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FDA Seeks to Fine Cochlear Implant Company

Posted Aug 24 2008 10:48pm

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.
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