Recruiting

EAS

Sponsor:

Hearts for Hearing

Code:

NCT07356128

Conditions

Bilateral Sensorineural Hearing Loss

Cochlear Implant

Hearing Preservation

Electric and Acoustic Simulation

Eligibility Criteria

Sex: All

Age: 5+

Healthy Volunteers: Accepted

Interventions

binaural processing over time

binaural processing over time for children and adults with normal hearing

Study Details

Brief summary:

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.

Conditions

Bilateral Sensorineural Hearing Loss

Cochlear Implant

Hearing Preservation

Electric and Acoustic Simulation

Study ID

NCT07356128

Start date

Jul 1, 2025

Status verified date

Jan, 2026

Completion date

Nov 30, 2028

Anticipated

Primary completion date

Nov 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Children with normal hearing

Adults with normal hearing

Children with bilateral steeply sloping sensorineural hearing loss

Adults with bilateral steeply sloping sensorineural hearing loss

Interventions

binaural processing over time

This study will not provide an intervention, but will study the effects of hearing technology on binaural processing for adults and children with bilateral steeply sloping sensorineural hearing loss

binaural processing over time for children and adults with normal hearing

Adults and children with normal hearing will be studied over time to characterize binaural processing and associated effects on speech perception in complex listening scenarios and spatial hearing abilities.

Primary outcome measure

  • EAS benefit for speech recognition in noise and spatial hearing abilities [ Time Frame: 2 years ]
  • Binaural cue sensitivity (interaural time and level differences) [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Rene H Gifford, PhD

405-548-4300rene.gifford@heartsforhearing.org

Sara Neumann, AuD

405-548-4300sara.neumann@heartsforhearing.org

Locations

Hearts for Hearing

Recruiting

Oklahoma City, Oklahoma, United States, 73120

Contacts

Rene H Gifford, PhD

405-548-4300rene.gifford@heartsforhearing.org

Sara Neumann, AuD

405-548-4300sara.neumann@heartsforhearing.org

More Information

Sponsor

Hearts for Hearing

Last update posted

Jan 21, 2026

Last verified

Jan, 2026

Keywords

  • sensorineural hearing loss
  • cochlear implant
  • electric and acoustic stimulation (EAS)
  • hearing preservation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hearts for Hearing on 2026-01-21.