Baseline Performance and Fitting Parameters for Sonova Products
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Speech performance in noise
研究概览
简要总结
The purpose of this study is to assess the effectiveness and optimization of various FDA approved products.
详细描述
This study uses a prospective within-subjects repeated-measures design in which each subject serves as her/his own control. The purpose of this study is to assess the effectiveness and optimization of various FDA approved hardware, signal preprocessing and processing software, fitting characteristics, and service delivery methods, such as remote support and/or tele-audiology on an expanded subject demographic. The insights gained from this study will be used to optimize listening configuration recommendations, refine audiological practice, and inform future innovations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide Informed Consent/Assent
- •Adults (age +18 years) and children (8-17 years) can be enrolled in this study
- •If child is aged 8-17 years, an assent will be completed, and the subject must be accompanied by a parent or legal guardian for all study activities
- •Have the functional capability to operate the controls for the device and to comply with all directions during the study as determined by the investigator conducting the consent/baseline visit
- •English language proficiency as determined by the investigator
排除标准
- •Have any significant medical condition that, in the opinion of any of the investigators, is likely to interfere with study procedures or likely to confound evaluation of study endpoints
结局指标
主要结局
Speech performance in noise
时间窗: 1 day
The primary efficacy endpoint is recorded AzBio sentences presented from a single loud speaker at 60 dBA. The recognition scores using the pinna-located microphone in quiet and noise captured at initial visit will be compared to the AzBio sentence recognition scores using the pinna-simulated microphone. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.
次要结局
- Localization performance(1 day)
- Analysis of usability and preference questionnaire(8 weeks)