Actively Recruiting
Preschool Hearing Screening
Led by University of California, San Francisco · Updated on 2026-02-02
13764
Participants Needed
1
Research Sites
226 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
P
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Preschool Hearing Screening
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 2:0 - 6:0 years
- Enrolled in a community-based preschool program
You will not qualify if you...
- Known permanent hearing loss, 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The University of California, San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
Research Team
J
Jihyun R Stephans, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
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