Middle-ear Reflex Testing Using Wideband Acoustic Immittance

Hearing Disorders Clinical Trial

— WAI-MEMR  

Official title:

Middle-ear Reflex Testing Using Wideband Acoustic Immittance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04875637
• Other study ID #: WAI-MEMR-MA-16780-02
• Status: Recruiting
• Phase: N/A
• Start date: January 21, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: July 2021
• Source: Mimosa Acoustics
• Contact: Patricia Jeng, Ph.D.
• Phone: 217 359 9740
• Email: psj[@]mimosaacoustics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 326
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Normal hearing or hearing loss

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Hearing Disorders

Intervention

Diagnostic Test:
• WAI-MEMR
Using wideband acoustic reflectance for middle-ear muscle reflex.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Mimosa Acoustics	Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WAI-MEMR	MEMR threshold	Through study completion, an average of 2 years