WAI-MEMR: Middle-ear Reflex Testing Using Wideband Acoustic Immittance

Sponsor

Mimosa Acoustics (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04875637

Collaborator

Vanderbilt University Medical Center (Other)

326

Enrollment

Location

Arm

19.3

Anticipated Duration (Months)

16.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hearing Disorders	Diagnostic Test: WAI-MEMR	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

326 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Middle-ear Reflex Testing Using Wideband Acoustic Immittance

Actual Study Start Date :

Jan 21, 2021

Anticipated Primary Completion Date :

Aug 31, 2022

Anticipated Study Completion Date :

Aug 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: MEMR Diagnostic Evaluation Middle Ear Muscle Reflex using wideband acoustic reflectance to assess hearing status.	Diagnostic Test: WAI-MEMR Using wideband acoustic reflectance for middle-ear muscle reflex.

Arm

Intervention/Treatment

Other: MEMR Diagnostic Evaluation

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

Diagnostic Test: WAI-MEMR

Using wideband acoustic reflectance for middle-ear muscle reflex.

Outcome Measures

Primary Outcome Measures

WAI-MEMR [Through study completion, an average of 2 years]
MEMR threshold

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Normal hearing or hearing loss

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232

Sponsors and Collaborators

Mimosa Acoustics
Vanderbilt University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mimosa Acoustics

ClinicalTrials.gov Identifier:

NCT04875637

Other Study ID Numbers:

WAI-MEMR-MA-16780-02

First Posted:

May 6, 2021

Last Update Posted:

Aug 5, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Mimosa Acoustics

middle ear muscle reflex

wideband acoustic immittance

Additional relevant MeSH terms:

Hearing Disorders

Study Results

No Results Posted as of Aug 5, 2021