Middle East MED-EL Observatory Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MED-EL CI systems.
- Who it may be relevant to
- Registry conditions: Cochlear Implants. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt, Saudi Arabia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device MED-EL CI systems
• Cochlear Implant (CI) and external audio processor
Primary outcome measures
- Hearing threshold level [Time frame: 5 years]
- Quality of hearing - adults [Time frame: 5 years]
- Auditory development - children (CAP) [Time frame: 5 years]
- Auditory development - children (SIR) [Time frame: 5 years]
- Auditory development - children (LEAQ) [Time frame: 5 years]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Saudi Arabia · 2 centers
- King Abdullah Ear Specialist Center (KAESC) — Riyadh
- King Saud Medical City — Riyāḑ
Egypt · 1 center
- Hearing and Speech Institute — Cairo
Identifiers
NCT: NCT03882229 · MED-EL_CRD_2018_01