Cochlear Implants
Conditions
Keywords
Registry, Observational Study
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.
Interventions
• Cochlear Implant (CI) and external audio processor
Sponsors
Study design
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Egypt, Saudi Arabia
Contacts
King Abdullah Ear Specialist Center