Cochlear implant complications and outcomes: National trends of the MAUDE database from 2016 to 2024
Otolaryngology–Head and Neck Surgery, 2026
In this national analysis of FDA MAUDE data from 2016 to 2024, we identified 34,426 patient complications, 33,487 device complications, and 26,377 reported clinical outcomes related to cochlear implants. While overall complication reporting increased from 2016 to 2020 and then plateaued or declined after 2020, certain complications (e.g., infection/inflammation, healing or skin issues, and device fit or malposition) continued to rise in proportion. Additionally, the proportion of serious outcomes such as hospitalizations and life-threatening events increased over time. These findings highlight evolving safety patterns and support the need for targeted device improvements and ongoing post-market surveillance to optimize cochlear implant outcomes.
Recommended citation: Habib DRS, Bishay AE, Habib MWS, Patro A, Langerman AJ, Moberly AC, Haynes DS, Tawfik KO. Cochlear implant complications and outcomes: National trends of the MAUDE database from 2016 to 2024. Otolaryngol Head Neck Surg. 2026. doi:10.1002/ohn.70297