A cochlear implant is an electronic device that improves hearing by bypassing damaged portions of the ear. A sound processor fitted behind the ear captures sound signals and sends them to an implanted receiver, which then delivers sound signals to the auditory nerve. A cochlear implant is an option for people with inner-ear damage, for whom hearing aids do not work well.
Advanced Bionics LLC is a California-based manufacturer of cochlear implants. They manufactured several models of cochlear implants, including Advanced Bionics HiRes 90K, Cochlear Americas Cl512, Advanced Bionics HiRes Ultra and Ultra 3D, and Med El Concerto and Sonata.
According to an Advanced Bionics cochlear implant lawsuit filed under the False Claims Act by a former Advanced Bionics engineer, Advanced Bionics allegedly made false claims in submitting Premarket Approval Applications to the Food and Drug Administration.
According to the U.S. Department of Justice Office of Public Affairs, Advanced Bionics, “Made false claims regarding the results of its 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.” They then allegedly sought reimbursement from Medicare, Medicaid, and other federally funded healthcare programs.”
Advanced Bionics has agreed to pay more than $12 million to resolve allegations that it misled federal health care programs regarding the radio-frequency (RF) emissions generated by some of its cochlear implant processors. This included a $1.24 million whistleblower reward to the engineer who brought the complaint.
In addition to the monetary settlement, Advanced Bionics entered into a five-year Corporate Integrity Agreement, which requires a robust independent review of their activities and processes during Premarket Approval Applications.
The False Claims Act protects whistleblowers from retaliation. As noted above, you may even be eligible for a monetary reward if the lawsuit is successful and results in the recovery of funds.
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