Middle East MED-EL Observatory Study

Cochlear Implants Clinical Trial

— MEMOS  

Official title:

Middle East MED-EL Observatory Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03882229
• Other study ID #: MED-EL_CRD_2018_01
• Status: Recruiting
• Start date: February 11, 2020
• Est. completion date: January 2025

Study information

• Verified date: April 2024
• Source: MED-EL Elektromedizinische Geräte GesmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cochlear Implants

Intervention

Device:
• MED-EL CI systems
• Cochlear Implant (CI) and external audio processor

Locations

Country	Name	City	State
Egypt	Hearing and Speech Institute	Cairo
Saudi Arabia	King Saud Medical City	Riyad
Saudi Arabia	King Abdullah Ear Specialist Center (KAESC)	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
MED-EL Elektromedizinische Geräte GesmbH

Countries where clinical trial is conducted

Egypt,  Saudi Arabia, 

Outcome

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