News release
Advanced Bionics LLC, a Valencia-based manufacturer of cochlear implant system devices, agreed to pay more than $12 million to resolve allegations that it misled federal health care programs regarding the radio-frequency emission generated by some of its devices, according to the U.S. Department of Justice.
“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 Boynton, head of the Department of Justice’s Civil Division, in a prepared statement.
“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,” he added.
Calls and emails to Advanced Bionics seeking comment were not returned on Tuesday.
According to the settlement, Advanced Bionics sought reimbursement from federally funded health care programs for its Neptune and Naida cochlear implant processors while knowing the devices were not as effective as presented.
The test at issue measured the extent to which cochlear implant systems generate radio frequency emissions that can potentially interfere with other devices that use the radio frequency spectrum such as telephones, alarm and security systems, television and radios.
The settlement resolves allegations that Advanced Bionics, in submitting pre-market approval applications to...
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