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.