Evaluation of a HiRes™ Optima Sound Processing Strategy for the HiResolution™ Bionic Ear
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 5
- 主要终点
- Speech Perception With Control and Experimental Conditions Both Tested in Quiet, in Speech-spectrum Noise, and in Multi-talker Babble Noise.
研究概览
简要总结
The purpose of this study is to compare a new sound processing strategy to the current sound processing strategy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Unilateral or bilateral user of CII/HiRes90K™ implant(s) (minimum of one year in each implanted ear), Harmony™ BTE processor(s) with HiRes Fidelity 120™ (with or without ClearVoice™) as preferred sound processing strategy
- •18 years of age or older at time of implant
- •Postlingual onset of severe-to-profound hearing loss (≥ 6 years of age)
- •At least moderate open-set speech recognition abilities (defined as CNC word score ≥ 50% in medical records or assessed at the Baseline Visit with implant alone for unilateral users, with both implants together for bilateral users)
- •English language proficiency
- •Willingness to use a Harmony™ BTE processor and refrain from ClearVoice™ use for the duration of the study
- •Willingness and ability to participate in all scheduled procedures outlined in the protocol
排除标准
- •Presence of any additional disabilities that would prevent or interfere with participation in the required speech perception testing
研究组 & 干预措施
Control first, then Experimental (Group A)
Initial subject use of Control Sound Processing Strategy for the first week, followed by subject use of Experimental (HiRes™ Optima) Sound Processing Strategy for the HiResolution™ Bionic Ear System for the second week.
干预措施: Control first, then Experimental (Device)
Experimental first, then Control (Group B)
Initial subject use of Experimental (HiRes™ Optima) Sound Processing Strategy for the first week for the HiResolution™ Bionic Ear System, followed by subject use of the Control Sound Processing Strategy for the second week.
干预措施: Experimental first, then Control (Device)
结局指标
主要结局
Speech Perception With Control and Experimental Conditions Both Tested in Quiet, in Speech-spectrum Noise, and in Multi-talker Babble Noise.
时间窗: 2 weeks
Sentence recognition with the new (experimental) and current (control) sound processing strategies will be compared. Subjects will be tested using the AzBio corpus of sentences, which consists of 33 lists of 20 sentences each (6 to 10 words per sentence) that are equated for intelligibility. The difference between the Control percent correct scores and Experimental percent correct scores will be used for the analysis (Experimental AzBio scores minus Control AzBio scores). Data from both Group A and Group B were pooled for the analysis.
Device-related Adverse Events
时间窗: 2 weeks
Device-related adverse events will be assessed to determine whether they impact current device safety performance.
次要结局
未报告次要终点