Trials / Completed
CompletedNCT03900897
Expanded Indications in the MED-EL Pediatric Cochlear Implant Population
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 247 (actual)
- Sponsor
- Med-El Corporation · Industry
- Sex
- All
- Age
- 7 Months – 5 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this investigation is to demonstrate the safety and effectiveness of MED-EL cochlear implants in children 7 months to 5 years, 11 months of age who fall outside the current FDA-approved candidacy criteria and, yet, continue to demonstrate insufficient functional access to sound with appropriately fit hearing aids and aural habilitation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MED-EL SYNCHRONY PIN Cochlear Implant | Subjects will be implanted with the MED-EL SYNCHRONY PIN Cochlear Implant System with +FLEX24, +FLEX28, +FLEXSOFT electrode arrays. Subjects will be fit with the SONNETEAS (ear-level) and/or RONDO 2 (single-unit) external audio processors. |
| OTHER | Cochlear Implant | Chart review of subjects implanted with a MED-EL cochlear implant under 6 years of age between January 2005 and October 2020. |
Timeline
- Start date
- 2019-06-17
- Primary completion
- 2023-11-01
- Completion
- 2023-11-01
- First posted
- 2019-04-03
- Last updated
- 2024-10-15
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03900897. Inclusion in this directory is not an endorsement.