NCT04741048撤回不适用
A Pre-market, Open-label Feasibility, Prospective, Single-arm Multicenter Feasibility Investigation of Hearing Performance Using the CI624 in Adults With Low-frequency Residual Hearing.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Cochlear
- 试验地点
- 2
- 主要终点
- Characterize hearing performance of the CI624.
研究概览
简要总结
The purpose of the feasibility study is to investigate hearing performance (audiometry and speech perception) using the CI624 in a group of adults (n=15) with low-frequency residual hearing who meet inclusion criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
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
- •18 years-of-age or older at the time of surgery.
- •Low-frequency threshold at 500 Hz ≤ 50 dB HL and high-frequency pure-tone average (PTA), 2000-8000 Hz ≥ 65 dB HL in the ear to be implanted.
- •Pure-tone average (PTA) (0.5k, 1k, 2k Hz) > 30 dB HL in the contralateral ear.
- •CNC word recognition scores (mean of two lists) ≤ 60% in the ear to be implanted and ≤ 80% in the contralateral ear.
- •English spoken as a primary language.
- •Willing and able to provide written informed consent.
排除标准
- •Individuals older than 70 years at the time of surgery.
- •Duration of severe to profound sensorineural hearing loss > 20 years per self-report.
- •Onset of sensorineural hearing loss, for the purpose of this study, prior to 5 years-of-age.
- •Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array.
- •Conductive overlay of 15 dB or greater at two or more frequencies, in the range of 250 through 1000 Hz in the ear to be implanted.
- •Hearing loss of neural or central origin.
- •Diagnosis of Auditory Neuropathy.
- •Active middle-ear infection.
- •Medical or psychological conditions that contraindicate undergoing surgery as determined by the Investigator.
- •Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the device and/or procedure, as determined by the Investigator.
- •Additional handicaps that would prevent or restrict participation in the audiological evaluations as determined by the Investigator.
- •Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
- •Investigator site personnel directly affiliated with this study and/or their immediate family (spouse, parent, child, or sibling).
- •Cochlear employees or employees of a Contract Research Organization (CRO) or contractors engaged by Cochlear for the purposes of this investigation.
- •Currently participating, or has participated in the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
结局指标
主要结局
Characterize hearing performance of the CI624.
时间窗: 14 months
Hearing performance of the CI624 will characterized using Constant Nucleus Constant (CNC) word recognition in quiet. Performance is scored as percent correct words.
次要结局
未报告次要终点
研究者
研究点 (2)
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