Expanded Indications in the Adult Cochlear Implant Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 5
- 主要终点
- Change in Percent Correct on Word Recognition in Quiet in Implanted Ear
研究概览
简要总结
The purpose of this investigation is to expand FDA-approved labeling for MED-EL cochlear implants to include adults who have moderate to profound sensorineural hearing loss and obtain limited benefit from appropriately fit hearing aids.
详细描述
Fifty (50) subjects, 18 years of age and older, will be implanted across the United States and Canada. Subjects with moderate to profound bilateral sensorineural hearing loss will be implanted with the MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System. .
Limited benefit from amplification is defined by test scores of 60% correct or less in the ear to be implanted (70% or less in the nonimplanted ear) on monosyllabic words in quiet. Subjects will be followed for twelve (12) months post-activation of the SONNETEAS Audio Processor.
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
- •Adults, 18 years of age or older at the time of implantation
- •Moderate to profound hearing loss in the low frequencies and severe to profound hearing loss in the high frequencies, bilaterally as defined by: Low-frequency PTA (250, 500, and 1000 Hz) greater than 40 dB High-frequencies not better than 65 dB (3000 Hz - 8000 Hz)
- •Sensorineural hearing loss, demonstrated by an air-bone gap of less than or equal to 10dB
- •Limited benefit from appropriately fit hearing aids, defined by CNC word score in quiet of 60% or less in the ear to be implanted and 70% or less in the non-implanted ear
- •CNC word score in quiet of greater than or equal to 10% in the ear to be implanted
- •Evidence of appropriately fit hearing aids as determined by the audiologist
- •Bilateral hearing aids should be considered standard of care, except in situations where the audiologist, physician, or potential subject determines that unilateral fit is optimal
- •Hearing aid fit should be verified through accepted measures such as functional gain or real-ear verification
- •If appropriately fit hearing aids have not been worn within the last year, a 30-day hearing aid trial must be completed prior to enrollment in the study
- •Fluent in English
- •No radiological contraindications
- •Ability to undergo general anesthesia
- •Appropriate motivation and expectation levels
- •Stated willingness to comply with all study procedures for the duration of the study
排除标准
- •Evidence that hearing loss is retrocochlear in origin
- •Active middle ear infection
- •Skin or scalp condition precluding use of external audio processor- Suspected cognitive impairment or organic brain dysfunction
- •History of prior use of a hearing implant
研究组 & 干预措施
Single-arm
Single-arm, repeated-measures study design with all subjects receiving a MED-EL cochlear implant
干预措施: MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System (Device)
结局指标
主要结局
Change in Percent Correct on Word Recognition in Quiet in Implanted Ear
时间窗: 6 months post-activation
CNC (Consonant Nucleus Consonant) word scores will be calculated as percent correct at baseline and at 6 months post-activation and reported as mean percentage-point improvement at 6 months post-activation compared to baseline.
Change in Percent Correct of Words Identified for Sentences in Noise in Implanted Ear
时间窗: 6 months post-activation
AzBio sentence recognition in noise scores will be calculated as percent correct of words in each sentence at baseline and at 6 months post-activation and reported as mean percentage-point improvement at 6 months post-activation compared to baseline.
次要结局
- Change in Global Score on Patient-reported Outcomes in Everyday Listening Condition(6 months post-activation)
- Number of Participants Experiencing an Adverse Device Effect (ADE)(Through study completion, or at least 1 year, 4 months post-implantation)
- Number of Participants With Residual Low-frequency Hearing(6 months post-activation)
- Change in Overall Score on Patient-reported Outcomes in Everyday Listening Condition(6 months post-activation)