Combining electric and acoustic hearing for better outcomes in children and adults

Binaural Cue Sensitivity in Children and Adults With Combined Electric and Acoustic Stimulation

This study tests if combining electric and acoustic hearing helps children and adults with cochlear implants understand speech better and hear sounds around them more clearly.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 5 Years and up
• Sex: All
• Sponsor: Hearts for Hearing (other)
• Locations: 4 sites (Edmond, Oklahoma and 3 other locations)
• Trial ID: NCT05923203 on ClinicalTrials.gov

What this trial studies

This study investigates the benefits of combined Electric and Acoustic Stimulation (EAS) in children and adults with cochlear implants. It aims to understand how this approach can improve speech understanding and spatial hearing by utilizing both electric and acoustic signals in the same ear. Participants will include both children and adults with varying degrees of hearing loss, and the study will assess their auditory processing abilities through behavioral and objective measures. The findings are expected to enhance the understanding of cochlear implant functionality and inform audiological management for EAS candidates.

Who should consider this trial

Good fit: Ideal candidates include children aged 5 to 17 and adults 18 years and older with cochlear implants and residual low-frequency acoustic hearing.

Not a fit: Patients with single-sided deafness or those with confounding diagnoses such as autism may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve hearing outcomes and quality of life for children and adults with cochlear implants.

How similar studies have performed: Previous studies have shown significant benefits of EAS in adults, but research on pediatric outcomes is limited, making this approach relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Children aged 5 to 17 years of age with either normal hearing (n=40) or at least 1 cochlear implant (CI) and binaural low-frequency acoustic hearing (n=40); adults aged 18+ years with either normal hearing (n=40) or at least 1 CI and binaural low-frequency acoustic hearing (n=40).
2. Experimental participants must have at least one CI and bilateral mild to severe sensorineural hearing loss For CI participants, audiometric thresholds in the non-CI ear must be consistent with at least a mild sensorineural hearing loss; that is, the investigators will not be enrolling participants with single-sided deafness (SSD) For CI participants, unaided audiometric thresholds must be less than or equal to 80 dB HL for 125 and 250 Hz, in both ears.
3. Nonverbal cognitive abilities within the typical range for all participants; adult participants must also pass cognitive screening via Montreal Cognitive Assessment (MoCA or HI-MoCA).
4. No confounding diagnosis such as autism, auditory neuropathy, neurological disorder, or general cognitive impairment.
5. Willingness to use EAS technology in the implanted ear(s) to be verified via data logging from cochlear implant and hearing aid software.

Exclusion Criteria:

1. Nonverbal intelligence standard score \< 85 (for any participant).
2. MoCA or HI-MoCA score \< 26 for adult participants.

Where this trial is running

Edmond, Oklahoma and 3 other locations

• Hearts for Hearing — Edmond, Oklahoma, United States (RECRUITING)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (COMPLETED)
• University Of Texas at Austin — Austin, Texas, United States (RECRUITING)
• University Of Wisconsin Madison — Madison, Wisconsin, United States (RECRUITING)

Study contacts

• Principal investigator: René H Gifford, PhD — Hearts for Hearing
• Study coordinator: René Gifford, PhD

Conditions: Cochlear Implant, Hearing Loss