Trials / Active Not Recruiting
Active Not RecruitingNCT06424262
Performance and Hearing-related Outcomes in Adults Implanted With the CI622D Dexamethasone-eluting Cochlear Implant Compared to Those Implanted With a Standard Cochlear Implant (CI622)
A Pivotal, Prospective, Multi-centre, Randomised Controlled, 6-month Blinded Investigation Followed by a 6-month Open-label Phase Evaluating the Efficacy of a Dexamethasone Eluting Slim Straight Electrode (CI622D) in the Reduction of Impedance as Compared to a Standard Slim Straight Electrode (CI622) in a Newly Implanted Adult Population With Post-linguistic, Bilateral, Moderately Severe to Profound Sensorineural Hearing Loss.
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- Sponsor
- Cochlear · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This clinical study will test a newly developed cochlear implant known as CI622D. This experimental cochlear implant has been designed to slowly release a drug called dexamethasone. Dexamethasone works to ease inflammation, which is common after any surgical procedure. The goal is to learn if there are added benefits in implant performance and hearing outcomes with the dexamethasone-releasing cochlear implant (CI622D) vs. the standard cochlear implant (CI622) without dexamethasone. The study will be conducted in adults with sensorineural hearing loss, a type of hearing loss caused by damage to the inner ear or auditory nerve. The study participants will undergo a series of tests that include testing their implant and their hearing. They will also complete questionnaires to see how they rate their hearing ability and their overall general health.
Conditions
- Hearing Loss, Bilateral Sensorineural
- Hearing Loss, Sensorineural
- Hearing Loss, Bilateral
- Hearing Loss, Cochlear
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CI622D | A dexamethasone-eluting Slim Straight electrode |
| DEVICE | CI622 | A standard Slim Straight electrode |
Timeline
- Start date
- 2024-06-17
- Primary completion
- 2025-11-05
- Completion
- 2026-05-01
- First posted
- 2024-05-22
- Last updated
- 2026-02-27
Locations
11 sites across 4 countries: Australia, France, Germany, United Kingdom
Source: ClinicalTrials.gov record NCT06424262. Inclusion in this directory is not an endorsement.