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."

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...*

Response to Mishka and Myself

One of the reasons I posted yesterday's blog was to reinforce to the Deaf community that hearing and deaf parents of children with cis are aware of the risks involved in implantation. We support each other not only by sharing our experiences, but by discussing controversial information, this is a fundamental part of the Cochlear Implant Community. As I said in the previous post, my purpose for posting was not to create insecurities or brand wars, it was merely to provide information. Fellow bloggers and concerned AB ci wearers left important comments on my blog that I would like to share, because their comments promote awareness, as well, especially regarding the integrity of Advanced Bionics.

Abbie said...
Just like Jennifer said, this is a five year old issue and there are NO new issues or concerns. Advanced Bionics is actively participating with the FDA to reach agreement on this issue.

Five years ago, Advanced Bionics issued the voluntary recall on their accord the minute that they noticed the rate with Vendor B component was prone to moisture issues was 1% lower then the Vendor A component. Not all of the Vendor B implants had this problem. Advanced Bionics issued a voluntary recall themselves and followed up with issuing letters to the implantees that received a Vendor B Implant and footed the bill for the re-implantation with a Vendor A implant.

The FDA is just playing catch up.
March 30, 2008 8:43 PM

Jennifer said...
Jodi, just thought I'd let you know that this fine is directed at something that happened four years ago, not something that's currently going on. AB voluntarily recalled all their defective implants at that particular time and it is just now being addressed. AB and the FDA are on good terms and this is all being worked out. I can send you more information on this if you'd like! :)
I do appreciate your willingness to share information such as this on your blog...but I feel that AB is a good, reliable, sound company and I'm very proud to be associated with it! :)

Rachel said...
Jennifer and Abbie are both right - This issue is not new and FDA is just playing catch up like all the other government related stuff. A similar analogy - I have a friend who got a speeding ticket a few years ago, and his insurance didn't increase his rates until a few years later.

Here are the news that was posted in 2004:

http://www.fda.gov/bbs/topics/news/2004/NEW01119.html
http://www.medicalnewstoday.com/articles/14002.php.html

AB could have made this situation worse by not notifying all of their clients about the vendor B issue. So, I would say good for AB being honest about their products by voluntarily recalling the products and willing to pay for the re-implantation before FDA had a chance to fine AB.

My issue was not at all with Advanced Bionics, I just want parents to have access to ALL information.

This was what I posted on the CI Circle in response to the news release:

I don't know what to think after reading all of this. First of all,
it really angers me that already parents have spoken up about
these failures, yet when new parents come to the list asking about
experiences and information, we all become delicate and diplomatic
so as not to have implant wars. I can understand the need for
diplomacy, but I at least hope that parents who have had such
experiences email these new parents off-group to give them a heads-
up at least to do more research. It's stressful enough implanting
for the first time, my heart goes out to all of these parents who
have to go through it again because of device failures. This is
really unsettling news, and I am so glad that the FDA has
investigated this. I hope they do fine, so it will serve as a
heads up to all other ci companies to create the best possible
products for OUR kids.

Discussing CI companies is a very delicate issue because for every implant failure, there is a parent who will defend their company until the end because that is how successful the cis are when they work without failure, but we do need to
realize there are failures and apparently more than I even imagined.
I don't know, when I was researching I wanted to know the good and
the bad, the uglier the better so I knew I could make an educated
decision...this is a tough issue for this group. The important thing
is that we support each other, provide relevant information in a
responsible way and try to avoid scaring other parents, who already
have to make such difficult decisions. I'm really sorry to hear
about this situation with Advanced Bionics and I hope they produce
an even stronger product as a result...Jodi

Paula left this comment:
If this issue is 4 or 5 years old, how come we are first hearing about it now? I'm usually very "up" on all the latest news, especially pertaining to cochlear implants and I was not aware of this particular AB recall.

I'm glad it is resolved at this point but I am concerned about the fact that when people are making decisions on implant manufacturers for themselves or their children they are not fully aware of current issues.

This was my point for posting...

PS. Happy Anniversary, Honey!
PSS. I'm outta here, don't know when I'll post again, until then - Be Good!

FDA Seeks to Fine Cochlear Implant Company

FDA Seeks $2.2 Mln Fine Against Advanced Bionics


WASHINGTON (Reuters) - The U.S. Food and Drug Administration said on Friday it wants to fine Advanced Bionics LLC, a maker of cochlear implant hearing aids, $2.2 million for alleged manufacturing violations that put patients at risk.

The FDA accused Advanced Bionics of failing to follow manufacturing standards to ensure the safety and quality of the hearing aids.

The company allegedly failed to sufficiently evaluate and select a new vendor to supply a critical component, and failed to properly test hearing aids containing the unapproved vendor's component, the FDA said in a statement.

"The hearing aids pose a public health risk due to excessive moisture, exposing patients to the risk of device failure, possible surgery, and the potential for additional hearing loss," the FDA said in a statement.

The FDA said it filed a complaint against Advanced Bionics and its co-chief executive officer, Jeffrey Greiner, last November and amended it on March 17. The company is based in Sylmar, California.

A company spokesman was not immediately available for comment.

On July 7, 2003, Advanced Bionics received FDA approval to market the HiRes90k Implantable Cochlear Stimulator, a hearing aid surgically implanted under the skin behind the ear, to treat profound hearing loss in adults and children.

The hearing aid is considered a Class III device by the FDA, the most stringent regulatory category for medical devices.

(Reporting by Julie Vorman; Editing by Brian Moss)

(Note: "hearing aid" is cochlear implant) This article was posted on the Pediatric Cochlear Implant Circle and I felt the need to blog about it as a parent of a child with a cochlear implant. You need to know that in general, parents do not speak about ci companies, because obviously everyone thinks theirs is the best and people would just get into brand wars. The Circle is strictly about providing support regarding pediatric issues, therapy, communication methods and your basic kid life experiences. However, here, promoting awareness is not only about glorifying the ci experience, it's about providing relevant information for any and all parents reading my blog. One of the members of the CI Circle wrote the following response to this article:

I am going to chime in here and just tell what I am feeling after hearing
this news. When I first read this on here I was relieved and angry at the
same time. I have had two AB failures and this last one has not been
reimplanted yet because of fighting with insurance and the doctors to
reimplant it. I now feel like because the FDA has finally done something I
might be able to finally get reimplanted after waiting for a year and a
half. I have had many problems with my AB implants since being implanted and
hope that others do not experience the same things. I know that there are
people out there who are very happy with their AB implants and I hope that
you never have to deal with the setbacks that come from poor manufacturing
that results in failures. Hopefully as a result of this I will be able to
get reimplanted with a device that is not AB (which is what we have been
fighting for for the last year and a half).

When I contacted this person requesting permission to blog her response, she sent me this email:

Hi Jodi,
It has been a long and frustrating journey and I am hopeful to get it resolved soon. I am lucky to have had the opportunity to try one of the new hearing aids made my Starkey in my unimplanted ear which is giving me more benefit then any hearing aid ever has. However, it is still not enough to compare with the hearing that I was able to get with a functioning cochlear implant.
I would be more then happy to allow you to blog about my experiences. I also feel like you do. The more people I can help through my experiences the better. Yes, for me it has been such a struggle but I am a young adult who is able to lip read and communicate, it hurts me so much to hear and know that this is happening to children who can often not explain how it feels or what it sounds like.

Hearing parents of deaf children who are currently researching brands for implantation need to be informed. Thankfully, the FDA exists and is apparently doing their job to ensure that the newest generation of cochlear implants are effective and safer for our kids.