Advanced Bionics LLC, a Valencia, California-based manufacturer of cochlear implant system devices, has agreed to pay more than $12 million to resolve allegations that it misled federal health care programs regarding the radio-frequency (RF) emissions generated by some of its cochlear implant processors.
"The United States expects device manufacturers to provide accurate information when they claim that their devices meet certain tests or standards," said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Department of Justice's Civil Division. "The integrity of our health care system depends on the government being able to rely on the information provided by manufacturers when they apply for permission to market their devices."