it out of my wallet with no insurance help?
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Unread 04-04-2012, 05:11 PM   #27
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Anyone implanted with the Envoy Esteem still have a high chance of more hearing loss and it will lead to either deafness or the cochlear implant.
That's why the procedure is limited to those with stable hearing loss as opposed to progressive loss leading towards deafness.

The Esteem can provide upwards of 60 decibels of gain, so it would help preserve hearing as opposed to accelerating hearing loss.
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Unread 04-08-2012, 04:53 AM   #28
RoseRodent
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Originally Posted by Cyborg View Post
Once it's commercially available in Australia, am I allowed to travel from the US and pay for it out of my wallet with no insurance help?
You will need enough money to keep travelling back to Australia for updates, repairs, remaps, etc. You can't send away your head like you can send away a processor, so you have to return in person for follow-ups. Also beware you need the correct type of visa for that kind of travel, you must not just get a tourist visa when you are travelling for medical treatment, you need a medical visa or you can potentially be turned around at the border.
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Unread 04-27-2012, 05:18 AM   #29
MichellePasinat
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An Envoy Esteem middle ear implant is a surgically implanted electronic device that provides a sense of sound to a person who is profoundly deaf or severely hard of hearing. These implants are often referred to as a bionic ear. Thanks!
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Unread 04-27-2012, 05:29 AM   #30
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Quote:
Originally Posted by MichellePasinat
An Envoy Esteem middle ear implant is a surgically implanted electronic device that provides a sense of sound to a person who is profoundly deaf or severely hard of hearing. These implants are often referred to as a bionic ear. Thanks!
Your information is incorrect.

The Esteem implantable hearing aid is for those who have mild- moderately severe HL.

CI is for those with severe to profound/total deafness.

They are two very different devices.

The "Bionic ear" reference was used decades ago referring to very early CIs.
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