The EarLens System Long Term Safety and Efficacy Definitive Multi-Center Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 6
- 主要终点
- Change in Mean Aided Word Recognition Scores (WRS) When Compared to the Baseline Unaided Condition.
研究概览
简要总结
The EarLens System is an assistive hearing device that is intended to provide amplification for the treatment of patients with sensorineural hearing impairment. The purpose of this multi-center definitive study is to assess the safety and efficacy of the EarLens System for subjects with bilateral mild to severe sensorineural hearing impairments wearing the fully activated system in their daily lives for a 4 month period of time. This study is designed to support US and International marketing applications to commercialize the EarLens System. The main efficacy hypothesis is that the EarLens System will be shown to improve speech understanding in quiet.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 85 years
- •Mild to severe hearing impairment between 125 to 4000 Hz
- •No significant conductive hearing impairment
- •Able and willing to commit to travel and time demands of the study
排除标准
- •Must not have known or active medical issues that would preclude having a device including:
- •an abnormal tympanic membrane
- •an abnormal middle ear or history of prior middle ear surgery other than tympanostomy tubes
- •an ear canal anatomy that prevents physicians from seeing adequate amount of the tympanic membrane
- •Must not have other known or active medical issues including:
- •history of chronic and recurrent ear infections in the past 24 mouths
- •history of dizziness and/or vertigo in the past 24 months
- •taking medications/treatments with known ototoxic effects
- •a rapidly progressive or fluctuating hearing impairment
- •having been diagnosed with having a compromised immune system
- •Must not fit the definition of a vulnerable subject, as per FDA regulations 21 CFR Parts 50 and 56
- •Must not have an ear canal anatomy that preclude manufacture of the device as determined by EarLens manufacturing personnel
结局指标
主要结局
Change in Mean Aided Word Recognition Scores (WRS) When Compared to the Baseline Unaided Condition.
时间窗: Baseline and 30 days
Change in mean aided Word Recognition Scores (WRS) when compared to the baseline unaided condition. WRS will be measured using 50-word NU-6 (Northwestern University Auditory Test No.6) recorded materials, presented at 45 dB Hearing Level on a per-ear basis with the test ear isolated for measurement and the results, expressed as a percentage of words correct, averaged across the two ears for each subject. All subject data will then be averaged to obtain the means. The baseline unaided measurements will occur prior to device placement, and the aided condition will be measured at least 30 days post device placement.
Audiometric Safety as Shown by no Hearing Change Pre and Post Treatment
时间窗: Baseline and 120 days
The unaided air conduction hearing thresholds will be measured for each individual ear twice before device placement at Visit #1 and averaged to obtain the baseline unaided air conduction hearing thresholds, and the post wear unaided air conduction hearing thresholds will be measured after device removal at Visit #5. A PTA4 (Pure Tone Average at 4 frequencies; 500, 1000, 2000, and 4000 Hz) will be computed both for baseline unaided hearing pre-placement and unaided hearing post-removal for each ear, then averaged across both ears for each subject . A determination of "No Hearing Change" for the subject population will be made if the calculated Hearing Changes of the subject population are 10 dB or less.
次要结局
- Functional Gain Over the Frequency Range From 2000 to 10,000 Hz(Baseline and 30 days)
- Change in Aided HINT 90 Speech Reception Thresholds (SRTs) When Compared to the Baseline Unaided Condition.(Baseline and 30 days)