Multicenter evaluation of the digisonic SP cochlear implant fixation system with titanium screws in 156 patients.
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.
Guevara
Nicolas
N
Department of Otorhinolaryngology, Pasteur Hospital, Nice, France.
Sterkers
Olivier
O
Bébéar
Jean-Pierre
JP
Meller
Renaud
R
Magnan
Jacques
J
Mosnier
Isabelle
I
Amstutz
Isabelle
I
Lerosey
Yannick
Y
Triglia
Jean-Michel
JM
Roman
Stéphane
S
Gahide
Ivan
I
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
D014025:Titanium