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Clinical Trials/NCT00424307
NCT00424307
Unknown
Phase 4

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

Advanced Bionics14 sites in 2 countries60 target enrollmentJanuary 2007
ConditionsHearing Loss

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Hearing Loss
Sponsor
Advanced Bionics
Enrollment
60
Locations
14
Primary Endpoint
Assessment of Speech Perception Skills
Last Updated
14 years ago

Overview

Brief Summary

The primary purpose of this study is to track patient outcomes for bilateral cochlear implant recipients in a cohort of 60 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.

Registry
clinicaltrials.gov
Start Date
January 2007
End Date
April 2012
Last Updated
14 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Profound bilateral hearing loss
  • Have independently elected to undergo bilateral implantation of Advanced Bionics HiResolution Bionic Ear System
  • Age at implant: 12-36 months
  • No previous cochlear implant use
  • 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 study participation

Outcomes

Primary Outcomes

Assessment of Speech Perception Skills

Time Frame: Various time points

Secondary Outcomes

  • Health-Related Quality of Life and Assessment of Communicative Performance(Various time points)

Study Sites (14)

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