Nucleus Freedom Cochlear Implant System Pediatric Post-approval Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cochlear
ClinicalTrials.gov Identifier:
NCT00589511
First received: December 23, 2007
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

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.


Condition
Sensorineural Hearing Loss

Study Type: Observational
Study Design: Observational Model: Case-Only

Resource links provided by NLM:


Further study details as provided by Cochlear:

Primary Outcome Measures:
  • IT-MAIS [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • MAIS [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • MLNT [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • LNT [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Enrollment: 69
Study Start Date: October 2006
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Cochlear
ClinicalTrials.gov Identifier: NCT00589511     History of Changes
Other Study ID Numbers: CORP5183
Study First Received: December 23, 2007
Last Updated: August 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Cochlear:
Bilateral severe to profound sensorineural hearing loss

Additional relevant MeSH terms:
Deafness
Hearing Loss
Hearing Loss, Sensorineural
Ear Diseases
Hearing Disorders
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014