Early hearing aids for children with unilateral hearing loss
Studies hearing aid timing in children with unilateral hearing loss.
Key facts
- Who runs it
- Father Flanagan's Boys' Home
- Where
- Chapell Hill, Iowa City, and Omaha, United StatesSee the 3 sites
- Trial code
- Registry title
- Audiological Rehabilitation of Children With Unilateral Hearing Loss
- Status
- Recruiting
- People taking part
- 160 people, planned
- Started
- 1 Jul 2026
- Expected to end
- 30 Jun 2031
- Type of study
- Observational
- Treatments tested
- hearing aids
- Record updated
- 5 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children with hearing loss in one ear, and children with normal hearing in both ears. It studies how hearing aids and early help affect hearing, language and brain development.
- Age
- 6 Years to 16 Years
- Sex
- All
- Disease stage
- Hearing loss in one ear, with normal hearing in the other ear. In the poorer ear, a pure-tone average at .5, 1 & 2 kHz of ≥ 20 - <70 dB HL, or two or more thresholds of ≥ 20 - < 70 dB HL from 2-8 kHz. The hearing loss can be conductive, mixed or sensorineural.
- Earlier treatment
- Children with or without hearing aids can join. Children with a cochlear implant, rerouting device or implanted bone conduction device cannot join.
- Biomarker or test result
- Children with normal hearing need hearing thresholds from 0.25 - 8 kHz of ≤15 dB HL in both ears, and no history of neurodevelopmental, communication or sensory disorders.
Main reasons for not taking part
- Having a cochlear implant, rerouting device or implanted bone conduction device
- For the brain scan part only: current use of medicines that affect the brain, such as antidepressants, antipsychotics or anticonvulsants
- For the brain scan part only: a current major psychiatric diagnosis or substance abuse
- For the brain scan part only: a known neurological disorder or major illness affecting the brain, such as epilepsy, cerebral palsy, diabetes or HIV
- For the brain scan part only: any iron-containing metal implant, such as braces or a pacemaker
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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 take part
- Individuals with a cochlear implant, rerouting device, or an implanted bone conduction device will be excluded due to neuroimaging restrictions with implantable devices
- 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
- 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
- Current major psychiatric diagnosis
- 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
- For neuroimaging experiments only:
- Current substance abuse or substance dependence
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 16 years old?
Where in United States
- University of North Carolina, Chapell HillChapell Hill, United StatesContact: Caitlin Sapp, PhDNot yet recruiting
- University of IowaIowa City, United StatesContact: Wendy FickNot yet recruiting
- Boys Town National Research HospitalOmaha, United StatesContact: Amanda KnihalTaking people
About the trial
What the trial wants to find out
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:
Read full original descriptionShow less
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).
The group in the trial
- Unilateral hearing loss
Children with unilateral hearing loss with hearing aids and children with unilateral hearing loss without hearing aids.
Treatment: hearing aids
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Audiological Rehabilitation of Children With Unilateral Hearing Loss
- Plain-language title
- Early hearing aids for children with unilateral hearing lossGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT07911852, who can take part
- Record updated
- 5 November 2026