Advanced Bionics Naída CI M90 Manual Del Usuario página 33

CLINICAL BENEFITS
Advanced Bionics conducted two clinical studies of
AutoSense OS on the Naída CI M90 sound processor.
Results from both studies are reported below: the first
summary provides results from a confirmatory study
conducted at Advanced Bionics' location in Valencia,
CA and the second summary provides results from both
this confirmatory study and a multicenter pivotal trial
conducted across the United States.
Shown below is a summary of the confirmatory data.
Ten subjects were enrolled in a prospective study using
a within-subjects repeated-measures design where each
subject served as his/her own control. Five subjects used
the M Acoustic Earhook, while the remaining 5 used
the M T-Mic and electrical stimulation only. The data
presented below are pooled between the two cohorts.
Sentences in Quiet at 65 dBA
Across all subjects, similar sentence recognition scores
in quiet were observed between AutoSense OS and the
AutoSense OS Off program. See the table below.
N
Mean (SD)
Median
Min, Max
2 l a S
ISt uto enSe
a S
verage core
10
88.92 (11.068)
94.65
63.2, 96.7
oS 2 l
ISt
(%) oS o
a
verage
10
89.76 (11.677)
92.88
61.2, 99.3
a S
uto enSe
ff
S (%)
core
31