跳至主要内容
临床试验/NCT04875637
NCT04875637Unknown不适用

Middle-ear Reflex Testing Using Wideband Acoustic Immittance

Mimosa Acoustics1 个研究点 分布在 1 个国家目标入组 326 人开始时间: 2021年1月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
326
试验地点
1
主要终点
WAI-MEMR

研究概览

简要总结

This project will assess the middle-ear muscle reflex using wideband acoustic immittance which is a valuable method for evaluating infants, children, and adults. The developments will facilitate clinical applications that include hearing screening and diagnostic evaluation of persons of all ages with normal hearing and with hearing loss.

详细描述

Measurement of middle-ear muscle reflexes (MEMR) constitutes an important component of the standard of care in auditory function assessment and diagnostic audiology. An important component of the middle-ear test battery involves characterizing neural function through the eighth nerve-brainstem pathway which is accomplished through measurement of the MEMR. The evaluation component of this project will involve testing of human subjects using wideband acoustic immittance in the evaluation of middle-ear muscle reflexes. Subjects in this project will be infants, children and adults with normal hearing as well as with conductive, sensory, and neural hearing loss. All subjects will receive wideband acoustic immittance (WAI) and middle-ear muscle reflex (MEMR) testing. Baseline testing includes pure tone audiometry and otoacoustic emissions.

研究设计

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

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •Normal hearing or hearing loss

排除标准

  • 未提供

研究组 & 干预措施

MEMR Diagnostic Evaluation

Other

Middle Ear Muscle Reflex using wideband acoustic reflectance to assess hearing status.

干预措施: WAI-MEMR (Diagnostic Test)

结局指标

主要结局

WAI-MEMR

时间窗: Through study completion, an average of 2 years

MEMR threshold

次要结局

未报告次要终点

研究者

发起方
Mimosa Acoustics
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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