A multicenter study of device failure in European cochlear implant centers.
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.
Battmer
Rolf-Dieter
RD
Department of Otolaryngology, Medizinische Hochschule Hannover, Hannover, Germany. Battmer.Rolf-Dieter@mh-hannover.de
O'Donoghue
Gerard M
GM
Lenarz
Thomas
T
D003054:Cochlear Implants; D005060:Europe / Q000453:epidemiology; D006801:Humans; D017060:Patient Satisfaction; D011475:Prosthesis Failure; D011795:Surveys and Questionnaires