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
- 1
- 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
研究组 & 干预措施
No intervention
Participants will return to their original unaided state.
Amplification with added sound
Hearing aid will be fit to prescribed participant hearing loss and an added sound will be activated on the hearing aid.
干预措施: hearing aid amplification with an added sound (Device)
Amplification-only
Hearing aid will be fit to prescribed participant hearing loss.
干预措施: hearing aid amplification (Device)
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