Actively Recruiting
Binaural Cue Sensitivity in Children and Adults With Combined Electric and Acoustic Stimulation
Led by Hearts for Hearing · Updated on 2025-10-20
160
Participants Needed
4
Research Sites
13 weeks
Total Duration
On this page
Sponsors
H
Hearts for Hearing
Lead Sponsor
N
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how combined Electric and Acoustic Stimulation (EAS) using cochlear implants can benefit both children and adults with hearing loss. This study focuses on understanding speech recognition, binaural processing, and spatial hearing in individuals who use EAS, as compared to those with only cochlear implants or normal hearing. The trial aims to fill gaps in knowledge about how EAS affects hearing development, especially in children, and how it supports the binaural system's growth over time. Participants in the study include adults and children with cochlear implants fitted with an FDA-approved EAS system, which combines electric stimulation from the implant with acoustic amplification from a hearing aid in the implanted ear. The study also includes groups of age-matched normal hearing children and adults for comparison. The research will track outcomes at multiple time points, such as within one month of EAS activation, and at 6, 12, and 24 months, to observe both acute and long-term effects of EAS on hearing abilities. Throughout the study, participants will undergo tests measuring speech recognition in noise, spatial hearing ability, and sensitivity to binaural cues like interaural time and level differences. Behavioral and objective assessments, including cortical auditory evoked potentials, will be used to evaluate hearing outcomes. Data logging will verify EAS usage, and participants will be monitored over time to assess developmental trajectories and the benefits of EAS technology in real-world hearing situations.
CONDITIONS
Brief Title
Combined Electric and Acoustic Hearing (EAS) in Children and Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 5 to 17 years with normal hearing or with at least one cochlear implant and binaural low-frequency acoustic hearing
- Adults aged 18 years and older with normal hearing or with at least one cochlear implant and binaural low-frequency acoustic hearing
- Participants must have at least one cochlear implant and bilateral mild to severe sensorineural hearing loss
- Audiometric thresholds in the non-cochlear implant ear must indicate mild sensorineural hearing loss; participants with single-sided deafness are excluded
- Unaided audiometric thresholds must be 80 dB HL or better at 125 and 250 Hz in both ears
- Nonverbal cognitive abilities must be within the typical range
- Adults must pass cognitive screening using Montreal Cognitive Assessment (MoCA or HI-MoCA)
- Willingness to use EAS technology verified through device data logging
You will not qualify if you...
- Nonverbal intelligence standard score below 85
- MoCA or HI-MoCA score below 26 for adult participants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive a clinical fitting of a combined electric and acoustic stimulation (EAS) system, which includes a cochlear implant and hearing aid in the implanted ear(s). This fitting uses FDA approved clinical software and audiologic verification to provide low-frequency acoustic amplification and mid-to-high frequency electric stimulation.
Multiple visits including at or within 1 month of EAS activation, and follow-up visits at 6 months, 12 months, and 24 months (pediatric participants)
Duration - Up to 24 months
Participants are monitored over time to assess EAS benefit for speech recognition, spatial discrimination, and binaural cue sensitivity through behavioral and electrophysiological measures.
Visits coincide with treatment time points for outcome assessments at 1 month, 6 months, 12 months, and 24 months (pediatric participants)
Trial Site Locations
Total: 4 locations
1
Hearts for Hearing
Edmond, Oklahoma, United States, 73120
Actively Recruiting
2
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Completed
3
University Of Texas at Austin
Austin, Texas, United States, 78712
Actively Recruiting
4
University Of Wisconsin Madison
Madison, Wisconsin, United States, 53706
Actively Recruiting
Research Team
R
René Gifford, PhD
J
Jourdan T Holder, AuD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here