The Slow Wave DS8™ oral appliance therapy (OAT), initially FDA cleared for the prescription treatment of Obstructive Sleep Apnea (OSA) in 2021 (K191320) has now been dual cleared by the FDA 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 with studies showing that up to 50% of people who suffer from sleep bruxism also have OSA.^1,2,3

“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,” stated Slow Wave, Inc.® CEO Wayne Wagner. “This can help the 80% of current OSA sufferers who are undiagnosed^4,5 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 according to the National Institutes of Health (NIH) that affects about 13% of adults.⁶ 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” continued Wagner. “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 (lower jaw) to move down and forward in a natural position opening the airway during sleep. This approach ensures maximum 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, it is virtually impossible for a user to grind the teeth while wearing the appliance. However, the ramp design is different from other OAT products in that it does not lock the jaw into a static position all night as a method of keeping the airway open during sleep. Instead, 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, a condition warranted by most traditional oral appliances.

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. Products can be printed directly in a dentist’s office if they have a Formlabs printer and are generally available to patients within 24 – 48 hours of them receiving an intraoral scan.

Slow Wave, Inc. is headquartered in Spicewood, Texas, with lab and manufacturing near Austin, Texas. The company has 10 patents issued on the Slow Wave DS8 design with additional patents pending. The Slow Wave DS8 is the only dual FDA-cleared product on the market for the prescription treatment of both OSA and bruxism (marketed as BROSA). Slow Wave can be reached at (830) 220-5700. www.slowwave.net

References

1 Rintakoski K, Hublin C, Lobbezoo F, Rose RJ, Kaprio J. Genetic factors account for half of the phenotypic variance in liability to sleep-related bruxism in young adults: A nationwide Finnish twin cohort study. Twin Res Hum Genet. 2012;15:714–9. [PubMed] [Google Scholar]

2 Glaros AG. Incidence of diurnal and nocturnal bruxism. J Prosthet Dent. 1981;45:545–9. [PubMed] [Google Scholar]

3 Hoysosa H, Yamaguchi T, Mikami S, et al. Relationship between sleep bruxism and sleep respiratory events in patients with obstructive sleep apnea syndrome. Sleep Breath 2014;18:837-844

4 https://www.ama-assn.org/delivering-care/public-health/what-doctors-wish-patients-knew-about-sleep-apnea

5 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2727690/

6 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5026093/