Trial Outcomes & Findings for Perimodiolar Implant Performance in Adults With Low-Frequency Residual Hearing (NCT NCT04741009)
NCT ID: NCT04741009
Last Updated: 2026-08-17
Results Overview
To characterize hearing performance of the CI632 using the Consonant-Nucleus-Consonant (CNC) monosyllabic word recognition test in quiet (unilateral). Two CNC word lists will be administered at a level equal to 60 dBA in the sound field and scored as a total number of words correct, expressed as a percentage correct.
COMPLETED
NA
10 participants
14 months (12 months postactivation)
2026-08-17
Participant Flow
Participant milestones
| Measure |
CI632 Slim Modiolar Electrode
The Cochlear Ltd CI632 cochlear implant with Slim Modiolar Electrode
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Perimodiolar Implant Performance in Adults With Low-Frequency Residual Hearing
Baseline characteristics by cohort
| Measure |
All Participants
n=10 Participants
The Cochlear Ltd CI632 cochlear implant with Slim Modiolar Electrode
|
|---|---|
|
Age, Continuous
|
61.3 years
STANDARD_DEVIATION 9.8 • n=51 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=51 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=51 Participants
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=51 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic
|
10 Participants
n=51 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=51 Participants
|
PRIMARY outcome
Timeframe: 14 months (12 months postactivation)To characterize hearing performance of the CI632 using the Consonant-Nucleus-Consonant (CNC) monosyllabic word recognition test in quiet (unilateral). Two CNC word lists will be administered at a level equal to 60 dBA in the sound field and scored as a total number of words correct, expressed as a percentage correct.
Outcome measures
| Measure |
All Participants
n=9 Participants
The Cochlear Ltd CI632 cochlear implant with Slim Modiolar Electrode
|
|---|---|
|
To Characterize Hearing Performance of the CI632 in an Adult Population Under Expanded Indications for Use.
|
79.1 Percentage of words correct
Standard Deviation 5.8
|
Adverse Events
All Participants
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Participants
n=10 participants at risk
The Cochlear Ltd CI632 cochlear implant with Slim Modiolar Electrode
|
|---|---|
|
Ear and labyrinth disorders
Ear infection
|
10.0%
1/10 • 12 months
|
|
General disorders
Pain
|
10.0%
1/10 • 12 months
|
|
Nervous system disorders
Taste disorder
|
10.0%
1/10 • 12 months
|
|
Ear and labyrinth disorders
Tinnitus
|
20.0%
2/10 • 12 months
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • 12 months
|
|
Nervous system disorders
Numbness
|
10.0%
1/10 • 12 months
|
|
Skin and subcutaneous tissue disorders
Blister
|
10.0%
1/10 • 12 months
|
|
Ear and labyrinth disorders
Vertigo
|
10.0%
1/10 • 12 months
|
|
Ear and labyrinth disorders
Aural fullness
|
10.0%
1/10 • 12 months
|
|
General disorders
High blood pressure/ hypertension
|
10.0%
1/10 • 12 months
|
|
Ear and labyrinth disorders
Ear pain
|
10.0%
1/10 • 12 months
|
|
Nervous system disorders
Balance problems
|
10.0%
1/10 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place