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The PoNS device is indicated for use as a short term treatment of gait deficit due to mild to moderate symptoms from multiple sclerosis and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only.

The PoNS™ device is a non-implantable tongue stimulator that delivers electrical stimulation to the trigeminal and facial nerves for use as a short-term treatment of gait deficit due to mild to moderate symptoms from multiple sclerosis and is to be used as an adjunct to a supervised therapeutic exercise program. The device is for use in patients over 22 years of age by prescription only. The PoNS™ mouthpiece is held lightly in place by the lips and teeth around the neck of the tab that goes into the mouth and rests on the anterior, superior part of the tongue. The control unit is worn around the neck during session usage. It has 5 user-controlled buttons: power, information, intensity up, intensity down, and start/stop/pause. The control unit also records usage data including session duration and general activities performed which are captured by an accelerometer. During a patient's visit with a therapist is able to connect the control unit to a computer and, using software developed specifically for the PONSTM, view the usage data. The purpose of the usage data is to give the therapist information on how to improve a patient's execution of therapy by identifying potential areas of missed or shortened sessions. The PoNSTM System is comprised of a Controller, a Mouthpiece Retainer Case, a Charger, a Product Carry Case and the PoNSTM Software. Accessory components, also supplied, include a cable for connection to a computer running the PoNSTM software. Controller: The Controller includes the primary user interface and drive electronics for providing the electronic stimulation waveform. Through the user interface, the intensity of the stimulation waveform can be adjusted, the stimulation can be started and stopped, and the Controller can be powered on and off. The Controller user interface consists of a visual display, audio feedback and vibration feedback. Mouthpiece: The Mouthpiece houses the electrode array through which the stimulation waveform is applied to the patient's tongue. Electronics and software within the Mouthpiece control the timing of the stimulation waveform. The Controller sends commands to the Mouthpiece and receives status messages from the Mouthpiece via a cable that forms an integral part of the Mouthpiece assembly. Mouthpiece Retainer Case: The Mouthpiece Retainer Case is used to store the Mouthpiece between uses. The cable of the Mouthpiece wraps around the base of the Mouthpiece Retainer Case. There is a pocket in the Carry Case sized to house the Mouthpiece Retainer Case during storage. Charger: The Charger consists of a mains power adaptor that connects to the Controller via a standard USB Type-C connector and provides a low voltage power supply to recharge the Controller battery. Stimulation is disabled while the Charger is connected to the Controller.