Trial Outcomes & Findings for Design Improvements With SONNET 3 (NCT NCT06597747)
NCT ID: NCT06597747
Last Updated: 2025-12-31
Results Overview
The proportion of participants reporting improvement in design aspects of SONNET 3 (EAS) on a user survey
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Measured 1 month after baseline
Results posted on
2025-12-31
Participant Flow
Participant milestones
| Measure |
SONNET 3 (EAS)
Participants complete a take-home trial using SONNET 3 (EAS) audio processor
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Design Improvements With SONNET 3
Baseline characteristics by cohort
| Measure |
SONNET 3 (EAS)
n=20 Participants
Participants complete a take-home trial using SONNET 3 (EAS) audio processor
|
|---|---|
|
Age, Continuous
|
44.7 years
STANDARD_DEVIATION 24.1 • n=1000 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=1000 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=1000 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=1000 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=1000 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1000 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=1000 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=1000 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1000 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1000 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=1000 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=1000 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1000 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=1000 Participants
|
|
Cochlear Implant Experience
|
6.1 years
STANDARD_DEVIATION 5.3 • n=1000 Participants
|
PRIMARY outcome
Timeframe: Measured 1 month after baselineThe proportion of participants reporting improvement in design aspects of SONNET 3 (EAS) on a user survey
Outcome measures
| Measure |
SONNET 3 (EAS)
n=20 Participants
Participants complete a take-home trial using SONNET 3 (EAS) audio processor
|
|---|---|
|
Participants Reporting Improvement With SONNET 3 Design
|
20 Participants
|
SECONDARY outcome
Timeframe: Measured after study completion, an average of 7.5 monthsScore on a 6-point Likert scale (1 = Strongly Disagree to 6 = Strongly Agree; higher scores indicate better outcomes). Values reported are the average scores on subsections of the audiologist survey.
Outcome measures
| Measure |
SONNET 3 (EAS)
n=3 Participants
Participants complete a take-home trial using SONNET 3 (EAS) audio processor
|
|---|---|
|
Audiologist Satisfaction Ratings
SONNET 3 Design
|
5.4 Score on 6-point Likert scale
Standard Deviation 0.3
|
|
Audiologist Satisfaction Ratings
MAESTRO 11
|
5.5 Score on 6-point Likert scale
Standard Deviation 0.5
|
Adverse Events
SONNET 3 (EAS)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SONNET 3 (EAS)
n=20 participants at risk
Participants complete a take-home trial using SONNET 3 (EAS) audio processor
|
|---|---|
|
Ear and labyrinth disorders
Adverse Device Effect
|
5.0%
1/20 • Number of events 1 • Measured through study completion, an average of 7.5 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place