Early Experience of a New Implant System for Bone Conduction Hearing in the Pediatric Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cochlear
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Number of Participants Reporting Type and Severity of Adverse Events in the Pediatric Population Implanted With the Osia System
研究概览
简要总结
To study the initial experience with implanting and fitting a new Bone Conduction system in pediatric patient population with conductive, mixed or single-sided deafness.
详细描述
Experimental: Bone-conduction hearing device The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.
Device: Osia System An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea
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 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals 5 through 18 years of age will be eligible for inclusion in the investigation if all of the criteria below are met:
- •Conductive or mixed hearing loss in the ear to be implanted. Bone conduction thresholds with pure-tone average (PTA4; mean of 0.5, 1, 2, and 4 kHz) of less than or equal to 55 dB HL.
- •Subject does not benefit from or will not wear a conventional hearing aid.
- •Note: Candidates may include individuals seeking new implantation unilaterally (in one ear) or bilaterally (both ears) as well as individuals already implanted with a bone-anchored device seeking a second-side implant.
- •Single-sided sensorineural deafness who is a candidate for Baha surgery. Air conduction thresholds with a pure-tone average (PTA4; mean of 0.5, 1, 2, and 3 kHz) of less that equal to 20 dB HL in the good ear.
- •Subject does not benefit from or will not wear a conventional hearing aid
排除标准
- •Uncontrolled diabetes as judged by the investigator. Subject who has received radiotherapy in the area of implantation, or such radiotherapy is planned during the study period.
- •Current use of ototoxic drugs. Condition that could jeopardize osseointegration and/or wound healing or condition that may have an impact on the outcome of the investigation as judged by the investigator.
- •Insufficient bone quality and quantity for implantation of a BI300 Implant, as determined by the surgeon.
- •Unable to follow investigational procedures. Participation in another clinical investigation with pharmaceutical and/or device
结局指标
主要结局
Number of Participants Reporting Type and Severity of Adverse Events in the Pediatric Population Implanted With the Osia System
时间窗: Surgery to 12 months post-operative
Number, Type and Severity of Adverse Events will be tabulated and summarized.
次要结局
未报告次要终点