title: United States multicenter clinical trial of the cochlear nucleus hybrid implant system.
abstract: OBJECTIVE
  To evaluate the safety and efficacy of acoustic and electric sound processing for individuals with significant residual low-frequency hearing and severe-to-profound high-frequency sensorineural hearing loss.
  
  
  METHODS
  Prospective, single-arm repeated measures, single-subject design.
  
  
  METHODS
  Fifty individuals, ≥ 18 years old, with low-frequency hearing and severe high-frequency loss were implanted with the Cochlear Nucleus Hybrid L24 implant at 10 investigational sites. Preoperatively, subjects demonstrated consonant-nucleus-consonant word scores of 10% through 60% in the ear to be implanted. Subjects were assessed prospectively, preoperatively, and postoperatively on coprimary endpoints of consonant-nucleus-consonant words, AzBio sentences in noise, and self-assessment measures.
  
  
  RESULTS
  Significant mean improvements were observed for coprimary endpoints: consonant-nucleus-consonant words (35.8 percentage points) and AzBio sentences in noise (32.0 percentage points), both at P < 0.001. Ninety-six percent of subjects performed equal or better on speech in quiet and 90% in noise. Eighty-two percent of subjects showed improved performance on speech in quiet and 74% in noise. Self-assessments were positive, corroborating speech perception results.
  
  
  CONCLUSIONS
  The Nucleus Hybrid System provides significant improvements in speech intelligibility in quiet and noise for individuals with severe high-frequency loss and some low-frequency hearing. This device expands indications to hearing-impaired individuals who perform poorly with amplification due to bilateral high-frequency hearing loss and who previously were not implant candidates.
authors.affiliation: Department of Otolaryngology-Head and Neck Surgery, New York University, New York, New York.
authors.forename: J Thomas
authors.initials: JT
authors.lastname: Roland
authors.affiliation: Department of Otolaryngology-Head and Neck Surgery, University of Iowa, Iowa City, Iowa.
authors.forename: Bruce J
authors.initials: BJ
authors.lastname: Gantz
authors.affiliation: Department of Otolaryngology-Head and Neck Surgery, New York University, New York, New York.
authors.forename: Susan B
authors.initials: SB
authors.lastname: Waltzman
authors.affiliation: University of Washington Medical Center, Seattle, Washington, U.S.A.
authors.forename: Aaron J
authors.initials: AJ
authors.lastname: Parkinson
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003054:Cochlear Implants; D005260:Female; D006319:Hearing Loss, Sensorineural / Q000534:rehabilitation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D011788:Quality of Life; D016896:Treatment Outcome; D014481:United States
keywords: Cochlear implant; bimodal stimulation; electric-acoustic stimulation; hearing in noise; hearing preservation; hybrid cochlear implant