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VALENCIA, Calif., July 18 /PRNewswire/ -- Advanced Bionics agreed to settle an administrative complaint arising from a disagreement with the U.S. Food and Drug Administration (FDA). The FDA asserted that Advanced Bionics should have made a formal submission five years ago before using a second vendor for a particular component in its cochlear implant system. The component, called a feedthru, contained a hidden weakness that allowed a very slow leak of water molecules into the implanted devices containing this vendor's feedthrus while blocking the passage of much smaller helium and nitrogen gases. Until this situation, such a condition was universally believed to be impossible. After an extended period of one year or more, the slow leakage led to device failures, a product recall, and a termination of the second vendor.
Advanced Bionics responded to FDA's complaint asserting the following: (1) it had tested the component with state-of-the-art processes and equipment, which demonstrated that gas molecules much smaller than water molecules were completely blocked from passage; (2) until this hidden weakness was observed, the industry standard testing was considered sufficient to ensure hermeticity; (3) the FDA's own experts in late 2004 mistakenly diagnosed the failure mechanism of the devices containing moisture; (4) Advanced Bionics followed the FDA's guidelines regarding filings with the FDA; and (5) the FDA's approval to market Advanced Bionics' HiRes90K Implantable Cochlear Stimulator was based upon a recognition that the HiRes90K was a repackaging of the previous generation device called CII that used feedthrus from both vendors.
Although the FDA did not accept these arguments, Advanced Bionics
believes them to be true and denies that it violated the law. Nevertheless,
rather than continuing a protracted and costly legal process that would
likely harm its relationship with the FDA, Advanced Bionics has decided to
settle this issue and move on
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