Unilateral Hearing LossSHINENCT07911852
Audiological Rehabilitation of Children With Unilateral Hearing Loss
An observational study of Unilateral Hearing Loss, run by Father Flanagan's Boys' Home at 3 sites in United States.
Trial summary
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: 1. Read more about this study
- Who is it for?
- Ages 6 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Unilateral Hearing Loss
- What is being tested?
- hearing aids
- Type of treatment
- Medical device
- How many people
- 160 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jul 2026to 30 Jun 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children with normal hearing and children with unilateral hearing loss will be recruited from hospitals, audiology clinics, and education agencies across the United States.
Who may be able to join
- Children with normal hearing will have hearing thresholds from 0.25 - 8 kHz ≤15 dB HL in both ears.
- Children with normal hearing will have no history of neurodevelopmental, communication, or sensory disorders.
- Children with unilateral hearing loss will have hearing thresholds that meet the criterion for CNH in the better ear and three-frequency (.5, 1, \& 2 kHz) pure-tone average ≥ 20 - <70 dB HL or two or more hearing thresholds ≥ 20 - < 70 dB HL from 2-8 kHz in the poorer ear. H
- Children with unilateral hearing loss can have conductive, mixed, or sensorineural hearing loss.
Who cannot join
- Individuals with a cochlear implant, rerouting device, or an implanted bone conduction device will be excluded due to neuroimaging restrictions with implantable devices.
- For neuroimaging experiments only:
- Current use of the following medications: psychotropic medications or other medications with significant CNS effects (e.g., antidepressants, antipsychotics, anticonvulsants, alpha-agonists, adrenergic blockers, lithium, and sedating antihistamines), or other excluded medication.
- Current major psychiatric diagnosis.
- Current substance abuse or substance dependence.
- Diagnosis of a known neurological disorder or any major medical illness or injury impacting neurological/psychiatric function (e.g., diabetes, epilepsy, cerebral palsy, HIV, traumatic brain injury, significant environmental/toxic injury, neurodegenerative disorder, past meningitis/encephalitis).
- General medical conditions: any major medical conditions that would interfere with involvement in the study or may affect CNS function as judged by the investigative team.
- Presence of any ferrous metal implant, including orthodonture or pacemaker, which may interfere with the MEG data acquisition and/or be an MRI safety concern.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
University of North Carolina, Chapell Hill
Chapell Hill, North Carolina, 27599
Caitlin Sapp, PhD, 984-974-4479, Caitlin.Sapp@unchealth.unc.edu
Emily Buss, PhD
- Not yet recruiting
University of Iowa
Iowa City, Iowa, 52242
Wendy Fick, 319-335-8749, wendy-fick@uiowa.edu
Elizabeth Walker, PhD
- Recruiting
Boys Town National Research Hospital
Omaha, Nebraska, 68131
Amanda Knihal, 531-355-6533, Amanda.Knihal@boystown.org
Ryan McCreery, PhD
About this study
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:
- Do children with unilateral hearing loss with earlier access to hearing aids and early intervention have better speech understanding in noise than children with unilateral hearing loss with later or no access to intervention?
- Do children with unilateral hearing loss with earlier access to intervention have more typical responses in the brain than children with late or no access to intervention?
- Do children with unilateral hearing loss with earlier access to intervention have better speech and language skills than children with late or no access to intervention?
Read more
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:
- Answer questions about the child's health, developmental, and hearing histories.
- Receive hearing tests and speech recognition tests.
- Complete tests of speech and language abilities.
- A subset of eligible participants will undergo magnetic resonance imaging (MRI) and magneotencephalography (MEG).
Read the detailed description
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.
- Conditions
- Unilateral Hearing Loss
- Being tested
- hearing aids
- Keywords
- single-sided deafness, unilateral hearing loss, asymmetrical hearing loss, hearing aid, audiology, magnetoencephalography, magnetic resonance imaging, spatial hearing
- Medical subject headings
- Hearing Loss, Unilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hearing aidsDevice
Hearing aids amplify acoustic sound to provide access to acoustic cues for communication and spatial hearing.
| Study group | Role | What they receive |
|---|---|---|
| Unilateral hearing loss | Children with unilateral hearing loss with hearing aids and children with unilateral hearing loss without hearing aids. Receives: Device: hearing aids |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At enrollment, 12 months after enrollment and 24 months after enrollment.
Secondary outcomes (2)
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.
Measured: 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.
Measured: At enrollment, 12 months after enrollment, and 24 months after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start1 Jul 2026
- Primary completion30 Jun 2031 (estimated)
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Father Flanagan's Boys' Home
- Sponsor type
- University, hospital or other
- Collaborators
- University of Iowa, University of North Carolina, Chapel Hill, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Ryan McCreery, PhD, Principal investigator, Father Flanagan's Boys' Home
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911852
- Sponsor's protocol ID
- R01DC023371
- Other IDs
- R01DC023371
- Acronym
- SHINE
- Status last verified
- Nov 2026
- First submitted
- 27 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Audiological Rehabilitation of Children With Unilateral Hearing Loss
- ClinicalTrials.gov ID
- NCT07911852
- Acronym / sponsor ID
- SHINE / R01DC023371
- Conditions
- Unilateral Hearing Loss
- Keywords
- single-sided deafness, unilateral hearing loss, asymmetrical hearing loss, hearing aid, audiology, magnetoencephalography, magnetic resonance imaging, spatial hearing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Father Flanagan's Boys' HomeUniversity, hospital or other
- Collaborators
- University of Iowa, University of North Carolina, Chapel Hill, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 30 Jun 2031 (estimated)
- Study completion
- 30 Jun 2031 (estimated)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Do children with unilateral hearing loss with earlier access to hearing aids and early intervention have better speech understanding in noise than children with unilateral hearing loss with later or no access to intervention?
- Do children with unilateral hearing loss with earlier access to intervention have more typical responses in the brain than children with late or no access to intervention?
- Do children with unilateral hearing loss with earlier access to intervention have better speech and language skills than children with late or no access to intervention?
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:
- Answer questions about the child's health, developmental, and hearing histories.
- Receive hearing tests and speech recognition tests.
- Complete tests of speech and language abilities.
- A subset of eligible participants will undergo magnetic resonance imaging (MRI) and magneotencephalography (MEG).
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unilateral hearing loss | – | Device: hearing aidsChildren with unilateral hearing loss with hearing aids and children with unilateral hearing loss without hearing aids. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children with normal hearing and children with unilateral hearing loss will be recruited from hospitals, audiology clinics, and education agencies across the United States.
Key inclusion criteria (4 listed)
- Children with normal hearing will have hearing thresholds from 0.25 - 8 kHz ≤15 dB HL in both ears.
- Children with normal hearing will have no history of neurodevelopmental, communication, or sensory disorders.
- Children with unilateral hearing loss will have hearing thresholds that meet the criterion for CNH in the better ear and three-frequency (.5, 1, \& 2 kHz) pure-tone average ≥ 20 - <70 dB HL or two or more hearing thresholds ≥ 20 - < 70 dB HL from 2-8 kHz in the poorer ear. H
- Children with unilateral hearing loss can have conductive, mixed, or sensorineural hearing loss.
Key exclusion criteria (8 listed)
- Individuals with a cochlear implant, rerouting device, or an implanted bone conduction device will be excluded due to neuroimaging restrictions with implantable devices.
- For neuroimaging experiments only:
- Current use of the following medications: psychotropic medications or other medications with significant CNS effects (e.g., antidepressants, antipsychotics, anticonvulsants, alpha-agonists, adrenergic blockers, lithium, and sedating antihistamines), or other excluded medication.
- Current major psychiatric diagnosis.
- Current substance abuse or substance dependence.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hearing aidsHearing aids amplify acoustic sound to provide access to acoustic cues for communication and spatial hearing. | Device | Unilateral hearing loss |
Primary outcome
Spatial release from masking
Time frame: At enrollment
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.
Morphosyntax
Time frame: At enrollment, 12 months after enrollment and 24 months after enrollment.
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.
2 secondary outcomes
Localization
Time frame: At enrollment
Vocabulary
Time frame: At enrollment, 12 months after enrollment, and 24 months after enrollment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Yes. All IPD will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ryan McCreery, PhD principal investigator
Father Flanagan's Boys' Home
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unilateral Hearing Loss, run by Father Flanagan's Boys' Home at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ryan McCreery, PhD (531-355-6668, Ryan.McCreery@boystown.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spatial release from masking (time frame: At enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.