title: The MED-EL SONATATI 100 cochlear implant: an evaluation of its safety in adults and children.
abstract: 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.
authors.affiliation: Klinik fuer HNO-Kranke, Wuerzburg, Germany.
authors.forename: Joachim
authors.initials: J
authors.lastname: Mueller
authors.forename: Wolf-Dieter
authors.initials: WD
authors.lastname: Baumgartner
authors.forename: Benoit
authors.initials: B
authors.lastname: Godey
authors.forename: Anders
authors.initials: A
authors.lastname: Freijd
authors.forename: Sten
authors.initials: S
authors.lastname: Harris
authors.forename: Silke
authors.initials: S
authors.lastname: Helbig
authors.forename: Manuel Sainz
authors.initials: MS
authors.lastname: Quevedo
authors.forename: Wolf
authors.initials: W
authors.lastname: Mann
authors.forename: Ilona
authors.initials: I
authors.lastname: Anderson
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Gstoettner
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D019929:Cochlear Implantation; D003054:Cochlear Implants / Q000009:adverse effects*; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D014025:Titanium
chemical_list: D014025:Titanium