Summary: Daybreak offers a mail-in oral appliance therapy workflow that allows sleep physicians to keep sleep apnea patients in-house, reducing the need to refer them to local dentists for oral appliances. This service includes providing sleep tests, custom mandibular advancement … [Read more...]
Vivos Granted Reimbursement Codes for Oral Appliances for OSA
Summary: Vivos Therapeutics Inc has announced that the American Medical Association (AMA) will introduce new Current Procedural Terminology (CPT) codes for Vivos CARE oral appliances, effective Jan 1, 2025. These codes are expected to facilitate insurance coverage and … [Read more...]
FDA Clears Sleep Apnea Oral Appliance for Bruxism Therapy Too
Summary: The Slow Wave DS8 oral appliance, initially FDA-cleared for mild to moderate OSA, has now received clearance for the treatment of sleep bruxism. Marketed as BROSA for bruxism, the device offers a comprehensive solution for both conditions by relaxing jaw muscles and … [Read more...]
Apnimed Completes Enrollment Early in Phase 3 Study for Oral OSA Treatment
Summary: Apnimed has completed enrollment for its phase 3 SynAIRgy study, which will evaluate the efficacy and safety of its lead candidate AD109, a potential first oral therapy for obstructive sleep apnea (OSA). The trial will focus on adults with mild, moderate, and severe OSA. … [Read more...]
Custom Oral Appliances Comparison Guide
Company:Aiomega LLCAirway Management IncDream Systems DentalSleep LabGood Sleep CoGreat Lakes DentalTechnologiesOpen AirwayDental Solutions LtdPanthera DentalPanthera DentalProSomnus SleepTechnologiesProSomnus SleepTechnologiesProSomnus SleepTechnologiesSICAT GmbH & Co KGSlow … [Read more...]
Slide2Sleep’s Nylon Oral Appliance Offers More Strength, Comfort
Summary: Slide2Sleep released a nylon version of its Slide oral appliance in June 2023, offering increased strength and a slimmer profile compared to the acrylic model. This new model, crafted from type 12 nylon and 3D printed using selective laser sintering technology, addresses … [Read more...]
The Rise of Nylon Oral Appliances
By Alyx Arnett Manufacturers are increasingly turning to medical-grade nylon polyamide 12 as the material of choice for oral appliance therapy for sleep apnea. The recent influx of nylon options, made possible by 3D printing, is attributed to several factors, including … [Read more...]
Pilot Study Reveals High Preference of Oral Appliances for OSA
Summary: Vivos Therapeutics’ pilot study showed that 79% of newly diagnosed obstructive sleep apnea (OSA) patients preferred oral appliance therapy over CPAP. The study, conducted in multiple dental and ENT offices over seven months, involved 99 patients and demonstrated high … [Read more...]
Australian-Designed Oral Appliance Gains FDA Clearance
Summary: GoodSleepCo, an Australian medical device company, has received FDA 510(k) clearance for its hushd Pro Avera oral appliance, which treats snoring and mild to moderate obstructive sleep apnea. Custom-made splints reposition the lower jaw to prevent airway blockage during … [Read more...]
Colorado Sleep Centers to Offer Vivos Oral Appliances
Summary: Vivos Therapeutics Inc, a maker of oral appliance therapy for obstructive sleep apnea, has entered into a strategic marketing and distribution alliance with a Colorado-based sleep treatment provider. This marks a shift in Vivos’ distribution model. The alliance is … [Read more...]