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 opening the airway during sleep, while allowing patients to monitor OSA risk using over-the-counter devices like the Apple Watch, with rapid custom fitting available through 3D printing technology.
Key Takeaways:
- Dual FDA Clearance: The Slow Wave DS8 (marketed as BROSA for bruxism) is the only prescription oral appliance in the United States with dual FDA clearance for treating both OSA and sleep bruxism.
- Effective Bruxism Treatment: Unlike most bruxism devices that only prevent teeth grinding, the Slow Wave DS8 treats the underlying condition by relaxing the jaw muscles during sleep.
- Significant Patient Overlap: The dual-use device addresses a significant overlap between OSA and bruxism, potentially aiding many undiagnosed OSA patients.
The Slow Wave DS8 oral appliance therapy, initially FDA-cleared for the prescription treatment of mild to moderate obstructive sleep apnea (OSA) in 2021 (K191320) now has an additional FDA clearance for the treatment of sleep bruxism (K240463).
This makes the Slow Wave DS8, now marketed as BROSA when sold as a bruxism device by a dentist, the only dual-cleared OSA/bruxism prescription treatment available in the United States. While prescription devices for the treatment of OSA require a physician diagnosis and treatment prescription, sleep bruxism is classified as a dental condition that is treated by a dentist. The patient overlap in the two sleep conditions is significant.
“The FDA dual clearance now means that patients can see a dentist to treat their sleep bruxism and monitor their sleep using over-the-counter FDA-approved oxygen monitoring devices like the Apple Watch or various sleep rings to assess their risk of OSA,” says Slow Wave Inc CEO Wayne Wagner, in a release. “This can help the 80% of current OSA sufferers who are undiagnosed quickly get treated, then validate their concerns if a formal diagnosis and/or other medical help is still needed. In the meantime, the Slow Wave BROSA may be able to provide them relief for both conditions simultaneously. This approach will revolutionize and modernize the dental sleep world.”
Sleep bruxism is a repetitive jaw masseter muscle movement disorder in which a person grinds or clenches their teeth and is a relatively common sleep disorder. But unlike most devices used by dentists today, the Slow Wave DS8 actually treats the condition, not just the side effects of the condition. “Most bruxism devices on the market today are single-arch solutions,” Wagner says. “They typically cover just the upper teeth with the objective of stopping the effects of grinding. But this approach doesn’t treat the underlying condition, it just saves the teeth. The DS8/BROSA, through a patented design, actually relaxes the muscles of the jaw during sleep, which serves as a treatment for bruxism.”
The Slow Wave DS8 is a custom-fitted prescription oral appliance that incorporates a patented vertical opening and ramp design that allows the mandible to move down and forward in a natural position opening the airway during sleep. This approach ensures patient comfort while making more room for the tongue to naturally migrate forward, clearing the airway during sleep.
Because the device components cover both the upper and lower teeth arches, users find it virtually impossible to grind the teeth while wearing the appliance. The ramp design is different from other oral appliance therapy designs in that it does not lock the jaw into a static position all night as a method of keeping the airway open during sleep. It allows the brain of the user to move the tongue forward into a horizontal and vertical opening that is large enough for the tongue to return to its natural resting position during sleep. This eliminates the need for a morning repositioner to realign the jaw, according to Slow Wave.
The Slow Wave DS8 utilizes an intraoral closed bite scan and 3D printing technologies to produce a custom-fitted oral appliance that does not need to be adjusted by a dentist. The device can be printed directly in a dentist’s office if they have a Formlabs printer or are generally available to patients within 24 to 48 hours after an intraoral scan.
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