title: A multicenter study of device failure in European cochlear implant centers.
abstract: OBJECTIVE
  To evaluate the failure rate of cochlear implant systems across a range of European implant centers.
  
  
  METHODS
  Retrospective review.
  
  
  METHODS
  Tertiary care cochlear implant centers in Europe.
  
  
  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.affiliation: Department of Otolaryngology, Medizinische Hochschule Hannover, Hannover, Germany. Battmer.Rolf-Dieter@mh-hannover.de
authors.forename: Rolf-Dieter
authors.initials: RD
authors.lastname: Battmer
authors.forename: Gerard M
authors.initials: GM
authors.lastname: O'Donoghue
authors.forename: Thomas
authors.initials: T
authors.lastname: Lenarz
mesh_terms: D003054:Cochlear Implants; D005060:Europe / Q000453:epidemiology; D006801:Humans; D017060:Patient Satisfaction; D011475:Prosthesis Failure; D011795:Surveys and Questionnaires