SomnoMed announced this week that it has received Medicare approval for its new SomnoDent Herbst Advance Classic and Flex oral devices.

The devices, which effectively treat obstructive sleep apnea, have received full CMS/PDAC approval and were allocated the HCPCS Code of E0486 for DME billing, allowing for Medicare reimbursement in the United States. This allows dentists fitting the device to Medicare patients to apply for and be granted specified reimbursement for the device and treatment.

The SomnoDent Herbst Advance devices were officially launched in the U.S. earlier this month through SomnoMed’s network of educated sleep dentists. The products feature an innovative calibration mechanism, which are designed to make fitting and titration easier and more precise for dentists and patients.

Reaction from key opinion leaders to the device following its showing at the conventions of the AADSM (American Association of Dental Sleep Medicine) and the AASM (American Association of Sleep Medicine) earlier this summer has been positive and first orders are currently being processed.

Demand for custom made oral appliances as an alternative treatment for treating sleep apnea is expanding both domestically and worldwide. This is due, in part, to elevated awareness of sleep disordered breathing by physicians, dentists and patients.

Access to home sleep testing has also increased, creating a higher number of diagnosed patients seeking therapeutic solutions. Additional drivers of OSA treatment include expanded clinical research uncovering the link between sleep apnea and other severe medical conditions, along with patient non-compliance with CPAP devices.

"Medicare approval in the US is a huge step forward for the SomnoDent Herbst Advance devices and for sleep apnea treatment in general," said Dr. Peter Neustadt, Chairman and CEO of SomnoMed. "Not only does the approval further strengthen SomnoMed’s global leadership position in COATâ„¢ (Continuous Open Airway Therapy) treatment for obstructive sleep apnea, it enables a larger patient population access to the quality of life benefits that come with COAT treatment."

Dr. Neustadt also noted that the high level of compliance among patients using oral devices is giving COAT a distinct advantage over CPAP for the majority of patients