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Compassionate Use Arm - ABI541 ABI for 10 NF2 Patients

Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov · Datasets · License: Public Domain
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The Nucleus 24 Auditory Brainstem Implant (ABI) is the only FDA approved device for restoration of meaningful hearing in Neurofibromatosis Type 2 (NF2) patients. This device has been discontinued, meaning that there is no commercially approved device currently available. The replacement model, the ABI541 (an unapproved device), is being investigated in ongoing clinical trials. A compassionate use arm of a clinical trial allows patients with NF2 to be implanted with this new ABI.
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