Translingual Neuromodulation Device Receives FDA 510(k) Clearance for Stroke-Related Gait Deficit

Bioness Medical (Valencia, CA) announced that the Food and Drug Administration (FDA) granted 510(k) clearance for the PoNS (Portable Neuromodulation Stimulator) System for treatment of dynamic gait deficit due to chronic stroke symptoms. The device is cleared for use as an adjunct to a supervised therapeutic exercise program in patients aged 22 years and older.

PoNS is a noninvasive, nonimplantable prescription device that delivers neurostimulation through a mouthpiece that is placed on the tongue. The device is designed to stimulate branches of the trigeminal and facial cranial nerves during rehabilitation, with the goal of supporting neuroplasticity and functional recovery. The new clearance expands the device’s indication beyond its previous use for gait deficit associated with mild-to-moderate multiple sclerosis symptoms.

The clearance was supported by the PoNS Stroke Registrational Program, which included 159 chronic stroke survivors with gait deficit across 3 studies conducted at 10 centers in the United States and Canada. The studies evaluated PoNS used with routine physical rehabilitation therapy over 12 weeks, with additional follow-up 12 weeks after treatment completion to assess durability.

Stroke Registrational Program Results

• Active PoNS plus physical therapy was associated with a 5.37-point adjusted mean change in Functional Gait Assessment score at Week 12 compared with a 3.31-point change in the control group.
• The treatment group difference after propensity adjustment was 2.06 points (95% CI, 0.29 to 3.84; P=.0233), meeting the prespecified multiplicity threshold.
• Using a 6-point Functional Gait Assessment improvement threshold, 56.1% of participants treated with active PoNS responded compared with 11.1% of control participants.
• Durability of the Week 12 treatment effect was reported, with 89.7% of participants meeting the durability performance goal 12 weeks after treatment completion.
• Berg Balance Scale scores improved from baseline to Week 12 in the active PoNS group, although between-group separation was not statistically significant.
• Risk of falling was resolved in 17.4% of participants in the active PoNS group compared with 8.9% of control participants, a difference that was not statistically significant.

Across the registrational studies and existing real-world evidence, Bioness reported no treatment-related serious adverse events. Reported adverse events were described as unrelated to the PoNS device.

Source

Bioness Medical. Bioness Medical announces 510(k) clearance for PoNS (Portable Neuromodulation Stimulator) to manage patients recovering from stroke. News release. PR Newswire. Published June 29, 2026.