NCT00424307Unknown4 期
Development of Auditory Skills in Young Deaf Children With Bilateral Cochlear Implants
适应症
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 27
- 主要终点
- Assessment of Speech Perception Skills
研究概览
简要总结
The primary purpose of this study is to track patient outcomes for bilateral cochlear implant recipients in a cohort of 60 children, ages 12 to 36 months at time of surgery, who receive two implants in the same operation or in two different surgeries with the initial fitting of the devices separated by no more than six months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Profound bilateral hearing loss
- •Have independently elected to undergo bilateral implantation of Advanced Bionics HiResolution Bionic Ear System
- •Age at implant: 12-36 months
- •No previous cochlear implant use
- •English as the primary language spoken in the home
- •Parental willingness to follow study protocol
排除标准
- •Deafness secondary to meningitis
- •Presence of other conditions that could affect study participation
结局指标
主要结局
Assessment of Speech Perception Skills
时间窗: Various time points
次要结局
- Health-Related Quality of Life and Assessment of Communicative Performance(Various time points)
研究者
研究点 (27)
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