Recruiting

Hearing Screening

Sponsor:

UCLA

Code:

NCT06058767

Conditions

Hearing Loss

Hearing Disorders in Children

Hearing Loss, Sensorineural

Hearing Loss, Conductive

Hearing Loss, Unilateral

Eligibility Criteria

Sex: All

Age: 2 - 6

Healthy Volunteers: Not accepted

Interventions

Otoacoustic Emissions Testing

Pure Tone Audiometry

Study Details

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.

Conditions

Hearing Loss

Hearing Disorders in Children

Hearing Loss, Sensorineural

Hearing Loss, Conductive

Hearing Loss, Unilateral

Study ID

NCT06058767

Start date

Oct 1, 2023

Status verified date

Jan, 2026

Completion date

Feb 1, 2028

Anticipated

Primary completion date

Feb 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 6

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age 2:0 - 6:0 years
2. Enrolled in a community-based preschool program

Exclusion Criteria:

1. Known permanent HL, by parental or school report
2. Use of a hearing assistive device
3. Parent does not consent for hearing screening
4. Child was screened previously for this study
5. Child is not present in preschool on day of hearing screening

Study Design

Enrollment

13764 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

active comparator: Two-stage PTA+OAE hearing screening (TS-PO)

Children 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.

active comparator: Single-Stage OAE hearing screening (SS-O)

Children 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

Otoacoustic Emissions Testing

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.

Pure Tone Audiometry

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.

Primary outcome measure

  • Percentage of participants identified with hearing loss [ Time Frame: 6 months after screening ]

Central Contacts and Locations

Central contacts

Jihyun R Stephans, BS

415-530-0830Jihyun.stephans@ucsf.edu

Locations

The University of California, San Francisco

Recruiting

San Francisco, California, United States, 94158

Contacts

Jihyun R Stephans, BS

415-530-0830jihyun.stephans@ucsf.edu

David K Perez, BA

628-233-9937‬David.perez2@ucsf.edu

Principal Investigator:

Dylan K Chan, MD, PhD

More Information

Sponsor

University of California, San Francisco

Last update posted

Feb 2, 2026

Last verified

Jan, 2026

Keywords

  • Hearing Loss
  • Preschool Hearing Screening
  • Otoacoustic Emissions
  • Pure-Tone Testing
  • Childhood Hearing Screening
  • Childhood Hearing Loss

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-02-02.