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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MED-EL CI systems | Device | • Cochlear Implant (CI) and external audio processor |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects of any age and gender who are implanted or will be implanted with a MED-EL CI system.
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| Name | Affiliation | Role |
|---|---|---|
| Abdulrahman Ahmed Alsanosi, Prof. | King Abdullah Ear Specialist Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hearing and Speech Institute | Recruiting | Cairo | Egypt |
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| King Abdullah Ear Specialist Center (KAESC) | Recruiting | Riyadh | 11411 | Saudi Arabia |
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| King Saud Medical City | Recruiting | Riyāḑ | 12746 | Saudi Arabia |
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