Prosomnus announced Nov. 2, 2022, that it received FDA 510(k) clearance for its ProSomnus EVO [PH] sleep and snore device, a precision oral appliance therapy (OAT) device.
About ProSomnus EVO [PH]
The ProSomnus EVO [PH] sleep and snore device is intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea in adults.
The device is specifically engineered to meet Centers for Medicare Services (CMS) coding guidelines. It uses mechanical hinge components to precisely reposition and stabilize the patient’s jaw during sleep, increasing pharyngeal space and reducing the risk of upper airway collapse.
According to the company’s press release, the device is approximately 13% smaller than predicate devices. ProSomnus EVO [PH] devices are personalized and digitally manufactured based on a patient’s unique anatomy and treatment plan.
Additionally, the company’s FDA approval letter notes an optional feature. If a DentiTrac micro-recorder is completely embedded in the ProSomnus EVO [PH] sleep and snore device, clinicians can measure patient compliance in combination with the DentiTrac System.
About oral appliance therapy
OAT is a non-invasive treatment for snoring and sleep apnea, involving the use of a removable device worn in the mouth during sleep. These appliances, varying in appearance, are favored by some patients for their ease of use and portability, as they are smaller and more travel-friendly compared to traditional CPAP machines, taking a few weeks for most individuals to adapt to sleeping with them.
Read more industry news from the AASM.
