Recruiting

Hearing Aids

Sponsor:

Father Flanagan's Boys' Home

Code:

NCT07911852

Conditions

Unilateral Hearing Loss

Eligibility Criteria

Sex: All

Age: 6 - 16

Healthy Volunteers: Accepted

Interventions

hearing aids

Study Details

Brief 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. Our 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).

Conditions

Unilateral Hearing Loss

Study ID

NCT07911852

Start date

Jul 1, 2026

Status verified date

Oct, 2026

Completion date

Jun 30, 2031

Anticipated

Primary completion date

Jun 30, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 16

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Children with normal hearing will have hearing thresholds from 0.25 - 8 kHz ≤15 dB HL in both ears with 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. Hearing loss can be conductive, mixed, or sensorineural.

Exclusion Criteria:

  • Children with unilateral hearing loss who have 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, there are additional exclusion criteria. Participants will be excluded from MEG and MRI experiments if they have 1) 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, 2) current major psychiatric diagnosis, 3) current substance abuse or substance dependence at any time, 4) 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) 5) 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 or 6) 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.

Study Design

Enrollment

160 participants

Anticipated

Interventions and Outcome Measures

Arms

Unilateral hearing loss

Children with unilateral hearing loss with hearing aids and children with unilateral hearing loss without hearing aids.

Interventions

hearing aids

Hearing aids amplify acoustic sound to provide access to acoustic cues for communication and spatial hearing.

Primary outcome measure

  • Spatial release from masking [ Time Frame: At enrollment ]
  • Morphosyntax [ Time Frame: At enrollment, 12 months after enrollment and 24 months after enrollment. ]

Central Contacts and Locations

Central contacts

Ryan McCreery, PhD

531-355-6668Ryan.McCreery@boystown.org

Amanda Knihal

531-355-6533Amanda.Knihal@boystown.org

Locations

Boys Town National Research Hospital

Recruiting

Omaha, Nebraska, United States, 68131

Contacts

Amanda Knihal

531-355-6533Amanda.Knihal@boystown.org

Principal Investigator:

Ryan McCreery, PhD

More Information

Sponsor

Father Flanagan's Boys' Home

Last update posted

Nov 3, 2026

Last verified

Oct, 2026

Keywords

  • single-sided deafness
  • unilateral hearing loss
  • asymmetrical hearing loss
  • hearing aid
  • audiology
  • magnetoencephalography
  • magnetic resonance imaging
  • spatial hearing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-04. This information was provided to ClinicalTrials.gov by Father Flanagan's Boys' Home on 2026-11-03. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.