Trials / Recruiting
RecruitingNCT04506853
Single-Sided Deafness and Asymmetric Hearing Loss
Single-Sided Deafness and Asymmetric Hearing Loss Post-Approval Study
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 65 (estimated)
- Sponsor
- Med-El Corporation · Industry
- Sex
- All
- Age
- 5 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to evaluate the long-term safety and effectiveness of cochlear implantation of the approved population in adults and children with single-sided deafness and asymmetric hearing loss.
Detailed description
The study will be conducted as a single-subject, repeated measures, multi center study at 6 sites. Sixty-five subjects will be enrolled in this study. Six centers across the United States and Canada will recruit subjects into this study. Study subjects will be followed for a minimum of 3 years post-implantation of the device.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MED-EL Cochlear Implant System | Cochlear implant and audio processor |
Timeline
- Start date
- 2021-02-22
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
- First posted
- 2020-08-10
- Last updated
- 2025-09-24
Locations
6 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04506853. Inclusion in this directory is not an endorsement.