tVNS® E is not currently approved by the FDA and is considered an investigational device in the United States. However, health care professionals may request access to the device for their patients through the FDA’s Expanded Access Program (Compassionate Use). Additionally, researchers in the U.S. may purchase the device for investigational use in accordance with FDA regulations. 

How Can Patients Access tVNS® E in the U.S.? #

Through the Expanded Access (Compassionate Use) Program, health care professionals may request tVNS® E for patients who:

• Have a serious or life-threatening condition
• Have exhausted all available treatment options
• Do not qualify for an active clinical trial

This program allows access to investigational medical devices when no satisfactory alternative treatments are available.

Steps for a Health Care Professional to Request Expanded Access: #

1. Submit a Request to the FDA
   
   • Health care professionals must submit an expanded access request to the FDA.
   • No specific form is required, but the request should include:
     • The patient’s medical condition
     • Previous treatments attempted
     • Rationale for requesting tVNS® E
   • Further details on the process can be found on the FDA’s website:
     Expanded Access for Medical Devices
   • Our team is happy to provide the necessary information required for health care providers to prepare their compassionate use request.
     
2. Obtain Institutional Review Board (IRB) Approval
   • The request must receive review and approval from an Institutional Review Board (IRB) before treatment can begin.
     
3. Manufacturer Authorization
   • tVNS Technologies GmbH must provide authorization to supply the device under compassionate use. 
     
4. FDA Review & Approval
   • The FDA typically reviews requests within a few days and issues a decision.
   • If approved, the device can be used under physician supervision.

Who Covers the Cost? #

Patients should consult with their:

• Health care provider
• Insurance provider
• State or federal assistance programs

Since expanded access treatments are not typically covered by insurance, patients may need to self-fund the cost of the device.

How Can Researchers Purchase tVNS® E in the U.S.? #

We actively collaborate with research institutions across the United States that use tVNS® E for clinical studies and research. We require a copy of the IRB approval documentation to include with our shipping documents. 

• Researchers may purchase tVNS® E for investigational use in accordance with FDA regulations.
• We support researchers in preparing their IRB applications and navigating regulatory requirements.
• Due to the device’s well-established safety profile, tVNS® E studies are likely to be classified as non-significant risk (NSR) and qualify for an abbreviated IDE (Investigational Device Exemption), simplifying the approval process.

Next Steps #

If you are a health care professional or researcher interested in accessing tVNS® E in the United States, please contact us for additional information. We are committed to assisting with compassionate use and research requests and ensuring compliance with FDA regulations.