Trials / Not Yet Recruiting
Not Yet RecruitingNCT07338864
A Study to Evaluate Clinical Benefit, Performance and Safety of Cochlear Implants in Adults
A Post-market, Prospective, Observational Study to Evaluate Clinical Benefit, Performance and Safety of Cochlear™ Implants in an Adult Population: a Master Umbrella Investigation
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 66 (estimated)
- Sponsor
- Cochlear · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this clinical investigation is to demonstrate the performance, clinical benefit and safety of commercial cochlear implant systems. Speech performance and subjective hearing results, and comparison with cochlear implant results available in literature, is intended to demonstrate the performance and clinical benefit of the cochlear implant systems investigated in this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Cochlear Nucleus Nexa Cochlear implant (CI1032) | Participants will be implanted with a CI1032 cochlear implant as determined by the treating clinician |
| DEVICE | Cochlear Nucleus Nexa Cochlear implant (CI1022) | Participants will be implanted with a CI1022 cochlear implant as determined by the treating clinician |
| DEVICE | Cochlear Nucleus Nexa Cochlear implant (CI1012) | Participants will be implanted with a CI1012 cochlear implant as determined by the treating clinician |
Timeline
- Start date
- 2026-05-01
- Primary completion
- 2028-05-01
- Completion
- 2028-09-01
- First posted
- 2026-01-14
- Last updated
- 2026-04-02
Locations
1 site across 1 country: Germany
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07338864. Inclusion in this directory is not an endorsement.