Iowa/Nucleus 10/10 mm and Nucleus Freedom Feasibility Study - Full Text View

Sponsored by:	National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by:	National Institute on Deafness and Other Communication Disorders (NIDCD)
ClinicalTrials.gov Identifier:	NCT00594061

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

Genetics Home Reference related topics: nonsyndromic deafness

MedlinePlus related topics: Hearing Disorders and Deafness

U.S. FDA Resources

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

Further study details as provided by National Institute on Deafness and Other Communication Disorders (NIDCD):

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 Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	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

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

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

Principal Investigator:

Bruce J Gantz, MD

University of Iowa Department of Otolaryngology Pediatric Cochlear Implant Program

More Information

Responsible Party:	Univeristy of Iowa Department of Otolaryngology Pediatric Cochlear Implant Program ( Bruce J. Gantz, MD )
Study ID Numbers:	IA/NU G070130-S001, NIDCD P50 DC00242
Study First Received:	January 3, 2008
Last Updated:	January 3, 2008
ClinicalTrials.gov Identifier:	NCT00594061
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Study placed in the following topic categories:

Signs and Symptoms
Sensation Disorders
Hearing Disorders
Deafness
Otorhinolaryngologic Diseases
Sensorineural hearing loss

Hearing Loss, Bilateral
Neurologic Manifestations
Hearing Loss, Sensorineural
Hearing Loss
Ear Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009