Nucleus Freedom North American clinical trial

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. (C) 2007 American Academy of Otolaryngology-Head and Neck Surgery Foundation. All rights reserved.