Clinical Evaluation of the Cochlear Nucleus(R) CI532 Cochlear Implant in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cochlear
- 入组人数
- 96
- 试验地点
- 19
- 主要终点
- Change From Pre- to 6 Months Post-implantation Speech Recognition in Quiet in the Implanted Ear Alone
研究概览
简要总结
The purpose of this study is to gather long-term data on the FDA approved CI532 cochlear implant, and CP1000 (Nucleus 7) sound processor
详细描述
Appropriate candidates will receive a CI532 cochlear implant and be fit with the CP1000 sound processor. Imaging will be completed pre-op, intra-op, and post-op to assess implant location. Speech perception testing as well as subjective questionnaires will be administered over 12 months.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 years or older who have a bilateral postlinguistic sensorineural hearing loss.
- •Limited benefit from amplification as defined by test scores of 40% correct or less in the ear to be implanted and 50% or less in the contralateral ear on a recorded monosyllabic word test I. Consistent with the Minimum Speech Test Battery (2011), it is required that all subjects be evaluated at 60 dBA presentation level.
- •Bilateral moderate sloping to profound hearing loss
- •Minimum of 30 days experience with appropriately fit bilateral amplification, fit using the standardized National Acoustics Laboratory (NAL) fitting method
- •Proficient in English
- •Ability to complete testing -
排除标准
- •Previous cochlear implantation
- •Pre-linguistically deafened (onset of hearing loss at less than two years of age)
- •Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
- •Duration of severe to profound hearing loss greater than 20 years
- •Diagnosis of retro-cochlear pathology
- •Diagnosis of auditory neuropathy
- •Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device
- •Unwillingness or inability to comply with all investigational requirements
- •Additional cognitive, medical or social handicaps that would prevent completion of all study requirements-
结局指标
主要结局
Change From Pre- to 6 Months Post-implantation Speech Recognition in Quiet in the Implanted Ear Alone
时间窗: Preoperatively and 6 months post sound processor activation
Group mean Consonant Nucleus Consonant (CNC) word recognition in quiet measured pre-operatively and again at 6 month post sound processor activation compared to the group mean score in the preoperative, best unilateral condition. The CNC word test has a score range of 0-100% with higher values indicating better scores.
次要结局
- Change in Pre and Post Implantation Score on the Health Utility Index-3 (HUI3)(Preoperatively and 6 months post sound processor activaton)
- Evaluation of Change in Pre and Post Implantation Speech Recognition in Noise Scores in the Implanted Ear Alone(Preoperatively and 6 months post sound processor activation)