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Cochlear ImplantNCT05923203

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

A study testing Electric and acoustic stimulation (EAS) technology in the implanted ear(s)-this is the combination of a cochlear implant (CI) and hearing aid (HA) in the implanted ear(s) in people with Cochlear Implant and Hearing Loss, run by Hearts for Hearing at 4 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Cochlear implants are surgically implanted devices which restore the ability to hear to the hearing impaired. Improvements in surgery and electrodes have results in an increased number of adults and children who have residual hearing and can benefit from electric and acoustic hearing in the same ear. Read more about this study

Who is it for?
Ages 5 years and olderHealthy volunteers can take part
Conditions the study is for
Cochlear Implant, Hearing Loss
What is being tested?
Electric and acoustic stimulation (EAS) technology in the implanted ear(s)-this is the combination of a cochlear implant (CI) and hearing aid (HA) in the implanted ear(s)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
4 sitesUnited States
Study dates
5 Dec 2022to 31 Aug 2028
Phase
Interventional
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

Who may be able to join

  • 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).
  • 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.
  • 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).
  • No confounding diagnosis such as autism, auditory neuropathy, neurological disorder, or general cognitive impairment.
  • Willingness to use EAS technology in the implanted ear(s) to be verified via data logging from cochlear implant and hearing aid software.

Who cannot join

  • Nonverbal intelligence standard score < 85 (for any participant).
  • MoCA or HI-MoCA score < 26 for adult participants.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jourdan T Holder, AuD, PhD contact

jourdan.holder@heartsforhearing.org

United States4 sites, 3 recruiting
  • University Of Texas at Austin

    Austin, Texas, 78712

    Spencer Smith, PhD, spencer.smith@austin.utexas.edu

    Recruiting
  • Hearts for Hearing

    Edmond, Oklahoma, 73120

    René H Gifford, PhD, rene.gifford@heartsforhearing.org

    René H Gifford, PhD

    Recruiting
  • University Of Wisconsin Madison

    Madison, Wisconsin, 53706

    Shelly Godar, godar@waisman.wisc.edu

    Recruiting
  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Completed

Other trials in United States

About this study

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

Cochlear implants are surgically implanted devices which restore the ability to hear to the hearing impaired. Improvements in surgery and electrodes have results in an increased number of adults and children who have residual hearing and can benefit from electric and acoustic hearing in the same ear. This is called Electric Acoustic Stimulation (EAS). Many studies have shown that adult EAS users show significant benefits for speech understanding in noise and spatial hearing tasks as compared to a CI paired only with a contralateral HA. Even though this type of hearing is becoming more common, there is limited research on how it can be beneficial to children with CIs. The benefits of this study are a greater understanding of the participant's speech understanding, binaural processing, and spatial hearing. The results will help audiologists and researcher better understand how cochlear implants work, specifically when using electric and acoustic hearing in the same ear.

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. Research has 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 researchers 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, the investigators will compare acute and chronic EAS outcomes for speech recognition and spatial hearing as related to binaural cue sensitivity, cue weightings and underlying neural synchrony necessary for ITD resolution. The investigators 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.

AIM 1: Emergence of binaural cue sensitivity in EAS users. The investigators will investigate emergence of binaural sensitivity for ITD and ILD cues as well as ITD/ILD cue weighting, which is critical for children with developing binaural function and underlying neural synchronization. Hypotheses: 1a) Pediatric EAS users will demonstrate an emergence of binaural cue sensitivity following a period of chronic EAS use incorporating bilateral LF acoustic amplification, 1b) there will be a relationship between listener age and ITD/ILD weighting for lateralization with the youngest EAS candidates assigning greater weight to ILDs due to immaturities in neural synchronization, and 1c) the time course of pediatric acoustic ITD/ILD development will be correlated with absolute and interaural auditory sensitivity for LF acoustic hearing.

AIM 2: Degree and time course of EAS benefit for speech and spatial discrimination informed by behavioral and objective estimates of binaural cue utilization. The investigators will describe EAS listener performance (CI+HAbilat) and EAS benefit (CI+HAbilat - CI+HAcontra) for (1) tasks of speech recognition in co-located, diffuse, and spatially separated noise, and (2) tasks of spatial discrimination. The investigators will relate these to ITD/ILD sensitivity measured both behaviorally (Aim 1) and electrophysiologically (Aim 2) via cortical auditory evoked potentials (CAEPs) reflecting brainstem-initiated processes inherited by the central auditory system. Hypotheses: 2a) EAS benefit will be observed for speech recognition and spatial discrimination with chronic EAS use, which will be mediated by access to LF ITD cues estimated via both behavioral and objective measures, and 2b) there will be a relationship between behavioral and objective measures of binaural cue utilization and EAS benefit for speech recognition and spatial hearing.

Being tested
Electric and acoustic stimulation (EAS) technology in the implanted ear(s)-this is the combination of a cochlear implant (CI) and hearing aid (HA) in the implanted ear(s)
Medical subject headings
Hearing Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electric and acoustic stimulation (EAS) technology in the implanted ear(s)-this is the combination of a cochlear implant (CI) and hearing aid (HA) in the implanted ear(s)Other

    This is a clinical fitting of an FDA approved EAS system for study participants that have received or who are scheduled to receive a CI based on clinical recommendations (i.e. not study related). The investigators will activate the CI sound processor's integrated HA circuit to allow for low-frequency acoustic amplification and mid-to-high frequency electric stimulation in the implanted ear(s) using recommended and accepted clinical practices and audiologic verification. EAS fitting will be completed using FDA approved clinical software and thereby is within the electrical and clinical specifications of the FDA approved device and accompanying software.

Study groups in NCT05923203
Study groupRoleWhat they receive
Adult use of EASExperimentalClinical intervention; Adults with CI and the fitting of electric and acoustic stimulation (EAS) technology in the implanted ear(s).
Receives: Other: Electric and acoustic stimulation (EAS) technology in the implanted ear(s)-this is the combination of a cochlear implant (CI) and hearing aid (HA) in the implanted ear(s)
Pediatric use of EASExperimentalClinical intervention; Children with CI and the fitting of electric and acoustic stimulation (EAS) technology in the implanted ear(s).
Receives: Other: Electric and acoustic stimulation (EAS) technology in the implanted ear(s)-this is the combination of a cochlear implant (CI) and hearing aid (HA) in the implanted ear(s)
Children with Normal HearingNo interventionChildren with normal hearing; acoustic only
Adults with Normal HearingNo interventionAdult with normal hearing; acoustic only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in BEL sentence score demonstrating EAS benefit for speech recognition in noise (CIHA+HA - CI+HA)

    Speech recognition will be assessed with co-located (S0N0) and spatially separated noise (S0N90 and S0N270) using the BEL sentences with two different male or female talkers as the maskers. Target speech will be fixed at 70 dB SPL for both speech stimuli and the investigators will assess performance for two listening conditions: CI+HA and CIHA+HA.

    Measured: This will be measured at multiple time points including at or within 1 month of EAS activation (adults & peds), 6 months (adults & peds), 12 months (adults & peds, and 24 months (peds)

  2. Change in BKB-SIN score demonstrating EAS benefit for speech recognition in noise (CIHA+HA - CI+HA)

    Speech recognition will be assessed with co-located (S0N0) and spatially separated noise (S0N90 and S0N270) using the BKB-SIN test with multi-talker babble as the masker. Target speech will be fixed at 70 dB SPL for both speech stimuli and the investigators will assess performance for two listening conditions: CI+HA and CIHA+HA.

    Measured: This will be measured at multiple time points including at or within 1 month of EAS activation (adults & peds), 6 months (adults & peds), 12 months (adults & peds, and 24 months (peds)

Secondary outcomes (3)
  1. EAS benefit for minimal audible angle (MAA) (CIHA+HA - CI+HA)

    MAA thresholds will be obtained by presenting 2 successive stimuli from different positions in the horizontal plane and requesting that the listener indicate whether the 2nd stimulus was to the left or to the right of the standard. Noise stimuli will include a BBN (100-8000 Hz) and LF noise (100-800 Hz). Three listening conditions will be tested: 1) bilateral HA (HA+HA), 2) bimodal (CI+HA), and EAS (CIHA+HA).

    Measured: This will be measured at multiple time points including at or within 1 month of EAS activation (adults & peds), 6 months (adults & peds), 12 months (adults & peds, and 24 months (peds)

  2. ITD sensitivity

    ITD thresholds will be measured using tonal and noise-band carriers. This task will be completed using both acoustic and electric stimulation with the latter achieved via direct connection to the CI sound processor allowing for investigation of binaural interference.

    Measured: This will be measured at multiple time points including at or within 1 month of EAS activation (adults & peds), 6 months (adults & peds), 12 months (adults & peds, and 24 months (peds)

  3. ILD sensitivity

    ILD thresholds will be measured using tonal and noise-band carriers. This task will be completed using both acoustic and electric stimulation with the latter achieved via direct connection to the CI sound processor allowing for investigation of binaural interference.

    Measured: This will be measured at multiple time points including at or within 1 month of EAS activation (adults & peds), 6 months (adults & peds), 12 months (adults & peds, and 24 months (peds)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2023
  2. Study start5 Dec 2022
  3. Primary completion1 Jun 2028 (estimated)
  4. Study completion31 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
There will be four groups of study participants including two experimental groups (pediatric and adult EAS) as well as two control groups \[pediatric and adult listeners with normal hearing (NH).
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05923203
Sponsor's protocol ID
222052
Other IDs
1R01DC020194-01A1
Status last verified
Apr 2025
First submitted
7 Jun 2023
Last updated
20 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Electric and acoustic stimulation (EAS) technology in the implanted ear(s)-this is the combination of a cochlear implant (CI) and hearing aid (HA) in the implanted ear(s) in people with Cochlear Implant and Hearing Loss, run by Hearts for Hearing at 4 sites 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 5 inclusion and 2 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 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 René 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?

Change in BEL sentence score demonstrating EAS benefit for speech recognition in noise (CIHA+HA - CI+HA) (time frame: This will be measured at multiple time points including at or within 1 month of EAS activation (adults & peds), 6 months (adults & peds), 12 months (adults & peds, and 24 months (peds)). 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?
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 20 Oct 2025.

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