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

Deafness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00604474
• Other study ID #: 07030750
• Secondary ID: ACR0906
• Status: Withdrawn
• Phase: N/A
• First received: January 17, 2008
• Last updated: February 2, 2012
• Start date: October 2007
• Est. completion date: May 2010

Study information

• Verified date: February 2012
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Months to 36 Months

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deafness

Intervention

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

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject performance on speech perception tests		Two years post device activation	No
Secondary	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	No