FDA Seeking to Fine Advanced Bionics

[Guest guest]

FDA seeks $2.2 mln fine against Advanced Bionics

Fri Mar 28, 2008 3:26pm EDT

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, 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 Vorman; Editing by Moss)

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[Guest guest]

Alice,

I don't have the AB device, but I knew about the positioner problem

that was later resolved. It sounds like some new and serious problems

have developed since then. This article comes as a surprise to me. I

sincerely hope everything can be resolved for the sake of those who

have the AB device.

e

[Guest guest]

Hi e,

This fine is for something unrelated to the positioner problem

Advanced Bionics had. They had 2 manufacturers making implants, and one

of them wasn't making them correctly. As a result there was leakage in

the implant and device failure. INTERNAL device failure, requiring

removal of the implant and reimplanting. AB finally figured out who the

culprit was, and stopped getting the devices manufactured there.

Apparently whoever they replaced it with hasn't been FDA approved.

And that is what the fine is about. It is punitive damages for not

complying with FDA regulations with the new manufacturer they chose to

replace the one that was not doing the sealing correctly.

There have been ongoing problems with the AB implants for a while, and

finally FDA is hitting them where it hurts.

I feel sorry for anyone who got one of the faulty devices, or one that

was manufactured by the company that had so many failures, because they

may have to go through all this again down the line. On the other hand,

people who have had implants since this manufacturer was discontinued,

have had failures as well. So who knows.

Alice,

I don't have the AB device, but I knew about the positioner problem

that was later resolved. It sounds like some new and serious problems

have developed since then. This article comes as a surprise to me. I

sincerely hope everything can be resolved for the sake of those who

have the AB device.

e