The MED-EL SONATATI¹⁰⁰ cochlear implant: An evaluation of its safety in adults and children

Abstract

Conclusions: Data from 50 patients suggest that the SONATATI¹⁰⁰ cochlear implant (CI) is a safe and effective device. Objective: MED-EL has developed and tested a CI with titanium housing (the SONATATI¹⁰⁰), which has the same internal components as the PULSARCI¹⁰⁰. 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 SONATATI¹⁰⁰ 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.

Keywords::

• Titanium housing
• cochlear implant surgery

Acknowledgments

The authors thank Ms Simone Telser of MED-EL for her assistance in preparing this paper.

Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.