LittlEarsLittlears Auditory Questionnaire Validation Study in CI Children With LittlEARS My Diary: Language: North American English
Data Collection
Collected from today forward - ProspectiveEar Diseases+7
+ Hearing Disorders
+ Hearing Loss, Sensorineural
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: May 1, 2008
Actual date on which the first participant was enrolled.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 with normal hearing whose native language is German. A comparison was made between North American English speaking children with normal hearing and found that it was consistent with the German data. This study is to validate the questionnaire in children with cochlear implants.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.31 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Until 24 Months
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 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 Criteria: 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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 5 locations
Georgia Health Sciences University
Augusta, United StatesOpen Georgia Health Sciences University in Google MapsUniversity of North Carolina-Chapel Hill/CCCDP
Durham, United StatesVanderbilt University
Nashville, United StatesCook Children's Medical Center
Fort Worth, United States