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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMED-EL Elektromedizinische Geräte GesmbH

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Transfer of data of SONATA 2 cochlear implant recipients

    Other intervention

    Data from SONATA 2 cochlear implant recipients is transferred to CASTOR EDC

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Bisyllables recognition score in quiet

Time frame
pre-operative to 5 years post-operative

Secondary outcomes

1

Bisyllables recognition score in noise

Time frame
pre-operative to 5 years post-operative
2

Wearing time

Wearing time in hours of audio processor used together with SONATA 2 cochlear implant

Time frame
up to 5 years post-operative
3

Device parameter

Descriptive summary of which electrode type was used together with a SONATA 2 cochlear implant

Time frame
up to 5 years post-operative
4

Device parameter

Descriptive summary of which audio processor type was used together with a SONATA 2 cochlear implant

Time frame
up to 5 years post-operative

Other outcomes

Sponsors and contacts

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