NCT04559282已完成不适用
A Pivotal, Prospective, Single-centre, Randomized Test Order, Crossover, Open Label Study Comparing the Performance of a New Sound Processor With Unaided Hearing and Baha 5 in Adult Subjects With Conductive or Mixed Hearing Loss
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cochlear
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Hearing Performance of Speech in Noise for Unaided Hearing and the Baha 6 Max Assessed Via Adaptive Speech Test in Noise
研究概览
简要总结
The purpose of this clinical investigation is to test a new Sound Processor (SP) to compare hearing performance of the new Sound Processor with unaided hearing and Baha 5 SP in adult subjects and to investigate which device (new Sound Processor versus Baha 5) the subjects prefer.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subject (18-<70 years of age)
- •At least 12 months experience from using a Baha Connect system (percutaneous Baha)
- •Subject with a conductive or mild to moderate mixed hearing loss. that would benefit from improved hearing from bone conduction device as judged by the research audiologist
- •Willing and able to provide written informed consent
排除标准
- •Signs of infection around the implant site
- •Unable to follow investigational procedures
- •Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator
- •Investigator site personnel directly affiliated with this investigation and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
- •Cochlear employees
- •Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
结局指标
主要结局
Hearing Performance of Speech in Noise for Unaided Hearing and the Baha 6 Max Assessed Via Adaptive Speech Test in Noise
时间窗: Day 0, day 7 and day 14
Using validated lists of phonetically balanced sentences. Noise is kept constant at 65 dB Sound Pressure Level (SPL) and the speech is adapted stepwise to establish the speech-to-noise ratio providing a 50% level of understanding
Participant Preference for the Baha 6 Max or Baha 5 SP Assessed Via Questions in the eCRF
时间窗: Day 14
次要结局
- Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry(Day 0 and day 7)
- Hearing Performance for Baha 6 Max and Unaided Assessed Via Speech Test in Quiet(Day 0, day 7 and day 14)
- Descriptive Hearing Performance for the Baha 6 Max and Baha 5 SP in a Home/Normal Hearing Environment Assessed Via a Diary(Day 7 and day 14)
- Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating(Day 14)
- Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Adaptive Speech Test in Noise(Day 0 and day 7)
- Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Speech Test in Quiet(Day 0 and day 7)
- Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry(Day 0, day 7 and day 14)
- Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Internal Noise(Day 14)
- Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Listening Effort.(Day 14)
研究者
研究点 (2)
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