Trial Outcomes & Findings for Evaluation of a HiRes™ Optima Sound Processing Strategy for the HiResolution™ Bionic Ear (NCT NCT01616576)
NCT ID: NCT01616576
Last Updated: 2020-07-22
Results Overview
Sentence recognition with the new (experimental) and current (control) sound processing strategies will be compared. Subjects will be tested using the AzBio corpus of sentences, which consists of 33 lists of 20 sentences each (6 to 10 words per sentence) that are equated for intelligibility. The difference between the Control percent correct scores and Experimental percent correct scores will be used for the analysis (Experimental AzBio scores minus Control AzBio scores). Data from both Group A and Group B were pooled for the analysis.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
2 weeks
Results posted on
2020-07-22
Participant Flow
Investigators recruited study subjects from their clinic practice. Subjects were randomized to either Group A or Group B at the time of the baseline visit. First patient first visit occurred on May 25, 2012 and last patient last visit occurred on September 07, 2012.
Participant milestones
| Measure |
Control First, Then Experimental (Group A)
Initial subject use of Control Sound Processing Strategy for the first week, followed by subject use of Experimental Sound Processing Strategy for the HiResolution™ Bionic Ear System for the second week.
Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy.
Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System.
|
Experimental First, Then Control (Group B)
Initial subject use of Experimental Sound Processing Strategy for the first week for the HiResolution™ Bionic Ear System, followed by subject use of Control Sound Processing Strategy for the second week.
Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy.
Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of a HiRes™ Optima Sound Processing Strategy for the HiResolution™ Bionic Ear
Baseline characteristics by cohort
| Measure |
Control First, Then Experimental (Group A)
n=18 Participants
Initial subject use of Control Sound Processing Strategy for the first week, followed by subject use of Experimental Sound Processing Strategy for the HiResolution™ Bionic Ear System for the second week.
Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy.
Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System.
|
Experimental First, Then Control (Group B)
n=18 Participants
Initial subject use of Experimental Sound Processing Strategy for the first week for the HiResolution™ Bionic Ear System, followed by subject use of Control Sound Processing Strategy for the second week.
Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy.
Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Continuous
|
62.0 years
STANDARD_DEVIATION 14.81 • n=5 Participants
|
58.9 years
STANDARD_DEVIATION 13.86 • n=7 Participants
|
60.4 years
STANDARD_DEVIATION 14.22 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeksSentence recognition with the new (experimental) and current (control) sound processing strategies will be compared. Subjects will be tested using the AzBio corpus of sentences, which consists of 33 lists of 20 sentences each (6 to 10 words per sentence) that are equated for intelligibility. The difference between the Control percent correct scores and Experimental percent correct scores will be used for the analysis (Experimental AzBio scores minus Control AzBio scores). Data from both Group A and Group B were pooled for the analysis.
Outcome measures
| Measure |
Group A and Group B Data Pooled
n=36 Participants
Data from Group A (n=18) and Group B (n=18) were pooled for the statistical analyses. Control data consists of Week 1 data from Group A and Week 2 data from Group B; Experimental data consisted of Week 2 data from Group A and Week 1 data from Group B. The resulting mean Control score was subtracted from the mean Experimental score to yield a paired difference score (i.e. Experimental - Control = paired difference score). The paired difference score (n=36) is reported below for each listening condition.
|
Control
n=36 Participants
Data from Group A and Group B were pooled for the statistical analyses. Control data consists of Week 1 data from Group A and Week 2 data from Group B.
|
Experimental
n=36 Participants
Data from Group A and Group B were pooled for the statistical analyses. Experimental data consisted of Week 2 data from Group A and Week 1 data from Group B.
|
|---|---|---|---|
|
Speech Perception With Control and Experimental Conditions Both Tested in Quiet, in Speech-spectrum Noise, and in Multi-talker Babble Noise.
Quiet
|
0.2 Percent Correct
Standard Deviation 6.06
|
88.3 Percent Correct
Standard Deviation 11.15
|
88.5 Percent Correct
Standard Deviation 12.43
|
|
Speech Perception With Control and Experimental Conditions Both Tested in Quiet, in Speech-spectrum Noise, and in Multi-talker Babble Noise.
SSN
|
2.8 Percent Correct
Standard Deviation 8.28
|
61.2 Percent Correct
Standard Deviation 18.98
|
64.0 Percent Correct
Standard Deviation 18.11
|
|
Speech Perception With Control and Experimental Conditions Both Tested in Quiet, in Speech-spectrum Noise, and in Multi-talker Babble Noise.
MTB
|
2.2 Percent Correct
Standard Deviation 6.89
|
67.8 Percent Correct
Standard Deviation 17.13
|
70.0 Percent Correct
Standard Deviation 16.53
|
PRIMARY outcome
Timeframe: 2 weeksDevice-related adverse events will be assessed to determine whether they impact current device safety performance.
Outcome measures
| Measure |
Group A and Group B Data Pooled
n=18 Participants
Data from Group A (n=18) and Group B (n=18) were pooled for the statistical analyses. Control data consists of Week 1 data from Group A and Week 2 data from Group B; Experimental data consisted of Week 2 data from Group A and Week 1 data from Group B. The resulting mean Control score was subtracted from the mean Experimental score to yield a paired difference score (i.e. Experimental - Control = paired difference score). The paired difference score (n=36) is reported below for each listening condition.
|
Control
n=18 Participants
Data from Group A and Group B were pooled for the statistical analyses. Control data consists of Week 1 data from Group A and Week 2 data from Group B.
|
Experimental
Data from Group A and Group B were pooled for the statistical analyses. Experimental data consisted of Week 2 data from Group A and Week 1 data from Group B.
|
|---|---|---|---|
|
Device-related Adverse Events
|
0 Events
|
0 Events
|
—
|
Adverse Events
Control First, Then Experimental (Group A)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Experimental First, Then Control (Group B)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control First, Then Experimental (Group A)
n=18 participants at risk
Initial subject use of Control Sound Processing Strategy for the first week, followed by subject use of Experimental Sound Processing Strategy for the HiResolution™ Bionic Ear System condition for the second week.
Control Sound Processing Strategy: HiRes Fidelity 120™ Sound Processing Strategy, which is currently marketed sound processing strategy.
Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System.
|
Experimental First, Then Control (Group B)
n=18 participants at risk
Initial subject use of Experimental Sound Processing Strategy for the first week for the HiResolution™ Bionic Ear System, followed by subject use of the Control Sound Processing Strategy for the second week.
Control Sound Processing Strategy: HiRes Fidelity 120™ Sound Processing Strategy, which is currently marketed sound processing strategy.
Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System.
|
|---|---|---|
|
General disorders
Headache
|
5.6%
1/18 • Number of events 1
|
16.7%
3/18 • Number of events 3
|
|
General disorders
Cold
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
Additional Information
Cedric Navarro, Vice President of Regulatory/Clinical Affairs and Quality
Advanced Bionics, LLC
Phone: (661) 362-1963
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee PI agrees to submit any publication to Sponsor (S) at least 30 days prior to submission. Within 30 days of its receipt, S advises PI in writing of any information contained therein which is Confidential Information (CI) (other than Study Data) or which may impair the availability of patent protection for Inventions. S has the right to require PI to remove specifically identified CI and/or to delay the publication for an additional 60 days to enable S to seek patent protection for Inventions.
- Publication restrictions are in place
Restriction type: OTHER