Littlears Auditory Questionnaire: Validation Study in CI Children

Completed

Conditions studied: Hearing Loss

In brief

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.

Key facts

Study ID

NCT00785707

Run by

Med-El Corporation

People needed

31

Starts

2008-05-01

Expected to finish

2016-02-01

Last updated by the study team

2017-06-26

Who can join

Age: any, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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