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Published on: August 25, 2020
Nucleus Freedom North American clinical trial
Thomas Balkany1, Annelle Hodges, Christine Menapace
1University of Miami Ear Institute, Miami, FL 33101, USA. tbalkany@miami.edu
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.
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