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Updated: Jul 27, 2025
Author Spotlight: Advancements in Impedance Monitoring for Cochlear Implant Surgery
Published on: August 4, 2023
Complications of cochlear implants: a MAUDE database study
S Jinka1, S Wase1, A Jeyakumar1,2
1Northeast Ohio Medical University, Rootstown, Ohio, USA.
Objective:
A retrospective cross-sectional analysis was conducted of the US Food and Drug Administration's MAUDE (Manufacturer and User Facility Device Experience) database, to evaluate the complication profile of cochlear implantation according to manufacturer.
Methods:
A review of the MAUDE database was conducted from 1 January 2010 to 31 December 2020. Complications, including infection, extrusion, facial nerve stimulation, meningitis and cerebrospinal fluid leak, were identified using key word searches. The categorised data were analysed using a chi-square test to determine a difference in global complication incidence between three major cochlear implant manufacturers: manufacturer A (Cochlear Limited), manufacturer B (Med-El) and manufacturer C (Advanced Bionics).
Results:
A total of 31 857 adverse events were analysed. Implants of manufacturer C were associated with a statistically higher rate of infection (0.97 per cent), cerebrospinal fluid leak (0.07 per cent), extrusion (0.44 per cent) and facial nerve stimulation (0.11 per cent). Implants of manufacturer B were associated with a statistically higher rate of meningitis (0.07 per cent).
Conclusion:
Consideration of patient risk factors along with cochlear implant manufacturers can heighten awareness of cochlear implant complications pre-operatively, intra-operatively and post-operatively.
Insights
Cochlear implant complications vary by manufacturer. Advanced Bionics (manufacturer C) showed higher rates of infection, CSF leak, extrusion, and facial nerve stimulation, while Med-El (manufacturer B) had higher meningitis rates.
Area of Science:
- Otolaryngology
- Biomedical Engineering
- Medical Device Safety
Background:
- Cochlear implantation is a complex procedure with potential complications.
- Understanding manufacturer-specific complication profiles is crucial for informed decision-making.
Conclusions:
- Manufacturer-specific data on cochlear implant complications can enhance pre-operative, intra-operative, and post-operative awareness.
- Considering patient risk factors alongside manufacturer data can improve surgical outcomes and patient safety.
