Advanced Bionics HiRes Ultra and Ultra 3D Series Cochlear Implant Recall: Time Course of Anomalies.

Objectives: To estimate median survival time until the appearance of anomalies indicating a potential implant failure associated with fluid ingress in implanted cochlear implant (CI) devices of the initial version of Advanced Bionics HiRes Ultra and HiRes Ultra 3D series. Study Design: Retrospective review. Methods: Cochlear implantation was performed in a standard fashion. Implant integrity was tested at follow-up visits by measuring impedance and electrically evoked compound action potential (ECAP). Additional tests such as electrical field imaging (EFI) were conducted by the manufacturer. Based on these tests, the presence or absence of an anomaly was classified. Results: Of the 349 devices implanted at this institution, 181 showed anomalies in accordance with the special failure mode and for this reason, 120 implants were already explanted. The median survival time without anomalies was 1062 days. So far, the suspicion of device failures has been confirmed in all cases in which a post-implantation analysis was already available. Conclusions: Regular tests at the follow-up visits are necessary to monitor the integrity of CIs. [ABSTRACT FROM AUTHOR]