Pediatric Performance and Satisfaction of Oticon Medical Ponto on Softband.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Total GCBI Score
研究概览
简要总结
The study is a non-interventional, observational, study on users of Ponto sound processors who use their sound processors on a softband solution. The purpose of this study is to assess subjective benefit by evaluating performance and overall satisfaction of the Ponto on a Ponto Softband in pediatric users.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •currently using Oticon Medical Ponto sound processor on Oticon Medical Softband
排除标准
- 未提供
结局指标
主要结局
Total GCBI Score
时间窗: Single time point for completing survey
Total score on the Glasgow Childrens Benefit Inventory (GCBI) questionnaire. Score is calculated on a scale of -100 to +100. The higher the score, the more benefit.
Vitality GCBI Score
时间窗: Single timepoint for completion of survey
Vitality score on the Glasgow Childrens Benefit Inventory (GCBI) questionnaire. Score is calculated on a scale of -100 to +100. The higher the score, the more benefit.
Overall Satisfaction - Ponto Experience
时间窗: Single timepoint for completion of survey
Survey question: "How satisfied overall are you with your child's Ponto experience?"
Satisfaction With Softband
时间窗: Single timepoint for completion of survey
Survey question: "How satisfied overall are you with your child's softband?"
PEACH Overall Score
时间窗: Single timepoint for completion of survey
Overall score from the Parents' Evaluation of Aural/Oral Performance of Children questionnaire (PEACH questionnaire). PEACH score is calculated as percentage of the maximum score (thus score is on a scale of 0-100%). Higher score indicate better performance.
Quiet PEACH
时间窗: Single timepoint for completion of survey
Quiet score from the Parents' Evaluation of Aural/Oral Performance of Children questionnaire (PEACH questionnaire). PEACH score is calculated as percentage of the maximum score (thus score is on a scale of 0-100%). Higher score indicate better performance.
Noise PEACH
时间窗: Single timepoint for completion of survey
Overall score from the Parents' Evaluation of Aural/Oral Performance of Children questionnaire (PEACH questionnaire). PEACH score is calculated as percentage of the maximum score (thus score is on a scale of 0-100%). Higher score indicate better performance.
Psycho Social GCBI Score
时间窗: Single timepoint for completion of survey
Psycho social score on the Glasgow Childrens Benefit Inventory (GCBI) questionnaire. Score is calculated on a scale of -100 to +100. The higher the score, the more benefit.
Physical Health GCBI Score
时间窗: Single timepoint for completion of survey
Physical health score on the Glasgow Childrens Benefit Inventory (GCBI) questionnaire. Score is calculated on a scale of -100 to +100. The higher the score, the more benefit.
Behavior GCBI Score
时间窗: Single timepoint for completion of survey
Behavior score on the Glasgow Childrens Benefit Inventory (GCBI) questionnaire. Score is calculated on a scale of -100 to +100. The higher the score, the more benefit.
Use of Sound Processor
时间窗: Single timepoint for completion of survey
Survey question: "Think about how much your child used their sound processor(s) over the past two weeks. On an average day, how many hours did they use the sound processor(s)?"
Hearing Benefit
时间窗: Single timepoint for completion of survey
Survey question: "Think about a situation where your child wanted to hear better, before receiving their sound processor. Over the past two weeks, how much has the sound processor(s) helped in that situation?"
次要结局
未报告次要终点