Trials / Completed
CompletedNCT03031678
Electric-Acoustic Stimulation Extended Follow-up Post Approval Study
Office of Device Evaluation Lead-MED-EL EAS Extended f/u Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Med-El Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The MED-EL EAS Extended Follow-up Study is an extended follow-up of the subjects who were enrolled in the pivotal study to assess long-term safety and device performance.
Detailed description
The study will be conducted as a prospective, non-controlled, non-randomized, multicenter study at the 14 sites. Up to 68 available subjects who were enrolled in the pivotal study will be invited to participate in the extended follow-up. Study subjects will be followed for a minimum of 5 years post-implantation of the device.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Electric-Acoustic Stimulation (EAS) Cochlear Implant System | Combination of a cochlear implant and a hearing aid |
Timeline
- Start date
- 2016-12-01
- Primary completion
- 2019-12-01
- Completion
- 2019-12-01
- First posted
- 2017-01-25
- Last updated
- 2020-09-10
- Results posted
- 2020-09-10
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03031678. Inclusion in this directory is not an endorsement.