Web App Fitting Strategy Validation NSR Device Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- WSAUD A/S
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Abbreviated Profile of Hearing Aid Benefit (APHAB)
研究概览
简要总结
To be conducted with adult participants with mild-to-moderate hearing loss to validate the effectiveness of the Web App fitting strategy. Validation measures participant's perceived hearing aid benefit when using the Web App fitted hearing aids and when using standard-of-care fitted hearing aids.
详细描述
A prospective, randomized controlled, adaptive design, non-inferiority, pre-market and NSR device study. Completed in 26 adult subjects with mild-to-moderate hearing loss to validate the effectiveness of a Web App fitting strategy. Validation measured subject´s perceived hearing aid benefit when using the Web App fitted hearing aids and when using standard-of-care fitted hearing aids.
The adaptive study design began with a cross-over design of the first 12 subjects. At the interim analysis, the possibility of an interaction effect was evaluated as a nuisance parameter. In the absence of an interaction effect, the study was completed in cross-over design.
The standard-of-care fitted hearing aids were fitted to National Acoustic Laboratories Nonlinear Version 2 (NAL-NL2) prescriptive targets, verified by probe-mic real-ear measures (REM). The null hypothesis (H0) was that subject´s perceived hearing aids benefit using Web App fitted hearing aids is inferior to perceived benefit using standard-of-care fitted hearing aids, and the alternative hypothesis (Ha) was that subject´s perceived hearing aids benefit using Web App fitted hearing aids is non-inferior to that using standard-of-care fitted hearing aids.
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
- Double (Participant, Care Provider)
盲法说明
The masking only done at the final visit.
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
- •Adults 18 years of age or older,
- •Self-perceived mild to moderate hearing impairment,
- •Signed informed consent form (ICF),
- •Fluent in English listening and reading comprehension,
- •With or without prior experience with hearing aids. At least four subjects and maximum 30% of the total number of subjects enrolled in this study will have prior hearing aid experience.
- •Measured audiogram with at least four of the test frequencies 500 Hz, 1000 Hz, 2000 Hz, 3000 Hz, and 4000 Hz within fitting range of Web App fitted hearing aid
排除标准
- •Hearing aids do not fit into the person's ears with any of the offered silicone 'Click Sleeves' instant ear tips.
- •Abnormal conditions:
- •Severe hearing loss or deafness in at least one ear.
- •A steep decline in hearing ability within the last 90 days in one or both ears.
- •Active discharge within the last 90 days.
- •Dizziness.
- •A visible deformity of the ear.
- •Pain, or discomfort in the ear, or significant ear wax accumulation.
- •Audiometric air-bone gap equal to or greater than 15 decibels at 500 hertz Hz, 1,000 Hz, and 2,000 Hz.
结局指标
主要结局
Abbreviated Profile of Hearing Aid Benefit (APHAB)
时间窗: 14-17 Days hearing aid wearing time per fitting type
The APHAB consists of 24 questions across 4 subscales: Ease of Communication (EC), Background Noise (BN), Reverberation (RV), and Aversiveness (AV), assessing hearing difficulties in daily situations reported as percentage of problems (0-100%, 100% = highest number of problems). It evaluates hearing aid (HA) benefit by subtracting the reported % of problems with HA from without HA, yielding scores from 0 (no benefit) to 100 (maximum benefit) in each subscale. The study focuses on the communication subscales (EC, BN, RV) and calculates benefit score differences for each subscale after using A) Web-App-fitted and B) standard-of-care-fitted HAs. The difference-of-benefit scores are compared to non-inferiority margins from Cox\&Alexander (Ear\&Hearing 1995). Differences-in-benefit scores range from -100 to 100, with negative scores indicating greater benefit with Web-App-fitted HAs, 0 indicating identical benefit and higher scores indicating greater benefit with standard-of-care fitting.
次要结局
未报告次要终点