Advanced Bionics CI-5293 Instructions For Use Manual page 43

that listening in quiet was comfortable. Nine subjects (90.0%) agreed that listening
in noise was comfortable (7 subjects reported "Strongly Agree," 2 subjects reported
"Slightly Agree"), with 1 subject reporting slight disagreement.
All 10 subjects (100.0%) reported that AutoSense OS on the sound processor
was acceptable for use and daily wear, with 8 subjects (80.0%) reporting strong
agreement and 2 subjects (20.0%) reporting slight agreement with the statements
"The sound processor is acceptable for use" and "The sound processor is
acceptable for daily wear". The majority of subjects (80.0%) also agreed that
AutoSense OS on the sound processor met their listening needs. The 2 subjects that
slightly disagreed reported challenges in noisy environments, although one of these
subjects agreed that sound quality was acceptable and listening was comfortable in
noise. These questionnaire results indicate that the sound processor is acceptable for
use and satisfies users' listening needs.
Combined data from two clinical studies of Naída CI M90 sound processor
Each of the two studies enrolled 10 subjects for a total of 20 across four study sites.
Both studies used a prospective within-subjects repeated-measures design where
each subject served as his/her own control. All subjects wore the Naída CI M90
during clinical testing.
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