The MED-EL SONATATI(100) cochlear implant: An evaluation of its safety in adults and children

作者：Mueller Joachim; Baumgartner Wolf Dieter; Godey Benoit; Freijd Anders; Harris Sten; Helbig Silke; Sainz Quevedo Manuel; Mann Wolf; Anderson Ilona^*; Gstoettner Wolfgang

来源：Acta Oto-Laryngologica, 2011, 131(5): 504-511.

DOI：10.3109/00016489.2010.517783

• Titanium housing
• cochlear implant surgery

Conclusions: Data from 50 patients suggest that the SONATATI(100) cochlear implant (CI) is a safe and effective device. Objective: MED-EL has developed and tested a CI with titanium housing (the SONATATI(100)), which has the same internal components as the PULSARCI(100). Implant surgery should be less traumatic, as with these CIs smaller incisions and less drilling are involved. The study aimed to assess surgical issues pertaining to the implantation of the device, patient compatibility with the titanium of the implant housing, and other patient-related issues. Methods: Fifty patients were recruited into this multicenter study. In phase 1, 30 adults and in phase 2, 20 children received a SONATATI(100) cochlear implant. An intraoperative survey was completed by the surgeons for all patients. A postoperative survey was completed by the audiologists/fitting engineers at first fitting and 3 and 6 months after the first fitting to evaluate the safety and the efficacy of the device. Results: The device was proven to be effective in that it was stable in the implant bed and that minimally invasive surgery could be carried out. The device was proven to be safe after medium-term use and no unexpected adverse events were reported.

• 出版日期2011-5