Littlears Auditory Questionnaire: Validation Study in CI Children

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.

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Hearing Loss, Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

Up to 24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Georgia Health Sciences University, Augusta, Georgia, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

To Validate the LittleEARS Auditory Questionnaire

Time frame: 24 months

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.

Secondary outcomes

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

Time frame: 24 months

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. This outcome measure is reported as a change on the LEAQ scale from initial CI fitting to 24 months.

Sponsors and collaborators

Lead sponsor

Med-El Corporation

Industry

Registry information

Official study title

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

Acronym: LittlEars

Important dates

Study start: 2008
Primary completion: 2016
Study completion: 2016
First posted: Nov 5, 2008
Registry last updated: Jun 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed