A Post-market Interventional Cohort Study Evaluating the Clinical Efficacy of the Osia 2 System in the US Market.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cochlear
- 入组人数
- 20
- 试验地点
- 8
- 主要终点
- Change From Baseline in Adaptive Speech in Noise Test Score for Osia 2 System at 3 Months Post-surgery
研究概览
简要总结
To evaluate the clinical efficacy of the Osia 2 system in patients with conductive or mixed conductive hearing loss in a US cohort.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide written informed consent.
- •Proficient in English.
- •Hearing loss etiology of Conductive or Mixed Conductive loss.
- •Bone conduction PTA (.5, 1, 2, and 3 kHz) better than or equal to 55 dB HL in the treatment ear.
- •Aged 18 years and older.
排除标准
- •Unwilling to wear the treatment device or comply with the surgical and rehabilitation requirements of the study.
- •Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
- •Medical, audiological or psychological conditions, as judged by the investigator that might contraindicate participation in the clinical investigation.
- •Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
- •Cochlear employees or contractors engaged by Cochlear for the purposes of this investigation.
- •Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
- •Prior experience with a surgical bone conduction treatment option
- •Insufficient bone quality to support the BI300 implant as determined by the surgeon
结局指标
主要结局
Change From Baseline in Adaptive Speech in Noise Test Score for Osia 2 System at 3 Months Post-surgery
时间窗: Preoperative, 3 months post-surgery
Assessed with the Quick SIN test preoperative and at 3 months post-surgery. The Quick SIN test has a score range from +25.5 dB (decibel) SNR (signal-to-noise ratio) to -5 dB SNR. The participants are tested on 4 tests lists; each consists of 6 sentences (with 5 key words per sentence) that are presented at signal-to-noise ratios (SNR) which are decreased manually in 5-dB steps from 25 to 0. The key words in sentences are scored and counted as correct from an easy to difficult or unfavorable SNR. The best possible score on this test would be that of -5 dB SNR where all of the key words are repeated back correctly as a function of the SNR. The mean unaided preoperative score is substracted from the aided score at 3 months. A lower score indicates a better performance.
次要结局
- Number of Device or Procedure Related Adverse Events(6 months post-surgery)