Single-sided Deafness and Cochlear Implantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 5
- 主要终点
- Change in Speech recognition in noise
研究概览
简要总结
This observational study evaluates the effects of cochlear implantation in patients with deafness in one ear.
详细描述
Cochlear implant (CI) technology has been widely used for individuals with bilateral sensorineural hearing loss to improve the ability to perceive sound by bypassing the damaged portion of the inner ear. Recently in the U.S., Cochlear implantation has also been approved by the FDA for treatment of single-sided deafness. By restoring binaural hearing, cochlear implantation in unilateral hearing loss may improve hearing in noise and sound localization, however its audiologic outcomes and quality of life impact for patients remain incompletely understood.
This study aims to establish a prospective database to track and quantify the change in general health status, tinnitus severity, spatial hearing ability, and difficulty with communication in noise after unilateral cochlear implantation in patients with SSD undergoing routine medical and audiologic evaluation at the Johns Hopkins Cochlear Implant Center. Study participants will complete survey questionnaires and undergo standard-of-care audiological evaluation before and after cochlear implantation. Data collected in this study will be invaluable in gaining an in-depth understanding of the effects of cochlear implantation in patients with SSD in the context of current FDA guidelines, and lead to better counseling and patient selection for this treatment modality.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •For individuals ages 18 years-old and above, limited benefit from unilateral amplification is defined by test scores of 5% correct or less on monosyllabic consonant-nucleus-consonant (CNC) words in quiet when tested in the ear to be implanted alone.
- •Before implantation with a cochlear implant, individuals with SSD or AHL must have at least 1-month experience wearing a Contra Lateral Routing of Signal (CROS) hearing aid or other relevant device and not show any subjective benefit.
- •Medical and surgical clearance for cochlear implantation.
排除标准
- •Not meeting FDA candidacy criteria for cochlear implantation in SSD
- •Inability to perform audiologic tasks (e.g. non-English speaking)
- •Medical or surgical contraindication to general anesthesia or cochlear implant surgery
- •Does not wish to participate
结局指标
主要结局
Change in Speech recognition in noise
时间窗: Baseline and up to 1 year post-implantation
Change in Speech recognition in noise will be assessed using the percent correct on AzBio with multitalker babble at 8dB signal-to-noise ratio.
Change in Speech recognition in quiet
时间窗: Baseline and up to 1 year post-implantation
Change in Speech recognition in quiet will be assessed using the percent correct on Consonant-Noun-Consonant words and phonemes.
次要结局
- Change in Tinnitus handicap as assessed by the Tinnitus Handicap Inventory(Baseline and up to 1 year post-implantation)
- Change in Health utility as assessed by the Health Utility Index(Baseline and up to 1 year post-implantation)
- Change in Hearing aid benefit as assessed by the Abbreviated Profile of Hearing Aid Benefit(Baseline and up to 1 year post-implantation)
- Change in Spatial hearing as assessed by the Spatial Hearing Questionnaire(Baseline and up to 1 year post-implantation)