Deafness
Conditions
Keywords
Deafness, Hearing Loss, Cochlear Implants, Advanced Bionics, HiResolution Bionic Ear System
Brief summary
The primary objective to this study is to describe the auditory development and performance of young deaf children who receive bilateral implants during the first two years following device activation.
Detailed description
The primary purpose of this study is to track patient outcomes for bilateral cochlear implant recipients in a cohort of 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. Acquisition of auditory milestones and speech recognition skills, which underpin the development of spoken language, will be assessed on a battery of outcome measures typically used to quantify implant benefits. In addition, global quality of life and communicative performance will be assessed by parental proxy. Performance will be tracked after 3, 6, 12, 18, and 24 months of device use. The study also will identify variables that may predict the degree of bilateral implant benefit in young children (e.g., age at implant, pre-implant hearing thresholds, communication mode, family socioeconomic status, post-implant aided thresholds, simultaneous vs. staged placement of devices).
Interventions
DEVICEHiResolution Bionic Ear System (Cochlear Implant)
Subjects are required to have bilateral implantation of the Advanced Bionics HiResolution Bionic Ear System (Cochlear Implant)
Sponsors
University of California, San Francisco
Study design
Allocation
NA
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 (PTA\>= 90dB HL) * Have independently elected to undergo bilateral implantation of Advanced Bionics HiResolution Bionic Ear System and meet all the eligibility criteria for this device as described in the product labeling. * Age at implant: 12-36 months * Negligible benefit from hearing aids, defined as failure to reach developmentally appropriate milestones on IT-MAIS * No previous cochlear implant use * Normal/patent cochlea with no more than a mild partitioning defect in either ear * 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 performance on outcome measures or otherwise confound or interfere with study participation of outcomes measures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subject performance on speech perception tests | Two years post device activation |
Secondary
| Measure | Time frame |
|---|---|
| Speech recognition performance at various intervals. Global quality of life and functional communicative performance completed by parental proxy | 3, 6, 12, 18, and 24 months post device activation |
Countries
United States
Outcome results
None listed