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

Condition(s) studied

Investigational drug(s) / intervention(s)

Transfer of data of SONATA 2 cochlear implant recipients: Data from SONATA 2 cochlear implant recipients is transferred to CASTOR EDC

Study 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

Primary outcome measure(s)

• Bisyllables recognition score in quiet — pre-operative to 5 years post-operative

Trial sites (2)