Middle East MED-EL Observatory Study
ConditionCochlear Implants
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMED-EL Elektromedizinische Geräte GesmbH
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects who are implanted or will be implanted with a MED-EL CI system.
Signed written informed consent for data collection for registry purposes.
Disqualifiers
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.
Trial population
Subjects of any age and gender who are implanted or will be implanted with a MED-EL CI system.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
MED-EL CI systems
Device• Cochlear Implant (CI) and external audio processor
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Hearing threshold level
Audiometry testing (unaided)
Time frame
5 years2
Quality of hearing - adults
Results from the Hearing Implant Sound Quality Index (HISQUI 19)
Time frame
5 years3
Auditory development - children (CAP)
Results from the Categories of Auditory Performance (CAP)
Time frame
5 years4
Auditory development - children (SIR)
Results from the Speech Intelligibility Rating (SIR)
Time frame
5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov