Status:
COMPLETED
Outcomes in Children With Pre-operative Residual Hearing
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Med-El Corporation
Conditions:
High Frequency Sensorineural Hearing Impairment
Hearing Disorders in Children
Eligibility:
All Genders
60-215 years
Phase:
NA
Brief Summary
Purpose: Routine clinical care and pilot study data has shown evidence of postoperative hearing preservation in pediatric cochlear implant (CI) recipients. The primary aim of this study is to investig...
Detailed Description
As children with more residual hearing are receiving cochlear implants (CIs), there is an opportunity to preserve that hearing and provide combined electric and acoustic stimulation (EAS). The primary...
Eligibility Criteria
Inclusion
- Aged 5 through 17 years
- Spoken English as the primary language (speech perception testing conducted in English).
- Recipient of a MED-EL SYNCHRONY Cochlear Implant device.
- Pre-operative LFPTA of ≤ 75 dB HL.
- Willing and able to participate in study procedures.
- Realistic parental/patient expectations.
- Language skills judged to be adequate enough to perform study tasks.
Exclusion
- Inability to perform open set speech perception due to oral motor delays.
- Inability to perform test battery due to behavior or cognitive impairment
- Unwilling or unable to participate in study procedures.
- Cochlear nerve deficiency.
- Anatomical considerations that necessitated surgical modifications such as ossification, incomplete insertion, or placement in scala vestibuli.
Key Trial Info
Start Date :
May 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2023
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03379870
Start Date
May 25 2018
End Date
December 14 2023
Last Update
October 15 2024
Active Locations (1)
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1
The Children's Cochlear Implant Center at UNC
Durham, North Carolina, United States, 27713-6102