Cochlear Implantation in the Single-Sided Deafness in the Medicare Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 6
- 主要终点
- Performance of the Cochlear Implant System will be assessed through speech perception testing in noise completed through one year (12 months) post implantation.
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of cochlear implantation in adults 65 years of age and older.
详细描述
The study will be conducted as a single-subject, repeated measures, multi center study at 3 sites. Fifteen subjects will be enrolled in this study. Three centers in the United States and Canada will recruit subjects into this study. Study subjects will be followed for 12 months post-implantation of the device.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •65 years of age or older at the time of implantation
- •Unilateral profound hearing loss, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 90 dB or greater in the ear to be implanted
- •Sensorineural hearing loss in the ear to be implanted, as defined by an air-bone gap less than or equal to 10 dB at two or more frequencies out of 500, 1000, 2000, and 4000 Hz
- •Normal or near-normal hearing in the non-implanted ear, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 30 dB or less
- •Word recognition in the ear to be implanted of 5% or less on CNC word score in quiet
- •Previous experience with an appropriately-fit CROS, BI-CROS, bone conduction, or traditional hearing aid, as deemed appropriate by investigator
- •Fluent in English
排除标准
- •Duration of profound hearing loss of 10 years or more
- •Sudden onset of hearing loss within six months of implantation
- •Evidence of non-functional cochlear nerve or other retrocochlear hearing loss
- •Evidence of severe cochlear malformation (i.e., common cavity or ossification)
- •External or middle ear infection
- •Suspected cognitive concern
- •Other medical contraindication for surgery or anesthesia
研究组 & 干预措施
Study Procedure
干预措施: MED-EL Cochlear Implant System (Device)
结局指标
主要结局
Performance of the Cochlear Implant System will be assessed through speech perception testing in noise completed through one year (12 months) post implantation.
时间窗: One year (12 months) post implantation
The primary effectiveness endpoint will be change on speech in noise when speech is presented to the front and noise is presented to the acoustic hearing (contralateral) ear. The pre-operative, best aided score will be compared to the 6-month and 12-month CI score for AzBio sentences in noise (range of score 0-100, higher score is better). Improvement is defined as greater than or equal to 10 percentage points.
Performance of the Cochlear Implant System Will be Assessed Through Speech Perception Testing in Noise Completed Through One Year (12 Months) Post Activation.
时间窗: One year (12 months) post activation
The primary effectiveness endpoint will be change on speech in noise when speech is presented to the front and noise is presented to the acoustic hearing (contralateral) ear. AzBio sentences in noise will be administered at 60 dB SPL with a signal-to-noise ratio of 0 dB SNR. Pre-operatively, sentence testing will occur with a CROS hearing aid. The pre-operative, best aided score will be compared to the 6-month and 12-month CI score for AzBio sentences in noise. AzBio sentences in noise are scored as a percentage of words correctly repeated back out of the total number of words presented on the list (range of score 0-100, higher score is better). Improvement is defined as greater than or equal to 10 percentage points.
次要结局
- Performance of the Cochlear Implant System will be summarized through speech perception testing in noise completed through one year (12 months) post implantation.(One year (12 months) post implantation)
- Performance of the Cochlear Implant System will be assessed through speech perception testing in quiet completed through one year (12 months ) post implantation.(One year (12 months) post implantation)
- Safety will be evaluated for all study subjects through one year (12 months) post implantation.(One year (12 months) post implantation)
- Subjective benefit of the Cochlear Implant System will be assessed through one year (12 months) post implantation.(One year (12 months) post implantation)
- Performance of the Cochlear Implant System Will be Summarized Through Speech Perception Testing in Noise Completed Through One Year (12 Months) Post Implantation.(One year (12 months) post implantation)
- Performance of the Cochlear Implant System Will be Assessed Through Speech Perception Testing in Quiet Completed Through One Year (12 Months ) Post Implantation.(One year (12 months) post implantation)
- Subjective Benefit of the Cochlear Implant System Will be Assessed Through One Year (12 Months) Post Implantation.(One year (12 months) post implantation)