IMPORTANT SAFETY INFORMATION

No serious adverse events related to the PoNS device were reported in the MS RCTs or in use in clinical rehabilitation settings to treat balance and gait disorders.

Some individuals have reported headaches, fatigue, and excess salivation. Excess salivation during training sessions often occurs but generally improves as patients get used to wearing the mouthpiece.

Indication
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 for adults 22 years of age and over by prescription only.

Contraindications
The PoNS^® device delivers electrical stimulation directly to the surface of the tongue. Precautions for use are similar to those for transcutaneous electrical nerve stimulation (TENS).

Electrical stimulation should not be used:

• If there is an active or suspected malignant tumor
• In areas of recent bleeding or open wounds
• In areas that lack normal sensation

The PoNS^® has not been tested on, and thus should not be used by individuals who are pregnant. Do not use the PoNS^® if you are sensitive to nickel, gold or copper.

Use with caution
Electrical stimulation should only be used after seeking professional medical advice, and with caution in patients with any of the following:

• Implanted electronic devices, including:
  • Cardiac pacemakers
  • Cardioverter defibrillators
  • Deep Brain Stimulators
  • Vagal Nerve Stimulators
  • Sacral nerve stimulators
  • Cochlear Implants
• Metal in the mouth (e.g. piercings, braces, retainers, or other orthodontic appliance)
• Seizure disorders
• Epilepsy