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

Primary Purpose

Hearing Disorders

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WAI-MEMR
Sponsored by
Mimosa Acoustics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hearing Disorders focused on measuring middle ear muscle reflex, wideband acoustic immittance

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Normal hearing or hearing loss

Exclusion Criteria:

  • None

Sites / Locations

  • Vanderbilt University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

MEMR Diagnostic Evaluation

Arm Description

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

Outcomes

Primary Outcome Measures

WAI-MEMR
MEMR threshold

Secondary Outcome Measures

Full Information

First Posted
April 28, 2021
Last Updated
July 30, 2021
Sponsor
Mimosa Acoustics
Collaborators
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04875637
Brief Title
Middle-ear Reflex Testing Using Wideband Acoustic Immittance
Acronym
WAI-MEMR
Official Title
Middle-ear Reflex Testing Using Wideband Acoustic Immittance
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 21, 2021 (Actual)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
August 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mimosa Acoustics
Collaborators
Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Disorders
Keywords
middle ear muscle reflex, wideband acoustic immittance

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
326 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MEMR Diagnostic Evaluation
Arm Type
Other
Arm Description
Middle Ear Muscle Reflex using wideband acoustic reflectance to assess hearing status.
Intervention Type
Diagnostic Test
Intervention Name(s)
WAI-MEMR
Intervention Description
Using wideband acoustic reflectance for middle-ear muscle reflex.
Primary Outcome Measure Information:
Title
WAI-MEMR
Description
MEMR threshold
Time Frame
Through study completion, an average of 2 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Normal hearing or hearing loss Exclusion Criteria: None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Jeng, Ph.D.
Phone
217 359 9740
Email
psj@mimosaacoustics.com
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher Manrique, AA
Phone
217 359 9740
Email
crmanrique@mimosaacoustics.com
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda J Hood, Ph.D.
Phone
615-936-6920
Email
Linda.j.hood@vanderbilt.edu
First Name & Middle Initial & Last Name & Degree
Research Audiologist
Phone
615-936-6920

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Middle-ear Reflex Testing Using Wideband Acoustic Immittance

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