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
Study Type
OBSERVATIONAL
Enrollment
200
Data from SONATA 2 cochlear implant recipients is transferred to CASTOR EDC
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario y Politécnico La Fe
Valencia, Spain
Bisyllables recognition score in quiet
Time frame: pre-operative to 5 years post-operative
Bisyllables recognition score in noise
Time frame: pre-operative to 5 years post-operative
Wearing time
Wearing time in hours of audio processor used together with SONATA 2 cochlear implant
Time frame: up to 5 years post-operative
Device parameter
Descriptive summary of which electrode type was used together with a SONATA 2 cochlear implant
Time frame: up to 5 years post-operative
Device parameter
Descriptive summary of which audio processor type was used together with a SONATA 2 cochlear implant
Time frame: up to 5 years post-operative
Demographic information
descriptive summary of demographics
Time frame: pre-operative
Complications related to the device or procedure
Time frame: up to 5 years post-operative
Questionnaire scores
Hearing Implant Sound Quality Index (HISQUI19). Total score range from 19 to 133 points. The higher the score the better the outcome.
Time frame: pre-operative to 5 years post-operative
Questionnaire scores
Speech, Spatial, and Qualities of Hearing Scale (SSQ). Total score range from 0 to 10 points. The higher the score the better the outcome.
Time frame: pre-operative to 5 years post-operative
Questionnaire scores
LittlEars Auditory Questionnaire (LEAQ). Total score range from 0 to 35 points. The higher the score the better the outcome.
Time frame: pre-operative to 5 years post-operative
Questionnaire scores
Glasgow Benefit Inventory (GBI). Total score range from -100 to +100points. The higher the score the better the outcome.
Time frame: pre-operative to 5 years post-operative
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