Middle East MED-EL Observatory Study

Recruiting

• Conditions: Cochlear Implants

• Registration Number: NCT03882229
• Lead Sponsor: MED-EL Elektromedizinische Geräte GesmbH

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-01
• Study First Submitted QC: 2019-03-19
• Study First Posted: 2019-03-20
• Study Start: 2020-02-11
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-20
• Primary Completion: 2030-01
• Study Completion: 2030-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (3)

Hearing and Speech Institute; 🇪🇬 Cairo, Egypt

King Abdullah Ear Specialist Center (KAESC); 🇸🇦 Riyadh, Saudi Arabia

King Saud Medical City; 🇸🇦 Riyad, Saudi Arabia