Clinical trial Recruiting at 1 site Observational Ages 6 to 16

Hearing Aids for Children with One Good Ear

Official title: Audiological Rehabilitation of Children With Unilateral Hearing Loss

Run by Father Flanagan's Boys' Home · NCT07911852 · Data updated 2026-11-12

This study tests whether using a hearing aid in the affected ear and early intervention helps children with unilateral hearing loss improve speech in noise, brain responses, and language skills.

Quick facts

Study typeObservational
Ages6 Years to 16 Years
SexAll
Enrollment160 (estimated)
SponsorFather Flanagan's Boys' Home
Academic / other
Locations3 sites (Iowa City, Iowa and 2 other locations)
StatusRecruiting
StartedJuly 1, 2026
Main results expectedJune 30, 2031
Study endsJune 30, 2031
Registry record updatedNovember 5, 2026
Trial IDNCT07911852 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are children with unilateral hearing loss identified early and eligible for a hearing aid in the affected ear.

Probably not a fit

Children with unilateral hearing loss who do not use a hearing aid or have late/ongoing intervention may be less likely to experience the potential benefits.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study follows children with unilateral hearing loss to see how earlier access to a hearing aid and early intervention affects hearing, language, and neural development. Researchers will collect hearing tests, language measures, and neural data over time to understand how auditory experience shapes development. By comparing earlier versus later or no intervention, the study aims to identify patterns that could guide audiology practices. The project involves multiple sites and excludes implanted devices due to imaging requirements. It is funded by a collaboration including academic centers and a national institute.

Why it matters

Potential benefit: If successful, the findings could support earlier provision of hearing aids for kids with unilateral hearing loss and improve language and academic outcomes.

How similar studies have gone: Previous work in related areas suggests that early auditory experience can influence development, but evidence for early hearing aid use in unilateral loss has been limited and mixed.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Boys Town National Research Hospital
    Omaha, Nebraska, United States
    Recruiting
  • University of Iowa
    Iowa City, Iowa, United States
    Not yet recruiting
  • University of North Carolina, Chapell Hill
    Chapell Hill, North Carolina, United States
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.