Retrospectively Investigating Longitudinal Outcomes in MED-EL SONATA 2 Cochlear Implant Recipients.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transfer of data of SONATA 2 cochlear implant recipients.
- Who it may be relevant to
- Registry conditions: Cochlear Implant, SONATA 2, Cochlear Implantation. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Longitudinal Outcomes of SONATA 2 Cochlear Implant Recipients: a Retrospective Study
Overview
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.
Detailed description
Data from SONATA 2 CI recipients will be transferred to predefined fields in an electronic data capture system (CASTOR EDC) by the investigators. The data transfer starts after the approval of the Ethics Committees (EC). Data will be included for all subjects who meet the inclusion/exclusion criteria
Interventions
- Other Transfer of data of SONATA 2 cochlear implant recipients
Data from SONATA 2 cochlear implant recipients is transferred to CASTOR EDC
Primary outcome measures
- Bisyllables recognition score in quiet [Time frame: pre-operative to 5 years post-operative]
Secondary outcome measures (10)
- Bisyllables recognition score in noise [Time frame: pre-operative to 5 years post-operative]
- Wearing time [Time frame: up to 5 years post-operative]
- Hardware and device parameters [Time frame: up to 5 years post-operative]
- Demographic information [Time frame: pre-operative]
- Complications related to the device or procedure [Time frame: up to 5 years post-operative]
- Questionnaire scores [Time frame: pre-operative to 5 years post-operative]
- Questionnaire scores [Time frame: pre-operative to 5 years post-operative]
- Questionnaire scores [Time frame: pre-operative to 5 years post-operative]
- Questionnaire scores [Time frame: pre-operative to 5 years post-operative]
- Questionnaire scores [Time frame: pre-operative to 5 years post-operative]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 2 centers
- Hospital Universitario La Paz — Madrid
- Hospital Universitario y Politécnico La Fe — Valencia
Identifiers
NCT: NCT07697911 · MED-EL_CRD_2025_01