Middle East MED-EL Observatory Study

NCT03882229 | Recruiting

• 1 other identifier: MED-EL_CRD_2018_01
• Study Type: observational
• Target: 100
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

Cochlear Implants

Keywords

Registry; Observational Study

Outcome Measures

Primary Outcomes (5)

• Hearing threshold level

  Audiometry testing (unaided)

  5 years

• Quality of hearing - adults

  Results from the Hearing Implant Sound Quality Index (HISQUI 19)

  5 years

• Auditory development - children (CAP)

  Results from the Categories of Auditory Performance (CAP)

  5 years

• Auditory development - children (SIR)

  Results from the Speech Intelligibility Rating (SIR)

  5 years

• Auditory development - children (LEAQ)

  Results from the LittlEARS Auditory Questionnaire (LEAQ)

  5 years

Interventions

MED-EL CI systems DEVICE

• Cochlear Implant (CI) and external audio processor

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Subjects who are implanted or will be implanted with a MED-EL CI system.
• Signed written informed consent for data collection for registry purposes.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MED-EL Elektromedizinische Geräte GesmbH: lead

Study Sites (3)

Hearing and Speech Institute

Cairo, Egypt

RECRUITING

King Abdullah Ear Specialist Center (KAESC)

Riyadh, 11411, Saudi Arabia

RECRUITING

King Saud Medical City

Riyāḑ, 12746, Saudi Arabia

RECRUITING

Study Officials

• Abdulrahman Ahmed Alsanosi, Prof.

  King Abdullah Ear Specialist Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2019
• First Posted: March 20, 2019
• Study Start: February 11, 2020
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

SA (2); EG (1)