Device typeIntraoral negative-pressure sleep apnoea unit: An electrically-powered device intended for home management of obstructive sleep apnoea (OSA) by using low, negative air pressure in the mouth to pull the soft palate and tongue forward to increase the patency of the pharynx; this repositioning obstructs oral breathing while allowing nasal breathing. It consists of a control unit containing a pump and sensor(s), to detect and adjust air pressure within the oral cavity, connected to a specially designed mouthpiece; it may in addition include associated items (e.g., saliva container, absorbent pad). This is a reusable device.
FDA categoryIntraoral Pressure Gradient Device
Device ID04719878320184
Catalog number81000-07
AvailabilityPrescription
MRI safetyMR Unsafe