Office of Device Evaluation Lead-MED-EL EAS Extended f/u Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 7
- 主要终点
- Percentage of Words Correct As Assessed by CUNY Sentence Test.
研究概览
简要总结
The MED-EL EAS Extended Follow-up Study is an extended follow-up of the subjects who were enrolled in the pivotal study to assess long-term safety and device performance.
详细描述
The study will be conducted as a prospective, non-controlled, non-randomized, multicenter study at the 14 sites. Up to 68 available subjects who were enrolled in the pivotal study will be invited to participate in the extended follow-up. Study subjects will be followed for a minimum of 5 years 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
- Other
- 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
- •18 years of age or older at the time of implantation
- •Severe to profound sensorineural hearing loss for frequencies greater than 1500 Hz (i.e., threshold no better than 70 dB HL at 2000-8000 Hz)
- •Low-frequency thresholds up to and including 500 Hz no poorer than 65 dB HL
- •CNC word recognition score less than or equal to 60% in the ear to be implanted
- •CNC word recognition score less than or equal to 60% in the contralateral ear
- •English spoken as the primary language
排除标准
- •Conductive, retrocochlear, or central auditory disorder
- •Hearing loss in the ear to be implanted that has demonstrated a recent fluctuation at two or more frequencies of 15 dB in either direction in the last 2 years
- •Any physical, psychological, or emotional disorder that interferes with surgery or the ability to perform on test and rehabilitation procedures
- •Developmental delays or organic brain dysfunction
- •Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations
- •Unwillingness or inability of the candidate to comply with all investigational requirements
研究组 & 干预措施
Study procedures
干预措施: Electric-Acoustic Stimulation (EAS) Cochlear Implant System (Device)
结局指标
主要结局
Percentage of Words Correct As Assessed by CUNY Sentence Test.
时间窗: Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial
Long-term effectiveness of the Electric-Acoustic System will be assessed by speech perception testing in noise with CUNY sentences completed through five years post-implantation.
次要结局
- Classification of Residual Hearing at 5 Years Post Operatively as a Function of the HEARRING SCALE.(Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial)
- Percentage of Words Correct as Assessed by CNC Words in Quiet.(Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial)
- Subjective Benefit From EAS Through 5 Years Post Implantation Measured on the APHAB (Abbreviated Profile Hearing Aid Benefit) Questionnaire.(Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial)