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

Part of paid clinical trials in Edmond, Oklahoma.

Sponsor
Hearts for Hearing
Study ID
NCT05923203
Status
Recruiting
Apply to this trial

Conditions

  • Cochlear Implant
  • Hearing Loss

Eligibility Criteria

Sex
ALL
Age
5 Years - N/A
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) — 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 Details

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.

Key Dates

Start date
Dec 5, 2022
Status verified
Apr 2025
Primary completion
Jun 1, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
160 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

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) ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Hearts for HearingEdmondOklahoma73120
René H Gifford, PhD
[email protected]
René H Gifford, PhD (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37232-
University Of Texas at AustinAustinTexas78712
Spencer Smith, PhD
[email protected]
University Of Wisconsin MadisonMadisonWisconsin53706
Shelly Godar
[email protected]

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Hearts for Hearing· Edmond, OKVanderbilt University Medical Center· Nashville, TNUniversity Of Texas at Austin· Austin, TXUniversity Of Wisconsin Madison· Madison, WI

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