A Randomised Controlled Trial Comparing Bone Anchored Hearing Aid With Bonebridge
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Speech audiogram result at 6 months after switch on at 60 dBA in quiet using AB word lists
研究概览
简要总结
The Bonebridge is a new bone conducting implantable hearing aid. The investigators plan to randomize patients to receive either the Bonebridge or a conventional bone conducting hearing device. The investigators will then compare the surgical and audiological outcomes of the two groups.
详细描述
The new Bonebridge fully implanted, except for an external sound processor. It does not have any percutaneous parts like the Bone Anchored Hearing Aid. The investigators believe that this may improve wound healing and reduce problems with wound infection and skin overgrowth seen in Bone Anchored Hearing Aids.
There may also be audiological improvements by the use of the Bonebridge as the physical separation of the vibrating part from the sound processor should reduce feedback. The company also claims other audiological improvements in the Bonebridge.
The investigators wish to demonstrate whether this is actually the case by performing a study directly comparing the outcomes of the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Conductive Hearing Loss within criteria for Bonebridge
排除标准
- •Pregnancy
研究组 & 干预措施
Bone Anchored Hearing Aid
Implantation with a Bone Anchored Hearing Aid
干预措施: Bone Anchored Hearing Aid (Device)
Bonebridge
Implantation with a Bonebridge
干预措施: Bonebridge (Device)
结局指标
主要结局
Speech audiogram result at 6 months after switch on at 60 dBA in quiet using AB word lists
时间窗: Up to 1 year post-operatively
We will record and compare the standard speech audiometry results at a specific sound level in order to make a direct comparison of devices
次要结局
- Speech audiogram result at 60 dB A in noise using AB word lists(Up to 1 year after implantation)
- Patient reported outcome data(Up to 1 year following implantation)
- Time from surgery to device switch-on(Up to 3 months)
- Number of patient episodes required during study period(1 year from implantation)
- Time to complete wound healing(Up to 3 months from implantation)
研究者
Stephen Jones
Consultant ENT Surgeon
Ninewells Hospital