PoNS Device - Use & Availability

#1 Frequently Asked Question: How can I try a PoNS device? 

Please be aware that TCNL ceased operations on October 1, 2017 and will not be conducting any further PoNS research. Responses to any inquiries to TCNL may not be expected or may be very delayed due to lack of personnel. 

TCNL receives many inquiries asking when the PoNS™ device will be available for purchase or use as a medical device. The PoNS device is presently an investigational medical device. This means that it may only be used for research studies, not for medical treatment, under US Food & Drug Administration (FDA) regulations. 

TCNL, as an academic laboratory at the University of Wisconsin-Madison, used the PoNS device only for scientific research that furthered TCNL’s mission. TCNL cannot sell the PoNS device, provide it, or use it for any purpose other than for research under University-approved experimental protocols that are consistent with the University’s mission

Our Projects page lists previous TCNL projects and studies, now all completed. If you are interested in clinical research opportunities elsewhere, clinicaltrials.gov provides a US government listing of active clinical trials. You can try searching using the terms "PoNS balance" or "CN-NINM" for any PoNS studies external to TCNL. 

Humanitarian Use and Compassionate Use: Regrettably, due to regulatory concerns, neither the University of Wisconsin nor  TCNL as part of the University intends to seek FDA approval for FDA-defined humanitarian use or compassionate use of the PoNS device. We will post updates as appropriate. 

Physician Use / Case Studies: Due to regulatory concerns, TCNL is not supporting individual case studies using the PoNS device at this time. 

If you need to contact the TCNL leadership for any reason other than to inquire about treatment with the PoNS device, please send an email message to

     tcnl_inquiries@mailplus.wisc.edu 

and you will receive an automated response with further instructions. 

The TCNL staff deeply appreciates your understanding and patience in the lengthy and demanding process of conducting high-quality clinical research and complying with applicable federal, state, and local regulations. 


Helius Medical Technologies (Newtown, PA) is conducting clinical trials using their own version of the PoNS device with intention to market the device upon gaining appropriate regulatory (FDA) clearance. Helius has indicated in a press release that they expect FDA clearance in the second half of calendar year 2018. 

TCNL is separate from Helius and cannot provide any further information regarding Helius. Please contact Helius directly for further information. Disclosure: The TCNL co-directors (Yuri Danilov, Kurt Kaczmarek, Mitch Tyler) each have a financial interest in Helius and are consultants to Helius. Tyler is a Director of Helius. Kim Skinner is an employee of Helius. 

 

Our Projects

Click here to see a list of our projects.