BROSA
BROSA / (acronym):
Definition: The all-in-one oral appliance redefining dental care! This innovative solution, 3D printed from an Intraoral digital scan, treats Bruxism, serves as a retainer for teeth, and addresses Obstructive Sleep Apnea. Plus, it requires no adjustment and can be prescribed by a dentist or doctor.
FDA cleared for treatment of two sleep disorders: OSA and Bruxism, 510(k) #'s
Incorporates technology advances to deliver highest efficacy
Innovation - next gen products - all digital
Dentist and Physician-led solutions
Long-term monitoring of patient conditions
Innovation backed by multiple patents
FDA cleared for treatment of two sleep disorders: OSA and Bruxism, 510(k) #'s
Innovation - next gen products - all digital
Long-term monitoring of patient conditions
Incorporates technology advances to deliver highest efficacy
Dentist and Physician-led solutions
Innovation backed by multiple patents
B- Bruxism Treatment
The New Gold Standard for the treatment of Sleep Bruxism and Obstructive Sleep Apnea (OSA)
The Slow Wave BROSA covers both the top and bottom teeth and allows the jaw to stay in a resting position during sleep producing neuromuscular relaxation. Other sleep bruxism devices just stop you from grinding but don’t treat the underlying condition.
R- Retainer
Advantages of Slow Wave
- Can be prescribed by a Dentist
- Bite scanned from a Closed Centric Occlusion.
- No open bite registration required.
- No adjustments required
- Treatment of Sleep Bruxism and OSA
- 100% Digital from scanning to printing
O- Obstructive
1st 3D Printed dual FDA 510(K) cleared all in one Oral Appliance for the Treatment of Sleep Bruxism & Obstructive Sleep Apnea in the world
Slow Wave BROSA is the first all in one oral Appliance dual cleared by the FDA for the treatment of Sleep Bruxism and mild to moderate obstructive sleep apnea, to be 3D printed on a Formlabs printer using BioMed Clear. FDA 510(K) Bruxism: K240463 FDA 510(K) OSA: K191320
S- Sleep
No specialized scanner training required
Scanning a patient for the Slow Wave BROSA is just like scanning for clear aligners – with .a closed bite centric occlusion.
A- Apnea
The OSA/Bruxism Connection
Clinical trial studies have shown that Sleep Bruxism exists in almost ½ of all OSA sufferers. There is finally one product to treat them both!
Sleep Apnea & Sleep Bruxism
The link between Sleep Bruxism and Sleep Apnea
Sleep Bruxism is the medical term for clenching or grinding the teeth during sleep. While bruxism can happen at any time of day, it frequently occurs during sleep. Sleep bruxism can cause people to wake up in the morning feeling tired, with headaches and neck and jaw pain. Although sleep bruxism is a dental problem, it is also considered a sleep related movement disorder characterized by uncontrolled, involuntary physical movement during sleep (in this case, movement of the jaws).
Many health issues are linked to bruxism, such as stress and teeth misalignment, but one of the biggest risk factors is a serious condition called obstructive sleep apnea (OSA). This occurs when the throat musclesrelax during the night allowing the tongue to block the airway and interrupt breathing. The National Sleep Foundation states about a quarter of all people with OSA experience sleep bruxism.
Grinding is an indicator of obstructive sleep apnea
It’s unclear why the two are linked, but researchers believe that arousals caused by upper airway resistance leads to a stress response throughout the body. Once the stress response is activated, your heart and respiratory rates increase while stress hormones flood the bloodstream. Increased muscle activity in the jaw stimulated by this stress response may be a cause for clenching or grinding.
One Device to treat them both
For patients who grind their teeth, the new standard of care for treating bruxism today is with a BROSA oral appliance supplied by their dentist. BROSA is dual cleared for treating both Bruxism & Obstructive Sleep apnea (OSA). It is a dentist-prescribed solution that can generally be provided to patients within 48-72 hours of diagnosis. BROSA is a fully digital product designed from a 3-D scan taken by the dentist or dental assistant the same way they scan for aligners; this allows for a perfect fit with no need for adjustments. Conveniently BROSA can then be 3-D printed in the Slow Wave or dentist office.
If it is suspected or verified that a patient has both Bruxism and OSA, a BROSA appliance and the optional O2 monitoring ring, allows them to treat their bruxism and monitor their sleep apnea on their own. For most patients, the use of BROSA will produce a major reduction in apneas/hypopneas and regain all the health benefits of deep stage sleep. Even if a patient is otherwise healthy, sleep apnea is known to significantly increase the risk of high blood pressure, stroke, cancer, diabetes, depression, and obesity.
What makes BROSA different from other bruxism devices?
- BROSA is focused on treating Bruxism, not just protecting the teeth with a nightguard! Most bruxism products on the market today are actually just nightguards for protecting the teeth from cracking or wear associated with grinding. BROSA treats the ailment, not just the results of it.
- Because it is dual-cleared for OSA as well as bruxism, patients can use BROSA as a replacement for their CPAP if they have been diagnosed with mild-to-moderate OSA, treat their bruxism and get the benefits of a teeth retainer that will keep their teeth from moving.
- BROSA has the capability to be conveniently 3D printed in the dentist’s office ensuring patients receive their appliance in a timely manner and can begin regaining their health benefits of deep stage sleep and treat their bruxism.
- No adjustments needed by the dentist. The personalized BROSA appliance is made from a intraoral scan to fit a patient’s teeth perfectly without any need for adjustments, saving valuable chair-time.
- BROSA’s patented ramp design allows the brain to find the “sweet spot” in each patient for relaxed sleep. By making room for the tongue to move forward during sleep, instances of OSA are reduced, resulting in jaw clenching the pain associated with it being reduced as well. Teeth grinding and cracking are eliminated when wearing a BROSA.
- Slow Wave offers an O2 Ring as an option enabling patients who believe that they may have sleep issues other than bruxism to proactively monitor their own sleep oxygen and pulse rate changes.
FAQ
The Slow Wave BROSA is available by a dentist’s prescription. You must get a 3D scan of your teeth from your dentist. Scan instructions for your dental office to follow are available here.
The Slow Wave BROSA is custom fitted to your own mouth, it is very comfortable and makes sleeping easier.
The cost of the BROSA is determined by your dentist or physician. The manufacturer suggested retail price is $3,600 but for this you get two appliances. Why 2? Because odds are that you will lose one or your dog will eat it (if left available to them). Rather than sending you back to the dentist, we prefer to give you two appliances up-front.
Slow Wave provides an oxygen (O2) monitoring ring so all users can track their progression with the appliance. The O2 monitoring ring will display key metrics such as O2 desaturations, time spent under 90% O2, duration of sleep, and much more. The O2 monitoring ring Slow Wave provides is not your only option, brands like Apple and Samsung offer O2 monitoring devices for users to keep track of their O2.