December 20, 2022

Cochlear implant manufacturer Advanced Bionics LLC paid $11.4 million to resolve claims brought in a whistleblower action that the company falsely stated that the radio-frequency (RF) emissions generated by some of its cochlear implant processors met international standards when it submitted pre-market approval applications to the FDA.  The company allegedly knew that the devices did not meet standards, and manipulated testing conditions to obtain passing test results.  Whistleblower David Nyberg, a former engineer at Advanced Bionics, will receive a qui tam award of $1.9 million from the federal amount of the settlement.  DOJ; USAO ED PA

Tagged in: FCA Federal, FDA Fraud, Healthcare Fraud, Medical Devices and DME, Whistleblower Case, Whistleblower Rewards,