NCT06305039

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

Optimizing Bilateral and Single-sided-deafness Cochlear Implants for Functioning in Complex Auditory Environments - Part 2

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: University of Maryland, College Park · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2023-12-19
• Primary completion: 2028-05-31
• Completion: 2028-05-31
• First posted: 2024-03-12
• Last updated: 2025-03-28

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study