The Mi1000 CONCERTO PIN cochlear implant: An evaluation of its safety and stability in adults and children

Conclusion The study demonstrates the medium-term stability and safety of the CONCERTO PIN cochlear implant. The use of the CONCERTO PIN proved to be suitable for the use of a surgical technique without the need for suture fixation and resulted in short surgery duration and a low medium-term complication rate. Objective The primary aim was to provide data on medium-term safety and stability of the CONCERTO PIN cochlear implant in adults and children, and to collect feedback on the surgical technique used, which involved no drilling and no suture fixation. The secondary aim was to analyze surgery duration. Methods Implantation was performed using minimally invasive surgery. During surgery, data on the surgical procedure was collected by the attending surgeons or a designee. Safety and stability of the CONCERTO PIN were assessed at first fitting (1 month after implantation) and 6 months after first fitting. Results Ninety-nine patients were implanted with a CONCERTO PIN implant and one patient with a CONCERTO implant. The CONCERTO PIN implants implanted during this study were immobilized by pins and a tight periosteal pocket. The mean (+/- SD) surgery duration was 27:52 (+/- 9:19) min.