Binaural cue sensitivity with combined electric and acoustic hearing in children and adults
Binaural Cue Sensitivity in Children and Adults With Combined Electric and Acoustic Stimulation
Hearts for Hearing · NCT07356128
This project will test whether children and adults with cochlear implants and preserved low-frequency hearing can use binaural hearing cues better when they have both electric and acoustic stimulation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 5 Years and up |
| Sex | All |
| Sponsor | Hearts for Hearing (other) |
| Locations | 1 site (Oklahoma City, Oklahoma) |
| Trial ID | NCT07356128 on ClinicalTrials.gov |
What this trial studies
The project will enroll children (5-17) and adults (18+) who have cochlear implants with preserved low-frequency acoustic hearing, alongside normal-hearing control participants. Participants will complete behavioral tests of binaural hearing (including speech-in-noise, spatial hearing, and sensitivity to interaural time and level differences) and objective electrophysiologic measures across repeated visits to track changes over time. Device data logging will verify use of combined electric and acoustic stimulation (EAS) in the implanted ear(s). The goal is to describe the time course and mechanisms of binaural benefit from EAS across ages to inform clinical management.
Who should consider this trial
Good fit: Ideal candidates are children (5-17) or adults (18+) with at least one cochlear implant, bilateral mild-to-profound sensorineural loss with unaided thresholds ≤80 dB HL at 125 and 250 Hz, typical nonverbal cognition, spoken English as the primary communication mode, and willingness to use EAS as verified by data logging.
Not a fit: Patients with single-sided deafness, without preserved low-frequency hearing, or with excluded comorbidities such as autism, auditory neuropathy, significant neurologic disorders, or global cognitive impairment are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this work could help clinicians tailor EAS fittings and rehabilitation to improve speech understanding in noise and spatial hearing for cochlear implant users.
How similar studies have performed: Prior adult studies have shown consistent EAS benefits for speech-in-noise and spatial hearing and links between ITD/ILD sensitivity and benefit, but pediatric outcomes and developmental time courses remain under-studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pediatric EAS: aged 5-17; Adult EAS: aged 18+ years * At least one CI and bilateral mild to profound sensorineural hearing loss with unaided audiometric thresholds ≤ 80 dB HL at 125 and 250 Hz, in both ears. * Willingness to use EAS technology in the implanted ear(s) to be verified via data logging * Nonverbal cognitive abilities within the typical range * No co-morbid diagnoses such as autism, auditory neuropathy, neurological disorder, or general cognitive impairment * Use of spoken English as main mode of communication * For children and adults with normal hearing, they will demonstrate audiometric thresholds 20 dB HL or better from 250-8000 Hz Exclusion Criteria: * single-sided deafness (SSD)
Where this trial is running
Oklahoma City, Oklahoma
- Hearts for Hearing — Oklahoma City, Oklahoma, United States (RECRUITING)
Study contacts
- Study coordinator: Rene H Gifford, PhD
- Email: rene.gifford@heartsforhearing.org
- Phone: 405-548-4300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bilateral Sensorineural Hearing Loss, Cochlear Implant, Hearing Preservation, Electric and Acoustic Simulation, sensorineural hearing loss, cochlear implant, electric and acoustic stimulation, hearing preservation