NO_LONGER_AVAILABLENot Applicable

Compassionate Use Arm - ABI541 ABI for 10 NF2 Patients

United States

Plain-language summary

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.

Who can participate

Age range12 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of Neurofibromatosis Type 2; * Age of 12 years or older * Will be anticipated to be completely deaf as a result of bilateral neurofibromas of the auditory nerve, and/or their surgical removal. Exclusion Criteria: * Contraindications to surgery or general anesthesia * Intractable seizures or progressive, deteriorating neurological disorder * Unable to participate in behavioral testing and mapping with ABI * Unrealistic expectations on the part of the subject/family regarding possible benefits, risks, and limitations that are inherent to the procedure and prosthetic device

Trial details

NCT IDNCT02589912

SponsorMassachusetts Eye and Ear Infirmary

Sponsor typeOTHER

Study typeEXPANDED_ACCESS

View on ClinicalTrials.gov More Neurofibromatosis Type 2 trials