NCT04875637

Middle-ear Reflex Testing Using Wideband Acoustic Immittance

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 326 (estimated)
• Sponsor: Mimosa Acoustics · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Hearing Disorders

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	WAI-MEMR	Using wideband acoustic reflectance for middle-ear muscle reflex.

Timeline

• Start date: 2021-01-21
• Primary completion: 2022-08-31
• Completion: 2022-08-31
• First posted: 2021-05-06
• Last updated: 2021-08-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study