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Nucleus Freedom Cochlear Implant System Pediatric Post-approval Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00589511
Recruitment Status : Completed
First Posted : January 9, 2008
Last Update Posted : August 11, 2014
Sponsor:
Information provided by (Responsible Party):
Cochlear

Tracking Information
First Submitted Date December 23, 2007
First Posted Date January 9, 2008
Last Update Posted Date August 11, 2014
Study Start Date October 2006
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 8, 2008)
  • IT-MAIS [ Time Frame: 12 Months ]
  • MAIS [ Time Frame: 12 Months ]
  • MLNT [ Time Frame: 12 Months ]
  • LNT [ Time Frame: 12 Months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Nucleus Freedom Cochlear Implant System Pediatric Post-approval Study
Official Title Not Provided
Brief 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.
Detailed Description

The proposed study will include 50 pediatric subjects ages 1 year to 17 years, 11 months of age, implanted at up to 5 sites in the United States and Canada. The estimated duration of this multisite study is 18 to 24 months. The duration of individual subject participation is not to exceed 12 months.

The study will be conducted as a within-subject repeated measures experiment (in which each subject serves as his or her own control) in order to accommodate the heterogeneity that is well known to characterize hearing-impaired populations

Study Type Observational
Study Design Observational Model: Case-Only
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Children with bilateral severe to profound sensorineural hearing loss who undergo implantation with the Nucleus Freedom Cochlear Implant System
Condition Sensorineural Hearing Loss
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 7, 2014)
69
Original Estimated Enrollment
 (submitted: January 8, 2008)
50
Actual Study Completion Date June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Year to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00589511
Other Study ID Numbers CORP5183
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Cochlear
Study Sponsor Cochlear
Collaborators Not Provided
Investigators Not Provided
PRS Account Cochlear
Verification Date August 2014