Overview

This trial is active, not recruiting.

Condition hearing loss
Treatment hiresolution bionic ear system
Phase phase 4
Sponsor Advanced Bionics
Start date January 2007
End date April 2012
Trial size 60 participants
Trial identifier NCT00424307, ACR0906

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Assessment of Speech Perception Skills
time frame: Various time points

Secondary Outcomes

Measure
Health-Related Quality of Life and Assessment of Communicative Performance
time frame: Various time points

Eligibility Criteria

Male or female participants from 12 months up to 36 months old.

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

Additional Information

Official title Development of Auditory Skills in Young Deaf Children With Bilateral Cochlear Implants
Trial information was received from ClinicalTrials.gov and was last updated in June 2011.
Information provided to ClinicalTrials.gov by Advanced Bionics.