Frequently Asked Questions
How is the SomnoGuard different from other Oral Appliances provided by Dentists?
The SomnoGuard AP2 and SPX are Prefabricated, Custom Fitted Oral Appliances that combine a supporting hard outer shell and internal copolymer that when heated enables a precise, stable and long lasting impression. This design combines the clinical efficacy of a titratable two-piece appliance with the efficiency of delivery, immediate initiation of therapy and lower cost of a previously produced platform.
Appliances made by a dental lab are Custom Fabricated, based upon a mold obtained from a set of impressions and a bite registration, taken in a separate Dental office visit and requiring significant time and cost to product. Numerous design configurations are available based upon dentist preference, and universally contain the ability to adjust the position of the mandible relative to the maxilla (as the SomnoGuard does), The benefit of Custom Fabricated Appliances is that they are less bulky as the material is minimized to fit that specific patient, but with the SomnoGuard, the majority of excess material is on the lingual side of the teeth and not apparent to the patient.
The copolymer used in the SomnoGuard AP2 has been described as “softer” and more comfortable than the hard acrylic used in the manufacturing of Custom fabricated appliances. The harder material of custom fabricated appliances is more durable and will last longer, but typically nowhere near the 4-8 times as long as is the typical cost difference between the prefabricated and custom fabricated appliances.
The cost associated with Custom Fabricated appliances varies widely, but is reported between $1500-$6000, while the SomnoGuard is intended to be made available for around $500-$700.
The SomnoGuard AP2 and SPX are Prefabricated, Custom Fitted Oral Appliances that combine a supporting hard outer shell and internal copolymer that when heated enables a precise, stable and long lasting impression. This design combines the clinical efficacy of a titratable two-piece appliance with the efficiency of delivery, immediate initiation of therapy and lower cost of a previously produced platform.
Appliances made by a dental lab are Custom Fabricated, based upon a mold obtained from a set of impressions and a bite registration, taken in a separate Dental office visit and requiring significant time and cost to product. Numerous design configurations are available based upon dentist preference, and universally contain the ability to adjust the position of the mandible relative to the maxilla (as the SomnoGuard does), The benefit of Custom Fabricated Appliances is that they are less bulky as the material is minimized to fit that specific patient, but with the SomnoGuard, the majority of excess material is on the lingual side of the teeth and not apparent to the patient.
The copolymer used in the SomnoGuard AP2 has been described as “softer” and more comfortable than the hard acrylic used in the manufacturing of Custom fabricated appliances. The harder material of custom fabricated appliances is more durable and will last longer, but typically nowhere near the 4-8 times as long as is the typical cost difference between the prefabricated and custom fabricated appliances.
The cost associated with Custom Fabricated appliances varies widely, but is reported between $1500-$6000, while the SomnoGuard is intended to be made available for around $500-$700.
Is SomnoGuard covered by Insurance?
For OSA, very often, yes.
For Snoring, No.
The SomnoGuard is FDA cleared, indicated and effective for treating both Obstructive Sleep Apnea and Snoring. Addressing Snoring comprises a large portion of SomnoGuard use, but is not considered Medically Necessary by any insurer, leaving it to be an attractive solution for Snoring as a result of its clinical efficacy and relatively low cost compared to other treatment options and fully custom fabricated appliances.
When indicated for OSA, based upon a positive diagnosis by Unattended Sleep Study (HST) or Polysomnography, many commercial insurer medical policies cover Prefabricated Oral Appliances such as the SomnoGuard, based upon severity.
While policies vary significantly, generally Oral Appliance Therapy (OAT) is considered Medically Necessary in the following circumstances:
Mild OSA: First line option to PAP when AHI documented between 5–15 w/ concurrent complications (ESS>10, Hypertension, cognitive dysfunction, etc)
Moderate OSA: First line option to PAP with AHI 15-29.
Severe OSA (AHI ≥30): Required PAP trial, typically documented 90 day trial failure or concurrent use to lower PAP pressure
For OSA, very often, yes.
For Snoring, No.
The SomnoGuard is FDA cleared, indicated and effective for treating both Obstructive Sleep Apnea and Snoring. Addressing Snoring comprises a large portion of SomnoGuard use, but is not considered Medically Necessary by any insurer, leaving it to be an attractive solution for Snoring as a result of its clinical efficacy and relatively low cost compared to other treatment options and fully custom fabricated appliances.
When indicated for OSA, based upon a positive diagnosis by Unattended Sleep Study (HST) or Polysomnography, many commercial insurer medical policies cover Prefabricated Oral Appliances such as the SomnoGuard, based upon severity.
While policies vary significantly, generally Oral Appliance Therapy (OAT) is considered Medically Necessary in the following circumstances:
Mild OSA: First line option to PAP when AHI documented between 5–15 w/ concurrent complications (ESS>10, Hypertension, cognitive dysfunction, etc)
Moderate OSA: First line option to PAP with AHI 15-29.
Severe OSA (AHI ≥30): Required PAP trial, typically documented 90 day trial failure or concurrent use to lower PAP pressure
Is the SomnoGuard available in different sizes?
The SomnoGuard AP2 comes in one size that has been shown to fit the vast majority of patients. The SPX is a LOWER PROFILE device, designed to accommodate patients with a smaller mouth that find the AP to have too much “height” to be comfortable, and also has the ability to be custom fit to the dimensions of each individual's dental arch.
By moving the Titration mechanism to the lateral margins, the SPX profile is reduced by nearly 3mm in exchange for much less lateral freedom of movement and freedom of mouth breathing as the AP2 provides.
We also offer a Custom Manufactured AP Pro that is a solution in complex dental situations that cannot be accommodated with the prefabricated appliance.
The SomnoGuard AP2 comes in one size that has been shown to fit the vast majority of patients. The SPX is a LOWER PROFILE device, designed to accommodate patients with a smaller mouth that find the AP to have too much “height” to be comfortable, and also has the ability to be custom fit to the dimensions of each individual's dental arch.
By moving the Titration mechanism to the lateral margins, the SPX profile is reduced by nearly 3mm in exchange for much less lateral freedom of movement and freedom of mouth breathing as the AP2 provides.
We also offer a Custom Manufactured AP Pro that is a solution in complex dental situations that cannot be accommodated with the prefabricated appliance.
Who is qualified to perform the fitting of the SomnoGuard?
Anyone. The SomnoGuard is FDA registered as a prescription device but can be prescribed and potentially even self-administered. We try to discourage this method of delivery as being familiar with the three step process recommended for fitting to obtain precise impressions as well as accommodating the necessary bite registration, is the most efficient and effective method for optimizing fit, comfort and therefore compliance. Most practices designate a Nurse, PA, MA or other clinician to become proficient in the process, and many physicians will perform the fitting themselves, but it can be performed by any individual.
Anyone. The SomnoGuard is FDA registered as a prescription device but can be prescribed and potentially even self-administered. We try to discourage this method of delivery as being familiar with the three step process recommended for fitting to obtain precise impressions as well as accommodating the necessary bite registration, is the most efficient and effective method for optimizing fit, comfort and therefore compliance. Most practices designate a Nurse, PA, MA or other clinician to become proficient in the process, and many physicians will perform the fitting themselves, but it can be performed by any individual.
What is the code for Medically Necessary services?
Insurers recognize two billing codes for Custom Fitted Oral Appliances, HCPCS E0485 and CPT 21085. Which code is referenced depends upon the carrier. Both codes are global codes that cover the appliance, fitting and initial titration within a specified global period (typically 10 days). Only one code is used. An Administrative Assistant is available to help you identify codes, medical policy and preauthorization policies in your area.
Insurers recognize two billing codes for Custom Fitted Oral Appliances, HCPCS E0485 and CPT 21085. Which code is referenced depends upon the carrier. Both codes are global codes that cover the appliance, fitting and initial titration within a specified global period (typically 10 days). Only one code is used. An Administrative Assistant is available to help you identify codes, medical policy and preauthorization policies in your area.
Is Preauthorization Necessary?
Only when the proposed service is for documented OSA and the patient meets the criteria according to their carrier’s medical policy indicating it’s likely to be a covered service, should your staff call the insurer to determine eligibility and benefits and inquire if preauthorization is required. If it is, we provide a Certificate of Medical Necessity to support efficient submission.
Need to preauth varies by insurer and is often required. Aetna does not require preauth for services rendered by its participating providers.
Only when the proposed service is for documented OSA and the patient meets the criteria according to their carrier’s medical policy indicating it’s likely to be a covered service, should your staff call the insurer to determine eligibility and benefits and inquire if preauthorization is required. If it is, we provide a Certificate of Medical Necessity to support efficient submission.
Need to preauth varies by insurer and is often required. Aetna does not require preauth for services rendered by its participating providers.
What are the risks and complications?
Potential complications with any OAT device, especially used for a significant duration, include TMJ dysfunction, tooth movement, occlussal changes and damage to dental work, BUT the protocol for fitting and titrating the SomnoGuard dramatically lowers these risks.
Tomed GmbH advocates fitting and initiating therapy at or very near the patient's normal occlusion, thereby stabilizing the airway in the normal daytime position and minimizing any strain on the teeth, muscles and Temporal Mandibular Joint. Only when and if necessary is the lower (mandibular) tray advanced, very gradually, in small increments, until efficacy is achieved. By limiting this advancement to 2mm every other week, the musculature is permitted to accommodate the advancement without the strain that leads to the potential complications.
A consent form to acknowledge these risks, even with the minimized risk, is still encouraged and provided as part of the practice start-up kit.
Other minimal typically reported risks are hyper-salivation or dry mouth and muscle and teeth discomfort (typically from the patient clenching their teeth), these typically resolve with 3-4 nights of consistent use.
Potential complications with any OAT device, especially used for a significant duration, include TMJ dysfunction, tooth movement, occlussal changes and damage to dental work, BUT the protocol for fitting and titrating the SomnoGuard dramatically lowers these risks.
Tomed GmbH advocates fitting and initiating therapy at or very near the patient's normal occlusion, thereby stabilizing the airway in the normal daytime position and minimizing any strain on the teeth, muscles and Temporal Mandibular Joint. Only when and if necessary is the lower (mandibular) tray advanced, very gradually, in small increments, until efficacy is achieved. By limiting this advancement to 2mm every other week, the musculature is permitted to accommodate the advancement without the strain that leads to the potential complications.
A consent form to acknowledge these risks, even with the minimized risk, is still encouraged and provided as part of the practice start-up kit.
Other minimal typically reported risks are hyper-salivation or dry mouth and muscle and teeth discomfort (typically from the patient clenching their teeth), these typically resolve with 3-4 nights of consistent use.
Is there a warranty on the SomnoGuard?
Yes. The SomnoGuard comes with a one year warranty against any defects in workmanship and materials. This does not apply to premature wear or damage by misuse, lack of proper care or bruxism.
Yes. The SomnoGuard comes with a one year warranty against any defects in workmanship and materials. This does not apply to premature wear or damage by misuse, lack of proper care or bruxism.
Is there a satisfaction guarantee?
No. Oral Appliance Therapy, and the SomnoGuard specifically have been studied to demonstrate efficacy but are subject to human variables impacting compliance. Optimal efficacy through titration takes time and a degree of commitment by the patient. Satisfaction is subjective and has been found to be enhanced by the presence of fiscal motivation that would be undermined by a guarantee.
Once custom fitted the appliance cannot be reprocessed for another in any way and therefor has no value.
No. Oral Appliance Therapy, and the SomnoGuard specifically have been studied to demonstrate efficacy but are subject to human variables impacting compliance. Optimal efficacy through titration takes time and a degree of commitment by the patient. Satisfaction is subjective and has been found to be enhanced by the presence of fiscal motivation that would be undermined by a guarantee.
Once custom fitted the appliance cannot be reprocessed for another in any way and therefor has no value.
Can the SomnoGuard be refit?
Yes. The copolymer may be reheated and refit any number of times, both during the initial fitting process or at any point in its useful life if there is a change in the patient’s dentitia.
Yes. The copolymer may be reheated and refit any number of times, both during the initial fitting process or at any point in its useful life if there is a change in the patient’s dentitia.
What is the life expectancy of the SomnoGuard?
Approximately two years with proper care. Many have been reported to last longer while the life expectancy can be dramatically shortened with use by those suffering with severe Bruxism.
Approximately two years with proper care. Many have been reported to last longer while the life expectancy can be dramatically shortened with use by those suffering with severe Bruxism.
Can the SomnoGuard be used by patients with Bruxism?
Yes, though the typical lifespan of the device will be dramatically shortened with severe bruxists. The AP2 is designed with flat pads in the molar region to support the trays while in place that will bear much of the pressure and permit movement of the upper and lower trays that accommodates the grinding movement Bruxists make. The titration mechanism is not as strong a fulcrum point and is what typically wears first requiring replacement of the appliance. A discounted replacement program is available to replace the individual impacted tray in these cases to minimize the economic burden of maintaining the therapy solution for those dealing with Bruxism.
Yes, though the typical lifespan of the device will be dramatically shortened with severe bruxists. The AP2 is designed with flat pads in the molar region to support the trays while in place that will bear much of the pressure and permit movement of the upper and lower trays that accommodates the grinding movement Bruxists make. The titration mechanism is not as strong a fulcrum point and is what typically wears first requiring replacement of the appliance. A discounted replacement program is available to replace the individual impacted tray in these cases to minimize the economic burden of maintaining the therapy solution for those dealing with Bruxism.
Can the SomnoGuard be used for patients with TMJ?
Yes, but it is specifically not indicated for the treatment of TMJ. The lateral freedom of movement inherent in the design of the SomnoGuard AP2 provides mobility without the interlocking of the teeth that exacerbates TMJ and often permits use by TMJ sufferers.
Yes, but it is specifically not indicated for the treatment of TMJ. The lateral freedom of movement inherent in the design of the SomnoGuard AP2 provides mobility without the interlocking of the teeth that exacerbates TMJ and often permits use by TMJ sufferers.
How is the SomnoGuard maintained?
Brushing with a toothbrush and toothpaste, rinsing clean with tap water and tamping dry with a towel recommended after each use. Storing Dry, in its protective case, ideally open and out of direct sunlight, will optimize longevity. A whitening toothpaste is permissible to maintain the appearance while soaking the appliance in any solution is not recommended.
Do not store or soak for prolonged periods (>3 minutes) in a liquid as this will undermine the retention of the lining and outer tray of the appliance.
In the even that the AP2 titration screw is bent, we are pleased to provide a replacement as opposed to trying to straighten the bent screw, which will weaken it. The Locking Nut is provided and to be used to provide additional stability and strength for the shaft of the titration screw whenever advanced beyond the initial setting.
Brushing with a toothbrush and toothpaste, rinsing clean with tap water and tamping dry with a towel recommended after each use. Storing Dry, in its protective case, ideally open and out of direct sunlight, will optimize longevity. A whitening toothpaste is permissible to maintain the appearance while soaking the appliance in any solution is not recommended.
Do not store or soak for prolonged periods (>3 minutes) in a liquid as this will undermine the retention of the lining and outer tray of the appliance.
In the even that the AP2 titration screw is bent, we are pleased to provide a replacement as opposed to trying to straighten the bent screw, which will weaken it. The Locking Nut is provided and to be used to provide additional stability and strength for the shaft of the titration screw whenever advanced beyond the initial setting.
Can an in-lab titration study be performed with the Somnoguard?
Yes. Most insurers will cover an attended polysomnography for previously diagnosed OSA patients initiating OAT. It is recommended to titrate the appliance originally to subjective efficacy (according to the titration protocol) and then “fine tune” the titration from that derived setting during attended PSG.
Yes. Most insurers will cover an attended polysomnography for previously diagnosed OSA patients initiating OAT. It is recommended to titrate the appliance originally to subjective efficacy (according to the titration protocol) and then “fine tune” the titration from that derived setting during attended PSG.
What is reimbursement on the code and what do people charge for the SomnoGuard?
Pricing is at your discretion and varies according to practice location. Many price the full service at $500 - $700 to make it as accessible as possible while others charge >$1000 as part of a comprehensive sleep/airway service. Reimbursement by commercial insurers is typically ~$700, but varies significantly. Either way, a fraction of what fully custom fabricated appliances typically cost.
Pricing is at your discretion and varies according to practice location. Many price the full service at $500 - $700 to make it as accessible as possible while others charge >$1000 as part of a comprehensive sleep/airway service. Reimbursement by commercial insurers is typically ~$700, but varies significantly. Either way, a fraction of what fully custom fabricated appliances typically cost.
For answers to additional questions, please contact 1st Line Medical customer service at 866-720-8080 and speak to one of our Clinical Speciaists.