Pure-tone Audiometry Versus Otoacoustic Emissions for Preschool Hearing Screening
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 13,764
- Locations
- 1
- Primary Endpoint
- Percentage of participants identified with hearing loss
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 6 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 2:0 - 6:0 years
- •Enrolled in a community-based preschool program
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: Otoacoustic Emissions Testing (Other)
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.
Intervention: Pure Tone Audiometry (Other)
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.
Intervention: Otoacoustic Emissions Testing (Other)
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.
Intervention: Pure Tone Audiometry (Other)
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Percentage of participants with conductive hearing loss (CHL)(6 months after screening)
- Percentage of participants successfully screened(At screening)
- Percentage of participants referred for evaluation after screening(At screening)
- Percentage of children with sensorineural hearing loss (SNHL)(6 months after screening)
- Percentage of participants who underwent Intervention for HL(6 months after screening)
- Percentage of participants identified with hearing loss out of all referred(6 months after screening)