'Compassionate use' protocol for auditory brainstem implantation in neurofibromatosis type 2: Early House Ear Institute experience.

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'Compassionate use' protocol for auditory brainstem implantation in neurofibromatosis type 2: Early House Ear Institute experience.

Cochlear Implants Int. 2017 Jan;18(1):57-62

Authors: Roberts DS, Slattery WH, Chen BS, Otto SR, Schwartz MS, Lekovic GP

Abstract
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.

PMID: 28098509 [PubMed - indexed for MEDLINE]

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