N/A
N=29
Cochlear Implant With Dexamethasone Eluting Electrode Array
Sensorineural Hearing Loss · Bilateral Hearing Loss
Bottom Line
View on ClinicalTrials.gov: NCT04750642 ↗Enrolled (actual)
29
Serious AEs
17.2%
Results posted
Apr 2025
Primary outcome: Primary: Comparison of Monopolar (MP1+2) Impedance Measurement (kOhms) Between Randomization Groups at 6 Months Postoperative — 3.99; 8.66 kOhms
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CI632D (Device); CI632 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cochlear
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Monopolar (MP1+2) Impedance Measurement (kOhms) Between Randomization Groups at 6 Months Postoperative |
3.99; 8.66 | — |
| 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 |
39.5 | — |
| SECONDARY Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups |
2; 3; 12; 12; 8; 5 | — |
| SECONDARY 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; 68.0 | — |
| SECONDARY Comparison of Speech Perception Performance (AzBio Sentences in Quiet in Sound Booth Testing) Between Randomization Groups at Six Months Postoperative |
46.1; 55.3 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04750642). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.