Actively Recruiting

All Genders
NCT03882229

Middle East MED-EL Observatory Study

Led by MED-EL Elektromedizinische Geräte GesmbH · Updated on 2025-08-19

100

Participants Needed

3

Research Sites

516 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Middle East MED-EL Observatory Study

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects who are implanted or will be implanted with a MED-EL CI system.
  • Signed written informed consent for data collection for registry purposes.
Not Eligible

You will not qualify if you...

  • Lack of compliance with any inclusion criteria.
  • Subjects not receiving a MED-EL CI system due to medical or personal reasons after having consented.
  • Anything that, in the opinion of the Investigator, would place the subject at increased risk or preclude full compliance or completion of registry procedures.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 3 locations

1

Hearing and Speech Institute

Cairo, Egypt

Actively Recruiting

2

King Abdullah Ear Specialist Center (KAESC)

Riyadh, Saudi Arabia, 11411

Actively Recruiting

3

King Saud Medical City

Riyāḑ, Saudi Arabia, 12746

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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