The EarLens Contact Hearing Device (CHD) Spectrum Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 16
- 主要终点
- Change in Hearing Stability Using Unaided Air Conduction Thresholds.
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 the proposed study (Extended Investigation under the Continued Access Policy) is to continue to allow access to the investigational medical device with the collection of device utility and clinic process-flow data while the marketing application is under review at the FDA.
详细描述
The study is designed to obtain observational data and as such no primary safety or efficacy endpoints or sample sizes are computed. Information gathered about device utility and clinic procedures from the physician, audiologist as well as subject questionnaires will be analyzed for the purpose of optimizing the process flow in different types of practice settings. A subset of relevant safety and efficacy measures from the Definitive Study (DEN150002) will be collected and adverse events will be tracked and reported per applicable regulations.
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 8000 Hz.
- •Asymptomatic of retro-cochlear lesions or cleared of retro-cochlear lesion by MRI.
- •No significant conductive hearing impairment;
- •No more than a 10 dB air-bone gap at 3 of 4 tested frequencies (500, 1000, 2000, or 4000 Hz)
- •Normal Type A tympanometry (indicating normal mobility of the tympanic membrane and middle ear bones)
- •Greater than or equal to 50% on clinical speech discrimination demonstrating an ability to benefit from amplification;
- •Able and willing to commit to the travel and time demands of the study (available for 5 months or longer) and able to comprehend and comply with the study materials and instructions
- •Experience with 1 or 2 air conduction hearing aids or previously evaluated for use with hearing aids;
- •Fluent speaker of American English due to use of American English study materials
排除标准
- •The Subject must not have known or active medical issues that would preclude having a hearing device, including:
- •an abnormal TM (deemed perforated, inflamed or has a dimeric or monomeric area, or in any other way abnormal);
- •an abnormal middle ear or a history of prior middle ear surgery other than tympanostomy tubes;
- •an ear canal anatomy that prevents the physician from seeing an adequate amount of the tympanic membrane.
- •an anatomical configuration of the external auditory canal that prevents satisfactory placement of the TMT
- •a history of chronic and recurrent ear infections in the past 24 months;
- •a rapidly progressive or fluctuating hearing impairment;
- •diagnosed with having a compromised immune system which may impact the tissue of the auricle or ear canal, such as keratosis obturans, ichthyosis, eczema of the auricle or ear canal, or received radiation of the head ever or chemotherapy for cancer within the last six years.
- •Must not fit the definition of a vulnerable subject, as per FDA regulations 21 CFR Parts 50 and 56
结局指标
主要结局
Change in Hearing Stability Using Unaided Air Conduction Thresholds.
时间窗: Baseline and up to 90-day.
Hearing sensitivity was monitored using earphones with the TMT (Tympanic Membrane Transducer) in place, but with the audio processor removed. Baseline and study end measurements were compared. A PTA4 (Pure Tone Average at 4 frequencies; 500, 1000, 2000 and 4000 Hz) was computed both for baseline unaided hearing post-placement with TMT in place, and unaided hearing with TMT in place at the 90-day for each ear, then averaged across both ears for each subject. A determination of "No Hearing Change" for the subject was made if the calculated hearing changes of the subject population are 10dB or less.
次要结局
- Change in Speech Understanding in Noise.(Baseline and up to 90-day.)
- Change in Functional Gain Over the Frequency Range From 2000 to 10,000 Hz.(Baseline and up to 90-day.)
- Change in Subject's Self-Perceived Ability to Communicate.(Baseline and up to 90-day.)