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.

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.