Nucleus Freedom Cochlear Implant System Pediatric Post-approval Study

NCT00589511 | Completed

• 1 other identifier: CORP5183
• Study Type: observational
• Target: 69
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sensorineural Hearing Loss

Keywords

Bilateral severe to profound sensorineural hearing loss

Outcome Measures

Primary Outcomes (4)

• IT-MAIS

  12 Months

• MAIS

  12 Months

• MLNT

  12 Months

• LNT

  12 Months

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cochlear: lead

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2007
• First Posted: January 9, 2008
• Study Start: October 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: August 11, 2014

Record last verified: 2014-08