The reliability of hearing implants: report on the type and incidence of cochlear implant failures.

Cochlear Implants International
Paul Van de HeyningMario Zernotti

Abstract

Objectives: This study presents the data collected through a database on the type and incidence of cochlear implant device failures and major complications and quantifies the risk of failures across time based on the Association for the Advancement of Medical Instrumentation (AAMI) CI86:2017 standard. Methods: Information on reliability of MED-EL cochlear implants was collected from the MED-EL complaint database between 2003 and2013. Explants were categorized and device reliability was calculated according to the AAMI CI86:2017 standard principles. Results: Data were collected for 11662 devices (5462 children, 6200 adults). The mean duration of follow up was 46.16 months. The total failure rate for all devices and all subjects was 2.41%. Medical related explants (MRE) were significantly worse for children than for adults with the ceramic implants, C40+ (p = 0.008) and PULSAR (p = 0.020). Device failure explants (DFE) were significantly worse for children than for adults with all four devices in the study, the C40+ (p < 0.001), PULSAR (p < 0.001), SONATA (p < 0.001), and CONCERTO (p = 0.023). The mean annual failure rate for all subjects and devices was 0.63% (1.03% for children, 0.28% for adults). The mean annual failure rate w...Continue Reading

References

Jan 1, 1980·Pacing and Clinical Electrophysiology : PACE·R G Hauser
Jun 19, 2004·Audiology & Neuro-otology·Noel L Cohen
Jun 1, 2005·Auris, Nasus, Larynx·Jan Bernd WeiseSteffen Maune
Jul 15, 2005·Otology & Neurotology : Official Publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology·Amy-Anne Donatelli LassigSteven A Telian
Jul 15, 2005·Otology & Neurotology : Official Publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology·T J BalkanyS Staller
Nov 8, 2005·Otology & Neurotology : Official Publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology
Apr 19, 2006·Acta Oto-laryngologica·A A Orabi
May 15, 2007·Ear and Hearing·Douglas D Backous, Stacey D Watson
Jul 3, 2007·The Laryngoscope·Mathieu CôtéRichard Bussières
Dec 17, 2008·Archives of Otolaryngology--head & Neck Surgery·Frederic VenailMichel Mondain
Apr 18, 2009·Otology & Neurotology : Official Publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology·Rolf-D BattmerThomas Lenarz
Oct 29, 2011·The Journal of Laryngology and Otology·L MastersonR F Gray
Feb 20, 2014·The Laryngoscope·Jeffrey T WangMelville Da Cruz
Nov 22, 2017·Biomedical Instrumentation & Technology·Teresa Zwolan, Julie Verhoff

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Citations

Jun 20, 2020·Expert Review of Medical Devices·Uwe BaumannTobias Weißgerber
Apr 5, 2021·European Archives of Oto-rhino-laryngology : Official Journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : Affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery·Jingyuan ChenYongxin Li

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