Nucleus Freedom Cochlear Implant System Pediatric Post-approval Study (NCT00589511) | Clinical Trial Compass
CompletedNot Applicable
Nucleus Freedom Cochlear Implant System Pediatric Post-approval Study
69 participantsStarted 2006-10
Plain-language summary
The objective of this multisite study is to evaluate the performance of the Nucleus Freedom cochlear implant system in a large population of sequentially implanted pediatric subjects.
Who can participate
Age range1 Year – 18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1 year to 17 years, 11 months of age.
* Bilateral severe to profound sensorineural hearing loss for those 1 to 2 years of age. Severe hearing loss for those 2 years of age and older.
* Limited benefit from bilateral hearing aids. Limited benefit is defined as a lack of progress in the development of simple auditory skills in conjunction with appropriate amplification and intensive aural rehabilitation over a 3 to 6 month period.
* For younger children, unable to take speech perception tests due to age-related cognitive and linguistic limitations, limited benefit will be quantified using the Infant Toddler Meaningful Auditory Integration Scale (IT-MAIS)1 or Meaningful Auditory Integration Scale (MAIS)1.
* For older children, capable of speech perception tasks, limited benefit is defined as £ 30% on the recorded open-set Multisyllabic Lexical Neighborhood Test (MLNT)2 or Lexical Neighborhood Test (LNT) 2, depending on the child's cognitive and linguistic skills.
* English spoken as a primary language.
* Willingness to participate in and to comply with all requirements of the protocol.
Exclusion Criteria:
* Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array, as confirmed by medical examination and tests including MRI.
* Signs of retrocochlear or central origin to hearing impairment as confirmed by medical examination and tests including MRI.
* Medical or psychological conditions that would contrai…