ArticleOtolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery2026
Cochlear Implant Complications and Outcomes: National Trends of the MAUDE Database From 2016 to 2024.
Article in Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveAs 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. STUDY
designCross-sectional.
settingMulti-institution database.
methodsAdverse 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.
resultsFrom 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.
conclusionAlthough 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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.