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Randomized Controlled Trial
. 2007 May;136(5):757-62.
doi: 10.1016/j.otohns.2007.01.006.

Nucleus Freedom North American clinical trial

Thomas Balkany  1 , Annelle Hodges, Christine Menapace, Linda Hazard, Colin Driscoll, Bruce Gantz, David Kelsall, William Luxford, Sean McMenomy, J Gail Neely, Brian Peters, Harold Pillsbury, Joseph Roberson, David Schramm, Steven Telian, Susan Waltzman, Brian Westerberg, Stacy Payne
Affiliations
Randomized Controlled Trial

Nucleus Freedom North American clinical trial

Thomas Balkany et al. Otolaryngol Head Neck Surg. 2007 May.

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.

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