We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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):

Study Description
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.

Condition or disease
Sensorineural Hearing Loss

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 Design

Study Type : Observational
Actual Enrollment : 69 participants
Observational Model: Case-Only
Study Start Date : October 2006
Primary Completion Date : June 2009
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. IT-MAIS [ Time Frame: 12 Months ]
  2. MAIS [ Time Frame: 12 Months ]
  3. MLNT [ Time Frame: 12 Months ]
  4. LNT [ Time Frame: 12 Months ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.
More Information

Responsible Party: Cochlear
ClinicalTrials.gov Identifier: NCT00589511     History of Changes
Other Study ID Numbers: CORP5183
First Posted: January 9, 2008    Key Record Dates
Last Update Posted: August 11, 2014
Last Verified: August 2014

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

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