Sensorineural Hearing Loss Clinical Trial
Verified date | August 2014 |
Source | Cochlear |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Observational |
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.
Status | Completed |
Enrollment | 69 |
Est. completion date | June 2009 |
Est. primary completion date | June 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Year to 18 Years |
Eligibility |
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 contraindicate undergoing surgery (e.g., active middle ear infections, tympanic membrane perforation). - Additional handicaps that would prevent or restrict participation in the evaluations. - Unrealistic expectations on the part of the subject or subject's parents/guardians, regarding the possible benefits, risks and limitations that are inherent to the surgical procedure and prosthetic device. - Unwillingness or inability of the candidate or candidate's parents/guardians to comply with all study requirements. |
Observational Model: Case-Only
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Cochlear |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | IT-MAIS | 12 Months | No | |
Primary | MAIS | 12 Months | No | |
Primary | MLNT | 12 Months | No | |
Primary | LNT | 12 Months | No |
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