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Search / Trial NCT06305039

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

Launched by UNIVERSITY OF MARYLAND, COLLEGE PARK · Mar 1, 2024

Trial Information

Current as of July 23, 2025

Enrolling by invitation

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • For Bilateral Cochlear Implant Users Arm:
  • 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
  • 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:
  • Inclusion Criteria:
  • 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
  • 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 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:
  • Inclusion Criteria:
  • 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:
  • severe hearing loss
  • other known disability or neurological disorder

About University Of Maryland, College Park

The University of Maryland, College Park, is a leading research institution dedicated to advancing knowledge and innovation in various fields, including health and medicine. As a prominent clinical trial sponsor, the university leverages its extensive resources, interdisciplinary expertise, and commitment to rigorous scientific inquiry to facilitate impactful clinical research. The institution fosters collaborations among faculty, healthcare professionals, and industry partners to enhance patient care and drive advancements in medical science, ensuring compliance with ethical standards and regulatory requirements throughout the research process.

Locations

Bethesda, Maryland, United States

College Park, Maryland, United States

Patients applied

0 patients applied

Trial Officials

Matthew J. Goupell, PhD

Principal Investigator

University of Maryland, College Park

Joshua G. Bernstein, PhD

Principal Investigator

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

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported