We are attorneys who represent children and adults across the globe that have suffered from an Advanced Bionics cochlear implant device failure. A cochlear implant (CI) is a surgically implanted electronic device that provides a sense of sound to a person who is profoundly deaf or severely hard of hearing. As of April 2009, approximately 188,000 people worldwide had received cochlear implants; in the United States, about 30,000 adults and over 30,000 children are recipients. You may be here because you or a loved one has experienced a cochlear implant device failure. The failure may have been the result of high moisture in the device, which caused the device to stop working. If that is the case, we are here to try to help you.
There are three companies in the world that manufacture cochlear implants: Med-El, Cochlear Corporation, and Advanced Bionics. Advanced Bionics is based in the Los Angeles, California area, and Advanced Bionics was recently acquired by Sonova, a Swiss corporation. Advanced Bionics was previously controlled and owned by Boston Scientific Corporation. Over the course of its history, Advanced Bionics has manufactured three types of cochlear implants: (1) The Clarion / Clarion 1.2 / C1.2, (2) The Clarion II / CII, and (3) The HiResolution 90k / HiRes90k.
In 2004, Advanced Bionics issued a worldwide recall of all unimplanted Clarion and HiRes90k devices. The company was issued a Warning Letter by the United States Food and Drug Administration (FDA) in February 2005. Later, in March 2006, the company issued a second recall of all unimplanted HiRes90k devices containing a feedthrough manufactured by AstroSeal, Inc. / vendor B. Almost 4,500 persons around the world were implanted with HiRes90k with vendor B feedthrough components. It is believed many of these devices will prematurely fail.
In 2007, the FDA filed a civil action against Advanced Bionics alleging that Advanced Bionics sold and manufactured adulterated cochlear implants. Advanced Bionics settled that suit paying $1.1 Million Dollars on behalf of the company, and $75,000 on behalf of then CEO Jeff Greiner.
Today, you may be the recipient of a defective medical device. While the device was designed to change your life for the better, you may now be suffering from the aftermath of a failed cochlear implant. If you or a loved one has experienced a device failure, or your device is not working as you believe it should, we may be able to help.
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