Evaluation of the Baha SoundArc in Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cochlear
- 入组人数
- 32
- 试验地点
- 6
- 主要终点
- Patient Satisfaction Survey
研究概览
简要总结
The purpose of this study is to gather clinical performance data on the Baha SoundArc
详细描述
Current Baha recipients that are using a Baha SoftBand will be recruited to be fitted with an alternative non-surgical option for using their Baha Sound Processor. The subjects will be tested with there existing Baha Sound Processor on the SoftBand and will then be fitted with the Baha SoundArc where they will perform a one month take home trial. At the end of this trial, the subject will return for testing and evaluation of their experience with this new fitting option.
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
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Existing recipients using a Baha sound processor on a Softband for at least three months
- •Subjects aged 5 through 12 years of age
- •Subjects should be able to perform clinical testing adapted for age and developmental status, (Threshold sound field audiometry and basic monosyllabic word test, PBK)
- •Willingness on behalf of the subject's parent or guardian to complete study questionnaire
排除标准
- •Subject's inability to perform requisite test measures as described in the study protocol
研究组 & 干预措施
Experimental SoundArc study group
all subjects will receive the SoundArc intervention
干预措施: SoundArc (Device)
结局指标
主要结局
Patient Satisfaction Survey
时间窗: one month post fitting
To evaluate patient experience when using the Baha SoundArc after a one month take-home trial, compared to the existing Baha Softband on the Participant Take Home questionnaire (strongly agree, Agree, Neutral, disagree, strongly disagree)
Percentage Correct on Word Identification Task
时间窗: 4 weeks post fitting
one list of monosyllabic words (PBK words) was assessed at 60dBA, with word scores recorded as a percent correct.
次要结局
未报告次要终点