Littlears Auditory Questionnaire: Validation Study in CI Children

Status:	Completed
Conditions:	Other Indications, Other Indications
Therapuetic Areas:	Other
Healthy:	No
Age Range:	Any
Updated:	4/21/2016
Start Date:	May 2008
End Date:	February 2016

Littlears Auditory Questionnaire Validation Study in CI Children With LittlEARS My Diary: Language: North American English

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.

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

We found this trial at

sites

Vanderbilt University

2201 West End Ave
Nashville, Tennessee 37232

(615) 322-7311