Otoacoustic Emission Suppression Study

Otoacoustic Emission Suppression in Clinical Populations

The focus of this project is on a physiologic auditory response called the Medial Olivocochlear Reflex (MOCR) that assesses peripheral neural function. While neural hearing loss is a significant auditory disorder in patients of all ages, more than 50% of newborn infants are screened with a technology that is not sensitive to abnormalities in neural function. The development of a time-efficient and sensitive test system to assess the MOCR will provide significant benefit to infants and patients of all ages with neural deficits who would otherwise go undetected.

Study Overview

• Status: Completed
• Conditions: Neonatal Hearing Loss
• Intervention / Treatment: Diagnostic test: Medial-Olivocochlear Reflex (MOCR) Strength Measurement

Detailed Description

The objective of this study is to develop an optimized hearing testing method using otoacoustic emissions, that can be used to efficiently assess peripheral neural function (including retrocochlear disorders) using the medial olivocochlear reflex (MOCR). Measuring neural function via the MOCR. This reflex has been shown to be abnormal in patients with neural disorders. The focus of this project will be the development of a screening method that incorporates OAE screening and measurement of the MOCR in the same test procedure. The target population in the proposed research is infants, particularly those in environments where auditory brainstem response (ABR) screening is not performed routinely. Addition of the MOCR to screening where ABR is not performed will address the shortcoming of OAE screening which misses neural forms of hearing loss.

• Study Type: Observational
• Enrollment (Actual): 236

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adults and newborns with normal middle ear function and no external ear abnormalities such as atresia

Description

Inclusion Criteria:

• Normal middle-ear function
• Present TEOAEs.

Exclusion Criteria:

• Atresia or other external ear abnormalities not allowing recording of OAEs

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Newborns; Newborns from NICU or well-baby nursery.	Diagnostic test: Medial-Olivocochlear Reflex (MOCR) Strength Measurement; Otoacoustic emissions (OAE) will be recorded using an ear probe with and without an efferent Medial-Olivocochlear Reflex (MOCR) elicitor.
Newborn Hearing Screening Results; Newborns identified as having difficulty passing newborn hearing screening.	Diagnostic test: Medial-Olivocochlear Reflex (MOCR) Strength Measurement; Otoacoustic emissions (OAE) will be recorded using an ear probe with and without an efferent Medial-Olivocochlear Reflex (MOCR) elicitor.
Adults with Normal Hearing; Adults with normal hearing thresholds.	Diagnostic test: Medial-Olivocochlear Reflex (MOCR) Strength Measurement; Otoacoustic emissions (OAE) will be recorded using an ear probe with and without an efferent Medial-Olivocochlear Reflex (MOCR) elicitor.
Participants with Neural Hearing Loss; Participants, children and adults, with neural hearing loss.	Diagnostic test: Medial-Olivocochlear Reflex (MOCR) Strength Measurement; Otoacoustic emissions (OAE) will be recorded using an ear probe with and without an efferent Medial-Olivocochlear Reflex (MOCR) elicitor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Otoacoustic Suppression Measure	The decibel (dB) Sound Pressure Level (SPL) of the otoacoustic emission (OAE) response will be measured when recorded with and without an elicitor. The dB difference between the two measures, the OAE suppression, is used to calculate the Medial-Olivocochlear Reflex (MOCR) Strength. The elicitor is presented using a temporally separated and spectrally separated method, resulting in the two MOCR Strength measurements reported.	Within 48 hours of measurement

Collaborators and Investigators

• Sponsor: Intelligent Hearing Systems
• Collaborators: Vanderbilt University; National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Study Director: Linda J Hood, PHD, Vanderbilt University Medical School; Principal Investigator: Rafael E Delgado, PHD, Intelligent Hearing Systems Corp

Publications and helpful links

General Publications

• Hood LJ, Berlin CI, Bordelon J, Rose K. Patients with auditory neuropathy/dys-synchrony lack efferent suppression of transient evoked otoacoustic emissions. J Am Acad Audiol. 2003 Aug;14(6):302-13.
• Hood LJ, Berlin CI, Hurley A, Cecola RP, Bell B. Contralateral suppression of transient-evoked otoacoustic emissions in humans: intensity effects. Hear Res. 1996 Nov 1;101(1-2):113-8. doi: 10.1016/s0378-5955(96)00138-4.
• Abdala C, Mishra S, Garinis A. Maturation of the human medial efferent reflex revisited. J Acoust Soc Am. 2013 Feb;133(2):938-50. doi: 10.1121/1.4773265.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): June 23, 2023
• Study Completion (Actual): July 12, 2023

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: February 8, 2021
• First Posted (Actual): February 11, 2021

Study Record Updates

• Last Update Posted (Actual): August 16, 2024
• Last Update Submitted That Met QC Criteria: August 15, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: MOCR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The results from the project will be shared by presenting results at scientific conferences and publishing results in scientific journals. In addition, a de-identified database containing subject gender, age at recording, raw MOCR recordings, recording parameters and spectral analysis parameters will be maintained. The data will be shared with other centers conducting similar research under appropriate IRB approval.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No