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Retrospectively Investigating Longitudinal Outcomes in MED-EL SONATA 2 Cochlear Implant Recipients.
Sponsor: MED-EL Elektromedizinische Geräte GesmbH
Summary
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.
Official title: Longitudinal Outcomes of SONATA 2 Cochlear Implant Recipients: a Retrospective Study
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
200
Start Date
2026-09
Completion Date
2027-05
Last Updated
2026-07-13
Healthy Volunteers
No
Interventions
Transfer of data of SONATA 2 cochlear implant recipients
Data from SONATA 2 cochlear implant recipients is transferred to CASTOR EDC
Locations (2)
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario y Politécnico La Fe
Valencia, Spain