Cochlear Implant Complications and Outcomes: National Trends of the MAUDE Database From 2016 to 2024

As cochlear implant (CI) use expands, complications have become a growing concern. While prior studies analyzed CI failures, few have comprehensively assessed national complication temporal patterns and clinical outcomes. This study evaluates patient and device complication patterns and outcomes from 2016 to 2024.

Cross-sectional.

Multi-institution database.

Adverse events related to CIs from 2016 to 2024 were extracted from the US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database using CI-specific product codes. Complications and outcomes were categorized into themes. Poisson and quasi-Poisson regressions assessed trends in raw counts, and Cochran-Armitage tests evaluated proportional changes of specific complications and outcomes to total counts before (2016-2020) and after (2020-2024) a major voluntary field corrective action.

From 2016 to 2024, 34,426 patient complications, 33,487 device complications, and 26,377 clinical outcomes were reported. Between 2016 and 2020, all domains exhibited rising incidence and shifting complication proportions. From 2020 to 2024, overall complication counts plateaued or declined; however, specific issues such as healing/skin, infection/inflammation, and device fit/malposition/detachment continued to increase in proportion to the total number of complications. Hospitalizations and life-threatening outcomes also rose in proportion during this period.

Although overall CI complication reporting has stabilized post-2020, several complication subtypes and adverse outcomes continue to rise. These findings highlight evolving safety profiles of CIs and underscore the need for targeted device and surgical refinements as well as robust post-market surveillance to guide safer innovation.