Self Fitting Hearing Aid Clinical Investigation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- 1. Perceived hearing aid benefit- Abbreviated Profile of Hearing Aid Benefit (APHAB)
研究概览
简要总结
Pre-market Clinical Investigation whose primary purpose is to evaluate efficacy and effectiveness of self-fitting hearing aids
详细描述
The purpose of this study is to evaluate the outcomes of hearing aids with patient-driven fitting (PD) and clinician-driven fitting (CD). The participants will be 40 adults with mild to moderate symmetrical hearing loss. For each hearing aid fitting strategy, the participant will wear the hearing aids for 10 days. Lab and field outcomes will be measured. This study will determine if perceived hearing benefit and speech recognition performance with the PD fitting method is non-inferior to that with the CD fitting method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
盲法说明
participant is not told which fitting method they have been assigned to
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Native English speakers
- •Ability to complete questionnaires and laboratory assessments
- •Symmetric, mild to moderate sensorineural hearing loss
- •Informed consent completed with signature
- •Healthy outer ear/middle ear status
- •Limited hearing aid use (non-owners of hearing aids)
- •Exclusion criteria:
- •Inability to visit the Starkey Headquarters building for testing
- •Central or middle ear hearing pathology
- •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
- •Hearing loss outside of the specified criteria (Mild to Moderate Sensorineural hearing loss)
排除标准
- 未提供
结局指标
主要结局
1. Perceived hearing aid benefit- Abbreviated Profile of Hearing Aid Benefit (APHAB)
时间窗: The timeframe for this data collection will be unaided, and 14 days post-fitting.
This data will be collected through the APHAB (Abbreviated Profile of Hearing Aid Benefit). This is a 24-item survey of hearing aid benefit. This test will be administered in the unaided hearing aid condition, and in both the traditional and new fitting method conditions. Scores report the reduction in reported problems, and a higher score shows a larger reduction in problems in one condition than the other.
次要结局
- 1. Speech intelligibility - Quick Speech in Noise Test (QuickSIN)(Timeframe for this data collection will be unaided, and 14-days post-fitting.)