Development of Auditory Skills in Young Deaf Children With Bilateral Cochlear Implants

University of California San Francisco (UCSF)

Status

Withdrawn

Conditions

Deafness

Treatments

Device: HiResolution Bionic Ear System (Cochlear Implant)

Study type

Interventional

Funder types

Other

Identifiers

NCT00604474

07030750

ACR0906

Details and patient eligibility

About

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.

Full 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).

Sex

All

Ages

12 to 36 months old

Volunteers

No Healthy Volunteers

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.