An observational study in Unilateral Hearing Loss, sponsored by Father Flanagan's Boys' Home. Recruiting at 3 sites in United States. Open to participants aged 6 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Father Flanagan's Boys' Home · Observational
The goal of this study is to examine the effects of hearing aids and early intervention on hearing, language, and neural development in children with hearing loss in one ear, known as unilateral hearing loss. The main research questions are:
Researchers will collect hearing, language, and neural data and information about each child's access to intervention to examine the longitudinal impact of auditory experience on these outcomes.
Participants and their caregivers will:
More than 5 million children in the United States have hearing loss in one ear, known as unilateral hearing loss (UHL). The primary consequence of UHL is reduced spatial hearing, which is crucial for communication and functioning in everyday listening conditions. Children with UHL (CUHL) are at risk for delays in language and academic outcomes compared to peers with normal hearing in both ears. However, there are large individual differences in developmental outcomes that cannot be explained by the degree of hearing loss in the affected ear. CUHL also have a wide range of spatial hearing abilities, and there is currently limited evidence to link individual differences in spatial hearing to the wide range of developmental outcomes that are observed in CUHL. The lack of predictable patterns of risk for CUHL leads to inconsistent recommendations for audiological intervention or intervention that commences only after a child demonstrates fails to progress in language or academic outcomes. Audiologists have the option to improve spatial hearing in CUHL through fitting a hearing aid on the affected ear, but hearing aids are often not provided or are only provided at later ages, even when UHL is identified in the first few months of life. The lack of consistent practices around provision of hearing aids for CUHL is due to limited evidence that hearing aids can support binaural processing in CUHL. This project seeks to provide mechanistic evidence to support earlier and more timely intervention for CUHL. Researchers will use a metric referred to as auditory dosage to quantify auditory input to the affected ear based on aided and unaided speech audibility and consistency of hearing aid use. Auditory dosage is expected to be the primary predictor of individual differences in outcomes for CUHL. The core hypothesis of the proposal is that CUHL who have higher auditory dosage in their affected ear will have better spatial hearing, which in turn leads to better language and academic outcomes than peers with lower auditory dosage in their affected ear. Experiments will combine behavioral and neuroimaging measures of spatial hearing with and without amplification to assess how auditory dosage in the affected ear influences spatial hearing, language, and academic outcomes in CUHL. Researchers will analyze the effects of hearing aid distortion and auditory dosage on behavioral measures of spatial hearing with and without amplification. Structural and functional neuroimaging, including magnetoencephalography and magnetic resonance imaging, will be used to assess the impact of auditory dosage on spatial hearing in CUHL. The study will use an accelerated longitudinal design to assess the mediating effects of spatial hearing on the association between hearing aid distortion and auditory dosage and language and academic outcomes in CUHL. These experiments will provide mechanistic evidence to help guide decisions about audiological intervention for CUHL and lead to individualized interventions to improve spatial hearing, language, and academic outcomes for CUHL.
51 studies on the registry are indexed under Hearing Loss, Unilateral; 7 are open to participants now.
This study's planned enrollment of 160 is above the median of 75 across 13 observational studies indexed under Hearing Loss, Unilateral.
Browse Hearing Loss, Unilateral studies →Father Flanagan's Boys' Home is the lead sponsor of 19 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Nov 5, 2026. See what changed
Children with normal hearing and children with unilateral hearing loss will be recruited from hospitals, audiology clinics, and education agencies across the United States.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children with unilateral hearing loss with hearing aids and children with unilateral hearing loss without hearing aids.
Device: hearing aids
Hearing aids amplify acoustic sound to provide access to acoustic cues for communication and spatial hearing.
Spatial release from masking
Spatial release from masking is the difference in the speech recognition threshold for 50% sentence keyword recognition in decibels when a target talker and masker are co-located compared to when the target and masker are spatially separated.
Time frame: At enrollment
Morphosyntax
Morphosyntax is the combination of morphology (the internal structure of words) and syntax (the rules for arranging words into sentences), which quantifies how word forms and sentence structures work together to encode meaning. Morphosyntax will be measured using the Comprehensive Assessment of Spoken Language (CASL) Grammatical Morphemes subtest. This standardized instrument has a range from 0 - 20 with an average score of 10. The proportion of children with unilateral hearing loss who fall within the range of children with typical bilateral hearing matched for age and nonverbal intelligence will be compared.
Time frame: At enrollment, 12 months after enrollment and 24 months after enrollment.
Localization
Localization is the ability to identify the direction that a sound originates in the horizontal plane without visual cues. Localization will be measured in sound field in an 11-speaker array where the child must identify the azimuth of sounds presented from different locations. Localization errors are calculated as the difference in degrees between the child's indicated location and the location where the sound is presented. The range of errors can be 0 - 180 degrees. Children with unilateral hearing loss will be compared to children with typical bilateral hearing.
Time frame: At enrollment
Vocabulary
Vocabulary is the ability to understand and use word meaning. Vocabulary will be measured using the The Test of Integrated Language and Literacy Skills (TILLS) Vocabulary Awareness subtest. The subtest has a range of 0 - 20 with a mean score of 10. The proportion of children with unilateral hearing loss who fall within the range of children with typical bilateral hearing matched for age and nonverbal intelligence will be compared.
Time frame: At enrollment, 12 months after enrollment, and 24 months after enrollment.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — All IPD will be shared.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: The study protocol, statistical analysis plan, and informed consent forms will be made available at the beginning of the study. The analytic code will be made available as soon as data analysis commences. These will be made available via the project registry and will be maintained until 5 years after the study end date.
Access criteria: The IPD will be publicly available through a repository.
Data sharing details ↗ · www.osf.io
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Father Flanagan's Boys' Home