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

H

Hearts for Hearing

Status

Enrolling

Conditions

Electric and Acoustic Simulation
Cochlear Implant
Hearing Preservation
Bilateral Sensorineural Hearing Loss

Treatments

Behavioral: binaural processing over time for children and adults with normal hearing
Behavioral: binaural processing over time

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT07356128
5R01DC020194 (U.S. NIH Grant/Contract)
R01DC020194 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

There is a rapidly growing population of adult and pediatric cochlear implant (CI) recipients with acoustic hearing preservation in the implanted ear(s) allowing for combined Electric and binaural Acoustic Stimulation (EAS). Despite the rapid technological and surgical advancements that have led to this increased prevalence, there is limited research on EAS outcomes-particularly for pediatric EAS listeners-including the expected trajectory of benefit following EAS fitting and underlying mechanisms driving benefit in EAS users of all ages. Thus, the purpose of this project is to provide a comprehensive description of behavioral and electrophysiologic measures of binaural hearing in adults and children both with normal hearing and EAS users.

Full description

Cochlear implantation with minimally traumatic surgical techniques and atraumatic electrode arrays has led to an increasing prevalence of adult and pediatric cochlear implant (CI) recipients with the potential for combined Electric and binaural Acoustic Stimulation (EAS). Many studies have demonstrated that adult EAS users consistently exhibit significant benefits for speech understanding in noise and spatial hearing tasks as compared to a CI paired only with a contralateral HA. We have also demonstrated that sensitivity to interaural time difference (ITD) and interaural level difference (ILD) cues is correlated with EAS benefit for postlingually deafened adult listeners. Despite this active phase of discovery, there is still a striking paucity of research on EAS outcomes in pediatric CI users, the expected trajectory of benefit following EAS fitting, as well as underlying mechanisms driving EAS benefit (or lack thereof) in all populations. There is a disconnect between EAS availability and EAS utilization in all CI recipients and current audiological management of EAS candidates is not data driven. This is problematic given the protracted maturation of the binaural system and the fact that we do not understand what additional effects sensorineural hearing loss and combined EAS may have on the developing binaural system. The proposed research activities will describe the time course of binaural development using behavioral and objective responses to interaural differences in timing (phase) and level as well as allow for a natural factor investigation of a clinical intervention, the EAS fitting, on said development. Within the context of a clinical trial, we will compare acute and chronic EAS outcomes for speech recognition and spatial hearing as related to binaural cue sensitivity, cue weighting, and underlying neural synchrony necessary for ITD resolution. We have proposed a single-group assignment for both adult and pediatric EAS users and will also include chronological- and hearing-age-matched listeners with normal hearing (NH). A within-subjects, accelerated longitudinal design for both EAS and NH listeners will provide insight into the developmental trajectory of the binaural system for children NH and will provide a benchmark for interpreting effects of sensorineural hearing loss, asymmetry in audibility resulting from cochlear implantation, and EAS use on said trajectory. Our proposed research activities will help close the gap between what is technologically possible with EAS technology and what is clinically implemented by otologists and audiologists investigating development of binaural sensitivity and spatial hearing abilities. The resultant data will comprise the first comprehensive description of behavioral and electrophysiologic measures of binaural hearing in adults and children both with NH and EAS and will uncover information about our EAS clinical populations holding high potential for clinical application in device fittings as well as audiologic and otologic clinical recommendations regarding cochlear implantation.

Enrollment

200 estimated patients

Sex

All

Ages

5+ years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

200 participants in 4 patient groups

Children with normal hearing
Treatment:
Behavioral: binaural processing over time
Behavioral: binaural processing over time for children and adults with normal hearing
Adults with normal hearing
Treatment:
Behavioral: binaural processing over time for children and adults with normal hearing
Children with bilateral steeply sloping sensorineural hearing loss
Treatment:
Behavioral: binaural processing over time
Adults with bilateral steeply sloping sensorineural hearing loss
Treatment:
Behavioral: binaural processing over time

Trial documents
2

Trial contacts and locations

1

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Central trial contact

Rene H Gifford, PhD; Sara Neumann, AuD

Data sourced from clinicaltrials.gov

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