Hostname: page-component-6766d58669-fx4k7 Total loading time: 0 Render date: 2026-05-19T23:56:16.966Z Has data issue: false hasContentIssue false
  • English
  • Français

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
Get access Rights & Permissions [Opens in a new window]

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

Information

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

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

Article purchase

Temporarily unavailable

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.

References

Estimates – World Health Organization. In: https://www.who.int/health-topics/hearing-loss#tab=tab_1 [16 July 2018]Google Scholar
Ferguson, M, Kitterick, P, Chong, L, Edmondson-Jones, M, Barker, F, Hoare, D. Hearing aids for mild to moderate hearing loss in adults. Cochrane Database Syst Rev 2017;2017:CD012023Google Scholar
McRackan, T, Bauschard, M, Hatch, J, Franko-Tobin, E, Droghini, H, Nguyen, S et al. Meta-analysis of quality-of-life improvement after cochlear implantation and associations with speech recognition abilities. Laryngoscope. 2018;128(suppl 4):982–90CrossRefGoogle ScholarPubMed
Mulsow, J, Feeley, T, Tierney, S. Beyond consent-improving understanding in surgical patients. Am J Surg 2012;203:112–20CrossRefGoogle ScholarPubMed
MAUDE – Manufacturer and User Facility Device Experience. In: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm [28 June 2023]Google Scholar
Tambyraja, R, Gutman, M, Megerian, C. Cochlear implant complications: utility of federal database in systematic analysis. Arch Otolaryngol Head Neck Surg 2005;131:245–50CrossRefGoogle ScholarPubMed
Causon, A, Verschuur, C, Newman, T. Trends in cochlear implant complications: implications for improving long-term outcomes. Otol Neurotol 2013;34:259–65CrossRefGoogle ScholarPubMed
Cochlear Implant Comparison Chart. In: https://cochlearimplanthelp.files.wordpress.com/2021/06/cochlearimplantcomparisonchart_v11.3b.pdf [28 June 2023]Google Scholar
The truth about Cochlear's market share. In: https://www.intelligentinvestor.com.au/recommendations/the-truth-about-cochlears-market-share/142882 [28 June 2023]Google Scholar
Vila, P, Ghogomu, N, Odom-John, A, Hullar, T, Hirose, K. Infectious complications in pediatric cochlear implants. Laryngoscope 2007;117:1825–9Google Scholar
Ciorba, A, Bovo, R, Trevisi, P, Rosignoli, M, Aimoni, C, Castiglione, A et al. Postoperative complications in cochlear implants: a retrospective analysis of 438 consecutive cases. Eur Arch Otorhinolaryngol 2012;269:1599–603CrossRefGoogle ScholarPubMed
Farinetti, A, Gharbia, B, Mancini, J, Roman, S, Nicollas, R, Triglia, J. Cochlear implant complications in 403 patients: comparative study of adults and children and review of the literature. Eur Ann Otorhinolaryngol Head Neck Dis 2014;131:177–82CrossRefGoogle ScholarPubMed
Costerton, J, Montanaro, L, Arciola, C. Biofilm in implant infections: its production and regulation. Int J Artif Organs 2005;28:1062–8CrossRefGoogle ScholarPubMed
Vaid, N, Vaid, S, Manikoth, M. Case report – biofilm infection of a cochlear implant. Cochlear Implants Int 2013;14:117–20CrossRefGoogle ScholarPubMed
Macassey, E, Dawes, P. Biofilms and their role in otorhinolaryngological disease. J Laryngol Otol 2008;122:1273–8CrossRefGoogle ScholarPubMed
Cunningham, CD, Slattery, WH, Luxford, WM. Postoperative infection in cochlear implant patients. Otolaryngol Head Neck Surg 2004;131:109–14CrossRefGoogle ScholarPubMed
Rubin, LG, Papsin, B; Committee on Infectious Diseases and Section on Otolaryngology-Head and Neck Surgery. Cochlear implants in children: surgical site infections and prevention and treatment of acute otitis media and meningitis. Pediatrics 2010;126:381–91CrossRefGoogle ScholarPubMed
Kempf, HG, Stöver, T, Lenarz, T. Mastoiditis and acute otitis media in children with cochlear implants: recommendations for medical management. Ann Otol Rhinol Laryngol Suppl 2000;185:25–7CrossRefGoogle ScholarPubMed
Vijendren, A, Borsetto, D, Barker, E, Manjaly, J, Tysome, J, Axon, P et al. A systematic review on prevention and management of wound infections from cochlear implantation. Clin Otolaryngol 2019;44:1059–70CrossRefGoogle ScholarPubMed
Geraghty, M, Fagan, P, Moisidis, E. Management of cochlear implant device extrusion: case series and literature review. J Laryngol Otol 2014;128(suppl 2):S55–8CrossRefGoogle ScholarPubMed
Vaid, N, Roland, J, Vaid, S. Extracochlear electrode extrusion. Cochlear Implants Int 2011;12:177–80CrossRefGoogle ScholarPubMed
Connell, S, Balkany, T, Hodges, A, Telischi, F, Angeli, S, Eshraghi, A. Electrode migration after cochlear implantation. Otol Neurotol 2008;29:156–9CrossRefGoogle ScholarPubMed
Brown, K, Connell, S, Balkany, T, Eshraghi, A, Telischi, F, Angeli, S. Incidence and indications for revision cochlear implant surgery in adults and children. Laryngoscope 2009;119:152–7CrossRefGoogle ScholarPubMed
Gatto, A, Tofanelli, M, Piccinato, A, Antonio, J, Zucchini, S, Achilli, V et al. Cochlear implant surgery: how to fix receiver/stimulator avoiding extrusion. Ear Nose Throat J 2021;100(3 suppl):212–14SCrossRefGoogle ScholarPubMed
Bigelow, D, Kay, D, Rafter, K, Montes, M, Knox, G, Yousem, D. Facial nerve stimulation from cochlear implants. Am J Otol 1998;19:163–9Google ScholarPubMed
Van Horn, A, Hayden, C, Mahairas, A. Factors influencing aberrant facial nerve stimulation following cochlear implantation: a systematic review and meta-analysis. Otol Neurotol 2020;41:1050–9CrossRefGoogle ScholarPubMed
Wei, B, Shepherd, R, Robins-Browne, R, Clark, G, O'Leary, S. Pneumococcal meningitis post-cochlear implantation: preventative measures. Otolaryngol Head Neck Surg 2010;143(5 suppl 3):S9–14CrossRefGoogle ScholarPubMed
Eftekharian, A, Amizadeh, M. Cerebrospinal fluid gusher in cochlear implantation. Cochlear Implants Int 2014;15:179–84CrossRefGoogle ScholarPubMed
Melo, A, Martins, J, Silva, J, Quadros, J, Paiva, A. Cochlear implantation in children with anomalous cochleovestibular anatomy. Auris Nasus Larynx 2017;44:509–16CrossRefGoogle ScholarPubMed
Aldhafeeri, A, Alsanosi, A. Management of surgical difficulties during cochlear implant with inner ear anomalies. Int J Pediatr Otorhinolaryngol 2017;92:45–9CrossRefGoogle ScholarPubMed
Vartanyan, M, Hill, F, Orimoto, K, O'Leary, S. Stapes footplate defect as a source of CSF leak and otogenic meningitis in a patient with a cochlear implant. Ear Nose Throat J 2018;97:E31–2CrossRefGoogle Scholar
Attias, J, Ulanovski, D, Shemesh, R, Kornreich, L, Nageris, B, Preis, M et al. Air-bone gap component of inner-ear origin in audiograms of cochlear implant candidates. Otol Neurotol 2012;33:512–17CrossRefGoogle ScholarPubMed
Nelson, R, Hansen, K, Gantz, B, Hansen, M. Calvarium thinning in patients with spontaneous cerebrospinal fluid leak. Otol Neurotol 2015;36:481–5CrossRefGoogle ScholarPubMed
Saeed, H, Powell, H, Saeed, S. Cochlear implantation in X-linked deafness – how to manage the surgical challenges. Cochlear Implants Int 2016;17:178–83CrossRefGoogle ScholarPubMed
Ter Horst, L, Brouwer, MC, van der Ende, A, van de Beek, D. Community-acquired bacterial meningitis in adults with cerebrospinal fluid leakage. Clin Infect Dis 2020;70:2256–61CrossRefGoogle ScholarPubMed
Mancini, P, D'Elia, C, Bosco, E, De Seta, E, Panebianco, V, Vergari, V et al. Follow-up of cochlear implant use in patients who developed bacterial meningitis following cochlear implantation. Laryngoscope 2008;118:1467–71CrossRefGoogle ScholarPubMed
Gurtcheff, S. Introduction to the MAUDE database. Clin Obstet Gynecol 2008;51:120–3CrossRefGoogle Scholar
Gurtcheff, S, Sharp, H. Complications associated with global endometrial ablation: the utility of the MAUDE database. Obstet Gynecol 2003;102:1278–82Google ScholarPubMed
Tremaine, A, Avram, M. FDA MAUDE data on complications with lasers, light sources, and energy-based devices. Lasers Surg Med 2015;47:133–40CrossRefGoogle ScholarPubMed
Abi-Rafeh, J, Safran, T, Al-Halabi, B, Dionisopolous, T. Death by implants: critical analysis of the FDA-MAUDE database on breast implant-related mortality. Plast Reconstr Surg Glob Open 2019;7:e2554CrossRefGoogle ScholarPubMed
Raz, Y. The utility of the MAUDE database in researching cochlear implantation complications. Arch Otolaryngol Head Neck Surg 2005;131:251CrossRefGoogle ScholarPubMed
The FDA's MAUDE: Useful Insights for Medical Devices. In: https://www.americanbar.org/groups/litigation/committees/mass-torts/practice/2017/manufacture-and-user-facility-device-experience/ [28 June 2023]Google Scholar