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?

This trial aims to identify the best method for screening preschoolers for hearing loss to prevent speech and language delays. It compares two methods: a single-stage test using otoacoustic emissions (OAE), which checks for sounds produced by the inner ear, and a two-stage test combining pure-tone audiometry (PTA) and OAE. The goal is to determine if the simpler OAE test alone is as effective as the combined approach in detecting hearing issues. Children attending community-based preschools who do not have known hearing problems or use hearing aids may be eligible to participate. This study could lead to improved early detection and intervention for children who are deaf or hard-of-hearing, enhancing their communication skills. As an unphased trial, this study provides a unique opportunity to contribute to research that could advance early hearing loss detection in 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.

What prior data suggests that these hearing screening methods are safe for preschool children?

Research shows that otoacoustic emissions (OAE) testing and pure tone audiometry (PTA) are safe and well-tolerated methods for checking children's hearing.

OAE testing examines how the inner ear responds to sound. Studies have shown it's quick and causes no discomfort, making it ideal for young children. Experts recommend it as a reliable way to detect hearing problems early, allowing for prompt intervention.

Pure tone audiometry, in contrast, is considered the gold standard for hearing tests. It assesses how well a child can hear different sounds and is effective for children around five years old and up.

Both methods are supported by research and are commonly used in children's hearing tests. They are designed to be safe and comfortable, with no reports of serious side effects, making them trusted tools for early detection of hearing issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative methods for screening childhood hearing loss. The Single-Stage OAE (SS-O) approach is unique because it uses otoacoustic emissions to quickly detect hearing issues without needing a second test if the child passes. On the other hand, the Two-stage PTA+OAE method combines pure tone audiometry with otoacoustic emissions testing, offering a comprehensive assessment. These techniques could streamline the screening process, potentially making it faster and more efficient than traditional methods, which often rely on more extensive and time-consuming evaluations.

What evidence suggests that this trial's hearing screening methods could be effective for identifying hearing loss in preschoolers?

Research shows that checking for hearing issues using otoacoustic emissions (OAE) effectively identifies hearing loss in preschool children. Studies have found that OAE tests successfully detect hearing problems in almost all children tested, making it a dependable method. In this trial, one group of participants will undergo a single-stage OAE hearing screening. Pure-tone audiometry (PTA), often used with OAE, assesses how a child responds to different sounds. In this trial, another group will undergo a two-stage screening using both PTA and OAE. This approach is considered the best way to catch hearing issues early, ensuring quick identification of potential hearing problems, which can help prevent delays in speech and language development. ^{4 6 7 8 9}

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8855310/

Outcomes of an Early Childhood Hearing Screening ... In this cohort study, hearing screening was completed successfully in 99.6% of 6820 children in a resource-limited setting with a low (14%) loss-to-follow-up ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06058767

Study Details | NCT06058767 | Preschool Hearing Screening Multiple studies support the efficacy of OAE hearing screening in preschool-aged children ... Using otoacoustic emissions to screen young children for hearing ...

3. publications.aap.org publications.aap.org/pediatrics/article/132/1/118/31309/Using-Otoacoustic-Emissions-to-Screen-Young

Using Otoacoustic Emissions to Screen Young Children for ... OAE screening holds the potential for being an effective method for helping to identify young children with permanent hearing loss in primary ...

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK580483/

Otoacoustic Emissions - StatPearls - NCBI Bookshelf - NIH The all-or-nothing response from OAE makes OAE an excellent screening test for hearing loss. The universal newborn hearing screening program ...

5. infanthearing.org infanthearing.org/earlychildhood/docs/videotutorialcompanionhandbook.pdf

Early Childhood Hearing Screening & Follow-up OAE screening is the most appropriate method to identify young children at risk for permanent hearing loss because it is: ▫ Accurate. ▫ Feasible--does not ...

6. nationwidechildrens.org nationwidechildrens.org/specialties/audiology/oae-testing

Otoacoustic Emissions (OAE) Testing The OAE (Otoacoustic Emissions) test checks part of the inner ear's response to sound. The test is mostly done on infants and children.

7. asha.org asha.org/practice-portal/professional-issues/childhood-hearing-screening/?srsltid=AfmBOorXxsQXOdwUMqMetQSgp7lWsJ5P-F8Ls_Ypzw827EQvnZg5PpBY

Childhood Hearing Screening Hearing screening for children is a brief test to identify individuals at risk for hearing disorder, impairment, or disability for further intervention.

8. headstart.gov headstart.gov/publication/hearing-screening-fact-sheet

Hearing Screening Fact Sheet | HeadStart.gov For newborns, infants, and toddlers, early childhood hearing experts recommend otoacoustic emissions (OAE) evidence-based hearing screening.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11481827/

Role of Newborn Hearing Screening Done Over One Year ... Otoacoustic emission (OAE) tests are quick, non-invasive, and can detect cochlear function by measuring sound waves produced in the inner ear in ...