Iowa/Nucleus 10/10 mm and Nucleus Freedom Feasibility Study

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Bruce J Gantz, University of Iowa
ClinicalTrials.gov Identifier:
NCT00594061
First received: January 3, 2008
Last updated: June 12, 2012
Last verified: June 2012
  Purpose

The purpose of this study is to evaluate whether the Iowa/Nucleus 10/10 mm in one ear, in conjunction with a Nucleus Freedom implant in the other ear can provide useful binaural hearing in pediatric subjects who have bilateral severe to profound hearing loss and meet the criteria for cochlear implantation. The Iowa/Nucleus 10/10 mm cochlear implant has a short, 10 mm electrode array that it is inserted only into the more basal region of the cochlea. Unlike a conventional cochlear implant, the Iowa/Nucleus 10/10 mm is expected to preserve the regions of the cochlear partition that are apical to the electrode, thus leaving them available for possible future advances in the field of otolaryngology and hearing devices, such as mammalian hair cell regeneration techniques or improved implantable hearing devices. The Iowa/Nucleus 10/10 mm will be implanted in the contralateral ear from the Nucleus Freedom electrode array as a means of providing bilateral stimulation of auditory pathways while preserving the middle and apical regions of the scala media.


Condition Intervention
Hearing Loss, Sensorineural
Hearing Loss, Bilateral
Device: Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Iowa/Nucleus 10/10 mm and Nucleus Freedom Cochlear Implants Implanted Bilaterally in Children Ages 12-24 Months

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Speech Language Development [ Time Frame: Assessed longitudinally at 4, 8, and 12 months and annually thereafter ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Speech Perception Development [ Time Frame: Assessed longitudinally at 4, 8, and 12 months and annually thereafter ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: December 2007
Estimated Study Completion Date: May 2020
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Device: Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation
Participants will receive one standard Nucleus Freedom electrode array and an Iowa/Nucleus 10/10 mm electrode array on the contralateral side.

  Eligibility

Ages Eligible for Study:   12 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Twelve to twenty-four months of age at the time of implantation.
  • Audiometric thresholds for frequencies 250 to 8000 Hz in the severe-to-profound hearing range bilaterally. The type of hearing loss must be categorized as sensorineural in nature.
  • English spoken as a primary language (mono-lingual English speaking family, where English is the primary language).
  • Willingness to comply with all study requirements.
  • Multiple visits may be necessary preoperatively and/or postoperatively for data collection due to age and attention.
  • Minimum of three month hearing aid trial.
  • Patent cochlea and normal cochlear anatomy as shown by a CT Scan. It is standard clinical practice to perform a CT Scan on any patient pursuing cochlear implantation.
  • Must be in a habilitation/educational program with an emphasis on spoken language development.

Exclusion Criteria:

  • Medical or psychological conditions that contraindicate undergoing surgery.
  • Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array.
  • Developmental disabilities or other conditions that would prevent or restrict participation in the audiological evaluations and clinical trial.
  • Hearing loss of neural or central origin.
  • Unrealistic expectations on the part of the candidate and/or candidate's family,regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices.
  • Unwillingness or inability of the candidate to comply with all investigational requirements.
  • Active middle ear infection.
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594061

Locations
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Bruce J Gantz, MD University of Iowa Department of Otolaryngology Pediatric Cochlear Implant Program
  More Information

No publications provided

Responsible Party: Bruce J Gantz, Department Head --Department of Otolaryngology, University of Iowa
ClinicalTrials.gov Identifier: NCT00594061     History of Changes
Other Study ID Numbers: IA/NU G070130-S001, P50DC000242, NIDCD P50 DC00242
Study First Received: January 3, 2008
Last Updated: June 12, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 19, 2014