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Audiological Rehabilitation of Children With Unilateral Hearing Loss

RecruitingObservational studyHealthy volunteers welcome

Who can join

Ages 6 to 16 · All sexes · Healthy volunteers welcome

Full eligibility criteria
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

About the 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:

1. 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? 2. 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? 3. 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).

What is being tested

Sponsor: Father Flanagan's Boys' Home · Participants: 160 · Started: Jul 1, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07911852

Locations in the U.S.

IowaUniversity of Iowa, Iowa City (Not yet recruiting)
NebraskaBoys Town National Research Hospital, Omaha
North CarolinaUniversity of North Carolina, Chapell Hill, Chapell Hill (Not yet recruiting)

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.