NCT01933386Unknown4 期
Evaluation of Benefit for Treatment of Single Sided Deafness (SSD) Between Two Bone Conduction Prosthetic Devices; Osseointegrated Implant Versus Maxilla Anchored Removable Oral Appliance ("SoundBite")
适应症
干预措施
试验速览
- 阶段
- 4 期
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- APHAB Questionnaire
研究概览
简要总结
The primary objective of this study is to compare the SoundBite™ Hearing System to surgically implanted BCD systems.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be current users of a surgically implanted digitally programmable surgically implanted bone conduction device
- •Must be >18, <80 years old
- •Must be fluent in English, as determined by the PI
- •Must have diagnosis of SSD, time since onset (≥3 months)
- •Must have at least two contiguous molar or premolar teeth with no untreated tooth decay. Patients with tooth decay present are to first have restorations before being fitted for SoundBite
- •Healthy attachment to those teeth with tooth pockets limited to no more than 5mm
排除标准
- •Subjects with known hypersensitivity to any of the components including allergies to polymers.
- •Subjects that are unable to use their hands such as quadriplegics or others that are unable to comply with the warnings in the product's labeling.
- •Subjects with known or active secondary medical conditions associated with variable sensorineural hearing loss
研究组 & 干预措施
SoundBite
Other
SoundBite will be used for the first 30 days
干预措施: SoundBite (Device)
Surgically Implanted BCD
Other
The subject's own surgically implanted bone conduction device will be used for the first 30 days.
干预措施: SoundBite (Device)
结局指标
主要结局
APHAB Questionnaire
时间窗: 30 days
Comparison of the SoundBite™ System and surgically implanted bone conduction devices
次要结局
- Single Sided Deafness Questionnaire(30 days)
研究者
研究点 (3)
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