Recruiting

Observational Study

Sponsor:

Mimosa Acoustics

Code:

NCT04875637

Conditions

Hearing Disorders

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

WAI-MEMR

Study Details

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.

Conditions

Hearing Disorders

Study ID

NCT04875637

Start date

Jan 21, 2021

Status verified date

Jul, 2021

Completion date

Aug 31, 2022

Anticipated

Primary completion date

Aug 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Normal hearing or hearing loss

Exclusion Criteria:

  • None

Study Design

Enrollment

326 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: MEMR Diagnostic Evaluation

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

Interventions

WAI-MEMR

Using wideband acoustic reflectance for middle-ear muscle reflex.

Primary outcome measure

  • WAI-MEMR [ Time Frame: Through study completion, an average of 2 years ]

Central Contacts and Locations

Central contacts

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Research Audiologist

615-936-6920

More Information

Sponsor

Mimosa Acoustics

Last update posted

Aug 5, 2021

Last verified

Jul, 2021

Keywords

  • middle ear muscle reflex
  • wideband acoustic immittance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mimosa Acoustics on 2021-08-05.