#1 Frequently Asked Question: How can I try a PoNS device?
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, uses the PoNS device only for scientific research that furthers 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 any TCNL studies presently recruiting volunteer human subjects. If there are no TCNL studies of interest to you, clinicaltrials.gov provides a US government listing of active clinical trials.
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.
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 their SEC 10K filing (28 Jun 2016) that they expect FDA clearance in the third quarter of 2017.
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.