Advanced Bionics settles financial suit with 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 feedthru’s 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 that 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; until this hidden weakness was observed, the industry standard testing was considered sufficient to ensure hermeticity.

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.

In doing so, Advanced Bionics has agreed to pay the FDA $1.1 million and the CEO has agreed to pay $75,000.