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FDA Seeks Civil Penalties from Calif. Device Maker
Boult
post Mon Apr 7, 2008, 11:39 AM
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FDA Seeks Civil Penalties from Calif. Device Maker

FOR IMMEDIATE RELEASE
March 28, 2008

Media Inquiries:
Peper Long, 301-827-0599
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FDA Seeks Civil Penalties from Calif. Device Maker
The U.S. Food and Drug Administration (FDA) today announced it is seeking a $2.2 million penalty against a California hearing aid manufacturer for violations of federal law, including manufacturing standards violations and the failure to notify the FDA of a change in an outside supplier or vendor, which may have exposed recipients of the devices to unnecessary health risks.

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 agency's complaint, originally filed this past November and amended on March 17, seeks penalties against California medical device manufacturer Advanced Bionics, LLC and its president and co-CEO, Jeffrey H. Greiner.

The complaint alleges that Advanced Bionics shipped hearing aids to customers in the United States prior to filing appropriate supplemental information with the Agency, including a notice of changes made to the devices that affected their safety and effectiveness.

On July 7, 2003, Advanced Bionics received FDA approval to market the HiRes90k Implantable Cochlear Stimulator, a cochlear implant 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 devices.

The complaint alleges that the company failed to comply with the FDA's current Good Manufacturing Practice (GMP) requirements for devices. GMP requires that companies manufacturing medical devices for sale in the United States establish and follow quality systems procedures to assure the safety and quality of their products.

Advanced Bionic's alleged GMP violations include the failure to sufficiently evaluate and select a new vendor as the supplier of a critical device component and the failure to adequately validate the continued safety and effectiveness of the hearing aid by testing lots under actual or simulated use when the unapproved vendor's component was used.

The complaint also states that Advanced Bionics shipped hearing aids in violation of the law between January 2005 and July 2006. Two hearing aids shipped and implanted after a March 2006 recall contained the component from the unapproved vendor.

FDA's complaint states that the company's failure to file the required supplement occurred after a 2001 inspection. At that time, the company was cited for similar failures and made commitments to correct the problems.

Advanced Bionics, LLC, is located in Sylmar, Calif.

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Boult
post Mon Apr 7, 2008, 11:39 AM
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Information on the FDA’s recent announcement of intent to fine Advanced Bionics

Apr 7, 2008
Many of you have heard about the FDA's intent to fine Advanced Bionics. This announcement is about what happened five years ago in 2003. It's old news! We're trying to reach resolution with the FDA, but the process is complex and takes time. What you should take from these events is the following:


1. The fine is principally related to judgments the FDA is making about our quality system in 2003 --- five full years ago.


2. We are actively participating with the FDA to try and resolve these matters.


3. The process is complex and takes time.


4. The fine proposed by the FDA has no impact whatsoever on the ability of Advanced Bionics to operate its business.


5. The HiRes 90K is extremely reliable and, together with the Harmony, is the most durable implant system on the market.


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Boult
post Tue Jul 15, 2008, 06:40 PM
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Advanced Bionics' FDA Settlement


(IMG:http://bionicear.com/UserFiles/File/FDA%20Settlement%202008.pdf)
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Boult
post Tue Aug 12, 2008, 01:26 PM
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FDA Reaches Settlement with California Hearing Device Maker

FOR IMMEDIATE RELEASE
July 17, 200

Media Inquiries:
Peper Long, 301-827-6242
Consumer Inquiries:
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FDA Reaches Settlement with California Hearing Device Maker

The U.S. Food and Drug Administration (FDA) has reached a settlement with California hearing device manufacturer Advanced Bionics LLC and its president and CEO Jeffrey Greiner over alleged violations of federal law. The alleged violations involved the failure to notify the FDA of a change of outside supplier or vendor, which may have exposed patients to unnecessary health risks, such as device failure and surgery.

Under the terms of the settlement, agreed to on July 14, 2008, Advanced Bionics will pay a civil money penalty of $1.1 million. Greiner will pay $75,000.

On July 7, 2003, Advanced Bionics received FDA approval to market the HiRes90k Implantable Cochlear Stimulator, an implant surgically placed under the skin behind the ear to treat profound hearing loss in some adults and children. The FDA regulates cochlear implants as Class III devices—the most stringent regulatory category for medical devices.

The FDA’s complaint against Advanced Bionics, filed November 2007 and amended July 7, 2008, alleges that Advanced Bionics shipped cochlear implants to customers in the United States without first filing appropriate supplemental information with the FDA, including notice of a change of a component supplier. The failure to submit supplemental information prevented the FDA from being able to evaluate the potential impact of the changes on the safety and effectiveness of the device.

As a result, the FDA considered those devices—shipped to health care providers across the country after the company changed suppliers—to be adulterated, as they were no longer covered by the agency’s original product approval, granted in 2003.

In March 2006, Advanced Bionics conducted a recall of the unimplanted devices containing components from the unapproved supplier, because of excessive moisture that could leak into the devices and cause device failure and possible surgery.

The FDA’s complaint also stated that two devices containing the component from the unapproved supplier were shipped by Advanced Bionics after the March 2006 recall and subsequently implanted in patients.

Advanced Bionics and Greiner agreed to settle the complaint without admitting liability, and must remit payment to the U.S. Treasury within 10 days of settlement.

Advanced Bionics LLC, is based in Sylmar, Calif.

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