Optimizing Bilateral and Single-sided-deafness Cochlear Implants for Functioning in Complex Auditory Environments

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
University of Maryland, College Park
Study ID
NCT06305039
Status
Enrolling By Invitation

Conditions

  • Cochlear Hearing Loss
  • Hearing Loss
  • Hearing Loss, Sensorineural

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Diagnostic tests of cochlear implant or acoustic hearing function — DIAGNOSTIC_TEST
    Because the cochlear implant participants in the study will use cochlear implant devices that they have already received as part of their standard-of-care treatment, the medical device itself is not an intervention for the purposes of this study. The intervention here will be to carry out diagnostic tests of cochlear implant or acoustic hearing function. This will include perceptual tests of sound localization, speech understanding in noise, binaural fusion, and loudness comparisons.
  • Targeted aural rehabilitation of the poorer performing ear — BEHAVIORAL
    Subjects will undergo listening practice on a tablet computer over headphones at home. For the test group, the aural rehabilitation will be targeted at the poorer ear. For the comparison control group, a sham aural rehabilitation will present speech to both ears.

Study Details

Cochlear implants (CIs) are devices that partially restore hearing for people with severe to profound hearing loss. This research focuses on CI users who use bilaterally implanted devices (two CIs, one on each side) and also "single-sided deafness" (SSD) CI users who use one CI together with good acoustic hearing in their opposite ear. The goal is to measure and understand the impact of large input asymmetries across the two ears. These asymmetries are common in BI-CI listeners and always present in SSD-CI users. Although most CI listeners benefit from a second source of auditory input, this project measures how these asymmetries limit speech understanding and spatial hearing. The long-term goal is countering or compensating for input asymmetries. Electrophysiological measures are used to describe the health of the auditory system. Behavioral measures are used to assess if training improves performance. CT imaging is utilized to describe the placement of the CIs.

Key Dates

Start date
Dec 19, 2023
Status verified
Mar 2025
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
300 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Bilateral Cochlear Implant Users
  • Experimental: Unilateral Cochlear Implant Users with Single-Sided Deafness
  • Other: Non-Implanted Listeners with Acoustic Hearing

Primary Outcome Measure

Perceptual responses to sound level [ Time Frame: Post-treatment - after at least 6 months use of a cochlear implant if CI user. After enrollment for non-implanted listeners with acoustic hearing. ]

Locations (2)

FacilityCityStateZIPSite coordinators
Walter Reed National Military Medical CenterBethesdaMaryland20889-
University of Maryland, College ParkCollege ParkMaryland20742-

Find similar trials in Bethesda, MD

By research site
Walter Reed National Military Medical Center· Bethesda, MDUniversity of Maryland, College Park· College Park, MD

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