Trial Outcomes & Findings for Cochlear Implant With Dexamethasone Eluting Electrode Array (NCT NCT04750642)
NCT ID: NCT04750642
Last Updated: 2025-04-22
Results Overview
The impedance was measured across the active electrodes of the cochlear implant for each participant. Reduced impedances indicate less fibrotic obstruction caused by trauma associated with the electrode insertion.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
Six months postoperative
Results posted on
2025-04-22
Participant Flow
Participant milestones
| Measure |
CI632D Investigational Medical Device (IMD)
CI632D: CI632 cochlear implant with Slim Modiolar electrode including dexamethasone in the electrode within wells (CI632D)
|
CI632 Comparator Device
CI632: CI632 cochlear implant with Slim Modiolar electrode with market approval and does not include dexamethasone
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
15
|
|
Overall Study
COMPLETED
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
CI632D Investigational Medical Device (IMD)
CI632D: CI632 cochlear implant with Slim Modiolar electrode including dexamethasone in the electrode within wells (CI632D)
|
CI632 Comparator Device
CI632: CI632 cochlear implant with Slim Modiolar electrode with market approval and does not include dexamethasone
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Cochlear Implant With Dexamethasone Eluting Electrode Array
Baseline characteristics by cohort
| Measure |
CI632D Investigational Medical Device (IMD)
n=14 Participants
CI632D: CI632 cochlear implant with Slim Modiolar electrode including dexamethasone in the electrode within wells (CI632D)
|
CI632 Comparator Device
n=15 Participants
CI632: CI632 cochlear implant with Slim Modiolar electrode with market approval and does not include dexamethasone
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.6 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
66.3 years
STANDARD_DEVIATION 17.1 • n=7 Participants
|
68.9 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Croatian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
French Indian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Maori/European
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Six months postoperativePopulation: All implanted group. Thirteen participants in each arm completed the study. However, one participant from each arm did not complete the 6 month evaluation, which was the time frame for this outcome measure. Hence, the number of participants analyzed in each arm was 12.
The impedance was measured across the active electrodes of the cochlear implant for each participant. Reduced impedances indicate less fibrotic obstruction caused by trauma associated with the electrode insertion.
Outcome measures
| Measure |
CI632D Investigational Medical Device (IMD)
n=12 Participants
CI632D: CI632 cochlear implant with Slim Modiolar electrode including dexamethasone in the electrode within wells (CI632D)
|
CI632 Comparator Device
n=12 Participants
CI632: CI632 cochlear implant with Slim Modiolar electrode with market approval and does not include dexamethasone
|
|---|---|---|
|
Comparison of Monopolar (MP1+2) Impedance Measurement (kOhms) Between Randomization Groups at 6 Months Postoperative
|
3.99 kOhms
Standard Deviation 0.54
|
8.66 kOhms
Standard Deviation 1.45
|
PRIMARY outcome
Timeframe: Six months postoperativePopulation: All implanted group. Thirteen participants in each arm completed the study. However, one participant from each arm did not complete the 6 month evaluation, which was the time frame for this outcome measure. Hence, the number of participants analyzed in each arm was 12.
Scores on the CNC Words in Quiet test were expressed as a percentage of words repeated correctly by the participant in a sound booth. A higher score indicates better speech perception performance. This outcome measure included the CI632D group only.
Outcome measures
| Measure |
CI632D Investigational Medical Device (IMD)
n=12 Participants
CI632D: CI632 cochlear implant with Slim Modiolar electrode including dexamethasone in the electrode within wells (CI632D)
|
CI632 Comparator Device
CI632: CI632 cochlear implant with Slim Modiolar electrode with market approval and does not include dexamethasone
|
|---|---|---|
|
Change in Speech Perception Performance (Pre-recorded CNC Words in Quiet in Sound Booth Testing) Compared to Pre-operative Baseline Measured at 6 Months Postoperative With CI632D
|
39.5 percentage points
Standard Deviation 23.1
|
—
|
SECONDARY outcome
Timeframe: Twelve months postoperativePopulation: Intent-to-treat group at 12 months. This is the number of participants who were randomized.
Adverse events were recorded from baseline to 12 months postoperative.
Outcome measures
| Measure |
CI632D Investigational Medical Device (IMD)
n=14 Participants
CI632D: CI632 cochlear implant with Slim Modiolar electrode including dexamethasone in the electrode within wells (CI632D)
|
CI632 Comparator Device
n=15 Participants
CI632: CI632 cochlear implant with Slim Modiolar electrode with market approval and does not include dexamethasone
|
|---|---|---|
|
Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups
Discontinuation due to an AE
|
1 Participants
|
0 Participants
|
|
Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups
No adverse events
|
2 Participants
|
3 Participants
|
|
Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups
One or more AEs
|
12 Participants
|
12 Participants
|
|
Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups
One or more related (possibly, probably, definitely) AEs
|
8 Participants
|
5 Participants
|
|
Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups
Procedure related
|
7 Participants
|
4 Participants
|
|
Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups
Device related
|
5 Participants
|
3 Participants
|
|
Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups
Study drug related
|
1 Participants
|
2 Participants
|
|
Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups
One or more unanticipated adverse device effects (ADEs)
|
0 Participants
|
0 Participants
|
|
Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups
One or more serious AEs
|
3 Participants
|
2 Participants
|
|
Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups
One or more serious ADEs (SADEs)
|
1 Participants
|
0 Participants
|
|
Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups
One or more serious unanticipated ADEs (USADEs)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Six months postoperativePopulation: All implanted group. Thirteen participants in each arm completed the study. However, one participant from each arm did not complete the 6 month evaluation, which was the time frame for this outcome measure. Hence, the number of participants analyzed in each arm was 12.
Scores on the CNC Words in Quiet test were expressed as a percentage of words repeated correctly by the participant in a sound booth. A higher score indicates better speech perception performance.
Outcome measures
| Measure |
CI632D Investigational Medical Device (IMD)
n=12 Participants
CI632D: CI632 cochlear implant with Slim Modiolar electrode including dexamethasone in the electrode within wells (CI632D)
|
CI632 Comparator Device
n=12 Participants
CI632: CI632 cochlear implant with Slim Modiolar electrode with market approval and does not include dexamethasone
|
|---|---|---|
|
Comparison of Speech Perception Performance (Pre-recorded CNC Words in Quiet in Sound Booth Testing) Between the Randomization Groups at Six Months Postoperative
|
57.8 percentage points
Standard Deviation 17.6
|
68.0 percentage points
Standard Deviation 23.9
|
SECONDARY outcome
Timeframe: Six months postoperativePopulation: All implanted group. Thirteen participants in each arm completed the study. However, one participant from each arm did not complete the 6 month evaluation, which was the time frame for this outcome measure. Hence, the number of participants analyzed in each arm was 12.
Scores from the AzBio Sentences in Quiet test were expressed as a percentage of words repeated correctly by the participant in a sound booth. A higher score indicates better speech perception performance.
Outcome measures
| Measure |
CI632D Investigational Medical Device (IMD)
n=12 Participants
CI632D: CI632 cochlear implant with Slim Modiolar electrode including dexamethasone in the electrode within wells (CI632D)
|
CI632 Comparator Device
n=12 Participants
CI632: CI632 cochlear implant with Slim Modiolar electrode with market approval and does not include dexamethasone
|
|---|---|---|
|
Comparison of Speech Perception Performance (AzBio Sentences in Quiet in Sound Booth Testing) Between Randomization Groups at Six Months Postoperative
|
46.1 percentage correct
Standard Deviation 35.3
|
55.3 percentage correct
Standard Deviation 31.8
|
Adverse Events
CI632D Investigational Medical Device (IMD)
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
CI632 Comparator Arm
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CI632D Investigational Medical Device (IMD)
n=14 participants at risk
CI632D: CI632 cochlear implant with Slim Modiolar electrode including dexamethasone in the electrode within wells (CI632D)
|
CI632 Comparator Arm
n=15 participants at risk
Standard CI632 device
|
|---|---|---|
|
Surgical and medical procedures
Reimplantation due to electrode tip fold over
|
7.1%
1/14 • Baseline to 12 months postoperative
|
0.00%
0/15 • Baseline to 12 months postoperative
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
0.00%
0/14 • Baseline to 12 months postoperative
|
6.7%
1/15 • Baseline to 12 months postoperative
|
|
Ear and labyrinth disorders
Vertigo
|
7.1%
1/14 • Baseline to 12 months postoperative
|
0.00%
0/15 • Baseline to 12 months postoperative
|
|
Cardiac disorders
Aortic valve stenosis
|
7.1%
1/14 • Baseline to 12 months postoperative
|
0.00%
0/15 • Baseline to 12 months postoperative
|
|
Cardiac disorders
Arrhythmia
|
7.1%
1/14 • Baseline to 12 months postoperative
|
0.00%
0/15 • Baseline to 12 months postoperative
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract infection
|
0.00%
0/14 • Baseline to 12 months postoperative
|
6.7%
1/15 • Baseline to 12 months postoperative
|
Other adverse events
| Measure |
CI632D Investigational Medical Device (IMD)
n=14 participants at risk
CI632D: CI632 cochlear implant with Slim Modiolar electrode including dexamethasone in the electrode within wells (CI632D)
|
CI632 Comparator Arm
n=15 participants at risk
Standard CI632 device
|
|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
14.3%
2/14 • Baseline to 12 months postoperative
|
40.0%
6/15 • Baseline to 12 months postoperative
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/14 • Baseline to 12 months postoperative
|
6.7%
1/15 • Baseline to 12 months postoperative
|
|
Endocrine disorders
Hypoglycemia
|
0.00%
0/14 • Baseline to 12 months postoperative
|
6.7%
1/15 • Baseline to 12 months postoperative
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/14 • Baseline to 12 months postoperative
|
6.7%
1/15 • Baseline to 12 months postoperative
|
|
Gastrointestinal disorders
Heartburn
|
0.00%
0/14 • Baseline to 12 months postoperative
|
6.7%
1/15 • Baseline to 12 months postoperative
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Baseline to 12 months postoperative
|
0.00%
0/15 • Baseline to 12 months postoperative
|
|
Gastrointestinal disorders
|
7.1%
1/14 • Baseline to 12 months postoperative
|
0.00%
0/15 • Baseline to 12 months postoperative
|
|
General disorders
Chest pain
|
0.00%
0/14 • Baseline to 12 months postoperative
|
6.7%
1/15 • Baseline to 12 months postoperative
|
|
General disorders
Discomfort
|
7.1%
1/14 • Baseline to 12 months postoperative
|
0.00%
0/15 • Baseline to 12 months postoperative
|
|
General disorders
Fever
|
7.1%
1/14 • Baseline to 12 months postoperative
|
0.00%
0/15 • Baseline to 12 months postoperative
|
|
General disorders
Hypertension
|
0.00%
0/14 • Baseline to 12 months postoperative
|
6.7%
1/15 • Baseline to 12 months postoperative
|
|
General disorders
Wound dehiscence
|
7.1%
1/14 • Baseline to 12 months postoperative
|
0.00%
0/15 • Baseline to 12 months postoperative
|
|
Immune system disorders
Hypersensitivity
|
14.3%
2/14 • Baseline to 12 months postoperative
|
0.00%
0/15 • Baseline to 12 months postoperative
|
|
Infections and infestations
Viral infection
|
7.1%
1/14 • Baseline to 12 months postoperative
|
20.0%
3/15 • Baseline to 12 months postoperative
|
|
Injury, poisoning and procedural complications
Bruise
|
0.00%
0/14 • Baseline to 12 months postoperative
|
6.7%
1/15 • Baseline to 12 months postoperative
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/14 • Baseline to 12 months postoperative
|
6.7%
1/15 • Baseline to 12 months postoperative
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
1/14 • Baseline to 12 months postoperative
|
6.7%
1/15 • Baseline to 12 months postoperative
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
7.1%
1/14 • Baseline to 12 months postoperative
|
0.00%
0/15 • Baseline to 12 months postoperative
|
|
Musculoskeletal and connective tissue disorders
Cramps
|
0.00%
0/14 • Baseline to 12 months postoperative
|
6.7%
1/15 • Baseline to 12 months postoperative
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/14 • Baseline to 12 months postoperative
|
6.7%
1/15 • Baseline to 12 months postoperative
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.1%
1/14 • Baseline to 12 months postoperative
|
0.00%
0/15 • Baseline to 12 months postoperative
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
0.00%
0/14 • Baseline to 12 months postoperative
|
6.7%
1/15 • Baseline to 12 months postoperative
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non malignant neoplasm
|
0.00%
0/14 • Baseline to 12 months postoperative
|
6.7%
1/15 • Baseline to 12 months postoperative
|
|
Nervous system disorders
Balance problems
|
21.4%
3/14 • Baseline to 12 months postoperative
|
6.7%
1/15 • Baseline to 12 months postoperative
|
|
Nervous system disorders
Cognitive changes
|
0.00%
0/14 • Baseline to 12 months postoperative
|
6.7%
1/15 • Baseline to 12 months postoperative
|
|
Nervous system disorders
Dizziness
|
28.6%
4/14 • Baseline to 12 months postoperative
|
6.7%
1/15 • Baseline to 12 months postoperative
|
|
Nervous system disorders
Headache
|
64.3%
9/14 • Baseline to 12 months postoperative
|
40.0%
6/15 • Baseline to 12 months postoperative
|
|
Nervous system disorders
Numbness
|
0.00%
0/14 • Baseline to 12 months postoperative
|
6.7%
1/15 • Baseline to 12 months postoperative
|
|
Nervous system disorders
Undesired nerve stimulation
|
0.00%
0/14 • Baseline to 12 months postoperative
|
6.7%
1/15 • Baseline to 12 months postoperative
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/14 • Baseline to 12 months postoperative
|
6.7%
1/15 • Baseline to 12 months postoperative
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.00%
0/14 • Baseline to 12 months postoperative
|
6.7%
1/15 • Baseline to 12 months postoperative
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract infection
|
7.1%
1/14 • Baseline to 12 months postoperative
|
13.3%
2/15 • Baseline to 12 months postoperative
|
|
Skin and subcutaneous tissue disorders
Abscess
|
0.00%
0/14 • Baseline to 12 months postoperative
|
6.7%
1/15 • Baseline to 12 months postoperative
|
|
Skin and subcutaneous tissue disorders
Itching sensation
|
0.00%
0/14 • Baseline to 12 months postoperative
|
6.7%
1/15 • Baseline to 12 months postoperative
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/14 • Baseline to 12 months postoperative
|
6.7%
1/15 • Baseline to 12 months postoperative
|
|
Skin and subcutaneous tissue disorders
Skin inflammation
|
7.1%
1/14 • Baseline to 12 months postoperative
|
0.00%
0/15 • Baseline to 12 months postoperative
|
|
Surgical and medical procedures
Implant pain
|
14.3%
2/14 • Baseline to 12 months postoperative
|
6.7%
1/15 • Baseline to 12 months postoperative
|
|
Surgical and medical procedures
Inadequate pain relief
|
7.1%
1/14 • Baseline to 12 months postoperative
|
0.00%
0/15 • Baseline to 12 months postoperative
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place