NCT05265260已完成不适用
Barriers to Early Progress in Cochlear Implant Outcomes: a Non-interventional Feasibility Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cochlear
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Score of the French MBAA2 Sentence Recognition Test in Quiet
研究概览
简要总结
The aim of this study is to understand how audiometric, cognitive and electrophysiological results relate to sentence recognition score in adults using currently a Nucleus cochlear implant.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects, 18 years or older
- •Subjects unilaterally implanted or bilaterally implanted with at least 6 months separating the two cochlear implantations.
- •Subjects who have been implanted between January 2016 and December
- •Subjects have received a Nucleus CI: CI512, CI522 or CI532 cochlear implants with non-rotating magnet, or CI600 series equivalent CI612, CI622 and CI632 with rotating magnet and external sound processors CP900 or CP1000 behind-the-ear, or Kanso or Kanso 2 off-the-ear types.
- •Subjects who are fluent in French (language used in the questionnaire and speech tests)
- •Subjects who are not opposed to participating in the study
- •Subjects for who the medical record data is available throughout the defined data search period.
排除标准
- •Subjects with single-sided deafness (SSD).
- •Subjects who are not affiliated to the French Social Security.
- •Subjects who are under legal protection.
结局指标
主要结局
Score of the French MBAA2 Sentence Recognition Test in Quiet
时间窗: 1 month post activation
Participants are classified in good or poor performer based on the score of the French MBAA2 sentence recognition test. A good performer has a score of ≥90/100 correct sentence. A bad performer has a score of \<90/100 correct sentence.
次要结局
未报告次要终点
研究者
研究点 (1)
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