机构：[1]Antwerp University Hospital, University of Antwerp, Antwerp, Belgium,[2]Ear Science Centre, School of Surgery, The University of Western Australia, Nedlands, Australia,[3]Ear Science Institute Australia Implant Centre, Subiaco, Australia,[4]Medizinische Universität Wien, Universitätsklinik für Hals-, Nasen- und Ohrenkrankheiten, Vienna, Austria,[5]Universitätsklinik für HNO, Kopf- und Halschirurgie, Inselspital Bern, Bern, Switzerland,[6]Hospital Universitario La Paz, Institute for Health Research (IdiPAZ), Madrid, Spain,[7]Centre Hospitalier Universitaire de Rennes, Rennes, France,[8]Klinik und Poliklinik für Hals-, Nasen und Ohren- Krankheiten, Universität Würzburg, Würzburg, Germany,[9]Capital Medical University, Beijing Tongren Hospital, Beijing, People’s Republic of China,首都医科大学附属北京同仁医院首都医科大学附属同仁医院[10]Karolinska University Hospital, Karolinska vägen, 171 76 Solna, Sweden,[11]Madras ENT Research Foundation (MERF), No-1, 1st Cross Street, Off. II Main Road, Raja Annamalai Puram Chennai, Tamil Nadu 600028, India,[12]St. Petersburg ENT and Speech Research Institute, St. Petersburg, Russia,[13]ENT Super Speciality Institute and Research Center, East Hill, Kozhikode, Kerala 673005, India,[14]London Health Sciences Centre, London, Canada,[15]UNC Ear & Hearing Center at Chapel Hill School of Medicine, 170 Manning Dr #7070 Chapel Hill, NC 27514, USA,[16]Bradford Royal Infirmary, Bradford, United Kingdom,[17]Otolaryngology, Head & Neck Surgery Unit, School of Surgery, University of Western Australia, Fremantle Hospital, Fremantle, Australia,[18]Universitätsklinik für Hals- Nasen- Ohrenheilkunde Innsbruck, Innsbruck, Austria,[19]Institute of Physiology and Pathology of Hearing, Warsaw, Poland,[20]World Hearing Center, Nadarzyn, Poland,[21]Institute of Sensory Organs, Nadarzyn, Poland,[22]Kansas University Center for Hearing and Balance Disorders, 3901 Rainbow Blvd, Kansas City, KS 66160, USA,[23]Shinshu University School of Medicine, 3-1-1 Asahi, Matsumoto, Nagano 390-8621, Japan,[24]Instituto de ORL, Av Ambrosio Olmos 754, Córdoba, Argentina
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 was 0.90% for the C40+; 0.57% for the PULSAR; 0.46% for the SONATA; and 0.39% for the CONCERTO. Conclusions: Compared to adults, children had significantly worse MRE and DFE due to a higher risk of head trauma and more vulnerable skull anatomy. Further, the authors conclude that the AAMI standard will ensure a more comprehensive and transparent evaluation of cochlear implant reliability in the future.
第一作者机构：[1]Antwerp University Hospital, University of Antwerp, Antwerp, Belgium,[*1]Antwerp University Hospital, University Department of Otorhinolaryngology, Wilrijkstraat 10, BE-2650 Antwerp, Belgium.
通讯作者：
通讯机构：[1]Antwerp University Hospital, University of Antwerp, Antwerp, Belgium,[*1]Antwerp University Hospital, University Department of Otorhinolaryngology, Wilrijkstraat 10, BE-2650 Antwerp, Belgium.
推荐引用方式(GB/T 7714)：
Van de Heyning Paul,Atlas Marcus,Baumgartner Wolf-Dieter,et al.The reliability of hearing implants: report on the type and incidence of cochlear implant failures[J].COCHLEAR IMPLANTS INTERNATIONAL.2020,21(4):228-237.doi:10.1080/14670100.2020.1735678.
APA：
Van de Heyning, Paul,Atlas, Marcus,Baumgartner, Wolf-Dieter,Caversaccio, Marco,Gavilan, Javier...&Zernotti, Mario.(2020).The reliability of hearing implants: report on the type and incidence of cochlear implant failures.COCHLEAR IMPLANTS INTERNATIONAL,21,(4)
MLA：
Van de Heyning, Paul,et al."The reliability of hearing implants: report on the type and incidence of cochlear implant failures".COCHLEAR IMPLANTS INTERNATIONAL 21..4(2020):228-237
