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).


METHODS
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.


METHODS
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.


CONCLUSIONS
Higher stimulation rates do not necessarily result in improved performance.
Balkany
Thomas
T
University of Miami Ear Institute, Miami, FL 33101, USA. tbalkany@miami.edu
Hodges
Annelle
A
Menapace
Christine
C
Hazard
Linda
L
Driscoll
Colin
C
Gantz
Bruce
B
Kelsall
David
D
Luxford
William
W
McMenomy
Sean
S
Neely
J Gail
JG
Peters
Brian
B
Pillsbury
Harold
H
Roberson
Joseph
J
Schramm
David
D
Telian
Steven
S
Waltzman
Susan
S
Westerberg
Brian
B
Payne
Stacy
S
D000161:Acoustic Stimulation / Q000295:instrumentation; D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D003054:Cochlear Implants; D003638:Deafness / Q000601:surgery*; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D009622:Noise / Q000009:adverse effects; D011300:Preoperative Care; D011446:Prospective Studies; D011474:Prosthesis Design; D012720:Severity of Illness Index; D016037:Single-Blind Method; D013067:Speech Perception; D016896:Treatment Outcome