There are no approved Food and Drug Administration indications for pediatric auditory brainstem implant (ABI) surgery in the United States. Our prospective case series aims to determine the safety and feasibility of ABI surgery in pediatric patients <5 years old with congenital deafness at a tertiary North American center. The inclusion criterion was pre- or postlinguistic deafness in children not eligible for cochlear implantation. Seventeen candidates were evaluated (mean ± SD: age, 2.52 ± 0.39 years). Four patients underwent ABI surgery (age, 19.2 ± 3.43 months), including 4 primary procedures and 1 revision for device failure. Spontaneous device failure occurred in another subject postoperatively. No major/minor complications occurred, including cerebrospinal fluid leak, facial nerve injury, hematoma, and nonauditory stimulation. All subjects detected sound with environmental awareness, and several demonstrated babbling and mimicry. Poor durability of older implants underscores need for updated technology.
Keywords: ABI; auditory brainstem implant; clinical trial; deafness; hearing loss; nonneurofibromatosis type II; pediatric.
© American Academy of Otolaryngology—Head and Neck Surgery Foundation 2016.