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

Primary Purpose

Deafness

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HiResolution Bionic Ear System (Cochlear Implant)
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deafness focused on measuring Deafness, Hearing Loss, Cochlear Implants, Advanced Bionics, HiResolution Bionic Ear System

Eligibility Criteria

12 Months - 36 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Subject performance on speech perception tests

Secondary Outcome Measures

Speech recognition performance at various intervals. Global quality of life and functional communicative performance completed by parental proxy

Full Information

First Posted
January 17, 2008
Last Updated
February 2, 2012
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT00604474
Brief Title
Development of Auditory Skills in Young Deaf Children With Bilateral Cochlear Implants
Official Title
Development of Auditory Skills in Young Deaf Children With Bilateral Cochlear Implants
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Not sufficient enrollment
Study Start Date
October 2007 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deafness
Keywords
Deafness, Hearing Loss, Cochlear Implants, Advanced Bionics, HiResolution Bionic Ear System

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
HiResolution Bionic Ear System (Cochlear Implant)
Intervention Description
Subjects are required to have bilateral implantation of the Advanced Bionics HiResolution Bionic Ear System (Cochlear Implant)
Primary Outcome Measure Information:
Title
Subject performance on speech perception tests
Time Frame
Two years post device activation
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence Lustig, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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