Middle Ear Implant With MET V for Mixed Hearing Loss
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 130
- 主要终点
- CNC Word Recognition Scores
研究概览
简要总结
The purpose and objective of this study is to evaluate the safety and efficacy of the MET V System for the treatment of individuals with mixed hearing loss.
详细描述
The MET V System is an investigational, fully-implantable middle ear hearing prosthesis. A mixed hearing loss has both a sensorineural component and a conductive component that results when sound being delivered to an impaired cochlea is attenuated by a disordered outer or middle ear.
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
- •Adult men or women, 18 years of age or older
- •Moderate to severe mixed hearing loss, as a result of a combination of sensorineural hearing loss and chronic ear disease, prior failed tympanoplasties, severe otosclerosis, radical mastoidectomy, or congenital abnormality as evidenced by the following in the ear to be implanted:
- •Bone conduction thresholds are measurable at 0.5,1,2,3 and 4 kHz
- •Bone conduction thresholds are 20 dB or poorer at greater than 2 kHz
- •Air conduction thresholds are 35 dB or poorer at 0.5,1,2,3 and 4 kHz
- •Air-bone gap in ear to be implanted is greater than 15 dB at three or more frequencies from 0.5 - 4 kHz
- •Word recognition appropriate for sensorineural component of loss
- •Non-fluctuating and stable hearing status
- •a. as defined as by no significant change or progression in the bone conduction thresholds >15dB at two consecutive octaves for at least 12 months.
- •English Speaking (fluent)
- •Realistic expectations for the device
- •Willingness to sign the informed consent and participate in the study
排除标准
- •Vestibular disorder, including Meniere's Syndrome
- •Recurring otitis media over the past year (>2/year)
- •Non-organic hearing loss
- •Retrocochlear hearing loss
- •Central auditory nervous system disorder
- •Medical contraindications to surgery or use of the device
- •Women who are pregnant or at risk of becoming pregnant
- •Developmentally delayed or manifesting organic brain dysfunction
- •Persons with physical or geographic limitations that may render them incapable of completing scheduled study visits
结局指标
主要结局
CNC Word Recognition Scores
时间窗: Occurs at 3, 6, and 12 month follow-up visits
* The primary efficacy endpoint is the mean change in the implant ear from CNC word recognition (unaided for mixed hearing loss and aided with hearing aid for sensorineural hearing loss) scores at the six month follow-up. * The secondary efficacy endpoints include a speech perception outcome (BKB-SIN) measure and a subjective questionnaire (APHAB). The endpoint for the BKB-SIN is the mean change in score at the six month follow-up compared to the control. The endpoint for the subjective questionnaire (APHAB)is post-operative responses compared to the pre-operative control responses.
次要结局
- BKB-SIN and Subject Questionnaires(Will be monitored to 12 months)