Any envoy medical esteem recipients out there?

[mlb 10th inning]

Wirelessly posted (Blackberry Bold )

Cyborg - just stop.

Actually why don't you start a new thread for your fully-implantable CI rants.

I'm not ranting. I'm just being a good citizen.

I pay my taxes most of the time.

 

[mlb 10th inning]

Cyborg, you're getting way too excited, they take years with all the FDA approvals and testings and such before all the new stuff comes out.

It'll be faster if you donate your body to a robotics association or something.

I could travel to Europe to get the Totally Implantable Carina (commercially approved there). And, come back to the USA WITH the Totally Implantable Carina device inside my head. In the USA, they're still waiting for it.

I'm saving hundreds of thousands of dollars for the Totally Implantable CI. And I'm going to pay for it out of my pocket in Australia, and come back to the USA with the Totally Implantable cochlear implant inside my head while the FDA is still waiting to approve the Totally Implantable CI in the USA.

 

[mlb 10th inning]

Do you like it other than being hampered during water-related activities?

I have a love-hate relationship with the CI.

 

[mlb 10th inning]

12th International Conference on Cochlear Implants and Other Implantable Auditory Technologies

Thursday, May 3, 2012 Scientific Session III Oral Abstracts 3:00 PM – 5:00 PM


Topic:
Outcomes
Title:
Six Years of Experience with a Totally Implantable Cochlear Implant
Author(s):
Robert J Briggs, Helmut Eder, Peter M Seligman, Kerrie L Plant, John M Heasman, Robert C Cowan, Michelle R Knight, James Dalton, James Patrick
Presenter:
Robert J Briggs
Abstract:
Objectives To review the benefits, limitations and technical capability of a prototype totally implantable cochlear implant following six years experience at the HEARing CRC. Study Design The totally implantable implant has a lithium ion rechargeable battery, a package-mounted internal microphone and sound processing electronics that enable the use of ‘Invisible Hearing’ without the use of an external microphone. The implant also functions with an externally worn sound processor as a conventional cochlear implant. The three implanted subjects have used the device in both Invisible Hearing and standard modes of operation since the time of implantation. Hearing performance, patterns of device use, and reports of body noise have been closely monitored. In addition, technical data has been collected to assess the performance of the implantable battery and microphone. Results There have been no surgical or medical post-operative complications associated with use of the device. Although speech perception using Invisible Hearing mode is poorer than that obtained in the conventional mode, all subjects report some benefit associated with use of Invisible Hearing in their daily lives. Two subjects report that they are never without hearing, with Invisible Hearing used at all times when the external device is removed. Specific benefits have been reported, including use of the device when swimming and in providing sound awareness when sleeping. Limitations of the device occur as a result of body noise, and there has been no evidence of habituation to body noise over the six years of use. The rechargeable battery continues to function well, with a cycle time indicating that the low-power implant design is effective.Conclusion After six years use of the totally implantable system, the device continues to function well and recipients continue to report benefit associated with use of the device. This experience has provided important insight into the potential of such a system.


Otologics Phase 2 clinical trials

Otologics Fully Implantable Hearing Device Phase II Results

Drew M Horlbeck, MD (presenter)
Herman A Jenkins, MD
Ben J Balough, MD
Michael E Hoffer, MD


Abstract


Objective The efficacy of the Otologics Fully Implantable Hearing Device (MET) was assessed in adult patients with bilateral moderate to severe sensorineural hearing loss.


Methods Surgical insertion of this totally implanted system was identical to the Phase I study. A repeated-measures within-subjects design assessed aided sound field thresholds and speech performances with the subject's own, appropriately fit, walk-in hearing aid(s) and the Otologics Fully Implantable Hearing Device.


Results Six- and 12-month Phase II data will be presented. Ten patients were implanted and activated as part Phase II clinical trial. Three patients were lost to long term follow-up due to two coil failures and one ossicular abnormality preventing proper device placement. No significant differences between preoperative (AC = 59 dB, BC = 55 dB) and postoperative (AC = 61 dB, BC = 54 dB) unaided pure tone averages were noted (p < 0.05). Pure tone average implant aided thresholds (41 dB) were equivalent to that of walk-in-aided (37 dB) condition with no significant difference (p < 0.05) between patients’ walk-in-aided individual frequency thresholds and implant-aided thresholds. Word recognition scores and hearing in noise scores were similar between the walk-in-aided and for the implant-aided condition. Patient benefit scales will be presented at all end points.


Conclusions Results of the Otologics MET Fully Implantable Hearing Device Phase II trial provide evidence that this fully implantable device is a viable alternative to currently available hearing aids in patients with sensorineural hearing loss.


This is the Implantable microphone for the Totally Implantable CI




Cochlear buys patent rights for Otologics

From: AAP
September 09, 2009 10:00AM

HEARING implant company Cochlear has secured a license agreement to purchase patent rights, know-how as well as joint development activities with Otologics LLC for $US25 million ($29.02 million).


The agreement with the Colorado-based company will allow the company to use Otologics' technology with cochlear implants.

Cochlear chief executive Chris Roberts said the purchase was another step toward achieving the company's long term goal of developing a totally implantable cochlear implant.

"This will further expand our product range and reinforce our technologic leadership,'' Dr Roberts said.

"The purchase is particularly useful in the complex area of implantable microphones, vital for the development of a totally implantable cochlear implant.''

The purchase price of $US25 million is payable by the end of calendar 2011, plus a royalty on future net sales of certain products involving an implantable microphone.

Cochlear said the payment will be treated as acquired intangibles and amortised over approximately 15 years.

About $US8.5 million of the purchase price was paid by June 30 this year.

 

[kokonut]

Really?? I am not a paid spokesperson. I have never received a dime from Envoy except food and gas reimbursements during the clinical trial, the same as all the other trial patients. If I was a spokesperson, I'd have that second implant that I so desperately want. Yes, you remember me "hyping" it on the HLAA boards, because guess what? I received the implant and I like it! You have every right to be skeptical, and it's your opinion. The fact is, while it may not work for some, it has been successful for hundreds of patients. Am I completely snowed over by Envoy and the Esteem? No. There was talk about a possible pediatric study in the future, and guess what? I have absolutely no interest in even considering signing my child up for it. 1) Implantable hearing aids have obviously had success, but the concept is very new, and there's improvements to be made yet, and 2) I want my child to make that decision for herself when she's old enough.

There are a few insurance companies that now cover the Esteem (make that 100%). One can only hope that more will follow suit. I may be proven wrong, but I doubt Envoy's Esteem will crash and burn. But if it does, we - the patients - are covered. Of course they are out to make serious money - they spent millions developing a product that many HoH people want.

The thing is that you are enjoying it and it has been successful for you. You are not obligated to prove to anyone whether you are paid spokesperson or not other than to say "I'm not a paid spokesperson." If anybody continues to disagree or still skeptical, then that's their problem.

The Esteem is certainly a revolutionary device. I'm keeping my eye on it as well.

 

[deafdyke]

MandyMarie, why not just come to terms with being HOH? You're so fixtated on technology supposdely giving you "better access to the hearing world, it is CLEAR you never came to terms with actually being HOH......if you HAD, you wouldn't be franticly trying to be as "hearing sound quality as possible" And with "they make a device that many HOH people want?" That sounds like marketing to me.
And sorry but it IS going to crash and burn simply b/c not many insurances will cover it....there is a health care cost bubble coming up....and after it pops, even CIs will not be covered in full.

 

[deafdyke]

and I do remember you saying that "oh I qualified for the implant by using the tests from a crappy analog".......sigh.

 

[deafdyke]

If they don't cover hearing aids, and medical costs and insurance costs are SKY HIGH, then why would insurances cover it?
I just see a lot of hype about this..........EVERYONE should be very very cynical about this.

 

[kokonut]

MandyMarie, why not just come to terms with being HOH? You're so fixtated on technology supposdely giving you "better access to the hearing world, it is CLEAR you never came to terms with actually being HOH......if you HAD, you wouldn't be franticly trying to be as "hearing sound quality as possible" And with "they make a device that many HOH people want?" That sounds like marketing to me.
And sorry but it IS going to crash and burn simply b/c not many insurances will cover it....there is a health care cost bubble coming up....and after it pops, even CIs will not be covered in full.

How about stop ragging on her and just be happy for her? She enjoys her new hearing device technology, so be it. Nobody wants a Debbie Downer.

 

[TXgolfer]

If they don't cover hearing aids, and medical costs and insurance costs are SKY HIGH, then why would insurances cover it?
I just see a lot of hype about this..........EVERYONE should be very very cynical about this.

Cynical is a bad way to live....instead of being cynical why not spend the time putting the word out that insurance needs to cover this. Be positive and proactive.

 

[MosDeaf]

MandyMarie, why not just come to terms with being HOH? You're so fixtated on technology supposdely giving you "better access to the hearing world, it is CLEAR you never came to terms with actually being HOH......if you HAD, you wouldn't be franticly trying to be as "hearing sound quality as possible" And with "they make a device that many HOH people want?" That sounds like marketing to me.
And sorry but it IS going to crash and burn simply b/c not many insurances will cover it....there is a health care cost bubble coming up....and after it pops, even CIs will not be covered in full.

Perhaps you should look at yourself, and why you feel the need to tell other people what they should do and think. Mandy has improved the quality of her life because of the Esteem, and yet you feel the need to criticize her and accuse her of being a company spokesman. Why is that? Why can't you be happy for her and others? You sound like the stubborn deaf people who continued to criticize cochlear implantation long after it was shown to work for children and the late-deafened.

As for Envoy Medical, business is booming on the strength of their product.

 

[MandyMarie]

MandyMarie, why not just come to terms with being HOH? You're so fixtated on technology supposdely giving you "better access to the hearing world, it is CLEAR you never came to terms with actually being HOH......if you HAD, you wouldn't be franticly trying to be as "hearing sound quality as possible" And with "they make a device that many HOH people want?" That sounds like marketing to me.
And sorry but it IS going to crash and burn simply b/c not many insurances will cover it....there is a health care cost bubble coming up....and after it pops, even CIs will not be covered in full.

You know, in all the times I've run into your posts, I've never once seen you tell someone, "That's great! Even though <insert product here> isn't right for me, I'm glad it's working for you." As these other members have said, I don't have to explain myself or my choices to you. In the end, I'm doing what's best for me, and if I make the wrong decision, it's on me.

To everyone else, thank you for recognizing that I'm not some spokesperson who cannot come to terms with my hearing loss. There's no right or wrong answers. Some prefer sign language, some prefer hearing aids, some prefer CIs, and some prefer implants. We all do what makes us happy, regardless of how some random strangers may feel about it, and our choices make us no matter or no worse than anyone else.

 

[deafdyke]

Perhaps you should look at yourself, and why you feel the need to tell other people what they should do and think. Mandy has improved the quality of her life because of the Esteem, and yet you feel the need to criticize her and accuse her of being a company spokesman. Why is that? Why can't you be happy for her and others? You sound like the stubborn deaf people who continued to criticize cochlear implantation long after it was shown to work for children and the late-deafened.

As for Envoy Medical, business is booming on the strength of their product.

That's simple. She's a freaking spokesperson. Not nessarily a paid one.....but still...............all I can say is that a) she has ONLY posted on THIS thread and other related Esteem threads. I also find it EXTREMELY sad that she's so dependent on technology that she would rave about the Esteem......I know many HOH people who love their hearing aids, but they're just happy with a basic HA....b/c they got ASL and deaf culture....

 

[kokonut]

That's simple. She's a freaking spokesperson. Not nessarily a paid one.....but still...............all I can say is that a) she has ONLY posted on THIS thread and other related Esteem threads. I also find it EXTREMELY sad that she's so dependent on technology that she would rave about the Esteem......I know many HOH people who love their hearing aids, but they're just happy with a basic HA....b/c they got ASL and deaf culture....

She's only advocating for herself and how it has benefited her. No more than you being a spokesperson about ASL. But so what?

Funny how you talk about being dependent on technology as if it's a bad thing. Let's see, we have TTY, we have cellphones with texting ability, we have video phones, we have captioning on tv, captioning in movie theaters, we have CapTEL, we have hearing aids, cochlear implants, Esteem implants, we have the internet, email, etc, etc....

 

[MandyMarie]

It's okay, Kokonut. She joined another board and only posted on our Esteem-related threads, and wouldn't stop harrassing everyone about the Esteem until she was eventually banned. Someone who spends that much time worrying about what some stranger does in their own lives must have some issues. I'm so sorry that I'm not into ASL and deaf culture...I was mainstreamed my entire life and was never exposed to any deaf culture, so it wouldn't exactly make sense to start now, huh?

 

[MandyMarie]

Come to think of it..a person with vision impairments should embrace blind culture. It is so wrong for them to opt for surgery instead of glasses, right??

 

[kokonut]

It's okay, Kokonut. She joined another board and only posted on our Esteem-related threads, and wouldn't stop harrassing everyone about the Esteem until she was eventually banned. Someone who spends that much time worrying about what some stranger does in their own lives must have some issues. I'm so sorry that I'm not into ASL and deaf culture...I was mainstreamed my entire life and was never exposed to any deaf culture, so it wouldn't exactly make sense to start now, huh?

I understand and empathize with you on being mainstreamed. I was never exposed to deaf culture until I was 23 when I decided on a lark to go to Gallaudet University. Great experience. Saw the good, the bad and the ugly. It was a challenge at times. Sometimes they were just simply vicious (as they are even today as you can see) but mostly I made lots of good friends who still around today. It's never to early or late to see what deaf culture is all about. I have my preferences, of course, but it's a whole different world once you step into it. We're all basically in the same boat...just different worlds that overlap each other in places.

 

[MandyMarie]

I understand and empathize with you on being mainstreamed. I was never exposed to deaf culture until I was 23 when I decided on a lark to go to Gallaudet University. Great experience. Saw the good, the bad and the ugly. It was a challenge at times. Sometimes they were just simply vicious (as they are even today as you can see) but mostly I made lots of good friends who still around today. It's never to early or late to see what deaf culture is all about. I have my preferences, of course, but it's a whole different world once you step into it. We're all basically in the same boat...just different worlds that overlap each other in places.

I live in such a small town that I've never even seen/met but one deaf person except the two times I went to a deaf/HoH camp as a child (my nine year old daughter was supposed to attend for the first time this year, but she has a chronic disorder that has been particularly bad this year). My daughters and I dabble very lightly in ASL, and I'm hoping my college has an ASL class I can pick up. I've always been interested in deaf culture, but as someone who can function surprisingly well without hearing aids, my fit is more mainstreamed. Thanks to the Internet, I've made some great deaf/HoH friends, some of which I'm very close to. Most people are open-minded enough to know that everyone is different, and it's ultimately up to each person to decide what makes them happy.

You don't have a CI, right? Are you fluent in ASL?

 

[kokonut]

I live in such a small town that I've never even seen/met but one deaf person except the two times I went to a deaf/HoH camp as a child (my nine year old daughter was supposed to attend for the first time this year, but she has a chronic disorder that has been particularly bad this year). My daughters and I dabble very lightly in ASL, and I'm hoping my college has an ASL class I can pick up. I've always been interested in deaf culture, but as someone who can function surprisingly well without hearing aids, my fit is more mainstreamed. Thanks to the Internet, I've made some great deaf/HoH friends, some of which I'm very close to. Most people are open-minded enough to know that everyone is different, and it's ultimately up to each person to decide what makes them happy.

You don't have a CI, right? Are you fluent in ASL?

I wear a hearing aid in my right ear only. No problem using the phone and field radios which I use regularly. I'm fluent in sign language since age 23. Attended regular schools growing up. So, from that vantage point I saw attending Gallaudet University as an interesting challenge and the opportunity to learn sign language and add that to my tool box of things with me.

 

[kristy2078]

I would be particularly worried about the battery bit for quite a few reasons. I also think I know why they have that minimum 40% unaided speech comprehension score--deaf people with worse speech comprehension skills are less likely to benefit from implants, thus the company wants their statistics look good by having a majority of their patients be "successful."

As for insurance companies covering implants, I don't want that happening until hearing aids are covered. There's no reason to cover just implants and not the hearing aids. Right now, roughly 15 states require insurance to cover HAs for children, three for children and adults, and one for HAs and implants. **For some states, the requirement is there for the insurance in that given state, but the employer can choose to take the option or not (i.e. Arkansas). So, I am betting about half these states have solid rules and the other states (i.e. Arkansas) have weak rules), so maybe eight states are good to go for coverage on hearing aids. That's not a good number though, and if Romney gets elected and overturns ACA and pushes health care to the states, we may lose the coverage in those states.

There is a reason why medical procedures and services are so much more expensive in the US than in the other countries. ATM, we have no federal regulation on the costs and other countries do.