Compassionate Use Arm - ABI541 ABI for 10 NF2 Patients


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.

Study Start Date

Not specified

Estimated Completion Date

Not specified


  • Device: Nucleus Profile ABI541 Auditory Brainstem Implant


  • Neurology: Neurologic Oncology
  • Oncology: Neurologic Oncology
  • Otolaryngology: Otology/Neurotology

MeSH Terms

  • Ear Diseases
  • Hearing Loss
  • Hearing Loss, Sensorineural
  • Neurofibroma

Study ID

Massachusetts Eye and Ear Infirmary -- 15-113H



Trial ID


Study Type

Expanded Access

Trial Phase


Enrollment Quota

Not Listed


Massachusetts Eye and Ear Infirmary

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




12 Years to 80 Years

Accepts Healthy Volunteers

Not Listed

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Massachusetts Eye and Ear Infirmary - Boston, Massachusetts 2.8 miles Daniel J Lee MD FACS 617-573-3130 provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.