NCT03882229

Middle East MED-EL Observatory Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: MED-EL Elektromedizinische Geräte GesmbH · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

In the field of cochlear implant research, there are only few data on long-term observational studies available to gain knowledge on clinical effectiveness. Longitudinal comparisons of data collected in different clinics is challenging due to the heterogeneity in measures and procedure. This Registry represents a non-interventional systematic collection of clinical data in which prospective data from children and adults are collected as anonymized data sets, derived from original clinical records on appropriately informed subjects. Each subject will be treated as per clinical routine. The Registry will be implemented through a secure, cloud-based, platform that enables collection of anonymized data at consistent time intervals, thus enabling the comparison of repeated measures over time.

Conditions

• Cochlear Implants

Interventions

Type	Name	Description
DEVICE	MED-EL CI systems	• Cochlear Implant (CI) and external audio processor

Timeline

• Start date: 2020-02-11
• Primary completion: 2030-01-01
• Completion: 2030-01-01
• First posted: 2019-03-20
• Last updated: 2025-08-19

Locations

3 sites across 2 countries: Egypt, Saudi Arabia