Littlears Auditory Questionnaire: Validation Study in CI Children (LittlEars)

MED-EL

Status: Completed

Conditions: Hearing Loss

Study type: Observational

Funder types: Industry

Identifiers

NCT00785707

MED-EL NA 020

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: Under 24 months old

Volunteers: No Healthy Volunteers

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

Trial design

31 participants in 1 patient group

cochlear implant

Description:

children less than 24 months at time of cochlear implantation