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Search / Trial NCT05923203

Combined Electric and Acoustic Hearing (EAS) in Children and Adults

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Jun 27, 2023

Trial Information

Current as of July 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help people with hearing loss, especially children and adults who have cochlear implants (a device that helps restore hearing). The research focuses on combining two types of hearing: electric hearing from the cochlear implant and acoustic hearing from a hearing aid in the same ear. This combination, known as Electric Acoustic Stimulation (EAS), has shown to significantly improve how well adults understand speech, especially in noisy environments. However, there is still limited research on how this approach benefits children. By participating in this study, researchers hope to learn more about how EAS helps with speech understanding and spatial hearing in both children and adults.

To be eligible for this trial, participants must be between 5 and 17 years old with either normal hearing or at least one cochlear implant, or adults aged 18 and older with the same criteria. Participants need to have some level of hearing loss in both ears, and their cognitive abilities should be within the typical range. If chosen for the study, participants will use EAS technology, and their progress will be monitored to see how well this approach works. Overall, this study aims to enhance understanding of cochlear implants and improve hearing outcomes for those who use them.

Gender

ALL

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.

About Vanderbilt University Medical Center

Vanderbilt University Medical Center (VUMC) is a leading academic medical center located in Nashville, Tennessee, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, VUMC integrates cutting-edge scientific inquiry with patient-centered care, supporting a diverse array of studies aimed at enhancing medical knowledge and improving treatment outcomes. With a robust infrastructure and a multidisciplinary team of experts, VUMC fosters collaboration across various fields, ensuring the highest standards of safety and ethical considerations in its research endeavors. Through its dedication to medical discovery and education, VUMC plays a pivotal role in shaping the future of medicine.

Locations

Nashville, Tennessee, United States

Austin, Texas, United States

Madison, Wisconsin, United States

Patients applied

0 patients applied

Trial Officials

Jourdan T Holder, AuD, PhD

Principal Investigator

Vanderbilt University Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported