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Development of Auditory Skills in Young Deaf Children With Bilateral Cochlear Implants

This study has been withdrawn prior to enrollment.
(Not sufficient enrollment)
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00604474
First received: January 17, 2008
Last updated: February 2, 2012
Last verified: February 2012
History of Changes
  Purpose

The primary objective to this study is to describe the auditory development and performance of young deaf children who receive bilateral implants during the first two years following device activation.


Condition Intervention
Deafness
 Device: HiResolution Bionic Ear System (Cochlear Implant)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Development of Auditory Skills in Young Deaf Children With Bilateral Cochlear Implants

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Subject performance on speech perception tests [ Time Frame: Two years post device activation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Speech recognition performance at various intervals. Global quality of life and functional communicative performance completed by parental proxy [ Time Frame: 3, 6, 12, 18, and 24 months post device activation ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: October 2007
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Device: HiResolution Bionic Ear System (Cochlear Implant)
Subjects are required to have bilateral implantation of the Advanced Bionics HiResolution Bionic Ear System (Cochlear Implant)

Detailed Description:

The primary purpose of this study is to track patient outcomes for bilateral cochlear implant recipients in a cohort of children, ages 12 to 36 months at time of surgery, who receive two implants in the same operation or in two different surgeries with the initial fitting of the devices separated by no more than six months. Acquisition of auditory milestones and speech recognition skills, which underpin the development of spoken language, will be assessed on a battery of outcome measures typically used to quantify implant benefits. In addition, global quality of life and communicative performance will be assessed by parental proxy. Performance will be tracked after 3, 6, 12, 18, and 24 months of device use. The study also will identify variables that may predict the degree of bilateral implant benefit in young children (e.g., age at implant, pre-implant hearing thresholds, communication mode, family socioeconomic status, post-implant aided thresholds, simultaneous vs. staged placement of devices).

  Eligibility

Ages Eligible for Study:   12 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Profound bilateral hearing loss (PTA>= 90dB HL)
  • Have independently elected to undergo bilateral implantation of Advanced Bionics HiResolution Bionic Ear System and meet all the eligibility criteria for this device as described in the product labeling.
  • Age at implant: 12-36 months
  • Negligible benefit from hearing aids, defined as failure to reach developmentally appropriate milestones on IT-MAIS
  • No previous cochlear implant use
  • Normal/patent cochlea with no more than a mild "partitioning" defect in either ear
  • English as the primary language spoken in the home
  • Parental willingness to follow study protocol

Exclusion Criteria:

  • Deafness secondary to meningitis
  • Presence of other conditions that could affect performance on outcome measures or otherwise confound or interfere with study participation of outcomes measures.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00604474

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Lawrence Lustig, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00604474     History of Changes
Other Study ID Numbers: 07030750, ACR0906
Study First Received: January 17, 2008
Last Updated: February 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Deafness
Hearing Loss
Cochlear Implants
Advanced Bionics
HiResolution Bionic Ear System

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

ClinicalTrials.gov processed this record on May 19, 2013