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# Advanced Bionics Paying $12 Million Over False Claims
- URL: https://www.fdaweb.com/advanced-bionics-paying-12-million-over-false-claims/
- Published: 2023-01-03T12:00:00.000Z
- Updated: 2026-09-14T18:10:07.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153427

The Department of Justice says Advanced Bionics, a Valencia, CA, manufacturer of cochlear implant system devices, will pay more than $12 million to resolve a whistleblower’s allegations that it misled federal healthcare programs about the radio-frequency (RF) emissions generated by some of its processors. A department [statement](https://www.justice.gov/opa/pr/advanced-bionics-llc-pay-over-12-million-alleged-false-claims-cochlear-implant-processors?ref=fdaweb.com) says the settlement resolves allegations that the company, in submitting PMA applications to FDA for its Neptune and Naida processors, made false claims about the results of RF emissions tests.

“Advanced Bionics allegedly represented that its processors satisfied an internationally recognized emissions standard when, in fact, Advanced Bionics did not comply with that standard,” the statement says.

The department says that in addition to the civil settlement, the company entered into a five-year corporate integrity agreement with the HHS inspector general. That agreement requires an independent review of activities and processes relating to the preparation or submission of PMA applications to FDA and performance standards relevant to those PMAs. The company must also implement a robust compliance program that includes, among other things, a risk assessment program and compliance certifications from key managers and the board of directors.

The settlement reportedly provides that Advanced Bionics will pay about $11.36 million to the U.S. government and about $1.24 million to participating Medicaid states. The settlement resolves a whistleblower suit brought by former Advanced Bionics engineer **David Nyberg** under provisions of the False Claims Act. He will receive some $1.87 million of the federal settlement amount, the department says.