title: 'Compassionate use' protocol for auditory brainstem implantation in neurofibromatosis type 2: Early House Ear Institute experience.
abstract: To report the preliminary outcomes of auditory brainstem implantation (ABI) under a compassionate use protocol for two ABI devices that are not approved by the US Food and Drug Administration.
  
  
  
  A retrospective review was performed of neurofibromatosis type 2 (NF2) patients who underwent microsurgery for vestibular schwannoma (VS) and placement of either the Cochlear ABI541 or Med-El Synchrony ABIs. Peri-operative and device- related complications were reviewed. Audiometric performance was also evaluated.
  
  
  
  Seven patients received either the Cochlear ABI541 (6) or the Med-El Synchrony ABI (1) after the resection of VS. No device or patient-related complications occurred to date. Surgical times and early audiological performance are similar to our previous experience with the Cochlear ABI24 device.
  
  
  
  Early experience with the Cochlear ABI541 and Med-El Synchrony ABI devices under a compassionate use protocol suggest that both devices are safe with comparable utility to the Cochlear ABI24 device.
authors.affiliation: a House Clinic and House Ear Institute , 2100 West 3rd Street, Los Angeles , CA 90057 , USA.|b University of Connecticut School of Medicine , 263 Farmington Avenue, Farmington , CT 06030 , USA.
authors.forename: Daniel S
authors.initials: DS
authors.lastname: Roberts
authors.affiliation: a House Clinic and House Ear Institute , 2100 West 3rd Street, Los Angeles , CA 90057 , USA.
authors.forename: William H
authors.initials: WH
authors.lastname: Slattery
authors.affiliation: a House Clinic and House Ear Institute , 2100 West 3rd Street, Los Angeles , CA 90057 , USA.|c Department of Otolarygology, Head and Neck Surgery , William Beaumont Army Medical Center , El Paso , TX 79920 , USA.
authors.forename: Brian S
authors.initials: BS
authors.lastname: Chen
authors.affiliation: a House Clinic and House Ear Institute , 2100 West 3rd Street, Los Angeles , CA 90057 , USA.
authors.forename: Steve R
authors.initials: SR
authors.lastname: Otto
authors.affiliation: a House Clinic and House Ear Institute , 2100 West 3rd Street, Los Angeles , CA 90057 , USA.
authors.forename: Marc S
authors.initials: MS
authors.lastname: Schwartz
authors.affiliation: a House Clinic and House Ear Institute , 2100 West 3rd Street, Los Angeles , CA 90057 , USA.
authors.forename: Gregory P
authors.initials: GP
authors.lastname: Lekovic
mesh_terms: D000293:Adolescent; D000328:Adult; D001299:Audiometry; D038263:Auditory Brain Stem Implantation / Q000295:instrumentation* / Q000379:methods; D001307:Auditory Perception; D003051:Cochlea / Q000601:surgery; D003054:Cochlear Implants; D057176:Compassionate Use Trials; D018795:Device Approval; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016518:Neurofibromatosis 2 / Q000150:complications / Q000523:psychology / Q000601:surgery*; D009464:Neuroma, Acoustic / Q000209:etiology / Q000523:psychology / Q000601:surgery*; D011184:Postoperative Period; D012189:Retrospective Studies; D016896:Treatment Outcome; D055815:Young Adult
keywords: Acoustic neuroma; Auditory brainstem implantation; NF2; Vestibular schwannoma