Federal regulators have reached a settlement with Advanced Bionics over changes to production of one of its cochlear implants which could have exposed patients to unnecessary health risks. The California hearing device manufacturer agreed to pay a civil money penalty of more than $1 million. The head of the company will pay $75,000. Advanced Bionics issued a recall of the the HiRes90k Implantable Cochlear Stimulator in 2006 since materials for the implant came from an unapproved supplier. The FDA says excessive moisture that could leak into the devices and cause device failure and lead to possible surgery. Advanced Bionics admitting no liability.
