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Not Yet Recruiting NCT07697911

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

Conditions: Cochlear Implant, SONATA 2, Cochlear Implantation

Sex: All
Healthy volunteers: No
Enrollment: 200
Sponsor: MED-EL Elektromedizinische Geräte GesmbH

Location: Hospital Universitario La Paz Madrid

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.

Eligibility Criteria

Inclusion Criteria: * At least one MED-EL SONATA 2 cochlear implant with a compatible MED-EL audio processor Exclusion Criteria: * Lack of compliance with any inclusion criteria

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07697911). StuddyBuddy aggregates publicly available trial information.