Preschool Hearing Screening

January 29, 2026 updated by: University of California, San Francisco

Pure-tone Audiometry Versus Otoacoustic Emissions for Preschool Hearing Screening

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

1.1 Study Groups Each subject will undergo both PTA and OAE screening and be assigned post hoc to both TS-PO and SS-O groups with within-subject comparison of hearing screening outcomes.

1.2 Study Interventions In this study, we will compare the effectiveness of 1) TS-PO versus 2) SS-O in a community- based preschool setting to identify hearing loss. The interventions will be implemented in two distinct phases - a data collection phase, in which every subject will undergo both PTA and OAE screening; and group allocation phase, in which every subject will be allocated to both study groups (TS-PO and SS-O) virtually, for within-subject comparison.

1.2.1 Two-stage PTA+OAE Screening (TS-PO) Children will first undergo PTA screening, recommended for children aged 3 and older, using conditioned-play responses to 25 decibel (dB) HL pure tones at 1000, 2000, and 4000 Hz. Screening results include PASS, REFER, or UNABLE to test. Children unable to be tested immediately undergo OAE screening. Children who REFER either the PTA or the OAE test, or are UNABLE to be tested by both, are referred for further evaluation with their pediatrician. This two-stage method successfully screened 99.6% of preschoolers, with 3.1% identified with HL.

1.2.2 Single-Stage OAE Screening (SS-O) Children undergo screening with OAEs, detecting distortion-product OAEs in response to tone pairs centered at 2000, 3000, 4000, and 5000 Hz. Multiple studies support the efficacy of OAE hearing screening in preschool-aged children, with a success rate of 94% and identification of HL in 2.4%.

1.3 Study Timing and Duration Screening, recruitment, and enrollment will occur annually at each preschool site.

Hearing screening will take place annually. Diagnostic testing will be completed within 6 months of hearing screening.

1.4 Attrition and Study Withdrawal Subjects are enrolled at the moment of screening, and all possible outcomes (including failure or inability to complete screening and loss to follow-up) will be included in the final analysis, eliminating the opportunity for voluntary withdrawal or attrition.

1.5 Site Recruitment and Subject Enrollment Preschool site participation models vary based on whether site or study personnel perform hearing screening and case management. Three participation models are outlined based on who conducts screening and diagnosis.

Subject enrollment is performed by Site Personnel. A Screening and Enrollment Log (SEL) is maintained locally, with no identifiable information transmitted to the Study Team. Parents are notified of the hearing screening and study, with written or verbal permission obtained for screening. Children outside the inclusion age range (2.0-6.0 years) or with known permanent HL are not eligible. Children screened in previous years undergo annual screening, with only their first hearing screen used for analysis.

1.6 Study Procedures and Data Collection Screening Pathway Protocol covers site preparation, hearing screening, and screening outcomes. Screening Pathway Protocol involves screening personnel and training, including initial training and monitoring and quality assurance. Training levels of hearing screening personnel are defined as Level 1, Level 2, and Level 3 based on their screening experience. Data Collection involves collecting information on screening outcomes, equipment calibration, OAE and PTA screening protocols, PASS/REFER/UNABLE criteria, and randomization of test order. Randomization ensures unbiased test order presentation and is not related to group allocation.

1.7 Group Allocation

Group allocation occurs after Data Collection. Subjects are assigned to either the TS-PO or SS-O group based on primary data, including PTA and OAE results, hearing screen outcomes (PASS or REFER), and final hearing outcomes (HL or No HL). Allocation involves assigning PASS outcomes based on PTA and OAE results, while REFER outcomes lead to determining the actual final hearing outcome (HL or No HL). This process generates comprehensive datasets for both comparator groups for subsequent data analysis of primary and secondary outcome variables.

Study Type

Interventional

Enrollment (Estimated)

13764

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94158
        • Recruiting
        • The University of California, San Francisco
        • Contact:
        • Principal Investigator:
          • Dylan K Chan, MD, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: 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.
Other: 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.
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.
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants identified with hearing loss
Time Frame: 6 months after screening
Percentage of children identified with hearing loss; (number of children identified with hearing loss) / (number of all screened children)
6 months after screening

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants successfully screened
Time Frame: At screening
Percentage of all children screened who were successfully screened, which compares the ability of each screening method to adequately screen a diverse population of 2-5-year-old children in a community-based preschool setting; (number of all screened - number of those UNABLE) / (number of all screened)
At screening
Percentage of participants referred for evaluation after screening
Time Frame: At screening
Percentage of children referred after hearing screening; (number of those referred)/(number of all screened)
At screening
Percentage of participants identified with hearing loss out of all referred
Time Frame: 6 months after screening
Percentage of children referred that were found to have HL, which reflect the burden on preschools, screening programs, and clinical providers (PCPs and audiologists) due to referrals and false positives; (number of children identified with hearing loss)/(number of all referred)
6 months after screening
Percentage of children with sensorineural hearing loss (SNHL)
Time Frame: 6 months after screening
(number of children identified with SNHL)/(number of all screened)
6 months after screening
Percentage of participants with conductive hearing loss (CHL)
Time Frame: 6 months after screening
(number of children identified with CHL)/(number of all screened)
6 months after screening
Percentage of participants who underwent Intervention for HL
Time Frame: 6 months after screening
Percentage of children who underwent interventions such as cerumen management, medical and surgical management of otitis media, and hearing-aid fitting; (number of those that underwent intervention)/(number of all screened)
6 months after screening

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Patient-Centered Outcomes Research Institute

Investigators

  • Principal Investigator: Dylan K Chan, MD, PhD, The University of California - San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

September 21, 2023

First Submitted That Met QC Criteria

September 21, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CER-2022C2-27634

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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