Hearing Loss
Conditions
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.
Interventions
DEVICEHiResolution Bionic Ear System
Sponsors
Advanced Bionics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to 36 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of Speech Perception Skills | Various time points |
Secondary
| Measure | Time frame |
|---|---|
| Health-Related Quality of Life and Assessment of Communicative Performance | Various time points |
Countries
Canada, United States
Outcome results
None listed