America’s Highest efficacy OSA Device
Slow Wave DS8 delivers a better night’s sleep as the most effective Obstructive Sleep Apnea (OSA) oral appliance.
In a customer survey of 25 patients in 2023, 24 were returned to normal breathing during sleep while wearing the Slow Wave DS8.
This means that 94% of users, regardless of OSA condition (mild, moderate, or severe), were able to experience normal, restful sleep.
Normal breathing is industry-defined as equal to or less than 5 Apnea Hypopnea Index (AHI) events per hour. Apneas are periods when a person stops breathing and hypopneas are instances where airflow is blocked, causing shallow breathing.
FDA cleared for treatment of two sleep disorders: OSA and Bruxism, 510(k) #'s
Innovation - next gen products - all digital
Incorporates technology advances to deliver highest efficacy
Dentist and Physician-led solutions
Gold Standard
The New Gold Standard for the treatment of Sleep Bruxism and Obstructive Sleep Apnea (OSA)
The Slow Wave DS8 covers both the top and bottom teeth and allows the jaw to stay in a resting position during sleep producing neuromuscular relaxation.
Advantages
Advantages of Slow Wave
- Highest efficacy OSA treatment available
- 100% American customer support
- 100% Made in America by American Workers
- 100% American owned Small Business
- Does not lock your jaw into one position all night
1st 3D Printed FDA 510(K)
1st 3D Printed FDA 510(K) Intraoral Appliance for Snoring & Obstructive Sleep Apnea in the U.S.
Slow Wave DS8 is the first Oral Appliance Therapy (OAT) cleared by the FDA for snoring and mild to moderate obstructive sleep apnea, to be 3D printed on a Formlabs printer using BioMed Clear .
Training
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.
OSA
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!
What makes the Slow Wave DS8 ™ different?
DS8 Provides industry-firsts for OAT.
The Slow Wave DS8 is the first Oral Appliance Therapy (OAT) cleared by the FDA to treat mild to moderate obstructive sleep apnea, to be 3d printed on a Formlabs printer using BioMed Clear material. This means that a dentist can scan a patient’s mouth and transmit the scan to Slow Wave who can, in turn, design and print the appliance in the dentist office within a day or two.
Slow Wave DS8 was the first product approved under CMS billing code K1027 – which encompasses a new generation of oral appliance therapy
The DS8 was approved as an all-digital product – from digital teeth scanning to digital design and manufacturing on a 3D printer, with such a high degree of accuracy (1/100th mm), that…
It was the first product approved that required no adjustments by a dentist or user. The custom fit is perfect the first time, every time!
Testimonials
The Slow Wave DS8 oral appliances have totally replaced my need for the C-Pap. I have been reluctantly and painfully dependent on the C-Pap for several years due to snoring and moderate to severe sleep apnea. The devices take a little bit of getting used to and training, however the well trained and friendly staff at Slow Wave are always there to help. After a week or so, you will hardly know they are on your teeth and can also drink water. This treatment for snoring and sleep apnea goes well beyond the devices. They also teach you ways to sleep and proper habits to help you succeed in a great nights sleep with high oxygen numbers without the C-Pap. Spent my first Christmas away from home without my C-Pap this year! So nice!
Dr. Jimmy D. Bolton, D.C.
I have been dealing with sleep apnea for decades. Not that I needed confirmation, but this has been confirmed by at least three in-clinic sleep studies and reinforced by my wife every night for the majority of our 38-years of marriage.
After repeated and persistent “encouragement” by my wife tired of being woken up by my snoring, I waved the white flag of surrender and signed up to get a CPAP device. “What could be so bad about this” I thought to myself? “After all, many or our family and friends told me what a difference their CPAP machines had made in their lives.” However, when I pressed them on what a hassle it must be to strap on a mask each night, everyone of them said, “Yes, it’s a hassle and pain, but you get used to it.”
So, I signed up and worked with a leading provider of CPAP machines and got the top-of-the-line machine. It had all the bells and whistles. They were great to work with and sent me every kind of mask configuration they had but kept waking up gasping for air and finding my mask partially off my face. After months of trying, I came to the realization that a CPAP machine just isn’t for me.
My decision to not use my CPAP machine not only impacted me and my sleep but also my wife’s sleep. We were desperate, well at least my wife was desperate. I thought I was sleeping better without a CPAP, or so I thought but she wasn’t. It was at this point that my wife saw an advertisement for Slow Wave.
When I walked into their office, Wayne, Tina and staff were amazing. They patiently worked with me to dispelled all of my skepticism. So, I agreed to try the Slow Wave device and approach. To my shock and amazement, it worked!
There are two primary components to the Slow Wave system. The first is a blood oxygen monitoring ring I wear on my finger. It is the size of a Super Bowl ring that I got used to almost immediately. It alerts me in the night, via vibrating, when my blood oxygen levels have fallen to an unhealthy level. It gently wakes me up by gently vibrating so I wake up enough to change my sleeping position and immediately fall back to sleep. I have gotten to the point that I don’t even notice being wakened up. Another really nice feature of this ring is that not only monitors my oxygen levels in the night but then shares the data for each nights rest to an app and to my computer through a Bluetooth connection. I’m a data geek and find the data is really helpful. I have opted to share my data with Slow Wave and they provide me feedback and continued encouragement.
The second component of the Slow Wave system is a custom fit mouth piece that is very comfortable to wear. It keeps my mouth and tongue from going back into my throat. The combination of the blood oxygen monitoring ring and the mouth piece make such a difference.
The Slow Wave approach has dramatically changed the quality of my sleep and, as a result, having a huge impact of the quality my life. It is also important that I give a major “shoutout” to the Slow Wave staff. They patiently explained how everything worked and were fantastic in every step of the way. I encourage you to check out Slow Wave. You will not regret it.
David L.
I heard about Slow Wave and their idea of a totally out of the box approach to the treatment of obstructive sleep apnea. No more lugging around a machine with bunches of supplies that constantly need replacing. And no surgery to implant a device in your body with batteries that will need periodic replacement as one company is promoting. Just a unique, precision designed oral appliance that is worn in your mouth while you sleep and taken out each morning.
I’ll tell you what. It works for me. No more interrupted sleep for me or my wife. My sleep apnea events are greatly reduced to an acceptable level when I sleep while wearing the Slow Wave device according to the data collected easily each night with a wearable o2 ring.
My quality of life has been restored thanks to the fine folks at Slow Wave.
Raymond P.
Following a sleep apnea diagnosis by my pulmonologist, I was painlessly fitted with this wonderful oral appliance. Advice on sleeping positions was also provided. My results have been amazing, and I have avoided using a CPAP machine. I highly recommend that you try this effective alternative to CPAP. It has changed my life!
Barbara
FAQ
The Slow Wave DS8 is available only by a physician prescription. You must have a sleep study conducted showing that you have Obstructive Sleep Apnea (OSA) and a physician must write a prescription for the appliance (prescription form available here for your Dr. to use). Then, you must get a 3D scan of your teeth by your dentist. Scan instructions for your dental office to follow are available here.
The cost of the DS8 is determined by your dentist or physician. The manufacturer suggested retail price is $4800 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 you having to ask for a new one, we prefer to give you two appliances up-front.
No. Since your custom appliance was made from a 3D scan of your mouth, it is guaranteed to fit perfectly (to within 1/100th of a millimeter). If for any reason, you have an issue with fit, contact Slow Wave directly to discuss your issue.
Perhaps. The Slow Wave DS8 is FDA cleared for the treatment of mild to moderate OSA and snoring. However, the product was developed to treat your OSA because it is a deadly health issue. There are lots of different reasons why people snore and the DS8 is most likely to help with snoring associated with your OSA diagnosis but not for snoring caused by other issues.
Three years from date of delivery to you.
Yes. The DS8 is dual cleared by the FDA for the treatments of both OSA and bruxism (clenching and grinding of teeth). It also serves as a retainer that will hold your teeth in place while you sleep.
CPAP – CPAP adherence is low. Because of the mask, noise and discomfort the typical user only wears their CPAP 3 hours a night – but sleeps much longer than 3 hours. The Slow Wave DS8 is extremely comfortable and users have no problem wearing them all night every night. Some even wear the DS8 with their CPAP.
Other Oral Appliances – Other oral appliances (called Mandibular Advancement Devices – MAD) pull your bottom jaw forward and lock it in that forward position all night. This action also pulls your tongue forward during sleep. However, many patients develop jaw pain from having their jaw locked forward all night and have to resort to “morning repositioners” to get their jaw back into place in the morning. The efficacy of these devices is not as good as with the Slow Wave DS8 either. Click HERE to see the design and user advangages of the Slow Wave DS8.
Hypoglossal Nerve Surgery (Inspire™) – Surgery is a drastic and expensive solution with limited efficacy. Many people who have surgery experience side effects such as flaring of the teeth (these surgeries shock nerves pushing the tongue forward during sleep – but don’t give it anywhere to go). The DS8 works on the same principle – but allows your brain to stimulate the nerves and find the right resting spot for your tongue while you sleep – and allows your tongue to return to its natural resting spot.