FDA EIR - Cochlear Americas Inc. - February 22, 2018

Cochlear Americas Inc., based in Centennial, CO, underwent an FDA inspection from February 2 to February 22, 2018. This routine inspection, conducted under the Sponsors, Contract Research Organizations, and Monitors Compliance Program, focused on the sponsor's oversight of a clinical study for their Nucleus CI422 Cochlear Implant. The inspection resulted in an FDA-483, citing significant observations primarily related to inadequate investigator oversight and informed consent procedures, as per 21 CFR 812.46(a). Investigators at multiple sites failed to adhere to study agreements and regulatory requirements, specifically by using modified informed consent documents that were not approved by the sponsor or FDA, and which omitted critical safety information, such as warnings, precautions, and a statement regarding clinical trial registration. Some consents also included unverified statements about risk percentages. Additional issues included inaccurate and incomplete records for anticipated adverse device effects, with one serious adverse event not reported. The inspection also highlighted deficiencies in proper study monitoring, including delayed or inadequate monitoring visits, insufficient tracking of action items, and missing documentation for site qualifications and IRB approvals. Furthermore, the sponsor did not always ensure consistent training for personnel involved in monitoring activities. Cochlear Americas must address these observations to ensure compliance with federal regulations, with potential consequences ranging from warning letters to data rejection.