Binaural Cue Sensitivity in Children and Adults With Combined Electric and Acoustic Stimulation
2 other identifiers
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2025
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2025
CompletedFirst Submitted
Initial submission to the registry
July 16, 2025
CompletedFirst Posted
Study publicly available on registry
January 21, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2028
January 21, 2026
January 1, 2026
2.4 years
July 16, 2025
January 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
EAS benefit for speech recognition in noise and spatial hearing abilities
For children and adults who are pursuing cochlear implantation with acoustic hearing preservation, we will describe the rate of hearing preservation following implantation. This is critical as it is well-known that individuals with acoustic hearing preservation achieve significantly higher scores on tasks of speech recognition in noise, particularly with diffuse noise.
2 years
Binaural cue sensitivity (interaural time and level differences)
For children and adults with precipitously sloping, high-frequency sensorineural hearing loss pursuing cochlear implantation, we will describe binaural cue sensitivity pre- and post-implant.
2 years
Study Arms (4)
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
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
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.
Eligibility Criteria
Individuals with steeply sloping sensorineural hearing loss in both ears
You may qualify if:
- 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
You may not qualify if:
- single-sided deafness (SSD)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hearts for Hearing
Oklahoma City, Oklahoma, 73120, United States
Related Publications (8)
Gifford RH, Dorman MF, Skarzynski H, Lorens A, Polak M, Driscoll CL, Roland P, Buchman CA. Cochlear implantation with hearing preservation yields significant benefit for speech recognition in complex listening environments. Ear Hear. 2013 Jul-Aug;34(4):413-25. doi: 10.1097/AUD.0b013e31827e8163.
PMID: 23446225BACKGROUNDGifford RH, Davis TJ, Sunderhaus LW, Menapace C, Buck B, Crosson J, O'Neill L, Beiter A, Segel P. Combined Electric and Acoustic Stimulation With Hearing Preservation: Effect of Cochlear Implant Low-Frequency Cutoff on Speech Understanding and Perceived Listening Difficulty. Ear Hear. 2017 Sep/Oct;38(5):539-553. doi: 10.1097/AUD.0000000000000418.
PMID: 28301392BACKGROUNDGifford RH, Stecker GC. Binaural cue sensitivity in cochlear implant recipients with acoustic hearing preservation. Hear Res. 2020 May;390:107929. doi: 10.1016/j.heares.2020.107929. Epub 2020 Feb 26.
PMID: 32182551BACKGROUNDHolder JT, Morrel W, Rivas A, Labadie RF, Gifford RH. Cochlear Implantation and Electric Acoustic Stimulation in Children With TMPRSS3 Genetic Mutation. Otol Neurotol. 2021 Mar 1;42(3):396-401. doi: 10.1097/MAO.0000000000002943.
PMID: 33555745BACKGROUNDRoberts JB, Stecker GC, Holder JT, Gifford RH. Combined Electric and Acoustic Stimulation (EAS) in Children: Investigating Benefit Afforded by Bilateral Versus Unilateral Acoustic Hearing. Otol Neurotol. 2021 Aug 1;42(7):e836-e843. doi: 10.1097/MAO.0000000000003139.
PMID: 33859136BACKGROUNDGifford RH, Sunderhaus LW, Dawant BM, Labadie RF, Noble JH. Cochlear implant spectral bandwidth for optimizing electric and acoustic stimulation (EAS). Hear Res. 2022 Dec;426:108584. doi: 10.1016/j.heares.2022.108584. Epub 2022 Jul 28.
PMID: 35985964BACKGROUNDReinhart P, Parkinson A, Gifford RH. Hybrid Cochlear Implant Outcomes and Improving Outcomes With Electric-Acoustic Stimulation. Otol Neurotol. 2024 Dec 1;45(10):e749-e755. doi: 10.1097/MAO.0000000000004305.
PMID: 39514431BACKGROUNDFan Y, Gifford RH. Objective measure of binaural processing: Acoustic change complex in response to interaural phase differences. Hear Res. 2024 Jul;448:109020. doi: 10.1016/j.heares.2024.109020. Epub 2024 Apr 28.
PMID: 38763034RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2025
First Posted
January 21, 2026
Study Start
July 1, 2025
Primary Completion (Estimated)
November 30, 2027
Study Completion (Estimated)
November 30, 2028
Last Updated
January 21, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- November 30, 2028 is the anticipated date the de-identified IPD will be available. There is no end date determined as of yet.
- Access Criteria
- Interested investigators may reach out to the study PI (Rene Gifford, PhD) at rene.gifford@heartsforhearing.org to inquire about obtaining de-identified IPD starting November 30, 2028.
Once the study is complete, we will make the fully de-identified data set available to investigators upon request.