JPRN-jRCTs032190003已完成1 期
Clinical research of the bone conductive hearing system.
Suzuki Hiroaki0 个研究点目标入组 2 人开始时间: 2019年4月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2
研究概览
简要总结
In this study, we treated one patient with congenital bilateral microtia and atresia, and one patient with congenital unilateral atresia by using BONEBRIDGE. As a result, the hearing thresholds for both patients improved dramatically after BONEBRIDGE fitting. Monosyllable perception score in noise condition was improved in one patient.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 5age old 至 ot applicable（—）
- 性别
- All
入选标准
- •General inclusion criteria
- •1)Written informed consent was obtained from patient (or their guardians if they are minor).
- •2)The age of informed consent was 5 years old or above.
- •Audiometric inclusion criteria
- •1)Unilateral or bilateral conductive hearing loss or mixed hearing loss.
- •2)Patient affected ear fulfill the below bone conduction hearing thresholds.
- •The patients with bone conducting hearing thresholds in 500Hz to 4000Hz is under 45dBHL.
排除标准
- •(1)The patients with severe bone malformation and did not have enough setting space for bone conductive implantation.
- •(2)The patients with un-compatible to general anesthesia.
- •(3)The Patients with post cochlear hearing loss.
- •(4)The patients with skin problem and did not ware audio processor.
- •(5)The patients who assessed unsuitable for this clinical research from medical doctor.
研究者
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