Hearing Screening for Childhood Hearing Loss

Overseen By Jihyun R Stephans, BS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Permanent hearing loss, Hearing device, No consent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

28000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 28,000 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.

Do I need to stop my child's current medications for the trial?

The trial information does not specify whether children need to stop taking their current medications.

Is hearing screening using OAE testing safe for children?

Otoacoustic emissions (OAE) testing is widely used and validated as a reliable and objective tool for hearing screening in newborns and young children, with no safety concerns reported in the studies reviewed. ^{1 2 3 4 5}

How does the treatment Otoacoustic Emissions Testing and Pure Tone Audiometry differ from other treatments for childhood hearing loss?

Otoacoustic Emissions Testing and Pure Tone Audiometry are unique because they provide objective data for hearing screening, unlike subjective methods. OAE testing is widely used in newborn and early childhood screenings due to its reliability and ability to quickly identify hearing issues, which is crucial for early intervention. ^{1 2 4 5 6}

What data supports the effectiveness of the treatment Otoacoustic Emissions Testing for childhood hearing loss?

Research shows that otoacoustic emissions (OAE) testing is a reliable and objective tool for hearing screening in young children, often outperforming subjective methods. It is widely used in newborn hearing screening programs and is recognized for its ability to improve screening outcomes in various settings. ^{1 2 4 5 7}

Who Is on the Research Team?

Dylan K Chan, MD, PhD

Principal Investigator

The University of California - San Francisco

Are You a Good Fit for This Trial?

This trial is for preschool children aged between 2 and 6 years who are enrolled in community-based preschool programs. It's not for kids whose parents don't consent, those already screened in this study, absent on screening day, using hearing aids, or known to have permanent hearing loss.

Inclusion Criteria

I am between 2 and 6 years old.

You are currently attending a preschool in your community.

Exclusion Criteria

Parent does not consent for hearing screening

Child was screened previously for this study

My child will not be in preschool on the day of the hearing test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Annually

1 visit (in-person)

Data Collection

Children undergo both PTA and OAE screening to collect data for group allocation

Annually

1 visit (in-person)

Diagnostic Testing

Further testing for children who show potential hearing issues based on screening results

Within 6 months of screening

Follow-up

Participants are monitored for hearing outcomes and effectiveness of screening methods

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Otoacoustic Emissions Testing
• Pure Tone Audiometry

Trial Overview The study tests two methods of detecting hearing loss: a two-stage process with Pure-tone audiometry and Otoacoustic emissions (TS-PO), versus a single-stage Otoacoustic emissions test (SS-O). The goal is to see if SS-O alone can match the effectiveness of TS-PO when used in preschools.

How Is the Trial Designed?

Group I: Single-Stage OAE hearing screening (SS-O) Active Control 2 Interventions

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.

Group II: Two-stage PTA+OAE hearing screening (TS-PO) Active Control 2 Interventions

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.

Otoacoustic Emissions Testing is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Otoacoustic Emissions Testing for:

• Hearing loss detection in newborns and infants
• Hearing screening in preschool and school-age children

Approved in European Union as Otoacoustic Emissions Screening for:

• Neonatal hearing screening
• Pediatric hearing assessment

Approved in Canada as OAE Testing for:

• Newborn hearing screening
• Preschool hearing assessment

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

A review of 10 studies involving 119,714 newborns found that the pooled referral rate for Otoacoustic Emission (OAE) tests was 5.5%, with individual rates varying significantly from 1.3% to 39%.

Delaying the age of initial screening and using higher frequencies in OAE tests can reduce referral rates, suggesting that these adjustments may enhance the accuracy of newborn hearing screenings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Otoacoustic emissions in newborn hearing screening: a systematic review of the effects of different protocols on test outcomes. Akinpelu, OV., Peleva, E., Funnell, WR., et al.[2023]

Implementing otoacoustic emission (OAE) testing as a second-line screening method in a community-based preschool program significantly reduced referral rates from 8% to 5% and improved follow-up rates from 36% to 91% among 3257 children screened.

The use of OAE testing also increased the identification of hearing loss in children who were referred, with the rate of identifying pathology rising from 19% to over 50%, demonstrating its effectiveness in enhancing early detection of hearing issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of otoacoustic emissions to improve outcomes and reduce disparities in a community preschool hearing screening program. Cedars, E., Kriss, H., Lazar, AA., et al.[2020]

In a study of 200 preschool children, transient otoacoustic emissions (TEOAEs) screening resulted in fewer referrals due to cooperation issues compared to conventional pure tone behavioral testing, indicating TEOAEs may be more effective in young children.

TEOAEs screening also showed a higher percentage of children failing immittance screening (62%) compared to pure tone screening (44%), suggesting that TEOAEs may better identify children with potential hearing issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of two methods of hearing screening in the preschool population. Sideris, I., Glattke, TJ.[2014]

In a 10-month study involving 846 children under 5 years old, the use of otoacoustic emissions (OAE) technology in routine healthcare settings successfully identified permanent hearing loss in 3 children, demonstrating its effectiveness in early detection.

With a 96% pass rate for the OAE screening, the study supports the integration of OAE technology into primary care, highlighting its potential as a reliable method for identifying hearing issues in young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using otoacoustic emissions to screen young children for hearing loss in primary care settings. Foust, T., Eiserman, W., Shisler, L., et al.[2013]

A systematic review of 18 studies found that both pure-tone and otoacoustic emission (OAE) screenings can effectively identify hearing loss in preschool- and school-age children, but there is variability in their accuracy due to differences in testing methods.

Pure-tone screening demonstrated higher sensitivity compared to OAE screening, making it the preferred method for detecting hearing loss in children, although future research should standardize testing protocols for better consistency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Evidence-Based Systematic Review on the Diagnostic Accuracy of Hearing Screening Instruments for Preschool- and School-Age Children. Prieve, BA., Schooling, T., Venediktov, R., et al.[2018]

The study involving 133 children aged 2 to 7.5 years demonstrated that otoacoustic emissions (OAE) tests, specifically TEOAE and DPOAE, are reliable and noninvasive methods for early hearing screening, with high sensitivity (94.12% for TEOAE) and good specificity (78.95% for TEOAE).

Hearing loss was identified in 6.76% of the children, primarily conductive hearing loss linked to chronic otitis media, highlighting the importance of early screening to prevent long-term consequences of hearing impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Otoacoustic emissions in hearing screening in children]. Babac, S., Lazić, MP., Tatović, M., et al.[2019]

The GSI 70 OAE screener is a reliable tool for hearing screening in infants and young children, but it has a higher false negative rate compared to brainstem audiometry (ABR), indicating it may miss some cases of cochlear impairment.

Despite its limitations, the GSI 70 screener is sensitive and user-friendly, making it suitable for systematic hearing screenings in young patients, as demonstrated in a study involving 29 children aged 1 month to 7 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distortion evoked otoacoustic emission using GSI 70 analyzer for neonatal screening. Pourbakht, A., Sheykholeslami, K., Kaga, K.[2019]

Citations

1. Ireland pubmed.ncbi.nlm.nih.gov

Otoacoustic emissions in newborn hearing screening: a systematic review of the effects of different protocols on test outcomes. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Use of otoacoustic emissions to improve outcomes and reduce disparities in a community preschool hearing screening program. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

A comparison of two methods of hearing screening in the preschool population. [2014]

4. United States pubmed.ncbi.nlm.nih.gov

Using otoacoustic emissions to screen young children for hearing loss in primary care settings. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

An Evidence-Based Systematic Review on the Diagnostic Accuracy of Hearing Screening Instruments for Preschool- and School-Age Children. [2018]

6. Serbia pubmed.ncbi.nlm.nih.gov

[Otoacoustic emissions in hearing screening in children]. [2019]

7. Ireland pubmed.ncbi.nlm.nih.gov

Distortion evoked otoacoustic emission using GSI 70 analyzer for neonatal screening. [2019]