Nucleus Freedom Cochlear Implant System Pediatric Post-approval Study

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Brief Title

Nucleus Freedom Cochlear Implant System Pediatric Post-approval Study


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


Primary Outcome

IT-MAIS


Condition

Sensorineural Hearing Loss



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

69

Start Date

October 2006

Completion Date

June 2009

Primary Completion Date

June 2009

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.
      

Gender

All

Ages

1 Year - 18 Years

Accepts Healthy Volunteers

No

Contacts

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Administrative Informations


NCT ID

NCT00589511

Organization ID

CORP5183


Responsible Party

Sponsor

Study Sponsor

Cochlear


Study Sponsor

, , 


Verification Date

August 2014