Cochlear implant developer Advanced Bionics LLC will pay about $12 million to resolve allegations that it misled federal health care programs, the United States Department of Justice (DOJ) announced. The allegations were in connection with information provided within pre-market approval (PMA) applications to the FDA for cochlear implant processors, as reported by a DOJ press release dated December 20, 2022.
A former Advanced Bionics engineer, David Nyberg, brought a lawsuit against Advanced Bionics under the False Claims Act. The lawsuit asserted that Advanced Bionics made false claims in their PMA submissions to the Food and Drug Administration (FDA) for Advanced Bionics’ Neptune and Naida cochlear implant processors. Advanced Bionics allegedly made false assertions in the PMA submissions stating that the processors complied with a recognized emissions standard when the processors, in fact, did not comply with the standards.
As a result of the agreement, Advanced Bionics will pay roughly $11.36 million to the United States with approximately $1.87 million of the amount being paid to Mr. Nyber. Advanced Bionics will also pay approximately $1.24 million to the participating Medicaid States pursuant to additional agreements.