About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At least one MED-EL SONATA 2 cochlear implant with a compatible MED-EL audio processor
Disqualifiers
Lack of compliance with any inclusion criteria
Trial population
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.
Trial design
Cohort
Retrospective
Treatments tested in this trial
Transfer of data of SONATA 2 cochlear implant recipients
Other interventionData from SONATA 2 cochlear implant recipients is transferred to CASTOR EDC
Treatment groups
Trial outcomes
Primary outcomes
Bisyllables recognition score in quiet
Secondary outcomes
Bisyllables recognition score in noise
Wearing time
Wearing time in hours of audio processor used together with SONATA 2 cochlear implant
Device parameter
Descriptive summary of which electrode type was used together with a SONATA 2 cochlear implant
Device parameter
Descriptive summary of which audio processor type was used together with a SONATA 2 cochlear implant
Sponsors and contacts
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