Middle East MED-EL Observatory Study (MEMOS)

MED-EL

Status: Enrolling

Conditions: Cochlear Implants

Treatments: Device: MED-EL CI systems

Study type: Observational

Funder types: Industry

Identifiers

NCT03882229

MED-EL_CRD_2018_01

Details and patient eligibility

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.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.