Trends in Cochlear Implant Complications and Clinical Outcomes from 2016 to 2024

Introduction: Cochlear implant (CI) complications rose from 2005 to 2010, but no study has elucidated recent trends. This study aims to assess trends in CI patient and device complications as well as clinical outcomes from 2021 to 2024.

Methods: Patient complications, device complications, and clinical outcomes from 2021 to 2024 were extracted from the U.S. Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database, excluding entries unrelated to CIs. Complications were categorized into themes, and Cochran-Armitage tests were performed to assess trends.

Results: From 2021 to 2024, there were 17,871 patient complications and 17,214 device complications. Patient complications included device failure (23.2%), infection/inflammation (18.6%), and healing/skin (10.5%) issues. Device complications included size/malposition/detachment (19.0%), electrical (17.2%), and unexpected result/output (17.1%) issues. Clinical outcomes included hospitalization (3.5%) and life-threatening event/disability/death (0.4%). Across four years, there were positive trends in infection/inflammation (p=.005), healing/skin (p <.001), size/malposition/detachment (p <.001), and electrical (p <.001) issues as well as hospitalizations (p <.001) and life-threatening events/disability/death (p <.001). There were negative trends in device failures (p=.009) and unexpected results/output (p <.001).

Conclusions: Despite notable decreases in CI failure and unexpected results, there remain increasing rates of healing, malposition, and electrical issues as well as patient morbidity. These findings underscore the need for continued surveillance and targeted refinement of CIs to improve clinical outcomes and user experiences.