Evaluation of the Nucleus Hybrid™ L24 Cochlear Implant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cochlear
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Consonant Nucleus Consonant (CNC) Monosyllabic Word Score-Treated Ear (CO-PRIMARY)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy associated with the provision of acoustic and electric sound processing to individuals who demonstrate significant residual low-frequency hearing and profound high-frequency (above 1500 Hz) sensorineural hearing loss. Delivery of acoustic-electric stimulation will be provided by the Nucleus Hybrid L24 cochlear implant system.
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
- •Eighteen years of age or older at the time of implantation.
- •Severe to profound (a threshold average of 2000, 3000, & 4000 Hz > 75dB HL) sensorineural hearing loss for frequencies > 1500 Hz. Low-frequency thresholds up to and including 500 Hz should be no poorer than 60 dB HL.
- •Consonant Nucleus Consonant (CNC) monosyllabic word recognition score (mean of two lists) between 10% and 60%, inclusive (i.e., 10% <= score <= 60%), in the ear to be implanted.
- •CNC word recognition score in the contralateral ear equal to, or better than, the ear to be implanted but not more than 80%.
- •English spoken as a primary language.
排除标准
- •Duration of severe-to-profound hearing loss greater than 30 years.
- •Congenital hearing loss (for the purpose of this study, onset prior to 2 years-of-age).
- •Medical or psychological conditions that contraindicate undergoing surgery.
- •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 250 to 1000 Hz.
- •Hearing loss of neural or central origin.
- •Diagnosis of Auditory Neuropathy.
- •Active middle-ear infection.
- •Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices.
- •Unwillingness or inability of the candidate to comply with all investigational requirements.
- •Additional handicaps that would prevent or restrict participation in the audiological evaluations.
结局指标
主要结局
Consonant Nucleus Consonant (CNC) Monosyllabic Word Score-Treated Ear (CO-PRIMARY)
时间窗: 6 Months Postactivation
The co-primary study endpoints will be statistically significant differences between the mean, preoperative monosyllabic CNC word score (unilateral acoustic, ear to be implanted) and the postoperative monosyllabic CNC word scores (Hybrid mode) for the activated, Hybrid L24 cochlear implant subjects. The CNC Words test consists of 10 recorded lists of 50 monosyllabic words in CD format. For this study, two lists will be administered in quiet at a level equal to 60 dBA in the sound field and scored as a total number of words correct, which will be expressed as a percentage correct for this study.
AzBio Sentence Score in Noise - Treated Ear (Co-Primary)
时间窗: 6 Months Postactivation
The co-primary study endpoints will be statistically significant differences between the mean, preoperative AzBio Sentences score in noise (unilateral acoustic, ear to be implanted) and postoperative AzBio Sentences score in noise (Hybrid mode) for the activated, Hybrid L24 cochlear implant subjects. The AzBio Sentence Test consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in' unintelligible words. Each list includes 5 sentences from 4 different male and female speakers. Each word in the sentence counts towards the overall score.
次要结局
- Consonant Nucleus Consonant (CNC) Monosyllabic Words - Treated Ear(6 Months Postactivation)
- AzBio Sentence Score-Treated Ear(6 Months Postactivation)