Safety and Efficacy of Remote Programming of Nucleus Cochlear Implants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cochlear
- 入组人数
- 40
- 试验地点
- 8
- 主要终点
- Speech Perception on Monosyllabic Word Test, CNC Words
研究概览
简要总结
The purpose of this study is to demonstrate the safety and efficacy of Nucleus cochlear implant programming via telecommunication.
详细描述
Cochlear implant recipients will undergo remapping at a location remote from their audiologist via telehealth. Audiologists will use an internet meeting platform to remotely log into the subject's computer and control the programming software. Remote programming sessions will be completed both with and without the assistance of a trained facilitator, and speech understanding will be tested in between mapping sessions.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals aged greater than 12 years that are native English speakers and are capable of completing the study evaluation as deemed by their primary audiologist
- •Unilateral or bilateral cochlear implant recipients of a CI24RE, CI422 or CI500 series implant who are in possession of a backup sound processor
- •A minimum of 12 months' experience with a CP800 or CP900 series sound processor, and current MAP programmed within 12 months prior to Visit 1
- •Willingness to participate in and to comply with all requirements of the protocol
- •Able to demonstrate protocol competence as confirmed by primary audiologist
排除标准
- •Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations of remote service delivery
- •Unwillingness or inability of the candidate to comply with all investigational requirements
- •Additional handicaps that would prevent or restrict participation in the audiological evaluations
- •Inability to demonstrate basic technological skills for simple computer-based tasks and device connecting after training by primary audiologist
结局指标
主要结局
Speech Perception on Monosyllabic Word Test, CNC Words
时间窗: 2-4 weeks post remote programming session
Subjects will listen to and repeat monosyllabic words from the Consonant Nucleus Consonant word test measured by percentage of words correct to examine their speech perception abilities after each remote programming session.
次要结局
未报告次要终点