Complications of cochlear implants: a MAUDE database study

Abstract

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.

Keywords: Cochlear implantation; clinical audit; cochlear implants; evidence-based medicine; facial nerve.