Multicenter evaluation of the digisonic SP cochlear implant fixation system with titanium screws in 156 patients

Ann Otol Rhinol Laryngol. 2010 Aug;119(8):501-5. doi: 10.1177/000348941011900801.

Abstract

Objectives: 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.

Publication types

  • Multicenter Study

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Bone Screws*
  • Child
  • Child, Preschool
  • Cochlear Implantation / adverse effects
  • Cochlear Implantation / instrumentation*
  • Cochlear Implants*
  • Cohort Studies
  • Equipment Design
  • Female
  • Hearing Loss / diagnosis
  • Hearing Loss / etiology
  • Hearing Loss / therapy*
  • Humans
  • Infant
  • Male
  • Middle Aged
  • Prosthesis Failure
  • Retrospective Studies
  • Risk Factors
  • Titanium
  • Treatment Outcome
  • Young Adult

Substances

  • Titanium