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NOT YET RECRUITING
NCT07697911

Retrospectively Investigating Longitudinal Outcomes in MED-EL SONATA 2 Cochlear Implant Recipients.

Sponsor: MED-EL Elektromedizinische Geräte GesmbH

View on ClinicalTrials.gov

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

OTHER

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