Evaluation of Remote Fitting in Adult and Pediatric Users of the HiResolution Bionic Ear System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Speech Performance in Quiet After Chronic Use (EO Only)
研究概览
简要总结
This is a prospective within-subjects repeated-measures study that will enroll 17 users 13 years or older implanted with a HiResolution Bionic Ear System.
详细描述
The overall goal of this clinical study is to demonstrate the safety and efficacy of the remote fitting option. 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 described herein uses a non-inferiority design to determine whether sentence recognition in quiet is no worse with remote fitting than in an in-office setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All Subjects
- •Ability to provide Informed Consent/Assent
- •13 years of age or older
- •Unilateral or bilateral user of a HiResolutionTM Bionic Ear System (HiRes 90KTM, HiRes 90KTM Advantage, HiResTM Ultra, HiResTM Ultra 3D)
- •Minimum of 6 months of CI experience with a minimum of 1 month experience with a Naída CI or Sky CI sound processor
- •At least moderate open-set speech recognition abilities (defined as speech in quiet score ≥ 60% as assessed at Visit 1)
- •Minimum average score ≥ 3 on the Mobile Device Proficiency Questionnaire (MDPQ-16)
- •English language proficiency as determined by the Investigator
- •Willingness to use a BTE sound processor for the duration of the study
- •Inclusion Criteria Specific to Aidable Residual Hearing Group
- •Residual low frequency hearing sensitivity (pure tone average of < 70 dB HL for 125, 250, and 500 Hz) and a severe-to-profound high-frequency sensorineural hearing loss (pure tone average of ≥ 70 dB HL for 1,000, 2,000, 3000, 4,000, and 8,000 Hz) in the implanted ear for unilaterally implanted subjects and in both ears for bilaterally implanted subjects
- •Willingness to use an in-canal acoustic earhook for the duration of the study
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
研究组 & 干预措施
Electric Only
干预措施: Remote Fitting (Device)
Electric Only
干预措施: In-Office Fitting (Device)
Aidable Residual Hearing
干预措施: Remote Fitting (Device)
Aidable Residual Hearing
干预措施: In-Office Fitting (Device)
结局指标
主要结局
Speech Performance in Quiet After Chronic Use (EO Only)
时间窗: 2-3 weeks after fitting
The primary efficacy endpoint is the chronic AzBio sentence recognition scores in quiet captured two-to-three weeks post investigational remote fitting (visit 3) as compared to the chronic AzBio sentence recognition scores in quiet captured two-to-three weeks post control in-office fitting (visit 2). Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.
Speech Performance in Quiet - Chronic Use (Includes Overall - Both Groups)
时间窗: Test performed 2-3 weeks after fitting
The primary efficacy endpoint is the chronic AzBio sentence recognition scores in quiet captured two-to-three weeks post investigational remote fitting (visit 3) as compared to the chronic AzBio sentence recognition scores in quiet captured two-to-three weeks post control in-office fitting (visit 2). Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.
次要结局
未报告次要终点