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Middle-ear Reflex Testing Using Wideband Acoustic Immittance

Middle-ear Reflex Testing Using Wideband Acoustic Immittance

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04875637
Acronym
WAI-MEMR
Enrollment
326
Registered
2021-05-06
Start date
2021-01-21
Completion date
2022-08-31
Last updated
2021-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Disorders

Keywords

middle ear muscle reflex, wideband acoustic immittance

Brief 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.

Detailed 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.

Interventions

DIAGNOSTIC_TESTWAI-MEMR

Using wideband acoustic reflectance for middle-ear muscle reflex.

Sponsors

Vanderbilt University Medical Center
CollaboratorOTHER
Mimosa Acoustics
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* Normal hearing or hearing loss

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
WAI-MEMRThrough study completion, an average of 2 yearsMEMR threshold

Countries

United States

Contacts

Primary ContactPatricia Jeng, Ph.D.
psj@mimosaacoustics.com217 359 9740
Backup ContactChristopher Manrique, AA
crmanrique@mimosaacoustics.com217 359 9740

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026