Frequently Asked Questions
1. How does the PureSleep® device work?
PureSleep® works by a technique called ‘mandibular repositioning’ whereby the device gently holds your lower jaw forward, which creates an open airway through your throat, eliminating the vibrations that cause snoring. There is significant clinical research supporting the use of this technique. Click here to learn more.
2. Is it safe?
Mandibular repositioning to reduce snoring has been safely prescribed by dentists and physicians for over a decade, and the PureSleep® device has a remarkable record of safe and effective use. In fact, PureSleep® has been used by thousands of snorers without a single FDA reportable adverse event. As with all medical products, you should carefully read and follow all instructions and labeling before use to ensure that PureSleep® works safely and effectively. Click here to learn more about exactly how PureSleep® works.
3. Why does PureSleep® require a prescription?
PureSleep® is a Class II medical device which thereby requires a prescription from a licensed dentist or physician. The patented PureSleep® device has been cleared by the FDA for sale exclusively by The Pure Sleep Company and PureSleep® Partner physicians and dentists
4. Why do I need to answer this long phone or web questionnaire in order to get PureSleep®?
PureSleep® is a Class II medical device and thereby requires a prescription from a licensed dentist or physician. Our questionnaire guides you through a set of questions one would get from their doctor and ensures that you do not have any other conditions that might compromise the safety and effectiveness of the PureSleep® device.
5. How difficult is it to fit the device?
Fitting PureSleep® is quick and easy. All you do is immerse the device in boiling water and mold it to the shape of your mouth. We include a step-by-step Instruction Guide in your PureSleep® kit, and we highly suggest you read this in detail before doing the fitting.
6. Is PureSleep® adjustable?
Yes, PureSleep® is adjustable. There are 3 settings that loosen or tighten the device. You select the setting when you are initially fitting the device, however once molded that setting cannot be changed for the life of the product.
7. Does it hurt? Is it difficult to get used to the product?
Typically, the adjustment period takes about 3-5 nights of consistent use. It is perfectly normal for your jaw, teeth and gums to feel moderately sore and fatigued at first. This discomfort is much like getting braces or a retainer for the first time. However, it is not normal to experience severe, sharp or ongoing pain. These symptoms may be an indication of a more serious problem with your jaw called temporomandibular disorder (TMD). If you experience these symptoms or believe you have TMD, discontinue use immediately, contact your dentist or physician, and return your PureSleep® device for a full refund.
8. What if it doesn’t work for me? Can I return it?
Absolutely. But we know you didn’t buy it just to return it, so please give us a chance to help you with the adjustment and fitting process by calling our PureSleep® Helpline at 1-866-879-3777 or click here . And if within 30 days you need to return or replace the unit due to a mis-fitting, we are happy to make the exchange or refund your money in full.
9. How often should I replace my PureSleep® device?
Each PureSleep® device undergoes normal wear and tear through the course of wearing it every night. We recommend replacing the unit every 6-9 months. Some individuals grind their teeth more than others and therefore may need to replace the unit more often. It is possible to re-boil it up to 3-4 times if it needs to be reshaped.
10. I have a spouse who snores, and I’d love to give PureSleep® as a gift. Is there a way to do that?
Yes, PureSleep® makes a great gift for loved ones who snore. It’s easy to give PureSleep® as a gift – simply call us at 1-800-283-2667 to purchase a gift credit. Your loved one can then call us, present their gift code and take the phone-based prescription questionnaire, and the device will be sent to them. And if for any reason we are unable to prescribe PureSleep® for them, we will refund your money in full.
11. How does PureSleep® differ from the athletic mouthguards I see at my local sports store?
Though it may look similar, the PureSleep® device is significantly different from an athletic mouthguard. PureSleep® is an adjustable device designed to hold your lower jaw forward, thus opening up your airway while you sleep. Unlike athletic mouthguards, our patented device is made from two different high-quality plastics, both a hard plastic on the outside and a soft plastic on the inside, which gives it more structural rigidity, making it less bulky and therefore more comfortable since there’s less material overall. Our device is manufactured here in the USA with only American-sourced materials. Finally, an athletic mouthguard is only designed to protect your teeth and mouth from injury; it is not designed to hold your jaw in a specific position.
12. How does PureSleep® differ from other MRDs?
There are several key differences between PureSleep® and other MRDs. First and foremost, PureSleep® is adjustable via three settings that are selected when the initial fitting is done whereas most competitor products have only one setting. Secondly, unlike other MRDs and athletic mouthguards, our patented design includes two different kinds of high-quality plastic; a hard plastic on the outside and a soft plastic on the inside which gives it more structural rigidity makes it less bulky and therefore more comfortable since there’s less material overall. Finally, PureSleep® is manufactured here in the USA with only American-sourced materials unlike many competitor products which are manufactured overseas.
13. How long does it take to get my product after I’ve ordered?
Orders received online shipped to customers in the continental US will generally arrive in 2-weeks via standard shipping and 1-week rush shipping. Orders received over the phone take slightly longer to process and therefore generally arrive within 3-4 weeks standard shipping and 1-2 weeks rush shipping. We do ship to a select list of countries outside the US including Canada. All International orders outside Canada are shipped “air mail” and subject to the local duties and customs clearance procedures of each country.
14. Can PureSleep® be used to treat obstructive sleep apnea (OSA)?
No, PureSleep® is intended only for the reduction of snoring. It is not intended to treat sleep apnea or any other medical condition.
15. Can I buy PureSleep® through my dentist?
Yes, any licensed dentist or physician in the US or Canada can prescribe PureSleep® for you through our Dental and Medical Partner program. Applications for this program can be submitted here.