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Procedure
Cochlear Implants for Hearing Loss
N/A
Waitlist Available
Led By Joshua G. Bernstein, PhD
Research Sponsored by University of Maryland, College Park
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-treatment - after at least 6 months use of a cochlear implant if ci user. not collected for non-implanted listeners with acoustic hearing.
Awards & highlights
No Placebo-Only Group
Summary
"This trial looks at how cochlear implants help people with severe hearing loss. They are studying people with implants in both ears and those with an implant in one ear and good hearing in the other. They
Who is the study for?
This trial is for individuals with severe to profound hearing loss who are using cochlear implants (CIs). It's specifically aimed at those with bilateral CIs (one on each ear) or single-sided deafness (SSD), where one CI is used alongside normal hearing in the other ear. Participants should be able to undergo diagnostic tests, CT imaging, and targeted aural rehabilitation.
What is being tested?
The study measures how differences in auditory input between two ears affect speech understanding and spatial hearing in CI users. It involves diagnostic tests of CI function, electrophysiological measures of auditory health, CT imaging for CI placement assessment, and aural rehabilitation to see if training can improve performance.
What are the potential side effects?
While this trial does not involve medication that typically has side effects, participants may experience discomfort from diagnostic procedures or fatigue during aural rehabilitation sessions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-treatment - after at least 6 months use of a cochlear implant if ci user. not collected for non-implanted listeners with acoustic hearing.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-treatment - after at least 6 months use of a cochlear implant if ci user. not collected for non-implanted listeners with acoustic hearing.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Computed-tomography scan
Electrically evoked compound action potentials (ECAPs)
Electrode impedance (transelectrode impedance matrix)
+2 moreSecondary study objectives
Perceptual Fusion
Sound Localization
Spectrotemporal ripple sensitivity
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Unilateral Cochlear Implant Users with Single-Sided DeafnessExperimental Treatment2 Interventions
Group II: Non-Implanted Listeners with Acoustic HearingExperimental Treatment1 Intervention
Group III: Bilateral Cochlear Implant UsersExperimental Treatment2 Interventions
Find a Location
Who is running the clinical trial?
University of Maryland, College ParkLead Sponsor
159 Previous Clinical Trials
46,163 Total Patients Enrolled
2 Trials studying Hearing Loss
300 Patients Enrolled for Hearing Loss
Vanderbilt UniversityOTHER
710 Previous Clinical Trials
6,143,080 Total Patients Enrolled
9 Trials studying Hearing Loss
1,151 Patients Enrolled for Hearing Loss
Walter Reed National Military Medical CenterFED
143 Previous Clinical Trials
33,104 Total Patients Enrolled
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
361 Previous Clinical Trials
181,758 Total Patients Enrolled
61 Trials studying Hearing Loss
21,306 Patients Enrolled for Hearing Loss
Joshua G. Bernstein, PhDPrincipal InvestigatorWalter Reed National Military Medical Center; University of Maryland, College Park
Matthew J. Goupell, PhDPrincipal InvestigatorUniversity of Maryland, College Park
1 Previous Clinical Trials
300 Total Patients Enrolled
1 Trials studying Hearing Loss
300 Patients Enrolled for Hearing Loss