Bilateral Sensorineural Hearing LossNCT07356128
Binaural Cue Sensitivity in Children and Adults With Combined Electric and Acoustic Stimulation
An observational study of Bilateral Sensorineural Hearing Loss and Cochlear Implant, run by Hearts for Hearing at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bilateral Sensorineural Hearing Loss, Cochlear Implant, Hearing Preservation
- What is being tested?
- binaural processing over time and binaural processing over time for children and adults with normal hearing
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2025to 30 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Individuals with steeply sloping sensorineural hearing loss in both ears
Who may be able to join
- 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
Who cannot join
- single-sided deafness (SSD)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hearts for Hearing
Oklahoma City, Oklahoma, 73120
Rene H Gifford, PhD, 405-548-4300, rene.gifford@heartsforhearing.org
Sara Neumann, AuD, 405-548-4300, sara.neumann@heartsforhearing.org
About this study
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.
Read the detailed 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.
- Conditions
- Bilateral Sensorineural Hearing Loss, Cochlear Implant, Hearing Preservation, Electric and Acoustic Simulation
- Being tested
- binaural processing over time, binaural processing over time for children and adults with normal hearing
- Keywords
- sensorineural hearing loss, cochlear implant, electric and acoustic stimulation (EAS), hearing preservation
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
binaural processing over timeBehavioural
Also called binaural development
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 hearingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Children with normal hearing | Not described Receives: Behavioral: binaural processing over time; Behavioral: binaural processing over time for children and adults with normal hearing | |
| Adults with normal hearing | Not described Receives: Behavioral: binaural processing over time for children and adults with normal hearing | |
| Children with bilateral steeply sloping sensorineural hearing loss | Not described Receives: Behavioral: binaural processing over time | |
| Adults with bilateral steeply sloping sensorineural hearing loss | Not described Receives: Behavioral: binaural processing over time |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start1 Jul 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Bilateral Sensorineural Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hearts for Hearing
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356128
- Sponsor's protocol ID
- R01DC020194
- Other IDs
- 5R01DC020194
- Status last verified
- Jan 2026
- First submitted
- 16 Jul 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the study is complete, we will make the fully de-identified data set available to investigators upon request.
Publications
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.
PubMed 23446225Gifford 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.
PubMed 28301392Gifford 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.
PubMed 32182551Holder 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.
PubMed 33555745Roberts 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.
PubMed 33859136Gifford 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.
PubMed 35985964Reinhart 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.
PubMed 39514431Fan 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.
PubMed 38763034
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Binaural Cue Sensitivity in Children and Adults With Combined Electric and Acoustic Stimulation
- ClinicalTrials.gov ID
- NCT07356128
- Acronym / sponsor ID
- R01DC020194
- Conditions
- Bilateral Sensorineural Hearing Loss, Cochlear Implant, Hearing Preservation, Electric and Acoustic Simulation
- Keywords
- sensorineural hearing loss, cochlear implant, electric and acoustic stimulation (EAS), hearing preservation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hearts for HearingUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Children with normal hearing | – | Behavioral: binaural processing over time, Behavioral: binaural processing over time for children and adults with normal hearing |
| Adults with normal hearing | – | Behavioral: binaural processing over time for children and adults with normal hearing |
| Children with bilateral steeply sloping sensorineural hearing loss | – | Behavioral: binaural processing over time |
| Adults with bilateral steeply sloping sensorineural hearing loss | – | Behavioral: binaural processing over time |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals with steeply sloping sensorineural hearing loss in both ears
Key inclusion criteria (7 listed)
- 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.
- For children and adults with normal hearing, they will demonstrate audiometric thresholds 20 dB HL or better from 250-8000 Hz
Key exclusion criteria (1 listed)
- single-sided deafness (SSD)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| binaural processing over timeAlso: binaural developmentThis 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 | Behavioural | Adults with bilateral steeply sloping sensorineural hearing loss, Children with bilateral steeply sloping sensorineural hearing loss, Children with normal hearing |
| binaural processing over time for children and adults with normal hearingAdults 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. | Behavioural | Adults with normal hearing, Children with normal hearing |
Primary outcome
EAS benefit for speech recognition in noise and spatial hearing abilities
Time frame: 2 years
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.
Binaural cue sensitivity (interaural time and level differences)
Time frame: 2 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Background: PubMed 23446225Gifford 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.
- Background: PubMed 28301392Gifford 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.
- Background: PubMed 32182551Gifford 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.
- Background: PubMed 33555745Holder 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.
- Background: PubMed 33859136Roberts 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.
- Background: PubMed 35985964Gifford 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.
- Background: PubMed 39514431Reinhart 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.
- Results publication: PubMed 38763034Fan 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.
- Individual participant dataSharing planned: Yes. Once the study is complete, we will make the fully de-identified data set available to investigators upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bilateral Sensorineural Hearing Loss and Cochlear Implant, run by Hearts for Hearing at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rene H Gifford, PhD (405-548-4300, rene.gifford@heartsforhearing.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EAS benefit for speech recognition in noise and spatial hearing abilities (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07356128, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.