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

NCT ID: NCT06305039

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-19
• Study Completion Date: 2028-05-31

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Bilateral Cochlear Implant Users

Group Type: EXPERIMENTAL

Diagnostic tests of cochlear implant or acoustic hearing function

Intervention Type: 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

Intervention Type: 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.

Unilateral Cochlear Implant Users with Single-Sided Deafness

Group Type: EXPERIMENTAL

Diagnostic tests of cochlear implant or acoustic hearing function

Intervention Type: 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

Intervention Type: 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.

Non-Implanted Listeners with Acoustic Hearing

Group Type: OTHER

Diagnostic tests of cochlear implant or acoustic hearing function

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• two cochlear implants
• acquired their hearing loss during adulthood or late childhood (post-lingual onset)
• native English speaker
• primarily use oral language
• at least six months of cochlear implant use
• Sufficient corrected or uncorrected visual acuity (20/50 or better) to read large-font text

• one cochlear implant in one ear and a second ear with some acoustic hearing
• acquired their hearing loss during adulthood or late childhood (post-lingual onset)
• native English speaker
• primarily use oral language
• at least six months of cochlear implant use
• Sufficient corrected or uncorrected visual acuity (20/50 or better) to read large-font text

• audiometrically normal hearing or near-normal hearing, or mild/moderate hearing loss
• Sufficient corrected or uncorrected visual acuity (20/50 or better) to read large-font text

Exclusion Criteria

• people who do not use oral language will be excluded.
• people with less than six months of device use will be excluded
• other known disability or neurological disorder
• women who are pregnant will be excluded from the CT portion of the study
• people with any unaided audiometric tone-detection threshold better than 60 dB HL at standard audiometric frequencies (250-8000 Hz) in either ear will be excluded

For Unilateral Cochlear Implant User with Single-Sided Deafness Arm:

• people who do not use oral language will be excluded.
• people with less than six months of device use will be excluded
• other known disability or neurological disorder
• women who are pregnant will be excluded from the CT portion of the study
• people with any unaided audiometric tone-detection threshold better than 60 dB HL at standard audiometric frequencies (250-8000 Hz) in the implanted ear will be excluded
• people with an acoustic pure-tone average threshold (octave frequencies 250-4000 Hz) > 30 dB HL in the non-implanted ear

For Non-Implanted Listeners with Acoustic Hearing Arm:

• severe hearing loss
• other known disability or neurological disorder

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

Walter Reed National Military Medical Center

FED

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: collaborator

University of Maryland, College Park

OTHER

Sponsor Role: lead

Responsible Party

Matthew Goupell

Professor, Department of Hearing and Speech Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew J. Goupell, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, College Park

Joshua G. Bernstein, PhD

Role: PRINCIPAL_INVESTIGATOR

Walter Reed National Military Medical Center; University of Maryland, College Park

Locations

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

University of Maryland, College Park

College Park, Maryland, United States

Countries

United States

Other Identifiers

1R01DC020506-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2089705

Identifier Type: -

Identifier Source: org_study_id