Speech Intelligibility in Quiet and Noise for New Versus Legacy Hearing Aids
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Speech intelligibility (% words repeated back correctly) in quiet and noise for new vs. legacy hearing aids
研究概览
简要总结
This clinical investigation is designed to compare audiological performance (i.e., measurements of sound quality and speech understanding) between Starkey's new receiver-in-canal device and a commercially available legacy receiver-in-canal device.
详细描述
Starkey is investigating a new hearing aid with several new audiological features. These features have been assessed for benefit, individually, but this clinical investigation will serve as a test for safety and efficacy with all hearing aid features, together. The design of this study is a single-blinded, crossover design and will be conducted at Starkey's headquarters in Eden Prairie, MN.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults, minimum age of 18
- •Native English speakers
- •Ability to complete questionnaires and laboratory assessments
- •Symmetric, mild to moderately-severe sensorineural hearing loss
- •Informed consent completed with signature
排除标准
- •Inability to visit the Starkey Headquarters building for testing
- •Central or middle ear hearing problems
- •Medical contraindications to wearing hearing aids
- •Learning disability, major cognitive handicap, or serious neurological or psychiatric disease that would prevent or restrict participation, as determined by the PI or designee
结局指标
主要结局
Speech intelligibility (% words repeated back correctly) in quiet and noise for new vs. legacy hearing aids
时间窗: Four weeks
IEEE sentences will be presented to the research participants in quiet and in background noise. The percent words repeated back correctly will be scored and serve as the reported result of this outcome measure.
次要结局
- First fit ratings of sound quality on subjective questionnaires for the new vs. legacy hearing aids(Four weeks)
- Safety of the new, receiver-in-canal devices through tracking of adverse events(Four weeks)