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.
Clinicians should review emerging complication trend data from the MAUDE database to inform pre-operative counseling and post-surgical monitoring protocols for cochlear implant patients.
As cochlear implant candidacy expands globally, understanding real-world complication trends from a national surveillance database is essential for improving surgical safety standards and informed consent.
- 01Study analyzed FDA MAUDE adverse-event reports for cochlear implants across an 8-year period (2016–2024).
- 02Findings reflect national trends in CI complications as the implant recipient population grows.
- 03MAUDE is a passive surveillance database, meaning under-reporting is a known limitation.
- 04Results can inform pre-surgical counseling and help identify which complication types are increasing over time.
- 05Published in Otolaryngology–Head and Neck Surgery (OHN journal, doi: 10.1002/ohn.70297).
Cochlear implant complication trends can be identified and tracked using the FDA MAUDE database from 2016 to 2024.
studypartially supportedCochlear implant use has expanded over the study period, increasing the importance of complication surveillance.
studysupported- PMID
- 42171210
- DOI
- 10.1002/ohn.70297.
- Journal
- Otolaryngology–Head and Neck Surgery
- Publication type
- research_article
- Evidence level
- 4
- Population
- Cochlear implant recipients with reported adverse events in the FDA MAUDE database, 2016–2024
- Intervention
- Cochlear implantation
Primary outcomes
National trends in cochlear implant complications; Types and frequency of adverse events reported to MAUDE