Trial Outcomes & Findings for Usability of the CP950 Sound Processor (NCT NCT02727842)

Last Updated: 2018-09-12

Results Overview

To evaluate usability of the CP950 sound processor using the CP950 Take Home Questionnaire for existing cochlear implant users. Specifically: 1. Patient Reported Hearing Performance 2. Retention \& Comfort 3. Ease of use 4. Use of remote controls 5. Look \& feel 6. Reliability 7. Maintenance \& use

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

1 month

Results posted on

2018-09-12

Participant Flow

Unit of analysis: Sound processor per participant

Participant milestones

Participant milestones
Measure	Treatment Group All patients will receive the CP950 Sound Processor and be part of the treatment group for one month which is programmed via the wireless programming pod CP950 Sound Processor: An off-the-ear processor configuration with identical functionality to the commercially approved CP910/920 processor Wireless programming pod: The CP950 Sound Processor will be programmed by the wireless programming pod, which is needed as the interface to commercially approved programming software
Overall Study STARTED	30 1
Overall Study COMPLETED	30 1
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Usability of the CP950 Sound Processor

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Group n=30 Participants All patients will receive the CP950 Sound Processor and be part of the treatment group for one month which is programmed via the wireless programming pod CP950 Sound Processor: An off-the-ear processor configuration with identical functionality to the commercially approved CP910/920 processor Wireless programming pod: The CP950 Sound Processor will be programmed by the wireless programming pod, which is needed as the interface to commercially approved programming software
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Population: All enrolled subjects

Outcome measures

Outcome measures
Measure	All Subjects n=30 Participants All study participants were analyzed in the treatment group.
Patient Satisfaction Through Usability of the CP950 Sound Processor as Measured by the CP950 Take Home Questionnaire Satisfiaction with retention accessory	22 Participants
Patient Satisfaction Through Usability of the CP950 Sound Processor as Measured by the CP950 Take Home Questionnaire Satisfaction with hearing performance	28 Participants
Patient Satisfaction Through Usability of the CP950 Sound Processor as Measured by the CP950 Take Home Questionnaire Agreed sound processor is comfortable	27 Participants
Patient Satisfaction Through Usability of the CP950 Sound Processor as Measured by the CP950 Take Home Questionnaire Agreed sound processor is easy to use	28 Participants
Patient Satisfaction Through Usability of the CP950 Sound Processor as Measured by the CP950 Take Home Questionnaire Satisfied with look and feel of processor	27 Participants
Patient Satisfaction Through Usability of the CP950 Sound Processor as Measured by the CP950 Take Home Questionnaire Agreed sound processor was reliable	29 Participants
Patient Satisfaction Through Usability of the CP950 Sound Processor as Measured by the CP950 Take Home Questionnaire Agreed sound processor is easy to clean	24 Participants

Adverse Events

Treatment Group

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment Group n=30 participants at risk There were no unanticipated or serious adverse events reported. The All-Cause Mortality rate was zero.
Product Issues Mircrophone housing	3.3% 1/30 • Number of events 1 • 1 year There were no unanticipated or serious adverse events reported. The All-Cause Mortality rate was zero.
Product Issues Skin flap	3.3% 1/30 • Number of events 1 • 1 year There were no unanticipated or serious adverse events reported. The All-Cause Mortality rate was zero.

Additional Information

Kimberly Nix, Clinical Project Manager

Cochlear Americas

Phone: 303-264-2340

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER