Cochlear Implantation, Sensorineural Hearing Loss
Conditions
Keywords
retrospective data collection
Brief 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.
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
OTHERTransfer of data of SONATA 2 cochlear implant recipients
Data from SONATA 2 cochlear implant recipients is transferred to CASTOR EDC
Sponsors
MED-EL Elektromedizinische Geräte GesmbH
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bisyllables recognition score in quiet | pre-operative to 5 years post-operative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bisyllables recognition score in noise | pre-operative to 5 years post-operative | — |
| Wearing time | up to 5 years post-operative | Wearing time in hours of audio processor used together with SONATA 2 cochlear implant |
| Device parameter | up to 5 years post-operative | Descriptive summary of which electrode type was used together with a SONATA 2 cochlear implant |
| Demographic information | pre-operative | descriptive summary of demographics |
| Complications related to the device or procedure | up to 5 years post-operative | — |
| Questionnaire scores | pre-operative to 5 years post-operative | Hearing Implant Sound Quality Index (HISQUI19). Total score range from 19 to 133 points. The higher the score the better the outcome. |
Countries
Spain
Contacts
CONTACTJasmine Rinnofner
Outcome results
None listed