Observational registry for cochlear implant patients in the Middle East
Middle East MED-EL Observatory Study
This study collects long-term information on how well MED-EL cochlear implants work for children and adults in the Middle East to improve understanding of their effectiveness.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | MED-EL Elektromedizinische Geräte GesmbH Industry-sponsored |
| Locations | 3 sites (Cairo and 2 other locations) |
| Trial ID | NCT03882229 on ClinicalTrials.gov |
What this trial studies
This observational registry collects long-term clinical data on the effectiveness of MED-EL cochlear implants in children and adults. It aims to address the lack of comprehensive data in cochlear implant research by systematically gathering anonymized data from various clinics. The study utilizes a secure cloud-based platform to ensure consistent data collection at regular intervals, allowing for longitudinal comparisons over time. Participants will receive treatment according to standard clinical practices while their data is collected for registry purposes.
Who should consider this trial
Good fit: Ideal candidates include individuals who are currently implanted or will be implanted with a MED-EL cochlear implant system.
Not a fit: Patients who are not receiving a MED-EL cochlear implant system or those unable to comply with the study requirements may not benefit.
Why it matters
Potential benefit: If successful, this registry could enhance understanding of cochlear implant effectiveness and improve patient outcomes.
How similar studies have performed: Other observational studies in cochlear implant research have shown success in gathering valuable data, making this approach a continuation of established methodologies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects who are implanted or will be implanted with a MED-EL CI system. * Signed written informed consent for data collection for registry purposes. Exclusion Criteria: * 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 the subject's full compliance with or completion of the registry procedures.
Where this trial is running
Cairo and 2 other locations
- Hearing and Speech Institute — Cairo, Egypt (Recruiting)
- King Abdullah Ear Specialist Center (KAESC) — Riyadh, Saudi Arabia (Recruiting)
- King Saud Medical City — Riyāḑ, Saudi Arabia (Recruiting)
Study contacts
- Principal investigator: Abdulrahman Ahmed Alsanosi, Prof. — King Abdullah Ear Specialist Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.