Middle East MED-EL Observatory Study (MEMOS)

April 8, 2024 updated by: MED-EL Elektromedizinische Geräte GesmbH

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects of any age and gender who are implanted or will be implanted with a MED-EL CI system.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hearing threshold level
Time Frame: 5 years
Audiometry testing (unaided)
5 years
Quality of hearing - adults
Time Frame: 5 years
Results from the Hearing Implant Sound Quality Index (HISQUI 19)
5 years
Auditory development - children (CAP)
Time Frame: 5 years
Results from the Categories of Auditory Performance (CAP)
5 years
Auditory development - children (SIR)
Time Frame: 5 years
Results from the Speech Intelligibility Rating (SIR)
5 years
Auditory development - children (LEAQ)
Time Frame: 5 years
Results from the LittlEARS Auditory Questionnaire (LEAQ)
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MED-EL Elektromedizinische Geräte GesmbH

Investigators

  • Principal Investigator: Abdulrahman Ahmed Alsanosi, Prof., King Abdullah Ear Specialist Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2020

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

March 1, 2019

First Submitted That Met QC Criteria

March 19, 2019

First Posted (Actual)

March 20, 2019

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MED-EL_CRD_2018_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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