Compassionate Use Arm - ABI541 ABI for 10 NF2 Patients

NO_LONGER_AVAILABLE

Conditions studied: Neurofibromatosis Type 2, Severe Profound Sensorineural Hearing Loss

In brief

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.

Key facts

Study ID

NCT02589912

Run by

Massachusetts Eye and Ear Infirmary

Last updated by the study team

2019-12-06

Who can join

Age: 12 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Massachusetts Eye and Ear Infirmary — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.