Middle East MED-EL Observatory Study

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.

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Key information

Conditions

Cochlear Implants

Sex eligibility

All sexes

Study type

Observational

Primary location

Hearing and Speech Institute, Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MED-EL CI systems

Device

Cochlear Implant (CI) and external audio processor

Primary outcomes

Hearing threshold level

Time frame: 5 years

Audiometry testing (unaided)
Quality of hearing - adults

Time frame: 5 years

Results from the Hearing Implant Sound Quality Index (HISQUI 19)
Auditory development - children (CAP)

Time frame: 5 years

Results from the Categories of Auditory Performance (CAP)
Auditory development - children (SIR)

Time frame: 5 years

Results from the Speech Intelligibility Rating (SIR)
Auditory development - children (LEAQ)

Time frame: 5 years

Results from the LittlEARS Auditory Questionnaire (LEAQ)

Sponsors and collaborators

Lead sponsor

MED-EL Elektromedizinische Geräte GesmbH

Industry

Registry information

Acronym: MEMOS

Important dates

Study start: 2020
Primary completion: 2030
Study completion: 2030
First posted: Mar 20, 2019
Registry last updated: Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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