Initial Results of a Safety and Feasibility Study of Auditory Brainstem Implantation in Congenitally Deaf Children.

ABSTRACT:

Objective

To determine the safety and feasibility of the auditory brainstem implant (ABI) in congenitally deaf children with cochlear aplasia and/or cochlear nerve deficiency.

Study design

Phase I feasibility clinical trial of surgery in 10 children, ages 2 to 5 years, over a 3-year period.

Setting

Tertiary children's hospital and university-based pediatric speech/language/hearing center.

Intervention(s)

ABI implantation and postsurgical programming.

Main outcome measure(s)

The primary outcome measure is the number and type of adverse events during ABI surgery and postsurgical follow-up, including behavioral mapping of the device. The secondary outcome measure is access to and early integration of sound.

Results

To date, nine children are enrolled

SUBMITTER: Wilkinson EP 

PROVIDER: S-EPMC5266605 | biostudies-literature | 2017 Feb

REPOSITORIES: biostudies-literature