Longitudinal Outcomes of SONATA 2 Cochlear Implant Recipients: a Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Bisyllables recognition score in quiet
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least one MED-EL SONATA 2 cochlear implant with a compatible MED-EL audio processor
排除标准
- •Lack of compliance with any inclusion criteria
结局指标
主要结局
Bisyllables recognition score in quiet
时间窗: pre-operative to 5 years post-operative
次要结局
- Bisyllables recognition score in noise(pre-operative to 5 years post-operative)
- Wearing time(up to 5 years post-operative)
- Hardware and device parameters(up to 5 years post-operative)
- Complications related to the device or procedure(up to 5 years post-operative)
- Questionnaire scores(pre-operative to 5 years post-operative)
- Demographic information(pre-operative)
- Device parameter(up to 5 years post-operative)