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

Summary

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.

Conditions

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

Interventions

DIAGNOSTIC_TEST

Diagnostic tests of cochlear implant or acoustic hearing function

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.

BEHAVIORAL

Targeted aural rehabilitation of the poorer performing ear

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.

Sponsors & Collaborators

• National Institute on Deafness and Other Communication Disorders (NIDCD)

  collaborator NIH

• Walter Reed National Military Medical Center

  collaborator FED

• Vanderbilt University

  collaborator OTHER

• University of Maryland, College Park

  lead OTHER

Principal Investigators

• Matthew J. Goupell, PhD · University of Maryland, College Park

• Joshua G. Bernstein, PhD · Walter Reed National Military Medical Center; University of Maryland, College Park

Study Design

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-19

Primary Completion

2028-05-31

Completion

2028-05-31

FDA Device

Yes

Countries

• United States

Study Locations