N/A
N=31
Littlears Auditory Questionnaire: Validation Study in CI Children
Hearing Loss
Bottom Line
View on ClinicalTrials.gov: NCT00785707 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: To Validate the LittleEARS Auditory Questionnaire — 34.75 units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric
- Sex
- All
- Sponsor
- Med-El Corporation
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Validate the LittleEARS Auditory Questionnaire |
34.75 | — |
| SECONDARY Change in LEAQ Scale Score of Cochlear Implanted Children Over 24 Months After First CI Fitting |
28.78 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00785707). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.