title: Multicenter evaluation of the digisonic SP cochlear implant fixation system with titanium screws in 156 patients.
abstract: OBJECTIVE
  We describe and evaluate the process of fixation of the Digisonic SP cochlear implant with two titanium screws.
  
  
  METHODS
  The characteristics of this implant allow cochlear implantation using a minimal incision, a subperiosteal pocket, and fixation with two titanium screws, without drilling a custom-fitted seat or creating suture-retaining holes in the skull. The fixation system relies on two tailfins for use of osseo-integratable screws, incorporated into the cochlear implant housing. The first version of this fixation system was modified after a case of device migration: the size of the titanium insert inside the silicone tailfin was increased. Data on 156 patients (8 months to 86 years of age) from a 4-year period in 6 cochlear implantation centers were retrospectively evaluated. Ten patients have undergone bilateral implantation.
  
  
  RESULTS
  Of 166 implantations, 4 postoperative infections and 1 device failure after head trauma were reported. No cerebrospinal fluid leaks or epidural hematomas were reported. One device migration was observed in the first series; no device migrations occurred in the second series.
  
  
  CONCLUSIONS
  The fixation system with screws embedded in the Digisonic SP involves a fast and simple surgical technique that seems to efficiently prevent implant migration.
authors.affiliation: Department of Otorhinolaryngology, Pasteur Hospital, Nice, France.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Guevara
authors.forename: Olivier
authors.initials: O
authors.lastname: Sterkers
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Bébéar
authors.forename: Renaud
authors.initials: R
authors.lastname: Meller
authors.forename: Jacques
authors.initials: J
authors.lastname: Magnan
authors.forename: Isabelle
authors.initials: I
authors.lastname: Mosnier
authors.forename: Isabelle
authors.initials: I
authors.lastname: Amstutz
authors.forename: Yannick
authors.initials: Y
authors.lastname: Lerosey
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Triglia
authors.forename: Stéphane
authors.initials: S
authors.lastname: Roman
authors.forename: Ivan
authors.initials: I
authors.lastname: Gahide
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001863:Bone Screws; D002648:Child; D002675:Child, Preschool; D019929:Cochlear Implantation / Q000009:adverse effects / Q000295:instrumentation*; D003054:Cochlear Implants; D015331:Cohort Studies; D004867:Equipment Design; D005260:Female; D034381:Hearing Loss / Q000175:diagnosis / Q000209:etiology / Q000628:therapy*; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D011475:Prosthesis Failure; D012189:Retrospective Studies; D012307:Risk Factors; D014025:Titanium; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D014025:Titanium