Actively Recruiting
Middle East MED-EL Observatory Study for Cochlear Implant Users
Led by MED-EL Elektromedizinische Geräte GesmbH · Updated on 2025-08-19
100
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a long-term observational study to collect consistent clinical data from children and adults who have cochlear implants, specifically those with MED-EL CI systems. The goal is to better understand the clinical effectiveness of cochlear implants over time by using standardized measures and procedures across different clinics, which has been a challenge in past research. Participants will receive cochlear implant treatment as part of their usual clinical care without any changes or experimental interventions from the study. The study uses a secure, cloud-based platform to collect anonymized clinical data at regular intervals, facilitating the comparison of hearing and auditory development outcomes over time. During the study, researchers will gather data on hearing thresholds, quality of hearing in adults, and auditory development in children using various assessment tools such as CAP, SIR, and LEAQ over a five-year period. This data collection is non-interventional and follows participants through their standard care, with the aim of monitoring outcomes and observing long-term trends in cochlear implant performance.
CONDITIONS
Brief Title
Middle East MED-EL Observatory Study
Who Can Participate
Eligibility Criteria
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.
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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Varies based on individual implantation timing
Participants receive a MED-EL cochlear implant system and external audio processor.
Duration - Up to 5 years
Participants are observed to assess hearing threshold levels, quality of hearing, and auditory development over 5 years after cochlear implant implementation.
Regular follow-up visits over 5 years
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
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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