OBJECTIVE: To evaluate the failure rate of cochlear implant systems across a range of European implant centers. STUDY DESIGN: Retrospective review. SETTING: Tertiary care cochlear implant centers in Europe. MATERIAL AND METHODS: A postal questionnaire was designed to assess the incidence and mode of total device failure and was sent to 34 European clinics. RESULTS: Twenty seven (79%) centers replied providing data on 12,856 devices of which 488 (3.79%) had undergone total device failure. Of 8,581 Nucleus devices (Cochlear, Sydney, Australia), 169 had failed; of 1,761 Advanced Bionics systems (Advanced Bionics, Sylmar, USA), 123 had failed; of 1987 Med El devices (Med-El, Innsbruck, Austria), 179 had failed; and of 527 MXM devices (Laboratoires MXM, Vallauris, France), 17 had failed. Six (22%) centers never reported failures to competent authorities. CONCLUSIONS: The study suggests that the overall reliability of cochlear implant systems is satisfactory but that reliability varies considerably between individual systems. There is a compelling need for agreed international definitions of failure and for the adoption of uniform reporting protocols. A common database, independent of the industry, would offer greater transparency to users and clinics.
OBJECTIVE: To evaluate the failure rate of cochlear implant systems across a range of European implant centers. STUDY DESIGN: Retrospective review. SETTING: Tertiary care cochlear implant centers in Europe. MATERIAL AND METHODS: A postal questionnaire was designed to assess the incidence and mode of total device failure and was sent to 34 European clinics. RESULTS: Twenty seven (79%) centers replied providing data on 12,856 devices of which 488 (3.79%) had undergone total device failure. Of 8,581 Nucleus devices (Cochlear, Sydney, Australia), 169 had failed; of 1,761 Advanced Bionics systems (Advanced Bionics, Sylmar, USA), 123 had failed; of 1987 Med El devices (Med-El, Innsbruck, Austria), 179 had failed; and of 527 MXM devices (Laboratoires MXM, Vallauris, France), 17 had failed. Six (22%) centers never reported failures to competent authorities. CONCLUSIONS: The study suggests that the overall reliability of cochlear implant systems is satisfactory but that reliability varies considerably between individual systems. There is a compelling need for agreed international definitions of failure and for the adoption of uniform reporting protocols. A common database, independent of the industry, would offer greater transparency to users and clinics.
Authors: William G Morrel; Asitha D L Jayawardena; Susan M Amberg; Benoit M Dawant; Jack H Noble; Robert F Labadie Journal: Laryngoscope Date: 2018-12-24 Impact factor: 3.325
Authors: Rolf-Dieter Battmer; Douglas D Backous; Thomas J Balkany; Robert J S Briggs; Bruce J Gantz; Andrew van Hasselt; Chong Sun Kim; Takeshi Kubo; Thomas Lenarz; Harold C Pillsbury; Gerard M O'Donoghue Journal: Otol Neurotol Date: 2010-10 Impact factor: 2.311
Authors: Jeffrey L Hendricks; Jennifer A Chikar; Mark A Crumling; Yehoash Raphael; David C Martin Journal: Hear Res Date: 2008-06-07 Impact factor: 3.208
Authors: Maria Stella Arantes do Amaral; Ana Cláudia Mirândola B Reis; Eduardo T Massuda; Miguel Angelo Hyppolito Journal: Braz J Otorhinolaryngol Date: 2018-02-16