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Middle-ear Reflex Testing Using Wideband Acoustic Immittance (WAI-MEMR)

M

Mimosa Acoustics

Status

Unknown

Conditions

Hearing Disorders

Treatments

Diagnostic Test: WAI-MEMR

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04875637
WAI-MEMR-MA-16780-02

Details and patient eligibility

About

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.

Full 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.

Enrollment

326 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Normal hearing or hearing loss

Exclusion criteria

  • None

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

326 participants in 1 patient group

MEMR Diagnostic Evaluation
Other group
Description:
Middle Ear Muscle Reflex using wideband acoustic reflectance to assess hearing status.
Treatment:
Diagnostic Test: WAI-MEMR

Trial contacts and locations

1

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Central trial contact

Patricia Jeng, Ph.D.; Christopher Manrique, AA

Data sourced from clinicaltrials.gov

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