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MED-EL Cochlear Implants (CI) provide auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing-impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition.
However, there is only few evidence from large long-term observational studies available to gain knowledge on clinical effectiveness of cochlear implants. With continued pressure on healthcare system budgets, there is an increasing demand for evidence-based research that demonstrates an intervention is effective in the real-world environment across large and diverse populations. Currently, there is a paucity of data concerning the long-term outcomes of subjects implanted with a SONATA 2 cochlear implant from representative samples of the population. This retrospective study aims at analyzing SONATA 2 cochlear implant data from clinical routine.
Data from SONATA 2 CI recipients will be transferred to predefined fields in an electronic data capture system (CASTOR EDC) by the investigators. The data transfer starts after the approval of the Ethics Committees (EC). Data will be included for all subjects who meet the inclusion/exclusion criteria
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transfer of data of SONATA 2 cochlear implant recipients | Other | Data from SONATA 2 cochlear implant recipients is transferred to CASTOR EDC |
| Measure | Description | Time Frame |
|---|---|---|
| Bisyllables recognition score in quiet | pre-operative to 5 years post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Bisyllables recognition score in noise | pre-operative to 5 years post-operative | |
| Wearing time | Wearing time in hours of audio processor used together with SONATA 2 cochlear implant | up to 5 years post-operative |
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Inclusion Criteria:
Exclusion Criteria:
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In this retrospective observational study, the inclusion and exclusion criteria encompass all individuals with a SONATA 2 cochlear implant at the study centers. By including all individuals with a SONATA 2 cochlear implant from the study centers, the investigation population is representative of the target population. The investigation population is representative of "real-world" users of SONATA 2 cochlear implant.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jasmine Rinnofner | Contact | +43577881694 | jasmine.rinnofner@medel.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
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| Hardware and device parameters | Descriptive summary of which electrode type and audio processor type was used together with a SONATA 2 cochlear implant | up to 5 years post-operative |
| Demographic information | descriptive summary of age at implantation, date of implantation, gender, type and duration of hearing loss, indications | pre-operative |
| Complications related to the device or procedure | up to 5 years post-operative |
| Questionnaire scores | Hearing Implant Sound Quality Index (HISQUI19) | pre-operative to 5 years post-operative |
| Questionnaire scores | Speech, Spatial, and Qualities of Hearing Scale (SSQ) | pre-operative to 5 years post-operative |
| Questionnaire scores | Nijmegen Cochlear Implant Questionnaire (NCIQ), LittlEars Auditory Questionnaire (LEAQ), Glasgow Benefit Inventory (GBI) | pre-operative to 5 years post-operative |
| Questionnaire scores | LittlEars Auditory Questionnaire (LEAQ) | pre-operative to 5 years post-operative |
| Questionnaire scores | Glasgow Benefit Inventory (GBI) | pre-operative to 5 years post-operative |
| Hospital Universitario y Politécnico La Fe | Valencia | 46026 | Spain |
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