TY - JOUR
T1 - Pediatric auditory brainstem implantation
T2 - Surgical, electrophysiologic, and behavioral outcomes
AU - Teagle, Holly F.B.
AU - Henderson, Lillian
AU - He, Shuman
AU - Ewend, Matthew G.
AU - Buchman, Craig A.
N1 - Funding Information:
This work was supported, in part, by grants from National Institutes of Health (National Institute on Deafness and other Communication Disorders)/National Institute of General Medical Sciences (1R21 DC011383 and 1R03DC013153) and NIH/NIGMS (1R01DC016038), funding provided by the Weatherspoon family, and the pilot grant of Center for Perception and Communication in Children (COBRE) NIH/NIGMS (5P20 GM109023-03). All study participants were enrolled in the Food and Drug Administration (FDA)–approved clinical trial entitled “An Early Feasibility Study of the Safety and Efficacy of the Nucleus 24 Auditory Brainstem Implant in Children with Cochlear or Cochlear Nerve Disorder Not Resulting from Neurofibromatosis Type II” (approval number: IDE G120099). Cochlear Corp. generously donated Cochlear Nucleus 24M ABIs for this clinical trial.
Publisher Copyright:
© 2017 Wolters Kluwer Health, Inc.
PY - 2018
Y1 - 2018
N2 - Objectives: The objectives of this study were to demonstrate the safety of auditory brainstem implant (ABI) surgery and document the subsequent development of auditory and spoken language skills in children without neurofibromatosis type II (NFII). Design: A prospective, single-subject observational study of ABI in children without NFII was undertaken at the University of North Carolina at Chapel Hill. Five children were enrolled under an investigational device exemption sponsored by the investigators. Over 3 years, patient demographics, medical/surgical findings, complications, device mapping, electrophysiologic measures, audiologic outcomes, and speech and language measures were collected. Results: Five children without NFII have received ABIs to date without permanent medical sequelae, although 2 children required treatment after surgery for temporary complications. All children wear their device daily, and the benefits of sound awareness have developed slowly. Intraand postoperative electrophysiologic measures augmented surgical placement and device programming. The slow development of audition skills precipitated limited changes in speech production but had little impact on growth in spoken language. Conclusions: ABI surgery is safe in young children without NFII. Benefits from device use develop slowly and include sound awareness and the use of pattern and timing aspects of sound. These skills may augment progress in speech production but progress in language development is dependent upon visual communication. Further monitoring of this cohort is needed to better delineate the benefits of this intervention in this patient population.
AB - Objectives: The objectives of this study were to demonstrate the safety of auditory brainstem implant (ABI) surgery and document the subsequent development of auditory and spoken language skills in children without neurofibromatosis type II (NFII). Design: A prospective, single-subject observational study of ABI in children without NFII was undertaken at the University of North Carolina at Chapel Hill. Five children were enrolled under an investigational device exemption sponsored by the investigators. Over 3 years, patient demographics, medical/surgical findings, complications, device mapping, electrophysiologic measures, audiologic outcomes, and speech and language measures were collected. Results: Five children without NFII have received ABIs to date without permanent medical sequelae, although 2 children required treatment after surgery for temporary complications. All children wear their device daily, and the benefits of sound awareness have developed slowly. Intraand postoperative electrophysiologic measures augmented surgical placement and device programming. The slow development of audition skills precipitated limited changes in speech production but had little impact on growth in spoken language. Conclusions: ABI surgery is safe in young children without NFII. Benefits from device use develop slowly and include sound awareness and the use of pattern and timing aspects of sound. These skills may augment progress in speech production but progress in language development is dependent upon visual communication. Further monitoring of this cohort is needed to better delineate the benefits of this intervention in this patient population.
KW - Auditory brainstem implant
KW - Pediatric outcomes
UR - http://www.scopus.com/inward/record.url?scp=85044321775&partnerID=8YFLogxK
U2 - 10.1097/AUD.0000000000000501
DO - 10.1097/AUD.0000000000000501
M3 - Article
C2 - 29023243
AN - SCOPUS:85044321775
SN - 0196-0202
VL - 39
SP - 326
EP - 336
JO - Ear and hearing
JF - Ear and hearing
IS - 2
ER -