Evaluation of the Clinical Benefit of the Hearing Aids Tinnitus Feature.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sonova AG
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Tinnitus Functional Index Evaluation (TFI)
研究概览
简要总结
Participants with hearing loss and Tinnitus will wear hearing aids with amplification-only or with an added sound, and have their tinnitus level evaluated before and after intervention.
详细描述
2 groups of adults with hearing loss and chronic bothersome tinnitus and no experience with amplification will participate in a cross over intervention study with 2 conditions of 4 weeks each: 1. fit with hearing aid (HA) amplification-only, and 2. fit with HA amplification with an added sound, returning to their original unaided condition after undergoing the intervention phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Hearing loss
- •candidate for hearing aid amplification
- •Bothersome chronic tinnitus (3 months+)
排除标准
- •age less than 18 years
- •normal hearing
- •tinnitus presence for less than 3 months
- •tinnitus not bothersome enough to warrant intervention
- •non hearing aid candidates
结局指标
主要结局
Tinnitus Functional Index Evaluation (TFI)
时间窗: TFI collected before intervention to serve as a baseline. TFI change from baseline will be assessed after each study condition, which will last 4 weeks/each.
Tinnitus Functional Index (TFI) questionnaire results, ranging from 0 to 100, with higher numbers indicating more severe (worse) Tinnitus interference in the person's quality of life.
次要结局
未报告次要终点