Status:
COMPLETED
Littlears Auditory Questionnaire: Validation Study in CI Children
Lead Sponsor:
Med-El Corporation
Conditions:
Hearing Loss
Eligibility:
All Genders
Up to 24 years
Brief Summary
The LittlEARS Auditory Questionnaire is designed to assess the development of the auditory behavior in children during the first two (hearing) years. The questionnaire has been validated on children w...
Eligibility Criteria
Inclusion
- General:
- Less than or 24 months of age prior to implantation
- Cochlear implant candidate deemed by the clinic
- To be implanted with a MED-EL cochlear implant PULSARCI100 or SONATATI100
- English as the primary language at home
- Realistic expectations of guardians
- Willing and available to comply with all scheduled procedures as defined in the protocol
- Medical:
- Good general health status, as judged by Primary Investigator
- No contraindications for surgery, in general, or cochlear implant surgery in particular
Exclusion
- General:
- Prior experience with any cochlear implant system
- Older than 24 months at time of implantation
- Medical:
- Severed or non-functional auditory nerve in the ear(s) to be implanted
- Cognitive and/or neurological dysfunction
Key Trial Info
Start Date :
May 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00785707
Start Date
May 1 2008
End Date
February 1 2016
Last Update
June 26 2017
Active Locations (5)
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1
Georgia Health Sciences University
Augusta, Georgia, United States, 30912
2
University of North Carolina-Chapel Hill/CCCDP
Durham, North Carolina, United States, 27713
3
Vanderbilt University
Nashville, Tennessee, United States, 37232
4
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104