Bilateral Cochlear Implant Benefit in Young Children

Advanced Bionics

Status and phase: Unknown; Phase 4

Conditions: Hearing Loss

Treatments: Device: HiResolution Bionic Ear System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00424307

ACR0906

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 12 to 36 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)