SomnoMed, manufacturer of oral devices for the treatment of mild to moderate obstructive sleep apnea, now offers compliance micro-recording technology in its wearable devices.
SomnoMed Inc is the first company to receive FDA 510(k) clearance to offer the compliance microrecording feature for its oral devices through the new product, SomnoDent with compliance recorder. SomnoMed is partnering with Braebon Medical Corp, maker of the DentiTrac technology, to introduce SomnoDent with compliance recorder powered by DentiTrac in the immediate future.
“The ability to objectively measure patient compliance is an important feature for COAT [continuous open airway therapy], when compared to other treatment modalities. Physicians and payors have told us that they want to have evidence that patients are wearing their SomnoDent and receiving treatment as prescribed,” says Peter Neustadt, M.Econ, DBA, SomnoMed’s executive chairman and CEO, in a release.
SomnoDent with compliance recorder is worn during sleep to provide COAT by moving the jaw slightly forward. This movement tightens the soft tissue and muscles of the upper airway, which prevents a collapse of the airway thus reducing apneas during sleep, the manufacturer says.
DentiTrac uses patented technology and anti-deception algorithms to determine when a patient is wearing their device, with results that can be transmitted to a HIPAA secure cloud portal for remote access by physicians.
Richard Bonato, PhD, RPSGT, CEO and cofounder of Braebon, says, “We are very pleased DentiTrac is launching in the US market. Accurate oral appliance compliance measurement is needed to level the playing field with traditional sleep apnea treatment called CPAP. In addition, the ability to reliably measure sleep apnea treatment adherence is a vital requirement for insurance payers. COAT is the number-one alternative to CPAP and we anticipate this will contribute to significant overall growth in the burgeoning field of dental sleep medicine and the use of oral appliance therapy for sleep apnea.”
Braebon has an agreement in place with SomnoMed Limited as the preferred worldwide dorsal fin oral appliance design and for exclusive distribution in the EU and parts of Australasia. At this time, the Braebon DentiTrac compliance system is only available from SomnoMed in the United States.