Expanded Indications in the Pediatric BONEBRIDGE Population
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 36
- 试验地点
- 11
- 主要终点
- Functional gain
研究概览
简要总结
This study will assess safety and efficacy of the MED-EL BONEBRIDGE Bone Conduction Implant in children under 12 years old with conductive or mixed hearing loss.
详细描述
This prospective multicenter IDE study will include 36 children implanted with the MED-EL BONEBRIDGE system at six academic medical centers across the US.
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
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Under 12 years of age
- •Unaided bone-conduction thresholds at 0.5, 1, 2, and 4 kHz better than or equal to 45 dB HL in the ear to be implanted
- •Sufficient air-bone gap (ABG) at in the ear to be implanted
- •HRCT scan that confirms sufficient bone quantity and quality to recess and fix the BCI in the ear to be implanted
- •Developmental, cognitive, and language skills needed to provide an unaided speech recognition threshold (SRT) in quiet with English spondees
- •Prior experience with acoustic or bone conduction hearing aids, unless candidate is unable to wear amplification for medical reasons
- •Parental commitment to comply with all study procedures
排除标准
- •Children under 3 years (36 months) of age
- •Chronic or non-revisable vestibular or balance disorders
- •Abnormally progressive hearing loss
- •Prior use of a hearing implant in the ear to be implanted
- •Current/ongoing use of a hearing implant in the contralateral/non-implant ear
- •Evidence that hearing loss is retrocochlear in origin
- •Medical condition that contraindicates implant surgery or anesthesia
- •Skin or scalp condition precluding use of external audio processor
研究组 & 干预措施
Study procedure
This single-arm, repeated-measures study includes study visits at baseline, surgery, device activation, and at 1, 3, 6, and 12 months post-activation.
干预措施: MED-EL BONEBRIDGE Bone Conduction Implant (Device)
结局指标
主要结局
Functional gain
时间窗: Up to six (6) months post-activation
Postoperative improvement in aided soundfield thresholds compared to preoperative unaided soundfield thresholds
Adverse events
时间窗: Up to six (6) months post-activation
Number and proportion of subjects experiencing serious device- and surgery-related adverse events
次要结局
- Unaided bone-conduction pure-tone average (BC-PTA)(Up to three (3) months post-activation)
- Post-intervention quality-of-life questionnaire(Up to six (6) months post-activation)
- Word recognition score(Up to six (6) months post-activation)