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Complications of cochlear implants: a MAUDE database study

Published online by Cambridge University Press:  06 June 2023

S Jinka ,
S Wase Open the ORCID record for S Wase [Opens in a new window]  and
A Jeyakumar Open the ORCID record for A Jeyakumar [Opens in a new window]
S Jinka
Affiliation:
Northeast Ohio Medical University, Rootstown, Ohio, USA
S Wase
Affiliation:
Northeast Ohio Medical University, Rootstown, Ohio, USA
A Jeyakumar*
Affiliation:
Northeast Ohio Medical University, Rootstown, Ohio, USA Department of Otolaryngology, Mercy Bon Secours, Youngstown, Ohio, USA
*
Corresponding author: Dr A Jeyakumar; Email: ajeyakumar@mercy.com
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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 implantationcochlear implantsfacial nerveclinical auditevidence-based medicine
Type
Main Article
Information
The Journal of Laryngology & Otology , Volume 137 , Issue 11 , November 2023 , pp. 1267 - 1271
Copyright
Copyright © The Author(s), 2023. Published by Cambridge University Press on behalf of J.L.O. (1984) LIMITED

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Footnotes

Dr A Jeyakumar takes responsibility for the integrity of the content of the paper

Some of the data were presented at the American Academy of Otolaryngology–Head and Neck Surgery Foundation Annual Meeting, 3–6 October 2021, Los Angeles, California, USA.

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