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

NCT ID: NCT00604474

Last Updated: 2012-02-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2010-05-31

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).

Conditions

Deafness

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: ACTIVE_COMPARATOR

HiResolution Bionic Ear System (Cochlear Implant)

Intervention Type: DEVICE

Subjects are required to have bilateral implantation of the Advanced Bionics HiResolution Bionic Ear System (Cochlear Implant)

Interventions

HiResolution Bionic Ear System (Cochlear Implant)

Subjects are required to have bilateral implantation of the Advanced Bionics HiResolution Bionic Ear System (Cochlear Implant)

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 36 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lawrence Lustig, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

ACR0906

Identifier Type: -

Identifier Source: secondary_id

07030750

Identifier Type: -

Identifier Source: org_study_id