Status:
WITHDRAWN
Subjective and Objective Performance With the SONNET2EAS
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Med-El Corporation
Conditions:
Hearing Loss
Hearing Disability
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
Purpose: The purpose of this study is to demonstrate the non-inferiority and new features of an external speech processor for cochlear implant recipients. Participants: This study seeks to enroll 15 ...
Detailed Description
Candidacy criteria for cochlear implantation include adults with normal-to-moderate low-frequency hearing and severe-to-profound high-frequency sensorineural hearing loss. A cochlear implant system in...
Eligibility Criteria
Inclusion
- Adult (≥18 years at date of enrollment/initial evaluation)
- MED-EL Cochlear Implant System recipient
- Unilateral cochlear implant recipient
- Unaided threshold of ≤65 decibels (dB) Hearing Level (HL) at 125 Hz in implanted ear
- Six months or greater of SONNETEAS listening experience
- Consistent device user, as deemed by research team
- Minimum of 10 enabled electrodes
- Consonant Nucleus Consonant (CNC) word score of ≥40% with SONNETEAS processor and contralateral ear plugged/masked
- Native English speaker (as all materials are written or spoken in English)
Exclusion
- Unaided pure tone average (500, 1000, 2000 Hz) ≤60 dB HL in the contralateral (non-implanted) ear
- Hearing technology other than a conventional hearing aid in the contralateral ear
- Unwilling, unable, or geographic limitations to participate in study procedures
- Unwilling to complete datalogging with the processor
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04721990
Start Date
April 1 2021
End Date
April 1 2023
Last Update
August 18 2021
Active Locations (1)
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1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599