A review of device failure in more than 23 years of clinical experience of a cochlear implant program with more than 3,400 implantees.

BACKGROUND

During the last 25 years, the cochlear implant (CI), an active implantable assistive hearing device designed to provide electrical stimulation to the inner ear of the profoundly hearing-impaired individual, has been provided to more than 150,000 recipients worldwide. More recently, implants have been placed in young children as young as 6 months old. With the expectation of lifelong implant use, as with all active implantable medical devices, CI device failure is an inherent risk. Comprehensive, transparent, and comparable information on the incidence of device failure is essential to support individual CI candidate decisions and that of those responsible for the CI program.

METHODS

An examination and analysis of our internal electronic database for more than 23 years of CI implant procedures in 3,417 recipients were performed. The cause and incidence of device failure per model and implant type were reported as cumulative survival rates (CSRs).

RESULTS

Our experience shows that at 6 years postimplant, there are significant differences in percent CSR and failure modes between implant CI models and CI brands for children and adult CI users. Typically, the percent CSR has increased for successive generations of implant models but not without exception. Failure modes are most commonly related to impact, electronic dysfunction, or leakage. After device failure, explant-reimplant is a safe and acceptable treatment option.

CONCLUSION

Percent CSR for CI devices at comparable postimplant time intervals varies, and as such, this information should continue to be carefully and systematically monitored and used by clinicians during counseling to support decisions by CI candidates, CI programs, and assist manufacturers in future developments.