Littlears Auditory Questionnaire: Validation Study in CI Children

Med-El Corporation31 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hearing Loss

Eligibility

Sex: ALLMax age: 24 Months

Medical Language ↔ Plain English

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

Locations (5)

Georgia Health Sciences University

Augusta, Georgia, United States

University of North Carolina-Chapel Hill/CCCDP

Durham, North Carolina, United States

Vanderbilt University

Nashville, Tennessee, United States

Cook Children's Medical Center

Fort Worth, Texas, United States

Outcomes

Primary Outcomes

To Validate the LittleEARS Auditory Questionnaire

The LittleEARS auditory questionnaire (LEAQ) uses parent responses to assess auditory behavior in children up to 24 months of age. The questionnaire is scored from 0 to 35 with 0 indicating poorer performance and 35 indicating better performance. There are no subscales for the questionnaire.

Time frame: 24 months

Secondary Outcomes

Change in LEAQ Scale Score of Cochlear Implanted Children Over 24 Months After First CI Fitting

Time frame: 24 months

Data from ClinicalTrials.gov

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