- KILLER IN YOUR BEDROOM
Estimated reading time: 9 minutes
Wow! Dental devices for snoring sound great!
So, I’m going to show you everything you need to know about their claims.
Do they stop you snoring?
Researched over 4 years, this comprehensive review, also looks at the regulatory framework governing the device manufacturers.
Let’s find out…
In case you’re not familiar with the acronym:
‘OTC’ stands for Over-the-Counter. Which means you don’t need a dental or medical prescription first.
Then read our free, definitive step-by-step how to stop snoring Guide.
This comprehensive Guide walks you through self-help, signposting, screening, professional assessment and diagnosis, the three categories of prescription treatment, follow-up and rounds off with a substantial FAQ.
After all, that’s what you buy them for…
Sadly, these gadgets do not always stop snoring. But don’t take my word for it, the BBC, when covering a ‘Which?’ report1 (the UK’s consumer champion) noted, that claims made for their success were an ‘exaggeration’.
Indeed, the BBC report had a callout box stating, “Many snoring products simply don’t live up to their claims”.
in other words… “they don’t work”.
Hmm… It seems lots of OTC dental devices are sold, and the Which? report is a bit old (2001), so could the Beeb and Which? have looked at the wrong devices?
Many snoring products simply don’t live up to their claims
You might think:
“I will try this (OTC device) and if it works, then I’ll get a custom one”?
Which on the face of it, seems reasonable…
Clinical research2 has shown that OTC dental devices bear little resemblance to custom-made ones.
If you fail with an OTC dental device for snoring, you may also think a custom-made anti-snoring device won’t work, which is known as a ‘false negative’.
This ‘false negative’ delays people getting valid help. Which for the snorer with undiagnosed sleep apnoea, who has tried and failed with an OTC dental device for snoring, is a potentially life-and-death issue.
They may kill themselves (and others) should they fall asleep in unsuitable circumstances
Over-the-Counter, dental devices for snoring range in cost from approx. £50 – £200 GBP. But remember you’re bypassing medical assessment and diagnosis, and then bypassing the dentist.
DIY appears to save money, but….
What are the risks of bypassing Dentists?
Moving past the medical risks of self-diagnosis for a moment…. which we’ll come to in Claim 5.
Dentists are experts in mouths, teeth and jaw-joints. Bypass them and self-fit your OTC dental devices for snoring and you’re asking for trouble.
Always a pleasure, having failed at DIY, to then ask an expert to clear up after you…
From a dental perspective, if you use an OTC dental device for your snoring you’re ‘going it alone’. The sleep-trained dentist would monitor your teeth for what is known as ‘uncontrolled orthodontic tooth movement’. Which means your teeth tilting in various undesired ways. This could result in a change to how the teeth in your upper and lower jaws bite together (creating what is known as a malocclusion).
That same sleep-trained dentist would also monitor your gums (periodontal condition) and jaw-joints. They wouldn’t prescribe a custom-made, dental device until they were sure it wasn’t going to harm you.
And, if they felt it necessary they would take X-rays to ensure your roots could withstand the lateral loads the device creates – and they carry professional indemnity insurance should anything go wrong…
While perspective is needed when considering tooth movement and breathing, a dentist and a custom-made, prescribed anti-snoring device can limit and control things.
PAIN – both short-term and perhaps permanent, chronic pain:
SHORT-TERM PAIN if you’re lucky, short-term pain from overloading individual teeth (typically the upper front incisors). This is short-term if you stop wearing the device, resume snoring, ‘put it down to experience’
PERMANENT (CHRONIC) JAW PAIN from an imposed incorrect ‘bite’ (when you close your teeth together). Jaw pain is known as temporo-mandibular joint dysfunction (TMD). It may be caused by devices that don’t close together evenly (known as a ‘premature posterior contact’) or devices that force your jaw to move beyond its limits.
Having tried to wear the OTC device a few nights and found yourself dribbling profusely when it’s in your mouth, experiencing tooth ache and jaw-ache in the morning…. you might now think to return it for a refund.
Nope. You’re unlikely to be successful with any claim on the promoted ‘Money-back guarantee’, because the device is now ‘used’. Gotcha!
Permanent pain and occlusal change
So, OTC anti-snoring devices have other costs, even if financially they at first appear ‘cheap’. They may cause you permanent, chronic pain and occlusal change (which means how your teeth ‘bite’ together).
In 2014, an eminent British dental expert, Dr R.J. Wassell, published in the British Dental Journal4 about ‘Over-the-Counter’ devices (he focused on devices for people who grind their teeth – ‘bruxists’). This is relevant, because he notes OTC devices sold online (and he includes those for snoring and sleep apnoea) are purchased by individuals as a possible alternative to manage their condition, without the need for a dental or medical consultation.
He notes safety information on many internet sites was “notable for its paucity” or was totally lacking. He points out that manufacturers are not obliged to provide safety information online, but it must be provided with the product and observes that the MAUDE adverse events database5, maintained by the FDA, “showed a number of potentially serious adverse events associated with these splints including choking hazards, tissue damage and occlusal changes”.
Dr Wassell advised the GDC about the OTC device market in 2014. What are we to conclude from their apparent inaction, some 7 years on? (updated 2021)
If you go around professional assessment, ‘treat’ yourself with an OTC gadget and amazingly no longer snore (which is unlikely) you might assume you’re fine.
You should be screened for sleep apnoea before using any dental device for snoring (see Claim 5) and we looked at why going the DIY route (cutting out the dentist) is a bit dumb in Claim 3. However, for the sake of argument, let’s explore this ‘Easy to Self-Fit’ claim.
IF you read the instructions, you’ll learn you must heat up each part and – while its hot – ‘squidge’ (for want of a better word) the device onto your teeth.
Repeat this for the other jaw.
For some devices, you must do both jaws AT THE SAME TIME and ensure both parts correctly line up. Or it won’t work and you can’t get your money back. Oh don’t forget to make sure it clicks comfortably into place or…
It won’t work.
If the pieces don’t line up – it won’t work – you will have to heat it up again, reform the material and try again. Assuming of course, that the material can withstand another heat cycle…
Try now to claim on the ‘Money-Back Guarantee’. Hah! Good luck with that!
But of course, this is exactly what the OTC dental device for snoring manufacturer wants. They’ve had your money after all – and there’s no comeback on them, if you give up. Regardless of whether it doesn’t work or causes you problems.
All the above assumes you fit the device – i.e. the shape of your mouth and the alignment of your jaws suit the device. Which is totally backwards, it would be like the shops only selling underpants in one or two sizes…
Anti-snoring devices, exist at the point where medicine and dentistry meet
Both are essential
Anti-snoring devices, exist at the point where medicine and dentistry meet.
I’ve highlighted the importance of the dental role.
But is a medical assessment essential?
Cutting out either professional is, shall we say, ‘foolish’? Bypassing assessment and/or prescription (going the DIY route), is risky because the snorer may have undiagnosed, and therefore untreated, sleep apnoea/apnea.
Some, but not all, OTC anti-snoring devices are adjustable in protrusion. In either relatively large steps or for more money, with a screw-thread at the front of the mouth, like a ‘volume control knob’!
The increment technology (approx. 2mm steps) is inherently flawed, because assuming everything else is good…, the difference between an effective position and a painful, impossible to tolerate one, may be much less e.g. 0.5mm.
Outcome: It won’t work
As for the ‘volume control knob’ type, you fit the device in one position and as you adjust it (most likely forwards, because you’re still snoring and think more advancement is required), the ‘biting’ relationship changes. Which changes the alignment of the upper and lower parts of the device, most likely making it hard or even impossible to close your mouth and put your teeth together evenly.
Now, you’re in trouble, whichever way you go:
Oh, and forget the ‘Money-Back Guarantee’ – you’ve used the device. Did you read the small-print? No, thought not.
I covered ‘Easy – Self-Fit’ (Claim 4) above, and arguably, yes, the overall shape of OTC dental devices for snoring approximates people’s teeth and jaws BUT,
and here’s the thing:
Above, are three more reasons why it’s pointless, struggling in the bathroom mirror with boiling water, squidging bits of hot plastic into your mouth.
Incidentally, custom-made, prescription devices would be remade or professionally adjusted if they exhibited these problems.
You guessed it…
It won’t work
Where everything gets lost with which Regulator is responsible
Claiming to be ‘NHS Recommended‘, is not something apparently regulated by the NHS. Consequently, it’s hard to find anything to substantiate, prove or disprove this claim – which is why they make it. Clever marketing. I can only guess that one rather uninformed NHS professional, in a moment of desperation perhaps, thought the OTC device was useful… and the manufacturer seized that opportunity.
In 2013, I contacted the United Kingdom’s Medicines and Healthcare Products Regulatory Authority (MHRA) about OTC devices. Time went by and not much appeared to happen. Months later, I chased them up. They suggested I contact the Advertising Standards Authority. Which I did. I also tried Trading Standards.
In desperation, I contacted the Care Quality Commission (CQC) who referred me back to the MHRA. The MHRA did eventually investigate, but couldn’t decide. So, “asked an Expert”, two in fact. Who couldn’t agree. Honestly, you couldn’t make this up.
I also contacted the Charities Commission because one business, seemed ‘confused’ about its commercial status, variously claiming to be a ‘not-for-profit’ organisation or a Charity.
The result of all the above?
The status quo: Encouraging snorers to DIY their diagnosis, ‘treatment’ and follow-up. Which is wrong on so many levels.
Regrettably, unlike snorers, the above regulatory organisations are (so far) silent…
As for claiming ‘FDA Cleared’ [FDA means Food and Drug Administration and they control the US market for medical devices]…. my advice is to read what it is cleared for.
OTC devices have been FDA cleared for snoring – not for sleep apnoea/apnea. This means the manufacturers can market them.
But, I must repeat, in the US (just like the rest of the world), there is:
NO WAY to differentiate between snoring and sleep apnoea/apnea symptoms without an overnight sleep study.
Seriously though, after reading this, do you think DIY is sensible? There’s more about the US system in Claim 9 below.
Relying on a manufacturer’s assertion the product or materials used are safe (which is what you do with an EU Class 1 device, US Class 2 device) leaves you potentially at risk, should the manufacturer not be entirely honest. I’m not saying they’re all dishonest but…
French firm, Poly Implant Prothese (PIP) manufactured breast implants using industrial grade silicone not medical device grade7,8. And this was for an implanted medical device (EU Class 3) that should have been tightly regulated. Not something seen as ‘low-risk’ e.g. an OTC anti-snoring device….
Having a professional at least look at the product before you rely upon it to help you breathe while you’re defenceless (asleep) might be considered a good idea!
Surely consulting an expert is no-brainer…?
A bunch of boring but essential rules exist for US and European medical devices. In medical device language, they control how devices are ‘placed on the market’.
In Europe, the medical device ‘Class’ is defined by the manufacturer, when they register with the ‘Competent Authority’. If they choose, they may opt for ‘Low-Risk’ (Class I) without any checks on this decision – no external assessment. They may then put the CE mark on their packaging.
Sadly, EU regulators appear impotent, despite my notification (and notifications by others and also some reputable professional organisations). They fail to protect the Public (yes, I did say that). They continue to allow unscrupulous businesses to sell dental devices for snoring directly to the Public, because the manufacturers have declared the product a ‘low-risk’ Class 1 device.
In May 2017, I happened to visit a leading brand, High Street pharmacy. Amongst the snore-relief products (which irritates me enough) I found an OTC dental devices for snoring that claimed to treat SLEEP APNOEA / APNEA… [lost for words].
In the US, the FDA does assess whether medical devices are safe and categorised correctly, before they’re sold. The FDA took legal action against one manufacturer9 – yet the device is still available. The FDA did make the manufacturer stop claiming their product treats sleep apnoea/apnea. Consequently, the manufacturer calls it a ‘Snore Relief Device’…
A quote below from an OTC anti-snoring device website Disclaimer (brand name removed), where they proclaim the device is for sale in Europe without a doctor’s prescription and the materials are safe [accessed 22 Oct 2016]:
Seriously, when you see disclaimers and legal notices like the below on a page – what does it tell you?!
“The XXXXX mouthpiece is designed to cure snoring but the United States, FDA will not allow us to make the claim that our mouthpiece is a cure for sleep apnea, which is a medical condition. Should you suffer from this complaint then you should consult your doctor. While we do not claim to cure sleep apnea, many people have found relief from it as an additional benefit of eliminating snoring with the XXXXX mouthpiece.
Though the FDA won’t allow us to sell the XXXXXX anti-snoring mouthpiece without a doctor or dentist prescription, it is approved for sale in Europe under the European Union Seal of Approval without a doctor’s prescription.
We have deliberately decided to not pursue FDA approval for our product because of the associated costs that we would have to pass on to you, our customer. It has always been our intent to provide a low-cost snoring relief solution. Rest assured, 100% of our product is sourced and made in the USA with non-toxic, latex and BPA-free materials.
It just so happens that the XXXXXX mouthpiece also works very well as a “sports” mouthpiece. That is why we have decided to only sell the very same “anti-snoring” mouthpiece in the United States as a XXXXXX brand “sports mouthpiece”.
Stating: “Should you suffer from this complaint [sleep apnoea/apnea] then you should consult your doctor”, is scandalous. It is impossible to differentiate between snoring and sleep apnoea (unless you’re a sleep-trained expert!) If it was easy, we wouldn’t need Doctors or sleep units….
Arguing the toss, by saying manufacturers comply with the rules, just means the rules are wrong, inadequate or in reality unpoliced. Regardless of which side of ‘the pond’ you are, unscrupulous manufacturers are swerving the existing rules and lack of action by the regulators to sell (in my view) incorrectly categorised products (that should be prescription items), directly to the naïve Public. Buyer beware!
To add insult to injury…. In the UK, dental devices for snoring (both OTC and custom-made) are classified by HMRC as ‘luxury items’10. Which means they’re standard rated (currently 20% VAT).
What an indictment!
It just goes to show, how poorly sleep-related breathing disorders, of which snoring is one, are understood.
If the proposed treatment is an anti-snoring device, you then have a dental examination prior to being prescribed an appropriate custom-made one.
Although not yet widely adopted, the UK refines this process further by permitting sleep-trained dentists to screen for sleep apnoea6, and in defined circumstances, provide a custom anti-snoring device, without a prior medical diagnosis. Sleep-trained dentist are ideally placed to help simple or ‘benign’ snorers.
This pragmatic solution short-circuits the costly, time-consuming and pointless referral to hospital, of anti-social snorers without sleepiness symptoms or other comorbidities (other related health problems).
The expensive-to-the-system (ask yourself who’s profiting?) alternative, which at the time of writing is current practice in the US and Europe is:
And they’ve cost the system how many thousands of pounds/euros/dollars? Perhaps in some US States things aren’t so bleak, so perhaps I’m being cynical. But this IS the overall picture.
We’ve been over the medical and dental consequences of buying OTC anti-snoring device, but to summarise:
Encouraging self-diagnosis and self-treatment to profit from sales of an OTC dental devices for snoring, is irresponsible, harmful to the individual’s health, costly and perhaps dangerous to society.
The step-by-step illustration below is meant to illustrate what typically happens. While fictitious and dramatised, it is based on typical disease progression.11
Time and Money
Everyone likes to save money, but OTC dental devices for snoring are a false-economy, and in my view incorrectly categorised medical devices, that delay sleep apnoea diagnosis and effective treatment.
The personal and socio-economic cost of quite possibly years of mismanaged, undiagnosed sleep apnoea, through the inappropriate sale and use of OTC dental devices for snoring, far exceeds the cost of consulting trained professionals.
Effective, life-transformational, sleep apnoea therapy is NHS funded (it’s ‘free’ in the UK) because it makes economic sense for the NHS to pay for it12. Businesses that sell OTC dental devices for snoring have flourished in a vacuum because, until now, there has been no viable alternative:
When ear plugs, self-help and pillows aren’t cutting it – it’s time to get serious.
A sleep-trained pharmacist can direct you to the most appropriate expert to help you stop snoring.
They can also help with lifestyle issues (which may be the underlying reason why you snore).
They will screen you for sleep apnoea and decide if you need further investigation i.e. a sleep study.
If you don’t need a sleep study they can direct you to a sleep-trained dentist for a custom-made, anti-snoring device.
Which is the first way to stop snoring and also treat mild to moderate OSA3, 4.
I am reliably informed, (name withheld) that should a medical professional, suggest to a snoring patient that they use an Over-the-counter dental device for snoring (self-fit), their professional indemnity insurer would consider them having acted outside their area of professional expertise.
They would then be personally liable for the dental consequences.
Clearly, the correct thing to do, is to refer to appropriate expertise: a sleep-trained dentist. I blogged about the need for Guidelines for the Medical Profession when it comes to oral appliance therapy, in 2012!
Here are two useful resources, if you’re struggling with a snoring problem: