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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This study has been withdrawn prior to enrollment.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

January 17, 2008
February 2, 2012
October 2007
May 2010   (final data collection date for primary outcome measure)
Subject performance on speech perception tests [ Time Frame: Two years post device activation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00604474 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Development of Auditory Skills in Young Deaf Children With Bilateral Cochlear Implants
Development of Auditory Skills in Young Deaf Children With Bilateral Cochlear Implants

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.

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).
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Deafness
Device: HiResolution Bionic Ear System (Cochlear Implant)
Subjects are required to have bilateral implantation of the Advanced Bionics HiResolution Bionic Ear System (Cochlear Implant)
Active Comparator: 1
Intervention: Device: HiResolution Bionic Ear System (Cochlear Implant)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
May 2010
May 2010   (final data collection date for primary outcome measure)

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.
Both
12 Months to 36 Months
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00604474
07030750, ACR0906
No
University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Lawrence Lustig, MD University of California, San Francisco
University of California, San Francisco
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP