Trial Outcomes & Findings for Innovations in Clinical Care of CE Approved Nucleus Cochlear Implant Recipients (NCT NCT05270876)

Last Updated: 2025-03-10

Results Overview

The difference between mean CNC scores (reported as percentage of correct answers) in quiet between the standard and novel fitting method

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

0 to 4 weeks after fitting

Results posted on

2025-03-10

Participant milestones
Measure	Study Cohort Recipients of cochlear implant or suitable for implantation Recipients received standard and novel fitting methods during the study
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Study Cohort n=20 Participants Recipients of cochlear implant or suitable for implantation Recipients received standard and novel fitting methods during the study
Age, Continuous	66.5 years n=20 Participants
Sex: Female, Male Female	8 Participants n=20 Participants
Sex: Female, Male Male	12 Participants n=20 Participants
Average period of CI experience	5.3 years n=20 Participants
Device type CI532	11 Participants n=20 Participants
Device type CI632	3 Participants n=20 Participants
Device type CI512	3 Participants n=20 Participants
Device type CI612	1 Participants n=20 Participants
Device type CI24RE(CS)	1 Participants n=20 Participants
Device type CI24RE(CA)	1 Participants n=20 Participants

Timeframe: 0 to 4 weeks after fitting

Population: All study recipients received the standard and novel fitting methods at different timepoints of the study.

The difference between mean CNC scores (reported as percentage of correct answers) in quiet between the standard and novel fitting method

Outcome measures
Measure	Study Cohort n=20 Participants Recipients of cochlear implant or suitable for implantation
Mean Difference Between Standard and Novel Fitting Method for Monosyllabic Word Scores in Quiet	3.8 difference in percentage correct answers Interval -1.041 to 8.641

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Study Cohort n=20 participants at risk Recipients of cochlear implant or suitable for implantation
General disorders Headache	10.0% 2/20 • 3 weeks Subjects were monitored over the study duration which was approximately 3 weeks.
General disorders Discomfort	15.0% 3/20 • 3 weeks Subjects were monitored over the study duration which was approximately 3 weeks.
General disorders Dizziness	10.0% 2/20 • 3 weeks Subjects were monitored over the study duration which was approximately 3 weeks.

Cochlear

Phone: +61294286555