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临床试验/NCT01780025
NCT01780025已完成不适用

Clinical Trial on Objective Measures in Implantable Hearing Devices for Subjects With Mixed Hearing Loss.

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
1
主要终点
auditory evoked potentials

研究概览

简要总结

The purpose of this study is to measure objectively the coupling from direct acoustic cochlear stimulation to the inner ear with a non-invasive technique of auditory evoked potentials.

详细描述

A new technique, called Direct Acoustic Cochlear Stimulation, has very recently been introduced to restore hearing in patients with severe hearing loss due to the immobility of a small ossicle in the middle ear, the stapes. A piston-like prosthesis, which is placed up into the inner ear, is connected to an implantable mechanical stimulator, named DACS. Unfortunately, as with other active middle ear implants, until now the correct function of this technique cannot be checked during the surgery, leading to a possibly variable outcome of hearing. In this project, the objective auditory evoked potentials, like Auditory Steady-State Response (ASSR), will be used to measure the efficacy of this method of inner ear stimulation. This highly innovative, non-invasive research will provide valuable insight in a new promising way of inner ear stimulation and may give a unique possibility to measure the correct connection from an implantable hearing device to the inner ear.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • mixed hearing loss

排除标准

  • 未提供

结局指标

主要结局

auditory evoked potentials

时间窗: 1 - 3 - 6 months

次要结局

  • speech audiometry(3 and 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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