Monday, July 28, 2008

Ummm. Off to DUBLIN!!! B L O G ON VACATION!


Well,260 posts later, I'm off to Dublin and I am not going to blog for 15 whole days. I need to get my head together, hang with some 16 year olds and DISCO. My kids are in excellent hands with my husband (THANK YOU!) And my sixteen year olds are in excellent hands, too...*grin*

The mail has been good to me, lately. I received a belated Easter package from a beautiful person filled with JOLLY RANCHER JELLY BEANS!!!!!!!!!
*AND*
a new book by a VERY special hot mother author that I will be reading while I'm not at the disco supervising insane teens. I will say that reading this book will be quite difficult, I started and couldn't see the words through my tears, but I'll do my best! (live for you, hot MAMMA!)

Something REALLY exciting happened with the ICOP and a sexy male author was involved, but that will just have to wait until I get back.

Let's just say that one day after I get back, a HURRICANE will be blowing through Grosseto and staying at my place. Prepare yourselves for some funny posts around the 14th of August:).

Don't think I'll be "sippin' on gin and juice," but I might just have myself a GUINNESS (or two)!!!!!!

CHEERS!
Jodi
(BTW, I will be checking my emails regularly, so if you need to contact me, do it here: jodi@rallycaps.net)

Friday, July 25, 2008

Rollin' Up My Sleeves!


Well...I just created a Google Group for Italians - the Pediatric Cochlear Implant Circle - only it's in Italian: Circolo Pediatrico Impianto Cocleare. It's kind of strange creating something in Italian, but I have to start some time. The good news is that I finally created an Italian support group. The bad news is that I AM THE ONLY MEMBER!!!!!!
As they say..."Rome wasn't built in a day!"

And then there's my own personal favorite..."If you build it...they will come!"
lol.

Thursday, July 24, 2008

Been Thinking...

I know that I got my insane personality from my mom and I think I might just be thankful for that, because I know that my life will never be boring. Mom, I read this today and thought of you: Rather than focusing your attention on painful childhood memories to attempt to discover the source of your problems, concentrate on those happy childhood memories...that butterfly will come.

More Zen: Never abandon a desire because you're tired. Ask it to go away with conviction.

I just got an email with this photo of the founding ICOP (International Coalition of Parents of Children who are Deaf and Hard of Hearing) members under the tree on the wet grass on that beautiful day in Cernobbio...

 


*smile*

Tuesday, July 22, 2008

Advanced Bionics Settlement and ...ZEN


There is just no time to breathe with the million projects I'm trying to get organized before leaving for Dublin with six crazed teenagers. A special friend suggested that I read up on my ZEN to find some equilibrium in this crazed period I'm living...so, I've been doing just that! Here are some little pearls, I've been contemplating...

1. I dreamed a thousand new paths, I woke up and resumed mine.
*I'm gonna throw up, the neighborhood kids are blasting High School Musical 2 tunes*
2. To be happy requires incredible courage: that of being oneself. (And, uh, who exactly am I???)
3. Those who are happy to be nothing in particular are noble persons. Don't fight. Be ordinary. (See, now this one goes against everything I am...I'm screwed)
4. Do not search for yourself in others. Look at yourself within yourself. (kind of like this one)
5. (This one is kind of cute...) Buddha says that our sufferance is derived from the fact that we do not see the true nature of things. Begin to see things for what they are...and not as you would like them to be.
6. Then, there was a book by Josh Swiller THE UNHEARD...kind of the entire book was ZEN for me, and the last chapter, entitled THE RAIN...touched me enormously.
There's something so sensual, sad, invigorating, beautiful, etc. about rain...kind of depends on your mood...where you are in your life and thoughts at the moment it comes pouring down.

----------------------------------------------------------------------------------
Onto the Advanced Bionics settlement comment left by Kimberly whose passion and experience in regard to this matter has led me to continue blogging about the situation.

Kimberly...thank you for your comments, I hope leaving them is cathartic for you and others in such a way as only writing your thoughts can be...:

It's me...Kimberly. I posted about my AB experience a few months ago. Obviously, I've been following the AB/FDA lawsuit and resulting settlement. My take?

Well, I'm hesitant to really voice my honest opinions. Sometimes it's more prudent to keep them to oneself, so I will keep the majority of my thoughts to myself. I believe everyone should form their own opinion by doing the research and not allowing themselves to be blinded one way or another. Let me give you an example:

It's like buying a car. I may have owned XXX brand for years, with no problems. However, it's time for an upgrade, too many miles on the old car and I want to upgrade. However, while I'm doing the research for a new XXX I read in the leading consumer magazine that the 2008 model has many manfacturing recalls. In fact the issues are so severe that they have led to an unacceptable amount of driver injuries, so many in fact that the National Auto Safety Board is suing the automaker for not following Federally mandated safety guidlines. Well, I never believe what I hear from just one source, so I do more research on the internet and find more and more negative information about the problem from numerous sources. My research shows that it's been an ongoing problem for several years. I begin to feel pretty lucky that I haven't had the problem with my previous model. However, as a smart consumer, I'm passing not only on the 2008 model, but I'm now shopping for brand X. I'm not going to let owner "loyality" jeopardize my safety of my loved ones. Even if I've never had a problem with my previous model. Especially when I hear that automaker "XXX" settled the lawsuit with the National Auto Safety Board instead of fighting it and proving to me, the consumer that it DID follow all the Federally Mandated safety laws.

What I will say, and this is just my opinion based on how I would react if I were being sued wrongfully. IF I HAD done everything I was supposed to do according to the FDA guidelines. I would have fought turning any monies over tooth and nail. I would have provided all the documentation to prove I followed all the mandated guidlines I was supposed to follow. I would have provided copies of all the documentation I gave to the FDA notifying them of the change of the manufaturer I was using and cleared myself of the allegations, Then countersued for my costs. I would have fought it openly, posted all my supporting documentation and proof that I followed all the guidelines on my web sites and kept the fight as open and public as possible. In other words, I would have done eveything possible to "clear my good name". Especially if I had the financial reserve to fight. (AB received a pretty substancial amount of money from Boston Scientific last year. The amount was disclosed on the web in the buy/sell agreement). However, I'm a fighter, and when I'm falsely accused, I'm going to fight to clear myself, my name and my reputation. But, that's just me.

As far as the response of AB "In the best interested of our consumers"...again prudence tells me to keep my opinion to myself. The one thing I will say....when a device fails (and I'm not even going to begin to address the failure related to the moisture issue. I have VERY strong feelings about that and I AM going to keep my lips zipped on that one. Sometimes being "prudent" is tough). ANY failure is a HUGE problem, but when it's related to a BASIC issue, that would have been detected had the device simply been tested PRIOR to leaving the manufacturer....it would have been caught. Period.
(I'm talking about the basics. Like a car company not starting an engine to see if it runs before sending it to a customer who special ordered the vehicle).

I know I keep going back to the car as an example. I do so for a reason. We are a pretty safety minded society. We wouldn't get behind the wheel of a 6000 pound machine if we knew if was unsafe. We count on the auto companies to build a car that is safe for those driving, being transported and traveling along side it. If we are that careful as a society about the safety of our transportation we should be even MORE vigilent about the saftey of our medical devices.

I'll close on one final thought:

Medical devices of ANY kind, not just class III, are designed to improve, safeguard, enhance or even restore life....and HOPE for millions of people everyday. The vast majority of them do just that. Millions of people are alive because of these wonderful devices. People hear, see, eat and breathe because of them. Whether it be a heart lung machine that keeps someone alive during open heart surgery, or a simple IV catheter that infuses life sustaining fluid and medication into a premature baby fighting to stay alive, or a cochlear implant that has given a deaf person the ability to perceive sound.

However, that being said, the companies that manufacture these products have a RESPONSIBILITY to do everything in their power to ensure their products are safe and DO NO HARM. Every now and then, something unforseen and unpreventable happens. It's tragic, and an ACCIDENT. However, when these companies decide NOT to follow the safety guidelines, the Federal Laws and something happens then they SHOULD be held accountable.

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More Zen:
Who obligates you to follow the highways of thought, traced by philosophers or by great psychoanalysts?
Sometimes, on the smaller streets, simple and real people can speak of their own truth.

Saturday, July 19, 2008

Cooool: Gettin' A (New) CI on MTV 1PM on SUN.


MTV to give once-deaf teen a starring roleEpisode will focus on Vernon boy's cochlear implant experience

*Note from me...before reading the article - ponder the title (Um, I'm not too happy about it)*

It was a major milestone in Chris Bryson's young life.

The Sussex County teen, who was born completely deaf, received a cochlear implant and had the device activated a month after surgery this spring at the Atlantic Rehabilitation Institute of Morristown Memorial Hospital.

In the days and weeks that followed, the 16-year-old learned to adjust to a new sensation -- hearing for the first time.

All while the cameras were rolling.

Chris, who lives in the Lake Walkill section of Vernon, will be featured in an episode of MTV's "True Life: I'm Deaf" airing on Sunday.

The award-winning documentary series, which showcases real-life stories of young people, shot the episode last winter, offering an intimate look at Chris' life before and after surgery.

Filming took place over six weeks at various locations, including at Chris' home, at Morristown Memorial Hospital and at Mountain Lakes High School, where Chris will be a junior in September.

The school has a program where hearing-impaired students -- who once attended the Lake Drive School of the Deaf in Mountain Lakes -- can take mainstream classes.

Chris, who was familiar with "True Life" and MTV's other reality shows, was one of two individuals selected for the episode on young people receiving cochlear implants and learning to hear.

"I was pretty stoked," Chris wrote in an e-mail to the Daily Record. "I've seen (the shows) all the time and I imagined what it would be like if I was on a show that everyone can see. I can't believe this is actually happening ... I feel like a celebrity right now."

Marshall Eisen, executive producer of "True Life," said the one-hour episode fits the series' primary focus on the experiences, niches and subcultures in the lives of young people.

"True Life: I'm Deaf" features the lives of both Chris and Amanda, a 22-year-old college student in Maryland who also was born profoundly deaf.

"This was an idea that came up that we thought would be really interesting -- to see how people who are deaf navigate through life, through the world," Eisen said.

"It's just a really kind of deeply felt emotional topic that has a lot of visual and sort of experiential moments that can make for compelling TV."

Chris' story fits the series profile, Eisen said.

"He had this quite interesting story of receiving a cochlear implant and allowing us to be there through that process and see what happens," said Eisen. "It's a pretty extraordinary moment, to see him hear ... to watch him take on this ability that most of us take for granted."

David Bryson, Chris' father, said his son -- the second-oldest of five boys -- received his first cochlear implant at the age of 7. The first device, a 1.2 model, was defective and emitted a constant whine before it stopped functioning, David Bryson said.
At that point, Chris stopped wearing the speech processor attached to the implant, but he was only able to communicate through sign language for years, said Gina Bryson, Chris' mother.

"When he got to be older, and more like a teen, his desire to communicate verbally kept increasing," she said. "His own desire was to have a device that works."

The Brysons learned that Advanced Bionics, the California-based manufacturer that supplied Chris' first cochlear implant, would replace the device with a more advanced model for free.

The company, which creates state-of-the-art hearing technology, also agreed to pay for Chris' surgery to have the new implant installed and activated, said Gina Bryson.

After Chris decided to have the surgery, the family learned of "True Life: I'm Deaf" through Advanced Bionics.

MTV had contacted the company, seeking individuals ages 16 to 24 who fit the bill, and also issued a casting call.

Three weeks before Chris was scheduled for surgery for the new implant, Gina Bryson e-mailed and sent photos of Chris to the network. MTV responded immediately, requesting permission to film, she said.

"It all happened very fast," she said. "The next thing we knew, they were here, filming."

New York-based Gigantic Productions, which produces the show for MTV, sent a two-woman crew to the Bryson home and then to the Summit Medical Group in Berkeley Heights, where Chris underwent surgery for the implant in February.

The cameras even captured some squirm-inducing moments, such as the incision that Dr. Jed Kwartler made in Chris' skull, right behind his ear, to install the implant, said Gina Bryson.

"I was a little uncomfortable initially, but was willing to do it for the sake of what we were doing," she said. "I just felt that it was something people should see and rejoice with us."

Following the surgery, Chris let the incision heal before heading to the Atlantic Rehabilitation Institute at Morristown Memorial for activation, or mapping, of the new implant for two days in March.

Christine Hoffman, lead audiologist at the Atlantic Rehabilitation Institute, said the Harmony model implant that Chris received processes sound more efficiently and is more frequency-specific than the 1.2 implant he previously had.

Mapping the implant requires measuring a patient's level of sound and discerning the comfortable decibel level, Hoffman said.

Hoffman, who also programmed the first implant that Chris received as a youngster, said she was conscious of the cameras recording her every move but was only asked by the producers to explain certain procedures.

"In the beginning, of course you're nervous that people are filming you," she chuckled. "But I totally forgot that they were there."

For Chris, the filming experience was "pretty fun," especially following his surgery when he engaged normally with his family and friends at the local basketball courts and skateboarding park.

Months after his surgery, Chris is happy with his new implant and is looking forward to speech therapy when school resumes in September.

"I just love everything about it and it helps me hear a lot ... it's more improved," he wrote in his e-mail.

"But it's pretty difficult because I haven't been practicing (speech) in a few years without the cochlear implant. ... Right now I'm working on it, and I'll always try my best no matter what."

Filming "True Life" gave him "the best courage and faith," he said.

"I'm so happy that everyone can see what deaf life is all about, and I hope they can understand deaf people," he wrote. "I think it's gonna be different seeing myself on MTV ... It's pretty wicked, man."

Friday, July 18, 2008

ASL-CI USER Heading for Harvard: He Thanks his Mom:)


A typical summer day in Grosseto lasts approximately three years, so when I don't post for a day, it's like I've missed a lifetime. One of the moms on the Circle posted this article, and I just wanted to share it, because it is yet another inspirational story...

Graduating St. George’s School senior turns stereotypes about the deaf on their ears

01:00 AM EDT on Wednesday, June 18, 2008

Editor’s note: Westley Resendes, of Middletown, graduated from St. George’s School on Memorial Day and is off to Harvard University in the fall but his story is much more complex. He tells it here in his own words.

I’ll start from the beginning: I was born profoundly deaf, and could not hear anything at all — not even if a 747 jet took off right over my head.

I would not truly hear until I was nine years old. When I was six, my parents inquired about a cochlear implant for me. At first the doctors were hesitant about my age, feeling that I was too old to benefit from it. Yet my parents still fought for my opportunity to hear.

The doctors from Children’s Hospital in Boston finally agreed to meet me and see if I was truly a viable candidate for a cochlear implant. Once they did, they realized that my lifelong dream was always to be part of the hearing world and I got my first implant in 1998, but my body rejected it.

I was sick for quite a while and eventually had to have it removed, taking away the newfound hearing I had had for only six months. However, the doctors, surprisingly, were willing to give me a second chance when I was 9, and in 1999 I heard successfully when my speech processor was activated.

My mom saying, “I love you,” was the first thing that came into my once-silent ears.

I wept because of the pain of the sound flooding the previously unused ears and, simultaneously, because of the joy that I had finally succeeded in my dream.

However, just because I could hear didn’t mean that I would necessarily understand everything. I had been attending speech therapy since I was six years old on a weekly basis — and still do today — to work on my listening and speaking skills. Even today, when the speech processor is not on my head, I cannot hear anything — not even my own voice.

However, I do not think of myself as deaf, as people tend to classify me.

I have always viewed myself as hearing impaired, but I can hear, just like everyone — only a little differently.

I attended the Rhode Island School for the Deaf (RISD) in Providence from kindergarten through third grade full time, as I couldn’t hear at all.

In the summer before fourth grade, I received my cochlear implant, and there began my journey into the hearing world.

I began to attend Community Preparatory School in Providence part time in fourth grade (spending the rest of my time at RISD) with the help of a sign-language interpreter.

Over the next five years, the balance of my time would shift to Community Prep; and by eighth grade I only went to RISD once a week to serve as director of periodicals in the school library.

Before I graduated from Community Prep, I began my search for high schools. I was primarily interested in staying closer to home, as I was not enthusiastic about the hour-long bus rides I had taken to Providence for the last nine years of my life.

I recall meeting Peter Anderson, an admissions officer at St. George’s School, at the high school fair at Community Prep. My dad and I asked whether it would be OK if I had an interpreter for classes at St. George’s.

Contrary to the reactions from officials of many other schools, he immediately showed great enthusiasm and acceptance for me and assured us that an interpreter would be perfectly fine. At that point, I knew that St. George’s was my dream school. I ultimately decided that I wouldn’t apply anywhere else. Fortunately, the admissions office at St. George’s liked me too, and they decided that I would be a good fit for their close community.

I have to mention my mom, who has been truly the most important factor in my success.

When she found out that I was hearing-impaired, she took it in stride and resolved to raise me the best way possible. She sacrificed everything for me, and became my first and most influential teacher. She helped me to start speech therapy when I was six and she made the decision to apply for a cochlear implant. I would not be in the hearing world — at Community Prep, St. George’s or Harvard without her. I owe everything to her.


*Adorable*

I went to St. George’s knowing no one at the school except my interpreter — Michele Neiley, whom I had the luck to work with since sixth grade at Community Prep. My new classmates were curious to see an additional adult in the room, signing to a student who happened to have a funny thing on his head (the speech processor for the cochlear implant).

I got through my first academic day fine, but then I was left alone for the required sports period. My interpreter would only be with me for the class day, not after school. I did not know this, so I was somewhat lost. I decided to manage football, as a doctor’s note barred me from playing contact sports because it posed too great of a risk to losing my hearing (by a head collision).

The football coaches were eager to take me under their wings and show me how to do things. Their investment soon paid off. I immediately enjoyed managing, knowing that my contributions would help the team for the better.

A strong memory of my first day at St. George’s was the freshman picnic outside Diman Hall (the freshman boys’ dormitory). That was my first social, non-academic, interaction with my classmates.

I recall that a circle of boys surrounded me and began to pepper me with questions like, “What’s that on your head?” and “Can you read lips?” With the help of a new friend that I had just made, I was able to explain who I was. They immediately met my response with remarks of enthusiastic interest, and I felt at that point that I had made the right decision to attend St. George’s.

From that very first day, I was accepted there, and that is the one thing that I will miss the most about the school. It is a very close-knit community and you will meet practically everyone on the campus at least once. The overall sense of acceptance of everyone there is truly incredible.

Later that week, I was walking by the chapel to [teacher] Doug Lewis’s geometry class and this very old, old man approached me over the hill, like the Ghost of Christmas Past.

It turned out that he was the conductor of the brass ensemble, Tony du Bourg. He pointed at me, and said, “Hey! Are you that West Resendes boy?” I timidly whispered yes. He said, “I want you to play music!”

I laughed, but then thought, “Okay, I’ll do it,” — primarily to make this man happy and secondly, to see if I could really do it.

I’ve always wanted to disprove stereotypes. Here is a piece of advice I always give out: Never allow a stereotype to define you. That’s why I joined the brass ensemble, that’s why I gave a speech to the whole school when I ran for senior prefect last year (and lost) and that’s why I gave a “chapel talk” in April of my senior year.

All of these were challenges that I overcame.

Once Tony du Bourg met me, I started out on the cymbals and I would play for chapel services (the school meets in chapel twice weekly, once for a formal Episcopalian Mass, and once for a senior chapel talk).

After a month, I started taking lessons on the baritone horn — which is a slightly smaller version of the tuba — and I’ve played both instruments for services as the only dual-instrumentalist for the brass ensemble for the past four years. (Sometimes, I had to use both instruments in the course of one song — there would be some quick instrument changes!)

I ran for senior prefect, which is St. George’s version of student government. There are 5 senior prefects selected from a field of usually 30 candidates through a school-wide election process.

I decided that I should run, regardless of my disability, so I would know that I had pursued my goal of “sameness” to my fullest.

I spend a month or so preparing my speech, practicing it endless times. The moment came and I was assigned the first speech of the night. I had never spoken to an audience of 350 students before and I must say that it was slightly intimidating, but rewarding at the same time, because for that moment everyone was listening to me, the first hearing-impaired student to attend St. George’s, give a speech on why I should be their senior prefect.

As I spoke, the pit in my stomach began to dissipate and that rousing feeling of success took its place. I had defied everyone’s expectations in speaking, in expressing my opinions in a public arena. Apparently, enough students understood and valued my message of student-faculty communication to propel me to the coveted Top Ten candidates through their votes.

In the end, I didn’t get the spot but it prepared me for the annual rite of passage for seniors — the chapel talk. Just like any other St. George’s senior, I was to have an opportunity to tell my peers about my journey.

I began penning my chapel talk months before I was scheduled to speak and I practiced it countless times in speech therapy.

When the day came, I chose “Amazing Grace” as the hymn to be sung that day, and after singing it, I walked up to the podium of the chapel.

Looking upon my audience of about 400 people, including students, faculty, staff and my parents, I felt wonderful.

I began my talk with a moment of silence, lasting a scant 15 seconds, so that the school community could have some idea of what it was like for me for my first 9 years. As I spoke my words, my peers listened to me attentively. As I concluded my talk, the school community rose from their seats and applauded for me. It was a truly wonderful moment for me.

I participated in a good number of extracurricular activities, and those certainly are my hobbies and interests. In the fall, I managed football and in the spring it was baseball. This spring I had a small moment of glory when I pinch-ran for a batter for the last home game against Thayer Academy.

Unfortunately, the batter after me grounded into a double play, but it was truly a pleasure to have a small taste of a varsity baseball game.

In the winter I served on the stage crew for the musical. That was truly a pleasure, as I was able to get my hands dirty with power tools and help to construct a fully functional set for the actors and actresses.

I had a cameo role in the musical every year, served as property master for junior and senior years, and was captain of the stage crew my senior year. I’ve written feature stories for the school newspaper for the last three years. I also was head of the Young Liberals Club this year and was a day prefect (a mentor for younger day students) for the last two years.

I expect my academic focus at Harvard to be on biology and neuroscience because it will help me toward my goal — one that some may call lofty.

One in every thousand people in the world has a problem with their auditory system. I am one of those people, and I want to change that.

I’ve kept a close eye on the development of the controversial research of stem cells and always wondered, could stem cells help us hear again?

I want to find a nonmechanical solution to help the hearing-impaired. I currently depend on a cochlear implant, which is a technological achievement in itself but I want to do better.

I want to be able to plant stem cells in the cochlea of the inner ear in place of the broken hair cells that are the most prominent cause of hearing impairment. My hope is that if stem cells can live up to the vaunted expectations, they should be able to regrow into hair cells, and restore hearing among millions.

I hope to work at the Stem Cell Institute at Harvard and just jump into the research that they are already conducting on stem cells and the regeneration of hair cells. College will be a continuation of my boundary-breaking journey, and I plan, just like stem cells, to live up to my own expectations.

Wednesday, July 16, 2008

Advanced Bionics Complaint...and Letter RE: FDA Settlement


Two months after my post FDA Seeks to Fine Cochlear Implant Company, a reader, Kimberly, posted the following comment:

I had my first AB implant done on the right in August of 2005. It worked great for a few months, then I started "hearing" loud popping, sounds like paper crinkling and the power cutting in and out. The device was failing. In December 2006 I had my left implant done an the right was a hit and miss. From the moment of activation the right didn't work right. A few electrodes were shorted out. I ended up having a bilateral revision done in March of 2007. The results, the right failed due to moisture and the left due to electrodes shorting out.

Both AB products, made by two different manufacturers. I am the first bilateral failure the clinic I went to has ever seen. Not to mention a bilateral failure for two entirely differnt reasons. The implants I have now are stll AB. Frankly I didn't want to use AB again, but my insurance wouldn't cover the other. As a result of the revision surgeries I lost what little natural hearing I had left. The blogger that said AB and the FDA are working this out...yep they sure are the FDA filed a 2.2 million dollar law suit. Sadly, the highest amount they could ask for. My opinion. AB got greedy and cut corners. At the expense of the very people they were suposed to provide a service to. They never even notified the FDA that they were using Vendor B, as Vendor B had not been approved by the FDA. If you want interesting reaading read the actual warning letter the FDA sent to AB and the lawsuit filed by AB. They can be read at http://www.pretiflaherty.com/mediacenter/news/items/2008_03_26_209.asp

I have never posted on a blog, but after reading some of the comments I was moved to do so.

Those who are saying that the whole AB fine is directed at something in the past are completely mistaken. It started in 2002 and AB continued to ship devices without the proper testing manufactured by a non FDA manufacturer until 2006. The proof is in the FDA lawsuit filed recently. Again take the time to read all the information. AB didn't even notify the providers they had shipped the defective implants to...again do the reading. The FDA letter to AB spells it out as does their lawsuit. I can guarantee we will all be reading about private lawsuits being filed.

As a AB receipient it's sad to say I can't recommend their product. I know what I've been through and am continuing to go through as a result of their poor QA/QI programs. While I certainly don't wish what I'm going through on anyone, I wish it had happened BEFORE I made my original decision on which company to go with. It certainly would NOT have been AB.

May 28, 2008 3:14 PM

I debated for a couple of weeks whether or not to post this comment. Then, at the NHS 2008 Conference I met a gentleman who works for Advanced Bionics, who suggested that I email him the complaint and he would send me some type of response. I sent him the complaint two weeks ago and still haven't received a response. I am not a very patient person, so I apologize for not having waited another two weeks for a response.

I will assume that the letter issued by Advanced Bionics on July 14th is a sort of response. It was issued here, I'm going to re-write it because I can't copy it from the pdf. Here goes...

Dear Patients and Professionals,

Today, Advanced Bionics agreed to settle a matter with the U.S. Food and Drug Administration (FDA), resulting from a decision we made in 2003. That decision concerned a determination that no formal FDA submission was needed when we added a new vendor (Vendor B, later terminated in March 2006)to our manufacturing operation. Four years later, in 2007, the FDA filed an administrative complaint against us stating the FDA's belief that a formal submission should have been filed. We responded to the Agency, pointing out that it had already approved both vendors when it approved the system.

While we do not agree with the FDA, we do believe that accepting its terms is in the best interest of our patients, our company and our need for a long-standing relationship with the Agency. So, we have decided to settle the matter, with the company paying 1,1 million dollars, and me, as CEO, paying 75 thousand dollars.

Over the years, we have increased our focus on the reliability of our entire implant system. At present, our internal device (Vendor A)has a 2 1/2 year CSR of 99.1%, and our external product durability leads the industry. That being said, we expect that the quality of our products will only get better in the years to come.

As we move forward, we are stronger than at any moment in our history: singularly focused on cochlear implants, well funded, possessing better leadership in key positions, and having a strategic plan built around patient care.

We very much look forward to continuing our partnership in this community. Please call me if you have any questions about these or other matters.

Very Sincerely,

Jeffrey H. Greiner
President and Co-CEO



*Wonder how Kimberly will take the news...*