On Friday, Distar’s Adjustable TheraSnore received Food and Drug Administration (FDA) 510(k) clearance to treat obstructive sleep apnea. Previously, the oral appliance had FDA clearance to treat snoring. The clearance number is K140663.
In November, the Adjustable TheraSnore received a HCPCS code for DME billing. Code E0485 was assigned.
The Adjustable TheraSnore advances the mandible by gently holding it in a protrusive position. The patient has complete vertical and lateral freedom of movement and is not “locked” into the appliance. It can be custom fit in the doctor’s office in less than 40 minutes.