SomnoGuard SPX review: Is This New Mandibular Adjustment Device Any Good?

SomnoGuard SPX is probably the type of product that would make you purchase immediately. However, a closer look at the price tag and the plastic build raises serious questions. Why do I have to pay so much for plastic? Is SomnoGuard worth its price tag?

Well, when you get right down to it, Somnoguard is one of the few rare adjustable Mandibular Adjustment devices that allow you to make lateral jaw adjustments. The device’s sophisticated design is a definite statement of comfort.

But is it truly worth its price tag? We will find about that in a minute. Before that, here is a snapshot of what we’ll talk about in this article.

• What is SomnoGuard SPX—exacatly?
• How SomnoGuard SPX precisely work
• Is the mouthpiece in treating snoring and sleep apnea
• How to Fit the SomnoGuard SPX
• How to Customize the Lower-Jaw Adjustment level
• Who will SomnoGuard Work for
• Who will the device not Work for
• What are the Unique Features of Somnoguard you won’t Find Anywhere Else?
• Will your insurance cover pay for the device in case you choose to go for it?
• And Plenty More

What`s SomnoGuard SPX

SomnoGuard SPX is a modern mandibular adjustment device from German manufacturer Tomed GmbH. The mouthpiece is one of the best prefabricated oral devices for managing snoring and obstructive sleep apnea.

In fact, it is the most recent model from Tomed GmbH. The SPX abbreviation stands for Sagital Positioner.

Since the product is created by a German manufacturer, the Better Business Bureau BBB does not have any record regarding the maker.

However, in 2018, SomnoGuard got FDA clearance in the United States. And like any other FDA-cleared Oral Appliance that treats Obstructive Sleep Apnea, SomnoGuard is only available by prescription.

Otherwise, the SPX is an ultra-low profile appliance suitable for users sensitive to the vertical height of the previous model of  SomnoGuard—the AP2.

The SomnoGuard device is above average. The design is so sophisticated with plenty of features. To describe it best, we’ll break it into two elements:

1. Product design
2. Materials used

Let’s begin with the design.

1. SomnoGuard SPX Design

The Dual-Tray MAD

The SPX is a two-pieces mouthpiece. Therefore, it fits over both the upper and the lower jaw. The two oral trays consist of a hard outer shell and thermoplastic material—copolymer with memory effect.

And the memory effect reverts the thermoplastic almost to its original size when heated. This allows a user to refit the mouthpiece if the previous fit wasn’t successful.

The Slot Adjusting Mechanism

The SomnoGuard SPX maintains the therapeutic position of the jaw. It does this with the help of a unique turnbuckle adjustment mechanism on the side.

The device comes with an adjustment screw for changing the position of the lower jaw for up to 10mm.

The freedom to decide the level of jaw advancement presents some cutting edge advantages to the user:

1. It enhances wearing comfort
2. And it distinguishes SomnoGuard SPX from other mouthpieces in the market, which only adjusts the lower jaw for up to 6 to 8mm

Plus, the unique slot mechanism at the core of the front part of the mouthpiece allows users to alter the tray’s width. All these adjustment features make SomnoGuard a rare Mandibular Adjustment Device.

Smaller Verticle Profile

SomnoGuard has a small vertical profile that minimizes the distance that separates the jaw apart, further enhances comfort and reduces the level of intrusion.

Pressure Distribution Design that Lowers Pressure on Teeth

Comfortably solve the excessive-pressure problem with the Smonoguard SPX that leverages the rear teeth and the front teeth only from the sides. The teeth at the back of the jaw are less sensitive, lowering the MAD’s pressure on the teeth.

The Boil and Bite fitting

The fitting process begins with a boil-and-bite process. The inner part touches the teeth and utilizes softer material than the outside shell.

Custom fitting involves heating the trays in boing water, separately, to soften the material and enable molding. Then you can mold the copolymer according to your jaw size by gently pulling the trays apart or pressing them together.

However, you can only mold the top and the bottom piece separately—you can not mold the two tray simultaneously.

After molding the mouthpiece, you can turn the screws to adjust its level of lower jaw advancing.

2. The material

Concerning material, Somnoguard utilizes thermoplastic material—copolymer that is biocompatible and contains no allergens, no latex, no silicone, and no plasticizers like BPA.

The lack of latex and being BPA-free makes the mouthpiece useful even for a person with an allergy to latex. Besides, the copolymer provides excellent retention for a snug fit throughout the night.

About the Manufacturer                                

The SomnoGuard is a product of a german family-run medical company called Tomed. Tomed GmbHis, a world of modern medical technology that started in 1997 in Bensheim, Germany.

Today, the head office is in Cologne, with several production sites all over Germany. The company serves two markets:

1. The antisnore world – producing and distributing Mandibular Advancement Devices, positioning aid, and nasal dilators to treat obstructive sleep apnea syndrome and snoring habits.
2. Obstetric and Gynecology market – actively producing and distributing medical appliance for contraception, treatment of urinary stress incontinence, and pregnancy-related discomfort that results from back, abdominal, and pelvic pains.

The company leverages the many years of experience that Dr. med. Fahri Yildiz has an ear, nose, and throat physician in snoring and obstructive sleep apnea.

Tomed GmbH works with various clinics, doctors, pharmacies, and institutes. His collaboration helps him to develop even more medical solutions from the exchange experience and feedback. As a result, the company continuously develops and improves its products.

The SomnoGuard SPXis one of the company’s newest devices. The company claims that the product is a new-generation grade appliance.

This begs the question: Is the device worth your time and money?

Let’s scrape in a little deeper:

What’s SomnoGuard SPX Device Classification?

The mouthpiece is Mandibular Adjustment Device(MAD). Like any other MAD, the device works by repositioning the lower jaw to keep the user’s airway when asleep preventing snoring and obstructive sleep apnea.

But is the device any different in its operation?

Let’s see how it works.

How Somnoguard Works

Snoring and sleep apnea occur due to constriction of a person’s airway, restricting natural airflow when asleep. The airflow restriction occurs when there is a narrowing of the air war at the tongue’s base.

For years, Oral Appliance Therapy has been the most common way to keep an open airway during sleep. To achieve this, the appliance advances and hold the lower jaw in a slightly forward position during sleep. This prevents the tongue and throat muscles from collapsing to the user’s airway.

And jaw advancement has proven effective. In fact, studies show that MADs have an efficacy rate of about 90% in treating snoring and sleep apnea.

SomnoGuard SPX as an above-average MAD, you’d expect it to work even better.

The mouthguard is FDA-approved. Most insurance companies cover it as a safe and reliable option for mild to moderate sleep apnea and snoring. But to qualify for insurance coverage on a Mandibular Adjustment Device, you will need a doctor or a sleep study prescription.

How Effective is SomnoGuard SPX

As far as functionality, the SomnoGuard SPX gets the job done. It gets you soundless sleep.

What makes it even far better is its ability to adjust the lower jaw protrusion level, especially in small 1mm increments. The incremental adjustment enables the device to treat different snoring and sleep apnea levels.

And if you find one setting doesn’t work for your situation, gradually advance the lower jaw advancement until you find a setting that works for you.

And here is one thing that makes SomnoGuard SPX more effective:

It has wide breathing holes at the front of the device. This makes the appliance usable to even mouth breathers without whistling effect.

How to Fit SmonoGuard SPX

Smonoguard comes with detailed step-by-step fitting instructions. Since the device requires a prescription to order, you can let your doctor execute the fitting process for you.

Either way, the fitting process isn’t complicated. Here is a simple guide to get you through the process. You’ll need:

• Two small bowls with a minimum base diameter of 10 cm (Avoid using plastic bowls)
• Heating sources like kettle or saucepan
• Pointed pliers
• Side cutter
• A file

The fitting process

1. Heat the trays separately in boiling water for approximately 60 seconds with the hard acrylic side down. The copolymer up( the trays are identical for both upper and lower jaw). Start with the upper tray
2. Then remove the SmonoGuard SPX from the boiling water, shake the water off, and allow it to cool for 60 seconds
3. Next, place the tray on the upper arch, and bite into the soft thermoplastic material with center marks. Ensure lateral margins match the contour; they are flexible at this point and hold for 15 seconds to create your teeth impression.
4. Press the copolymer of the outer and inner wall of the tray. Press the copolymer against the teeth, mostly in the  molar region, for another 15 seconds
5. With the lower jaw slightly forward,  keep the mouth closed  and swallow a few times and press the copolymer in the inner side of the teeth  with your tongue, particularly in the molar region
6. Close your mouth for 60 seconds until the material has hardens
7. Then carefully remove the mouthpiece from your mouth vertically, and asses retention, reposition and, if needed, apply pressure to the copolymer against the teeth
8. Put the tray with the impression in ice-cold water for 10 seconds
9. The check the fit
10. Finally, repeat the process with the other tray on the opposite arch

Note that you cannot execute the procedure on both trays simultaneously. One must precede the other.

After the molding process, extend the turnbuckle straps to the proper length to initiate therapy at normal occlusion (-3.5mm to +6.5mm).

Then attach straps to posts and trim any excess material with flush cutting snips. If the default adjustment doesn’t serve you well,  adjust 1mm/week until you crash the efficacy you need. You can then change the lower jaw advancement continuously using the turning screws in the middle of the connector

The manufacturer recommends physician or company-trained personnel fitting to get the maximum therapeutic result. However, it’s not necessary if you follow the fitting guide.

Here is a video guide to get you started through the fitting process.

And if you went wrong in the fitting process, and the fit is not perfect, here are two actions you can execute:

• If it is a partial correction, put the single spot of the tray in for about 10 seconds. Next, refit the tray to your mouth to remold the device to the specification you need
• For a complete refit, put the whole tray in the boiling water for about 60 seconds and re-execute the fitting process.

The copolymer, the SomnoGuard, uses reverts almost to its original form.

How to Adjust The Level of Lower Jaw Reposition Using SomnoGuard SPX

SomnoGuard uses screws to allow incremental adjustments in the lower jaw position. The screw is a medical-grade stainless steel material.

You can only adjust the lower jaw repositioning level when you disassemble the two trays. On the side, there is a scale that measures the amount of adjustment you make.

To adjust the level of lower jaw advancement, turn the screw within the connector with a spanner.

How to Care for SomnoGuard SPX

SomnoGuard requires few maintenance practices. Just brush the mouthpiece with toothbrush and toothpaste and rinse clean with tap water every morning you wakes up.

After drying it, store it in the casing that it came with direct sunlight for longevity.

At the same time, you can use a whitening toothpaste to maintain the appearance of the mouthpiece.

Alternatively, a person can use a unique cleaning product like Curaprox daily gel for daily cleaning, Curarox weekly concentrate weekly cleaning for weakly cleaning. All these you’ll find at Tomed GmbH official website or any other distributor authorized by the manufacturer.

At no circumstance should you use a conventional denture cleaner or cleaning tab with SomnoGuard. This is because the bleach will compromise the integrity of the device.

What’s more, do not soak the device in any solution. It will compromise the retention of the lining and outer tray of the mouthpiece.

And in case the screw of the SPX bend, contact the manufacturer for a free replacement instead of trying to straighten a bent screw that weakens it.

What Makes SomnoGuard SPX Unique from Other Mouthpieces Provided by Dentist?

From the physical appearance, the SomnoGuard is an above-average Mandibular Adjustment Device. It has plenty of unique features.

First, Somnoguard SPX is a prefabricated oral appliance. It combines a hard outer shell and an internal copolymer that creates precise, stable, and lasting mold on heating.

Second, the copolymer that Somnoguard utilizes is soft and more comfortable than the hard acrylic outer part. This more rigid material increases the device’s lifespan to 1½ years, far longer than any typical mouthpiece.

And lastly, the slot adjustment mechanism makes the device a fully-adjustable MAD—a rare feature in the mandibular adjustment world. An adjustable MAD is more comfortable to wear as the user chooses the jaw advancement level and the freedom of moving the jaws laterally when wearing the device.

Who is Smonoguard for?

• Persons with receding lower jaws
• Mouth breathers
• Mouth or throat snorers
• Every size of jaws
• Individuals with mild to moderate sleep apnea
• Persons with bruxism through the lifespan will lower

Who isn’t Somnoguard for?

• Denture wearers
• Persons with other orthodontic devices
• Persons with severe sleep apnea

Pros and Cons

Pros

• Present the freedom to adjust the level of lower jaw advancement
• It utilizes a modern design          
• The thermoplastic that SomnoGuard uses has a memory effect and revert almost to its original size
• Utilizes sophisticate design that highers wearing comfort
• The width of the tray is adaptable to any jaw size
• It allows mouth breathing
• Works even for persons with receding  lower jaw
• Allows mouth breathing from its whistle-free breathing air hole
• You can mold Somnoguard multiple times

Cons

• The mouthpiece frequently falls out
• The initial acquisition cost may keep others away from buying the product
• Some users complain that the device falls apart
• The screw may break
• It requests doctors prescription to order this device
• The need for a doctor’s or a sleep specialist prescription further highers the product’s price
• It might be hard to fit than the typical Mandibular Adjustment Device

Where Can you buy Somnoguard SPX?

You can order the Somnoguard SPX mouthpiece at several places:

1.  At a pharmacy
2. Directly from the manufacturer via Telephone—+4922117067206, Fax— +4922117067207, Or email—sales@tomed.com

What’s the Lifespan of SomnoGuard SPX?

The manufactures say that Somnoguard can last for up to 1.5 years. Such a lifespan is exemplary for any MAD. Even though durable, the lifetime cannot compensate for the high acquisition cost.

Does SomnoGuard require a doctor’s prescription?

Yes, every Somnoguard SPX order requires a doctor or a sleep specialist prescription. While the need for a prescription highers the acquisition cost, it might also save you the problem of going through the fitting process as the physician should do it for you.

What is the Pricing of SomnoGuard SPX?

You can only purchase Sonmoguard through your dentist or qualified sleep specialist.

The Somnoguard goes at $299.

However, it is more likely that your insurance company will cover the device, especially if your doctor prescribes it for sleep apnea.

Is Somnoguard SPX Insured with Insurance Companies?

It depends.

If your doctor or a sleep specialist prescribes SomnoGuard SPX for Obstructive Sleep Apnea, nearly all insurance companies cover it.

But when your doctor only prescribes it as an anti-snoring aid, most insurance companies do not cover them.

And here is the reason why:

The FDA clears SomnoGuard SPX as an effective treatment for both Obstructive Sleep Apnea and snoring. For the most part, however,  a large portion of users uses SomnoGuard to treat snoring, a condition which many insurers do not consider medically necessary.

Therefore, when your doctor prescribes an Obstructive Sleep Apnea appliance, nearly all commercial insurer medical policies cover prefabricated oral devices like the SomnoGuard.

All in all, policies vary. But nearly all insurance companies consider Oral Appliance Therapy medically necessary in conditions of any sleep apnea.

What are the Possible Side Effects of Using SmonoGuard?

1. Using mandibular adjustment devices like SomnoGuard for significant duration might cause:
2. Temporal Mandibular Joint (TMJ)dysfunction
3. Tooth Movement
4. Occlusal changes
5. Damage to dental work

However, the fitting and designing of SmonoGuard significantly diminish these risks. The manufacturer recommends appropriate and initiation therapy in the user’s normal occlusion, to stabilize the airway in the ordinary day position and reduce any strain on the teeth, jaw, and Temporal Mandibular Joint.

In fact, the manufacturer advocates lower tray advancement only when necessary. The user should use the default setting and only adjust the protrusion gradually in slow increments until one reaches maximum efficacy without extreme

 invasions. Limit advancement to 2mm/week to permit musculature to accommodate the advancement without straining, leading to complications.

• Hyper-drooling but this goes away after few days of use
• Dry mouth
• Jaw and teeth discomfort

The last three are minimal, but the most common risk people experience. However, thy c after 3-4 nights of consistent use.

What’s the Warranty of SomnoGuard SPX?

SomnoGuard SPX comes with a 1-year warranty against defects in workmanship and material. However, the warranty does not cover premature wear or damages from misuse, bruxism, or lack of proper care.                                     

What’s the Product Guarantee of the Somnoguard?

SomnoGuard has no satisfaction guarantee. Oral Appliance Therapy and the SomnoGuard SPX has high efficacy, but it varies depending on an individual. Plus, it might take an individual’s time and commitment to the device to be optimally efficient.

All these might undermine the satisfaction guarantee.

Hence, once you have custom-fitted the appliance, there no way the manufacturer will replace it because it will have no value.                                                           

SomnoGuard SPX and Bruxism

A person with bruxism (teeth grinding) can use SomnoGuard SPX, with the lifespan shortening significantly for severe bruxists.

SomnoGuard SPX and Persons with TMJ

A person with Temporal Mandibular Joined dysfunction can use the SPX, though the manufacturer hasn’t specified that. But because its design allows lateral jaw movements, SomnoGuard provides mobility without interlocking the teeth that exacerbate TMJ, thus accomodating persons with TMJ.

Can One Do Fitting of the SomnoGuard SPX Themselves?

Anyone can do the fitting process. Even though the FDA-registers the device as prescription-only, a sleep specialist can prescribe the appliance.

However, the person prescribing the SPX should be proficient in the fitting process. They should also perform the fitting themselves. And that doesn’t mean you can’t execute the boil-and-bite process yourself.

Is there a difference between the top and bottom trays?

Unlike other Mandibular Adjustment Device, the top and the bottom of SomnoGuard SPX are identical before fitting. It is up to you to choose which one you’ll use for the upper jaw and the other for the lower jaw.

After fitting, however, the upper tray will remain upper, and the lower will remain lower.

SomnoGuard SPX Review: Final verdict                                                                    

SomnoGuard SPX is a suite with robust features, including an ultra-low profile and prefabricated custom enhanced fitting. Pair that with high efficiency, comfort, and convenience, and it’s no wonder that SomnoGuard SPX has established itself as an unquestionably reliable oral device for snoring and Obstructive Sleep Apnea.

If budgeting isn’t a limiting factor in your search for a snore-aid, SomnoGuard SPX is an excellent option. However, suppose you’re on a limited budget. In that case, you should just pass this device and go for other, more cost-effective mandibular devices.