Published by If you or a loved one receive(ed) cochlear implant processors from Advanced Bionics that may have misleading test data affecting safety or performance, you may be eligible for compensation through a product liability or False Claims Act-based lawsuit.
At Schmidt & Clark, LLP, we represent individuals harmed by misrepresented medical devices and fraudulent regulatory claims. Our legal team is ready to help document your claim, identify responsible parties, and seek full recovery for injuries, medical costs, or program misuses.
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Table Of Contents
What’s the Problem?
Advanced Bionics LLC, a manufacturer of cochlear implant processors, allegedly submitted false data in its pre-market approval claims to the FDA concerning radio-frequency (RF) emissions, misrepresenting that certain processors complied with international emissions standards when they did not.
Federal healthcare programs—including Medicare, Medicaid, VA, and others—relied on these misrepresentations when reimbursing for devices under those claims. Individuals who used or depend on those processors may face performance issues or unaddressed risks due to those exaggerations.
Although no class-action lawsuit has yet been widely certified, whistleblower lawsuits have been filed, and settlements have been reached that may open doors for broader claims by affected users seeking damages for harm caused by reliance on false claims or misrepresented device safety or compliance.
Latest Advanced Bionics Updates
- December 20, 2022 – Advanced Bionics agrees to pay over $12 million to resolve allegations that it misled federal healthcare programs regarding RF emissions of its processors by using manipulated test conditions and shielding emissions during pre-market approval applications [1]
- July 25, 2025 – The company settles another False Claims Act complaint for nearly $13 million, brought by engineer David Nyberg, alleging improper emissions testing of Advanced Bionics’ cochlear implants during his time with the company, including claims that test units were turned off or shielded to pass RF emission tests [2]
- 2023 – Advanced Bionics pays $12.6 million in combined federal and state settlements over Medicaid fraud allegations related to those same misrepresentations in component and processor testing [3]
Advanced Bionics Statistics
- Device types – “Neptune” and “Naida” cochlear implant processors cited in the allegations
- Parties involved – Federal government, several state Medicaid programs, whistleblower relator David Nyberg
- Total settlements – Over $12 million federal; additional payments with states; approximately $13 million in related whistleblower settlement [1]
- Whistleblower award – About $1.87 million awarded to the relator for the first major case [1]
Regulatory & Legal Background
The False Claims Act allows private individuals (relators) to sue on behalf of the government when fraudulent claims are made to federal healthcare programs.
Advanced Bionics’ actions allegedly violated the FDA’s pre-market approval standards and international RF emission standards.
Misrepresenting compliance with such standards can constitute actionable fraud because approvals, reimbursements, and patient safety depend on truthful testing and accurate reporting.
Possible Injuries & Side Effects
While the primary harm is financial or regulatory, device users may experience secondary harm due to false performance expectations or undisclosed interference risks. Potential harms include:
- Interference with other medical or safety devices caused by excessive RF emissions
- Reduced device performance or unexpected malfunctions if the processor does not meet claimed standards
- Emotional and psychological distress from discovery of misrepresented safety claims
Do You Qualify for an Advanced Bionics Cochlear Implant Lawsuit?
- You have used one of the Advanced Bionics “Neptune” or “Naida” implant processors covered under the allegations
- Your device was purchased or reimbursed through Medicare, Medicaid, or any other federal/state health program after its pre-market approval by Advanced Bionics
- You suffered measurable harm — financial loss, device performance issues, safety issues, or emotional distress — from reliance on representations made by Advanced Bionics
- You have documentation such as device model, purchase or reimbursement records, medical records, or any communications showing device issues or regulatory investigations
Evidence Required for a Claim
- Medicare/Medicaid or insurance reimbursement records showing device billed under alleged misrepresentations
- Proof of device model and processor (“Neptune,” “Naida,” etc.) and version used
- FDA documentation and regulatory filings; testing reports if available
- Communications, lab testing, or expert reports that identify failures or deviations in RF emissions
- Personal medical and device performance records showing any device malfunction, interference, or health impacts
Damages You Can Recover
- Reimbursement of overpaid costs or device expenses
- Compensation for reduced device performance or supplementary medical care
- Emotional distress, loss of trust, or psychological harm
- Legal fees associated with bringing the claim under the False Claims Act
- Punitive damages in jurisdictions allowing them in case of deliberate misconduct
Statute of Limitations
The False Claims Act imposes specific time limits for filing claims, often within several years after the fraudulent conduct is discovered. State equivalents or related claims may have different deadlines, typically between one and four years, depending on state law. Because these issues arose from regulatory filings and testing, early legal consultation is essential to preserve rights and evidence.
Frequently Asked Questions
- How do I know if my cochlear implant processor is affected? – Check whether it’s a Neptune or Naida model and whether the procurement or reimbursement was supported by pre-market approval submissions.
- Has Advanced Bionics admitted wrongdoing? – The company settled without admitting liability in many cases, as per federal practice.
- What should a device user do now? – Keep your implant device’s documentation, contact your provider, and consult with legal counsel if you have concerns about performance or safety.
- Will reimbursement be impacted if I join a lawsuit? – Typically payments or refunds under settlements don’t prevent individual rights to sue, but it depends on settlement terms and local law.
References
- https://www.justice.gov/archives/opa/pr/advanced-bionics-llc-pay-over-12-million-alleged-false-claims-cochlear-implant-processors
- https://www.fcacounsel.com/blog/advanced-bionics-settles-false-claims-act-case-for-13-million/
- https://www.stateagreport.com/news/advanced-bionics-must-pay-12-6-million-to-settle-medicaid-fraud-allegations/