Implantation With the Nucleus CI532 Cochlear Implant in Adults
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Cochlear
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- AzBio Sentence Recognition in Noise
研究概览
简要总结
The aim of this study is to investigate the clinical benefit for patients implanted with the Nucleus® CI532 cochlear implant.
The Nucleus® CI532 has a pre-curved, perimodiolar array, the EA32, which is introduced into the cochlea through a straightening sheath.
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
- •Meet current cochlear implant criteria at the implanting center
- •18 years or older with bilateral sensorineural hearing loss
- •Limited benefit from appropriate binaural hearing aids
- •Moderate to profound hearing loss in the low frequencies and profound hearing loss in the mid to high frequencies
- •Preoperative unaided threshold between 40 and 65 dB HL, inclusively, at 250 Hertz (Hz) and 500 Hz in the ear to be implanted
- •Fluent speaker in the language used to assess clinical performance
排除标准
- •Evidence of hearing loss prior to age 5
- •Sensorineural severe to profound hearing loss greater than 20 years at and above 2000Hz
- •Simultaneous bilateral implantation prior to the study
- •Medical or psychological conditions that contraindicate undergoing general anesthesia or surgery
- •Cochlear anomaly that might prevent complete insertion of the electrode array
- •Hearing impairment due to lesion or neuropathy of the acoustic nerve, VIII nerve, or central auditory pathway
- •Active middle ear infection
- •Tympanic membrane perforation
- •Unrealistic expectations
- •Unwillingness or inability co comply with all investigational requirements
- •Patients with existing cerebral shunts or drains
- •Recurrent episodes of bacterial meningitis
研究组 & 干预措施
Surgical
Subjects to be implanted with the CI532 cochlear implant in one ear
干预措施: CI532 cochlear implant (Device)
结局指标
主要结局
AzBio Sentence Recognition in Noise
时间窗: 3 months post-activation
The AzBio Sentence test was recorded at 3 months prior to subject withdraw. Not collected at endpoint. AzBio Tests 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 toward the overall score and the resulting score is presented in percent correct.
次要结局
- Speech, Spatial, and Qualities of Hearing Scale(6 months post-activation)
- Glasgow Benefit Inventory(6 months post-activation)