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

NCT00604474 | Withdrawn

• 2 other identifiers: 07030750ACR0906
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Deafness

Keywords

Deafness; Hearing Loss; Cochlear Implants; Advanced Bionics; HiResolution Bionic Ear System

Outcome Measures

Primary Outcomes (1)

• Subject performance on speech perception tests

  Two years post device activation

Secondary Outcomes (1)

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

  3, 6, 12, 18, and 24 months post device activation

Study Arms (1)

1

ACTIVE COMPARATOR

Device: HiResolution Bionic Ear System (Cochlear Implant)

Interventions

HiResolution Bionic Ear System (Cochlear Implant) DEVICE

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

1

Eligibility Criteria

• Age: 12 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Deafness; Hearing Loss

Interventions

Cochlear Implants

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neural Prostheses; Implantable Neurostimulators; Electrodes, Implanted; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Prostheses and Implants; Hearing Aids; Sensory Aids

Study Officials

• Lawrence Lustig, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2008
• First Posted: January 30, 2008
• Study Start: October 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: February 6, 2012

Record last verified: 2012-02

Locations

US (1)