Recruiting

EAS

Sponsor:

Hearts for Hearing

Code:

NCT05923203

Conditions

Cochlear Implant

Hearing Loss

Eligibility Criteria

Sex: All

Age: 5+

Healthy Volunteers: Accepted

Interventions

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)

Study Details

Brief 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. 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.

Conditions

Cochlear Implant

Hearing Loss

Study ID

NCT05923203

Start date

Dec 5, 2022

Status verified date

Apr, 2025

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Jun 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. 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).
2. 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.
3. 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).
4. No confounding diagnosis such as autism, auditory neuropathy, neurological disorder, or general cognitive impairment.
5. Willingness to use EAS technology in the implanted ear(s) to be verified via data logging from cochlear implant and hearing aid software.

Exclusion Criteria:

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

Study Design

Enrollment

160 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Adult use of EAS

Clinical intervention; Adults with CI and the fitting of electric and acoustic stimulation (EAS) technology in the implanted ear(s).

experimental: Pediatric use of EAS

Clinical intervention; Children with CI and the fitting of electric and acoustic stimulation (EAS) technology in the implanted ear(s).

no intervention: Children with Normal Hearing

Children with normal hearing; acoustic only

no intervention: Adults with Normal Hearing

Adult with normal hearing; acoustic only

Interventions

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)

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.

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) ]
  • Change in BKB-SIN 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) ]

Central Contacts and Locations

Central contacts

René Gifford, PhD

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

Jourdan T Holder, AuD, PhD

jourdan.holder@heartsforhearing.org

Locations

Hearts for Hearing

Recruiting

Edmond, Oklahoma, United States, 73120

Contacts

René H Gifford, PhD

rene.gifford@heartsforhearing.org

Principal Investigator:

René H Gifford, PhD

University Of Texas at Austin

Recruiting

Austin, Texas, United States, 78712

Contacts

Spencer Smith, PhD

spencer.smith@austin.utexas.edu

University Of Wisconsin Madison

Recruiting

Madison, Wisconsin, United States, 53706

Contacts

Shelly Godar

godar@waisman.wisc.edu

More Information

Sponsor

Hearts for Hearing

Last update posted

Oct 20, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Hearts for Hearing on 2025-10-20.