FDA 483 - Cochlear Americas Inc. - October 21, 2021

An FDA inspection of Cochlear Americas Inc. in Lone Tree, CO, revealed a significant issue regarding a non-significant risk device study. The firm failed to meet abbreviated requirements for investigational device exemptions (IDEs), specifically concerning the informed consent process. The informed consent used by an investigational site included assigned likelihoods for risks not found in the sponsor's labeling and additional study procedures not defined in the Clinical Investigational Plan, without documented sponsor review and approval.