title: Clinical evaluation of the Clarion CII HiFocus 1 with and without positioner.
abstract: OBJECTIVE
  To study the clinical outcomes concerning speech perception of the Clarion CII HiFocus 1 with and without a positioner and link those outcomes with the functional implications of perimodiolar electrode designs, focusing on intrascalar position, insertion depth, stimulation levels, and intracochlear conductivity pathways.
  
  
  METHODS
  The speech perception scores of 25 consecutive patients with the Clarion CII HiFocus 1 implanted with a positioner and 20 patients without a positioner were prospectively determined. Improved multislice CT imaging was used to study the position of the individual electrode contacts relative to the modiolus and their insertion depth. Furthermore, stimulation thresholds, maximum comfort levels, and dynamic ranges were obtained. Finally, these data were associated with intracochlear conductivity paths as calculated from the potential distribution acquired with electrical field imaging.
  
  
  RESULTS
  Implantation with a Clarion Hifocus 1 with positioner showed significantly higher speech perception levels at 3 mos, 6 mos, and 1 yr (p < 0.05) after implantation. Basally, the positioner brought the electrode contacts significantly closer to the modiolus, whereas apically no difference in distance toward the modiolus was present. Moreover, the patients with the electrode array in a perimodiolar position showed deeper insertions. The T-levels and dynamic range were not significantly different between the positioner and nonpositioner patients. Furthermore, the intracochlear conductivity paths showed no significant differences. However, a basal current drain is present for the shallowly inserted nonpositioner patients.
  
  
  CONCLUSIONS
  A basally perimodiolar electrode design benefits speech perception. The combination of decreased distance to the modiolus, improved insertion depth, and insulating properties of the electrode array have functional implications for the clinical outcomes of the perimodiolar electrode design. Further research is needed to elucidate their individual contributions to those outcomes.
authors.affiliation: Ear, Nose, and Throat Department, Leiden University Medical Center, Leiden, The Netherlands.
authors.forename: F B
authors.initials: FB
authors.lastname: van der Beek
authors.forename: P P B M
authors.initials: PP
authors.lastname: Boermans
authors.forename: B M
authors.initials: BM
authors.lastname: Verbist
authors.forename: J J
authors.initials: JJ
authors.lastname: Briaire
authors.forename: J H M
authors.initials: JH
authors.lastname: Frijns
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001301:Audiometry, Pure-Tone; D001309:Auditory Threshold; D003051:Cochlea / Q000000981:diagnostic imaging* / Q000601:surgery; D019929:Cochlear Implantation / Q000379:methods* / Q000592:standards; D003054:Cochlear Implants / Q000592:standards; D017097:Electric Impedance; D005260:Female; D034381:Hearing Loss / Q000534:rehabilitation* / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D012044:Regression Analysis; D013067:Speech Perception / Q000502:physiology*; D014057:Tomography, X-Ray Computed