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

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ClinicalTrials.gov Identifier: NCT00594061
Recruitment Status : Completed
First Posted : January 15, 2008
Results First Posted : May 23, 2018
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Bruce J Gantz, University of Iowa

Brief Summary:
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 or disease Intervention/treatment Phase
Hearing Loss, Sensorineural Hearing Loss, Bilateral Device: Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2007
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
There is no arm to this study--(each participant serves ashis or her own control). Blinding or masking procedures are not included in the design, as it is not possible to conceal the presence or absence of a cochlear implant from device recipients and/or clinical investigators.
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.



Primary Outcome Measures :
  1. Pre-school Language Test [ Time Frame: 48 months ]
    Assesses global language skills using toys and pictures. This test assess auditory comprehension and expressive communication and a total language score is calculated. The reported score was assessed at 48 months post-implantation. The total language standard score ranges from 50-150. A higher total score indicates better performance. A raw score for total language is calculated and converted into a standard score.


Secondary Outcome Measures :
  1. Phonemically Balanced-Kindergarten Test (PB-K)-Bilateral [ Time Frame: 56 months ]
    PB-K Test was constructed to be an open-set test of word understanding for children. It is scored as a percentage of words correct. The test was measured using the Iowa/Nucleus 10/10 mm and Nucleus Freedom together, the Iowa/Nucleus 10/10 mm only, and the Nucleus Freedom electrode only conditions. The higher the score, the better the word understanding. The post-operative time point for this score was reported on average at 56 months post-implantation.



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Ages Eligible for Study:   12 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00594061


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

Responsible Party: Bruce J Gantz, Department Head --Department of Otolaryngology, University of Iowa
ClinicalTrials.gov Identifier: NCT00594061     History of Changes
Other Study ID Numbers: 200710716
First Posted: January 15, 2008    Key Record Dates
Results First Posted: May 23, 2018
Last Update Posted: May 23, 2018
Last Verified: May 2018

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