Trial Outcomes & Findings for An Actual Use, Open-label Study Assessing Usability of Remote Assist to Program Cochlear Implant Recipients (NCT NCT04987021)
NCT ID: NCT04987021
Last Updated: 2024-02-21
Results Overview
Usability rating scale: 1 = unable to complete; 2 = Completed after help using document; 3 = Completed after trying an incorrect option; 4 = Completed after some exploration; 5 = Complete at first attempt.
COMPLETED
NA
15 participants
Immediately after the participants´ first use of the Nucleus Smart App with Remote Assist Custom Sound Pro 6.3, on average half an hour after participants have completed all tasks.
2024-02-21
Participant Flow
Participant milestones
| Measure |
Nucleus Smart App With Remote Assist Custom Sound Pro 6.3
Remote Assist Custom Sound Pro 6.3 to enable clinicians to use the App to remotely to program the recipients sound processors.
Cochlear Implant (CI)-CI500 series, CI600 series or Freedom series cochlear implants: The Remote Assist (RA) System is intended to support clinicians to conduct a remote programming session with their CI recipients.
|
|---|---|
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Overall Study
STARTED
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15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Nucleus Smart App With Remote Assist Custom Sound Pro 6.3
n=15 Participants
Remote Assist Custom Sound Pro 6.3 to enable clinicians to use the App to remotely to program the recipients sound processors.
Cochlear Implant (CI)-CI500 series, CI600 series or Freedom series cochlear implants: The Remote Assist (RA) System is intended to support clinicians to conduct a remote programming session with their CI recipients.
|
|---|---|
|
Age, Continuous
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63 years
n=15 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=15 Participants
|
|
Region of Enrollment
Australia
|
15 participants
n=15 Participants
|
|
Age at test
|
63 years
n=15 Participants
|
PRIMARY outcome
Timeframe: Immediately after the participants´ first use of the Nucleus Smart App with Remote Assist Custom Sound Pro 6.3, on average half an hour after participants have completed all tasks.Usability rating scale: 1 = unable to complete; 2 = Completed after help using document; 3 = Completed after trying an incorrect option; 4 = Completed after some exploration; 5 = Complete at first attempt.
Outcome measures
| Measure |
Nucleus Smart App With Remote Assist Custom Sound Pro 6.3
n=15 Participants
Remote Assist Custom Sound Pro 6.3 to enable clinicians to use the App to remotely to program the recipients sound processors.
Cochlear Implant (CI)-CI500 series, CI600 series or Freedom series cochlear implants: The Remote Assist (RA) System is intended to support clinicians to conduct a remote programming session with their CI recipients.
|
|---|---|
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Number of Participants Who While Using the Final Version of Remote Assist, Are Able to Complete the Primary Tasks (Score of 5 on the Usability Rating Scale)
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13 Participants
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Adverse Events
Nucleus Smart App With Remote Assist Custom Sound Pro 6.3
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nucleus Smart App With Remote Assist Custom Sound Pro 6.3
n=15 participants at risk
Remote Assist Custom Sound Pro 6.3 to enable clinicians to use the App to remotely to program the recipients sound processors.
Cochlear Implant (CI)-CI500 series, CI600 series or Freedom series cochlear implants: The Remote Assist (RA) System is intended to support clinicians to conduct a remote programming session with their CI recipients.
|
|---|---|
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Investigations
Sound levels uncomfortably loud
|
6.7%
1/15 • Number of events 1 • One day
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place