Compassionate Use Arm - ABI541 ABI for 10 NF2 Patients

Description

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

Interventions

  • Device: Nucleus Profile ABI541 Auditory Brainstem Implant

Specialties

  • 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

Status

Available

Trial ID

NCT02589912

Study Type

Expanded Access

Trial Phase

N/A

Enrollment Quota

Not Listed

Sponsor

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

Gender

Both

Ages

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 daniel_lee@meei.harvard.edu

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