Evaluation of Remote Programming of Cochlear Implants in Routine Cochlear Implant Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- 50% SRT measured as signal to noise ratio in DB (French Matrix test in noise)
研究概览
简要总结
This is a prospective and monocentric clinical investigation, non-interventional and non-randomized. The overall goal of this clinical study is to generate additional clinical data confirming the safety and efficacy of the remote programming functionality of Target CI version 1.5 and the AB Remote Support app. Hearing outcomes are expected to be similar whether a study subject's sound processor is programmed in the traditional method in the audiologist's office or whether programming is performed via remote fitting. Therefore, the study uses a non-inferiority design to determine whether sentence recognition in noise is no worse with remote fitting than in an in-office setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide informed consent
- •Ability to give feedback on hearing impressions
- •Aged 18 years of age or older
- •Implanted with a HiResolution Bionic Ear System (HiRes 90K or HiRes 90K Advantage or HiRes Ultra or HiRes Ultra 3D) on at least one side
- •Group 1 - Unilateral: no hearing device except contralateral routing of signals (CROS) device on the contralateral side
- •Group 2 - Bilateral: implanted on both sides
- •Group 3 - Bimodal: hearing aid on the contralateral side
- •Minimum of six months of cochlear implant experience
- •Minimum of one month experience with a Naída CI M or Sky CI M sound processor
- •Fluent in French language
- •Ability to be tested via speech perception test in noise
- •Smartphone user
排除标准
- •Clinical presentation indicative of potential implanted device malfunction
- •Unrealistic expectations regarding potential benefits, risks and limitations of the investigational device as determined by the Investigator
- •Unwillingness or inability of subject to comply with all investigational requirements as determined by the Investigator
- •Pregnancy and breast-feeding are not exclusion criteria.
结局指标
主要结局
50% SRT measured as signal to noise ratio in DB (French Matrix test in noise)
时间窗: one-month chronic use of remotely fitted sound processor
The primary efficacy objective is to demonstrate that speech recognition in noise after remote fitting is no worse than speech recognition in noise after in-office fitting.
次要结局
- Score in the Lafon phoneme test in quiet(one-month chronic use of remotely fitted sound processor)