Bilateral Cochlear Implant Benefit in Young Children

Advanced Bionics60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hearing Loss

Interventions

HiResolution Bionic Ear SystemDEVICE

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 36 Months

Medical Language ↔ Plain English

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

Locations (14)

Children's HEAR Center

Birmingham, Alabama, United States

House Ear Institute

Los Angeles, California, United States

University of California, San Francisco

San Francisco, California, United States

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

Time frame: Various time points

Data from ClinicalTrials.gov

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