Bilateral Hearing Loss, Sensorineural Hearing Loss
Conditions
Keywords
Cochlear Implant, Dexamethasone, Bilateral Hearing Loss, Sensorineural Hearing Loss
Brief summary
An evaluation of Cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.
Detailed description
The primary objectives of the pivotal evaluation is to show the efficacy of the dexamethasone eluting electrode through reduction in electrode impedances as compared to a standard electrode and the improvement of speech recognition from preoperative baseline. The secondary objectives are to assess the benefit-risk balance of a dexamethasone eluting electrode as similar to a standard electrode by comparison of adverse events and speech outcomes.
Interventions
Sponsors
NAMSA
Avania
Vanderbilt University
Cochlear
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Post-lingual, bilateral, moderate (≥ 40 dB HL) to profound sensorineural hearing loss at 250, 500and 1000 Hz and profound high-frequency hearing loss, defined by a pure-tone average (PTA) threshold, 2000 through 8000 Hz, ≥ 90 dB HL. * 18 years or older at time of consent.
Exclusion criteria
* Abnormal cochlear and middle ear anatomy * History with cochlear implant surgery * Allergy to dexamethasone * Women who are pregnant or plan to become pregnant * Unable/unwilling to comply to study requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Monopolar (MP1+2) Impedance Measurement (kOhms) Between Randomization Groups at 6 Months Postoperative | Six months postoperative | 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. |
| 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 | Six months postoperative | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups | Twelve months postoperative | Adverse events were recorded from baseline to 12 months postoperative. |
| Comparison of Speech Perception Performance (Pre-recorded CNC Words in Quiet in Sound Booth Testing) Between the Randomization Groups at Six Months Postoperative | Six months postoperative | 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. |
| Comparison of Speech Perception Performance (AzBio Sentences in Quiet in Sound Booth Testing) Between Randomization Groups at Six Months Postoperative | Six months postoperative | 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. |
Countries
Australia, New Zealand, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CI632D Investigational Medical Device (IMD) CI632D: CI632 cochlear implant with Slim Modiolar electrode including dexamethasone in the electrode within wells (CI632D) | 14 |
| CI632 Comparator Device CI632: CI632 cochlear implant with Slim Modiolar electrode with market approval and does not include dexamethasone | 15 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | CI632D Investigational Medical Device (IMD) | CI632 Comparator Device | Total |
|---|---|---|---|
| Age, Continuous | 71.6 years STANDARD_DEVIATION 8.5 | 66.3 years STANDARD_DEVIATION 17.1 | 68.9 years STANDARD_DEVIATION 13.6 |
| Race/Ethnicity, Customized Croatian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized French Indian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Maori/European | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 12 Participants | 14 Participants | 26 Participants |
| Region of Enrollment Australia | 2 participants | 3 participants | 5 participants |
| Region of Enrollment New Zealand | 1 participants | 1 participants | 2 participants |
| Region of Enrollment United States | 11 participants | 11 participants | 22 participants |
| Sex: Female, Male Female | 8 Participants | 7 Participants | 15 Participants |
| Sex: Female, Male Male | 6 Participants | 8 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 15 |
| other Total, other adverse events | 9 / 14 | 10 / 15 |
| serious Total, serious adverse events | 3 / 14 | 2 / 15 |
Outcome results
Primary
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
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.
Time frame: Six months postoperative
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CI632D Investigational Medical Device (IMD) | 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 |
Primary
Comparison of Monopolar (MP1+2) Impedance Measurement (kOhms) Between Randomization Groups at 6 Months Postoperative
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.
Time frame: Six months postoperative
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CI632D Investigational Medical Device (IMD) | Comparison of Monopolar (MP1+2) Impedance Measurement (kOhms) Between Randomization Groups at 6 Months Postoperative | 3.99 kOhms | Standard Deviation 0.54 |
| CI632 Comparator Device | Comparison of Monopolar (MP1+2) Impedance Measurement (kOhms) Between Randomization Groups at 6 Months Postoperative | 8.66 kOhms | Standard Deviation 1.45 |
Secondary
Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups
Adverse events were recorded from baseline to 12 months postoperative.
Time frame: Twelve months postoperative
Population: Intent-to-treat group at 12 months. This is the number of participants who were randomized.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CI632D Investigational Medical Device (IMD) | Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups | Procedure related | 7 Participants |
| CI632D Investigational Medical Device (IMD) | Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups | One or more unanticipated adverse device effects (ADEs) | 0 Participants |
| CI632D Investigational Medical Device (IMD) | Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups | One or more related (possibly, probably, definitely) AEs | 8 Participants |
| CI632D Investigational Medical Device (IMD) | Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups | One or more serious AEs | 3 Participants |
| CI632D Investigational Medical Device (IMD) | Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups | Device related | 5 Participants |
| CI632D Investigational Medical Device (IMD) | Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups | One or more serious ADEs (SADEs) | 1 Participants |
| CI632D Investigational Medical Device (IMD) | Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups | One or more AEs | 12 Participants |
| CI632D Investigational Medical Device (IMD) | Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups | One or more serious unanticipated ADEs (USADEs) | 0 Participants |
| CI632D Investigational Medical Device (IMD) | Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups | Study drug related | 1 Participants |
| CI632D Investigational Medical Device (IMD) | Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups | Discontinuation due to an AE | 1 Participants |
| CI632D Investigational Medical Device (IMD) | Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups | No adverse events | 2 Participants |
| CI632 Comparator Device | Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups | Discontinuation due to an AE | 0 Participants |
| CI632 Comparator Device | Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups | No adverse events | 3 Participants |
| CI632 Comparator Device | Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups | One or more AEs | 12 Participants |
| CI632 Comparator Device | Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups | One or more related (possibly, probably, definitely) AEs | 5 Participants |
| CI632 Comparator Device | Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups | Procedure related | 4 Participants |
| CI632 Comparator Device | Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups | Device related | 3 Participants |
| CI632 Comparator Device | Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups | Study drug related | 2 Participants |
| CI632 Comparator Device | Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups | One or more unanticipated adverse device effects (ADEs) | 0 Participants |
| CI632 Comparator Device | Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups | One or more serious AEs | 2 Participants |
| CI632 Comparator Device | Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups | One or more serious ADEs (SADEs) | 0 Participants |
| CI632 Comparator Device | Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups | One or more serious unanticipated ADEs (USADEs) | 0 Participants |
Secondary
Comparison of Speech Perception Performance (AzBio Sentences in Quiet in Sound Booth Testing) Between Randomization Groups at Six Months Postoperative
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.
Time frame: Six months postoperative
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CI632D Investigational Medical Device (IMD) | 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 |
| CI632 Comparator Device | Comparison of Speech Perception Performance (AzBio Sentences in Quiet in Sound Booth Testing) Between Randomization Groups at Six Months Postoperative | 55.3 percentage correct | Standard Deviation 31.8 |
Secondary
Comparison of Speech Perception Performance (Pre-recorded CNC Words in Quiet in Sound Booth Testing) Between the Randomization Groups at Six Months Postoperative
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.
Time frame: Six months postoperative
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CI632D Investigational Medical Device (IMD) | 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 |
| CI632 Comparator Device | Comparison of Speech Perception Performance (Pre-recorded CNC Words in Quiet in Sound Booth Testing) Between the Randomization Groups at Six Months Postoperative | 68.0 percentage points | Standard Deviation 23.9 |