PURE SLEEP and other do-it-yourself "cures"
There is a mail-order device that is advertised heavily on TV that purports to be an FDA-cleared device appropriate for snoring. The device is called PURESLEEP and was invented by a dentist, Dr. Douglas Fenton.
According to the PURESLEEP web site:
" PureSleep is an FDA-cleared prescription dental device and uses a technique called 'mandibular repositioning' which has been clinically validated through years of research and testing. For the first time ever, it is available without a visit to the dentist or physician. That translates into savings of more than 80% off the price a dentist would charge!"
(If the manufacturer is reading this post, I would appreciate it if he would comment and post the FDA Clearance number and registration date because I could find no reference to the PureSleep Device at the FDA web site.I will happily retract the comments about FDA approval if the FDA reference material is provided)
Even so, the statement "prescription dental device" implies that a dentist must prescribe the appliance which clearly is refuted by the statement "available without a visit to the dentist or physician."
The web site goes on to state:
"PureSleep is an FDA-cleared prescription dental device, now available for the first time without visiting a physician or dentist. To determine if it is appropriate to prescribe PureSleep to you, it is necessary to answer a few simple questions on this website or by calling an automated voice response system, using the toll-free number below -- any time, day or night. In either case, your answers to these questions will be recorded, and if appropriate, PureSleep will be prescribed to you and your order will be shipped."
(THE FDA states: Intraoral devices to treat snoring and/or obstructive sleep apnea are prescription devices unless adequate directions for use (21 CFR 801.5) are developed and FDA clears a 510(k) specifically for over-the-counter (OTC) distribution.)
The questions, as posted on the web site:
"PureSleep is an FDA-cleared, prescription device. Because of this, you must be at least 18 years old to purchase or use PureSleep. Furthermore, before we can provide you with a PureSleep device, we will need to ask you some questions about your health. The Pure Sleep Company is not liable for any damages or injuries resulting from false or erroneous information provided by you.
Are you at least 18 years old?
Do you agree to the terms and conditions?
The questions continue:
Having answered all questions in the negative, I was taken to the following screen:
Great! Your responses to the questionnaire indicate that it would be appropriate for you to use the PureSleep stop snoring solution.
You have the option of making two payments of $29.95 ($59.90 total) plus $7.95 for shipping and handling. However most of our customers prefer the ease and convenience of a single payment - and you can still take advantage of our risk-free 30-day Money Back Guarantee.
To purchase PureSleep, simply select a payment option below and then click the "Continue" button below. Your order will then be transfered to our secure shopping cart where you can complete your purchase.
I prefer the ease and convenience of a single payment.
I prefer to make two payments.
PLEASE NOTE: There is not one question that attempts to determine whether or not the purchaser may have obstructive sleep apnea. And yet the device is supposedly cleared just for snoring. Even if relevant questions were asked, every reputable scientific article states that history alone cannot make the diagnosis of sleep apnea and that it must be confirmed with a sleep study.
Let us realize that even if this device was approved for over-the-counter sale as an anti-snoring mouthpiece, people most likely to purchase it are loud snorers and are often likely to have overlying mild to severe sleep apnea.
Big problem!
Sleep apnea is a serious medical problem that can lead to heart disease, stroke, high blood pressure, diabetes, motor vehicle accidents due to drowsing off while driving and even erectile dysfunction. Even though the device may control the snoring, it may not adequately treat sleep apnea leaving you open, in extreme cases, for death while you sleep.
There are no easy answers in medicine or dentistry. If you have sleep apnea or even if you snore heavily with pauses in breathing at night (observed by your bed partner), have high blood pressure and if you are tired during the day you should be evaluated by a sleep physician or dentist trained in sleep medicine.
PLEASE DON't DO IT YOURSELF. It's not a joke. If you find that you need an oral appliance have it constructed by a dentist who has been trained in this therapy. Often your medical insurance will cover the charges.
As in all things caveat emptor - it's your health and your life.
Dr. Barsh
According to the PURESLEEP web site:
" PureSleep is an FDA-cleared prescription dental device and uses a technique called 'mandibular repositioning' which has been clinically validated through years of research and testing. For the first time ever, it is available without a visit to the dentist or physician. That translates into savings of more than 80% off the price a dentist would charge!"
(If the manufacturer is reading this post, I would appreciate it if he would comment and post the FDA Clearance number and registration date because I could find no reference to the PureSleep Device at the FDA web site.I will happily retract the comments about FDA approval if the FDA reference material is provided)
Even so, the statement "prescription dental device" implies that a dentist must prescribe the appliance which clearly is refuted by the statement "available without a visit to the dentist or physician."
The web site goes on to state:
"PureSleep is an FDA-cleared prescription dental device, now available for the first time without visiting a physician or dentist. To determine if it is appropriate to prescribe PureSleep to you, it is necessary to answer a few simple questions on this website or by calling an automated voice response system, using the toll-free number below -- any time, day or night. In either case, your answers to these questions will be recorded, and if appropriate, PureSleep will be prescribed to you and your order will be shipped."
(THE FDA states: Intraoral devices to treat snoring and/or obstructive sleep apnea are prescription devices unless adequate directions for use (21 CFR 801.5) are developed and FDA clears a 510(k) specifically for over-the-counter (OTC) distribution.)
The questions, as posted on the web site:
"PureSleep is an FDA-cleared, prescription device. Because of this, you must be at least 18 years old to purchase or use PureSleep. Furthermore, before we can provide you with a PureSleep device, we will need to ask you some questions about your health. The Pure Sleep Company is not liable for any damages or injuries resulting from false or erroneous information provided by you.
Are you at least 18 years old?
Do you agree to the terms and conditions?
The questions continue:
- Have you ever been diagnosed with central sleep apnea?
- Do you have chronic asthma, emphysema, or any other severe respiratory disorder?
- Do you have loose teeth, abscesses, or severe gum disease?
- Do you have full dentures, or are you presently undergoing orthodontic treatment?
- Have you had a dental implant within the last year? Note that crowns, caps, and bridges are not dental implants.
- Have you been diagnosed with temporomandibular disorder -- sometimes called TMD or TMJ?
- Does it hurt when you open your mouth wide or yawn?
- Does it hurt when you chew, or use the jaws?
- Does it hurt when you are not chewing or using the jaws?
- Is your jaw pain worse on waking?
- Do you have pain in front of the ears or ear aches?
- Do you have jaw muscle (cheek) pain?
- Do you have pain in the temples?
- Do you have pain or soreness in the teeth?
- Do your jaw joints make noise so that it bothers you or others?
- Do you find it difficult to open your mouth wide?
- Does your jaw ever lock closed so you cannot open it?
- Does your jaw ever lock open so you cannot close it?
- Do you have a problem with your bite being uncomfortable?
Having answered all questions in the negative, I was taken to the following screen:
Great! Your responses to the questionnaire indicate that it would be appropriate for you to use the PureSleep stop snoring solution.
You have the option of making two payments of $29.95 ($59.90 total) plus $7.95 for shipping and handling. However most of our customers prefer the ease and convenience of a single payment - and you can still take advantage of our risk-free 30-day Money Back Guarantee.
To purchase PureSleep, simply select a payment option below and then click the "Continue" button below. Your order will then be transfered to our secure shopping cart where you can complete your purchase.
I prefer the ease and convenience of a single payment.
I prefer to make two payments.
PLEASE NOTE: There is not one question that attempts to determine whether or not the purchaser may have obstructive sleep apnea. And yet the device is supposedly cleared just for snoring. Even if relevant questions were asked, every reputable scientific article states that history alone cannot make the diagnosis of sleep apnea and that it must be confirmed with a sleep study.
Let us realize that even if this device was approved for over-the-counter sale as an anti-snoring mouthpiece, people most likely to purchase it are loud snorers and are often likely to have overlying mild to severe sleep apnea.
Big problem!
Sleep apnea is a serious medical problem that can lead to heart disease, stroke, high blood pressure, diabetes, motor vehicle accidents due to drowsing off while driving and even erectile dysfunction. Even though the device may control the snoring, it may not adequately treat sleep apnea leaving you open, in extreme cases, for death while you sleep.
There are no easy answers in medicine or dentistry. If you have sleep apnea or even if you snore heavily with pauses in breathing at night (observed by your bed partner), have high blood pressure and if you are tired during the day you should be evaluated by a sleep physician or dentist trained in sleep medicine.
PLEASE DON't DO IT YOURSELF. It's not a joke. If you find that you need an oral appliance have it constructed by a dentist who has been trained in this therapy. Often your medical insurance will cover the charges.
As in all things caveat emptor - it's your health and your life.
Dr. Barsh
posted by Dr. Larry Barsh at
9:19 AM
1 Comments:
Learn more about sleep apnea and treatment options at http://www.obstructednose.com
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