Light-Driven Contact Hearing Aid for Broad-Spectrum Amplification: Safety and Effectiveness Pivotal Study.
Light-Driven Contact Hearing Aid for Broad-Spectrum Amplification: Safety and Effectiveness Pivotal Study.
复制标题
DOI：
10.1097/mao.0000000000001300
复制
发表时间：
2017-03
期刊：
影响因子：
--
通讯作者：
Puria S
中科院分区：
文献类型：
--
作者：
Gantz BJ;Perkins R;Murray M;Levy SC;Puria S
证明光驱动接触式助听器的安全性和有效性，以支持FDA批准。一项单组、开放标签研究性器械临床试验。两个私人诊所和一个医院的耳鼻喉科诊所。43例（86耳）轻度至重度双侧感音神经性听力损伤受试者。经由光驱动接触式助听器递送的双侧放大，所述光驱动接触式助听器包括具有定制平台的鼓室透镜（透镜）以直接驱动凸耳，以及耳后声音处理器（处理器），所述耳后声音处理器将声音编码成光脉冲以向所述透镜无线递送信号和功率。主要安全性终点是在120天测量间隔时确定残余无辅助听力“无变化”（PTA 4<10 dB）。 主要疗效终点是在30天测量间隔时使用NU-6进行的单词识别与基线无辅助病例相比的改善。次要疗效终点包括使用全向和定向麦克风时，2至10 kHz的功能增益和噪声中语音相对于基线无辅助情况的改善。 研究中86只耳朵的结果确定PTA 4的平均变化为-0.40 dB，表明残余听力没有变化（p <0.0001）。 未发生严重器械或手术相关不良事件或非预期不良事件。与无辅助的表现相比，有Earlens辅助的单词识别显著改善（p <0.0001），平均合理化反正弦单位为35%。 在2至10 kHz范围内，平均功能增益为31 dB。 对于全方向和定向麦克风模式，噪音听力测试中，与无辅助情况相比，平均语音识别阈值提高分别为0.75 dB（p = 0.028）和3.14 dB（p <0.0001）。 安全性和有效性数据支持获得FDA批准的重新分类510（k）提交。
Demonstrate safety and effectiveness of the light-driven contact hearing aid to support FDA clearance. A single-arm, open-label investigational-device clinical trial. Two private-practice and one hospital-based ENT clinics. Forty-three subjects (86 ears) with mild-to-severe bilateral sensorineural hearing impairment. Bilateral amplification delivered via a light-driven contact hearing aid comprising a Tympanic Lens (Lens) with a customized platform to directly drive the umbo and a behind-the-ear sound processor (Processor) that encodes sound into light pulses to wirelessly deliver signal and power to the Lens. The primary safety endpoint was a determination of “no change” (PTA4 < 10 dB) in residual unaided hearing at the 120-day measurement interval. The primary efficacy endpoint was improvement in word recognition using NU-6 at the 30-day measurement interval over the baseline unaided case. Secondary efficacy endpoints included functional gain from 2 to 10 kHz and speech-in-noise improvement over the baseline unaided case using both omnidirectional and directional microphones. The results for the 86 ears in the study determined a mean change of −0.40 dB in PTA4, indicating no change in residual hearing (p < 0.0001). There were no serious device- or procedure-related adverse events, or unanticipated adverse events. Word recognition aided with the Earlens improved significantly (p < 0.0001) over the unaided performance, by 35% rationalized arcsine units on average. Mean functional gain was 31 dB across 2 to 10 kHz. The average speech-recognition threshold improvement over the unaided case for the Hearing in Noise Test was 0.75 dB (p = 0.028) and 3.14 dB (p < 0.0001) for the omnidirectional and directional microphone modes, respectively. The safety and effectiveness data supported a de novo 510(k) submission that received clearance from the FDA.