Validating a Self-fitting Hearing Aid
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Abbreviated profile of hearing aid benefit
研究概览
简要总结
Eargo, Inc. has developed a hearing aid that contains self-fitting gain software that allows adults with mild-to-moderate hearing loss to test their hearing sensitivity and program hearing aids to match their measured hearing loss. Traditionally, hearing aids are custom programmed by a hearing health professional based on a professional hearing test. This technology has the potential to improve affordability and accessibility of hearing aids for adults with mild-to-moderate hearing loss. We propose to validate Eargo's self-fitting software in a clinical trial comparing self-fitting hearing aid outcomes to the same hearing aid fit by a professional following usual clinical best practice for fitting hearing aids.
详细描述
The study will recruit 30-50 adults age 18 and over with mild-to-moderate hearing loss in both ears. We will aim to recruit a sample with roughly equal number of males and females and new and experienced hearing aid users (defined by any hearing aid use within the previous 6 months). Hearing loss will be measured using the results of a standard clinical hearing test.
We will use a within-subject, crossover design in which all participants will complete both field trial hearing aid conditions (self-fit and clinically fit hearing aids). The order of the field trials will be randomized across participants to account for any potential order effects. After each field trial, participants will visit the lab to complete study outcome measures, including hearing aid benefit, subjective sound quality, and speech in noise intelligibility testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
盲法说明
Participants will be randomly assigned and will not know which fit is first.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mild to moderate hearing loss ability to follow written directions,
排除标准
- •inability to use software during first visit
研究组 & 干预措施
audiologist arm
A research audiologist will fit the participant with the hearing devices according to usual clinical best practice procedures.
干预措施: Fitting algorithm (Other)
self-fit arm
Participants will follow manufacturer's printed instructions to complete the self-hearing test using the hearing aids and a provided app to program their hearing aids.
干预措施: Fitting algorithm (Other)
结局指标
主要结局
Abbreviated profile of hearing aid benefit
时间窗: 2-3 weeks
Survey of subjective benefit
Speech in noise test, AZ Bio sentences
时间窗: Immediately after fitting
Sentence recognition test in background noise
次要结局
- Subjective sound quality rating(2-3 weeks)