Actively Recruiting

Phase Not Applicable
Age: 2Years - 6Years
All Genders
NCT06058767

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

Age: 2Years - 6Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 2:0 - 6:0 years
  • Enrolled in a community-based preschool program
Not Eligible

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

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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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Preschool Hearing Screening | DecenTrialz