Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)

Myosa is a family of intraoral mouthguard devices designed to treat snoring and mild to moderate obstructive sleep apnea in adults 18+ years old. The devices work by advancing the mandible, repositioning the tongue, and training nasal breathing during sleep. Models S1H, S1, S2, and S3 are pre-fabricated devices; S1M and S2M are moldable boil-and-bite versions. The Myosa for Snorers line (S1, S1M, S2) is marketed over-the-counter for snoring treatment only.

Myosa appliances are made of silicone (pre-fabricated models) or EVA over a hard polypropylene core (boil-and-bite models). They slightly advance the jaw forward and guide the tongue forward and upward while training tongue elevation. This contrasts with SleepTight (passive tongue retention) and Zyppah (active silicone strap retention), though all devices position the tongue and advance the jaw to varying degrees.

Not stated in this summary.

Myosa is substantially equivalent to predicate devices (SleepTight Mouthpiece, Zyppah, and AVEOtsd) because all are intraoral mouthguards with the same intended indications—treating snoring and/or mild to moderate obstructive sleep apnea in adults. Although technological details differ (material and tongue-positioning mechanism), they share the same regulatory classification (21 CFR 872.5570), intended use, and general operating principle of airway opening and jaw/tongue repositioning.