Middle East MED-EL Observatory Study

MED-EL Elektromedizinische Geräte GesmbH100 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

100

Conditions

Cochlear Implants

Interventions

MED-EL CI systemsDEVICE

• Cochlear Implant (CI) and external audio processor

Eligibility

Medical Language ↔ Plain English

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.

Locations (3)

Hearing and Speech Institute

Cairo, Egypt

RECRUITING

King Abdullah Ear Specialist Center (KAESC)

Riyadh, Saudi Arabia

RECRUITING

King Saud Medical City

Riyāḑ, Saudi Arabia

RECRUITING

Outcomes

Primary Outcomes

Hearing threshold level

Audiometry testing (unaided)

Time frame: 5 years

Quality of hearing - adults

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

Time frame: 5 years

Auditory development - children (CAP)

Results from the Categories of Auditory Performance (CAP)

Time frame: 5 years

Auditory development - children (SIR)

Results from the Speech Intelligibility Rating (SIR)

Time frame: 5 years

Auditory development - children (LEAQ)

Results from the LittlEARS Auditory Questionnaire (LEAQ)

Time frame: 5 years