| Manufacturer |
Signifier Medical Technologies Limited |
| Device Classification |
FDA-authorized daytime therapy device for mild obstructive sleep apnea and snoring |
| Therapy Method |
Transoral Neuromuscular Electrical Stimulation (NMES) |
| Usage Schedule |
20 minutes per day |
| Therapy Duration |
6 weeks initial treatment period |
| Maintenance Therapy |
As little as twice per week after initial 6-week program |
| Session Structure |
Four 5-minute stimulation phases per session |
| Mouthpiece Replacement Interval |
Every 90 days from first use (biocompatibility and safety requirement) |
| Mouthpiece Material |
Medical-grade silicone |
| Device Components |
Control unit and intraoral mouthpiece |
| App Requirement |
Therapy delivered via device and controlled through companion app |
| Certifications |
ISO 13485:2016 certified manufacturer |
| Safety Approvals |
FDA-authorized; CE Mark; Health Canada approved |
| Intended Use |
Daytime therapy; no nighttime wearables required |
| Treatment Target |
Tongue muscle endurance and upper airway stabilization |
| Therapy Goal |
Prevent tongue collapse during sleep to restore normal nighttime breathing |
| Evidence Base |
Multiple clinical studies; 100+ patients across trials; objective improvements in AHI and ODI |
| Biocompatibility Requirements |
Mouthpiece lifespan restricted to 90 days according to international standards for hygiene and safety |
| Operational Environment |
Portable, compact device designed for daytime use anywhere |