Nucleus Freedom North American clinical trial

Otolaryngol Head Neck Surg. 2007 May;136(5):757-62. doi: 10.1016/j.otohns.2007.01.006.

Abstract

Objective: To evaluate hearing outcomes and effects of stimulation rate on performance with the Nucleus Freedom cochlear implant (Cochlear Americas, Denver, CO).

Study design and setting: Randomized, controlled, prospective, single-blind clinical study using single-subject repeated measures (A-B-A-B) design at 14 academic centers in the United States and Canada and comparison with outcomes of a prior device by the same manufacturer.

Patients: Seventy-one severely/profoundly hearing impaired adults.

Results: Seventy-one adult recipients were randomly programmed in two different sets of rate: ACE or higher rate ACE RE. Mean scores for Consonant Nucleus Consonant words is 57%, Hearing in Noise Test (HINT) sentences in quiet 78%, and HINT sentences in noise 64%. Sixty-seven percent of subjects preferred slower rates of stimulation, and performance did not improve with higher rates of stimulation using this device.

Conclusions: Subjects performed well, and there was no advantage to higher stimulation rates with this device.

Significance: Higher stimulation rates do not necessarily result in improved performance.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Acoustic Stimulation / instrumentation
  • Adolescent
  • Adult
  • Child
  • Child, Preschool
  • Cochlear Implants*
  • Deafness / surgery*
  • Female
  • Humans
  • Infant
  • Male
  • Middle Aged
  • Noise / adverse effects
  • Preoperative Care
  • Prospective Studies
  • Prosthesis Design
  • Severity of Illness Index
  • Single-Blind Method
  • Speech Perception
  • Treatment Outcome