跳至主要内容
临床试验/NCT00582946
NCT00582946已完成1 期

Wide-Bandwidth Open Canal Hearing Aid For Better Multitalker Speech Understanding

EarLens Corporation2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2006年5月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
16
试验地点
2
主要终点
Maximum Effective Sound Pressure Level (MEPO)

研究概览

简要总结

Our goal is to design and build a new hearing aid system, which mitigates the most common complaints that hearing aid users have. These include hearing in multi-talker situations, poor sound quality, unwanted whistling resulting from feedback, and a dislike of the sound of their own voice. Current efforts, with limited success, use signal processing methods rather than restoring more closely the normal auditory function. We plan to achieve our goal by reducing to practice three key enabling concepts. The first is to replace the current acoustic transducer with a non-acoustic mechanical output transducer that directly actuates the tympanic membrane (TM). This transducer, called the EarLens, floats on the tympanic membrane in a manner similar to the way a contract lens floats on the eye. The second is to increase the output bandwidth of the hearing aid. The third key concept is to place a wide-bandwidth microphone in the ear canal to capture the pinna diffraction cues similarly to the way the normal ear functions. Our central hypothesis is that a hearing aid that delivers amplified wide-bandwidth mechanical stimuli, directionally dependent cues, in an open canal configuration will perform better than conventional hearing aids when there are competing talkers in the background. First phase includes verification the capability of the system to deliver sufficient maximum equivalent pressure output (MEPO) to treat the degree of hearing loss in the target fitting range.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hearing loss less than 60 dB at any frequency, no conductive hearing loss

排除标准

  • Collapsed ear canal, damaged or repaired middle ear, too much sensory hearing loss

结局指标

主要结局

Maximum Effective Sound Pressure Level (MEPO)

时间窗: 1 month

A primary outcome measure of interest is an estimate of the insitu maximum equivalent pressure output (MEPO) of the EarLens system, which represents the sound pressure level that would have to be applied at the eardrum (or tympanic membrane) to produce the same degree of tympanic membrane (TM) vibration that the EarLens system produces with the coil current set to its maximum value, and given the anatomical constraints on the coupling between the coil and magnet for a given subject. The target fitting range included hearing loss up to 60 decibels (dB) Hearing Level (HL). In order for the device to be an effective hearing aid for this target population, the maximum output of the device needs to be able to provide output and gain to treat this maximum hearing loss.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Principal Investigator
主要研究者

Suzy Levy, Ph.D.

Director of Clinical, For Sunil Puria, Chief Scientist (no longer with company)

EarLens Corporation

研究点 (2)

Loading locations...

相似试验

Wide-Bandwidth Open Canal Hearing Aid For Better... | 临床试验