Preschool Hearing Screening
Pure-tone Audiometry Versus Otoacoustic Emissions for Preschool Hearing Screening
1 other identifier
interventional
13,764
1 country
1
Brief Summary
Children who are deaf or hard-of-hearing (D/HH) are at risk of speech and language delays, which can be mitigated through early identification and intervention. Identifying hearing loss (HL) during preschool is crucial, but the most effective hearing screening method for preschoolers remains uncertain. The purpose of this study is to learn whether, compared to the gold-standard two-stage Pure-tone audiometry (PTA) + otoacoustic emissions (OAE) screening (TS-PO), single-stage OAE (SS-O) screening alone is not inferior at identifying hearing loss when performed in a community-based preschool setting. This study holds the potential to improve early hearing loss detection and intervention among D/HH children, reducing the likelihood of speech and language delays. A diverse group of 13,764 preschool-age children across community-based preschool centers will be recruited. The intervention involves all subjects undergoing both PTA and OAE screening, with the order determined through randomization. Children who show potential hearing issues based on screening results or teacher concerns will receive further testing to determine the final hearing outcome. Group allocation will be post-hoc, based on their screening results. In addition to the primary objective, the study will compare other hearing screening measures and outcomes between the two methods (TS-PO and SS-O). This approach aims to reflect the real-life effectiveness of hearing screening in a diverse population. Ultimately, the study seeks to provide insights into an optimal hearing screening method that could prevent speech and language delays among D/HH children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2023
CompletedFirst Posted
Study publicly available on registry
September 28, 2023
CompletedStudy Start
First participant enrolled
October 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2028
February 2, 2026
January 1, 2026
4.3 years
September 21, 2023
January 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of participants identified with hearing loss
Percentage of children identified with hearing loss; (number of children identified with hearing loss) / (number of all screened children)
6 months after screening
Secondary Outcomes (6)
Percentage of participants successfully screened
At screening
Percentage of participants referred for evaluation after screening
At screening
Percentage of participants identified with hearing loss out of all referred
6 months after screening
Percentage of children with sensorineural hearing loss (SNHL)
6 months after screening
Percentage of participants with conductive hearing loss (CHL)
6 months after screening
- +1 more secondary outcomes
Study Arms (2)
Two-stage PTA+OAE hearing screening (TS-PO)
ACTIVE COMPARATORChildren initially undergo a PTA screening test, recommended by the American Academy of Audiology and supported by published evidence. This screening assesses their hearing ability through conditioned-play responses to 25 dB HL pure tones at 1000, 2000, and 4000 Hz, yielding results of PASS, REFER, or UNABLE to test. Those UNABLE to be tested will receive a second OAE screening. Children who REFER either the PTA or OAE test, or are UNABLE to be tested by both, are referred to their pediatrician for further evaluation and management. All children will undergo both PTA and OAE screening and the group allocation will be determined post hoc.
Single-Stage OAE hearing screening (SS-O)
ACTIVE COMPARATORChildren undergo only screening with OAEs, detecting distortion-product OAEs in response to tone pairs centered at 2000, 3000, 4000, and 5000 Hz. If they PASSED the OAE, they would be assigned a PASS for the SS-O Hearing Screen outcome; if they REFERRED or were UNABLE to test, they would be assigned a REFER. All children will undergo both PTA and OAE screening and the group allocation will be determined post hoc.
Interventions
The PTA testing is a hearing screening method used to assess an individual's ability to hear pure tones at different frequencies and at different sound levels. It is a behavioral test in which a child is conditioned to perform a play-based task upon hearing sounds at multiple frequencies.
An OAE (Otoacoustic Emissions) test is a non-invasive, quick, and commonly used hearing screening method. It is a non-behavioral test to access the function of the cochlea, which is the inner ear's sensory organ responsible for detecting sound.
Eligibility Criteria
You may qualify if:
- Age 2:0 - 6:0 years
- Enrolled in a community-based preschool program
You may not qualify if:
- Known permanent HL, by parental or school report
- Use of a hearing assistive device
- Parent does not consent for hearing screening
- Child was screened previously for this study
- Child is not present in preschool on day of hearing screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of California, San Francisco
San Francisco, California, 94158, United States
Related Publications (4)
Prieve BA, Schooling T, Venediktov R, Franceschini N. An Evidence-Based Systematic Review on the Diagnostic Accuracy of Hearing Screening Instruments for Preschool- and School-Age Children. Am J Audiol. 2015 Jun;24(2):250-67. doi: 10.1044/2015_AJA-14-0065.
PMID: 25760393BACKGROUNDCedars E, Kriss H, Lazar AA, Chan C, Chan DK. Use of otoacoustic emissions to improve outcomes and reduce disparities in a community preschool hearing screening program. PLoS One. 2018 Dec 10;13(12):e0208050. doi: 10.1371/journal.pone.0208050. eCollection 2018.
PMID: 30532159BACKGROUNDBrodie KD, David AP, Kriss H, Chan DK. Outcomes of an Early Childhood Hearing Screening Program in a Low-Income Setting. JAMA Otolaryngol Head Neck Surg. 2022 Apr 1;148(4):326-332. doi: 10.1001/jamaoto.2021.4430.
PMID: 35175312BACKGROUNDFoust T, Eiserman W, Shisler L, Geroso A. Using otoacoustic emissions to screen young children for hearing loss in primary care settings. Pediatrics. 2013 Jul;132(1):118-23. doi: 10.1542/peds.2012-3868. Epub 2013 Jun 3.
PMID: 23733793BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dylan K Chan, MD, PhD
The University of California - San Francisco
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2023
First Posted
September 28, 2023
Study Start
October 1, 2023
Primary Completion (Estimated)
February 1, 2028
Study Completion (Estimated)
February 1, 2028
Last Updated
February 2, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share