RecruitingNCT03882229

Middle East MED-EL Observatory Study


Sponsor

MED-EL Elektromedizinische Geräte GesmbH

Enrollment

100 participants

Start Date

Feb 11, 2020

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This registry study tracks patients in the Middle East who have received or will receive a cochlear implant made by MED-EL, a leading manufacturer of hearing implant systems. A cochlear implant is a surgically placed electronic device that helps people with severe to profound hearing loss by directly stimulating the auditory nerve. This registry collects long-term data on how patients do after the implant, helping researchers and doctors understand outcomes across different populations. Unlike a clinical trial testing a new device, this is an observational registry — participants simply consent to have their health data collected for research purposes. There are no age restrictions, making it open to infants through adults. The main requirement is that you are receiving a MED-EL cochlear implant system and are willing to have your data included. You may be eligible if: - You are being implanted or have already been implanted with a MED-EL cochlear implant system - You are willing to sign a consent form for data collection - You are in the Middle East region You may NOT be eligible if: - You did not end up receiving the MED-EL CI system after consenting, for medical or personal reasons - The investigator feels participation would put you at increased risk Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMED-EL CI systems

• Cochlear Implant (CI) and external audio processor


Locations(3)

Hearing and Speech Institute

Cairo, Egypt

King Abdullah Ear Specialist Center (KAESC)

Riyadh, Saudi Arabia

King Saud Medical City

Riyāḑ, Saudi Arabia

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NCT03882229


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