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FAQs Special Section

Everyone has their FAQs on sleep products. DynaFlex and ProSomnus offer answers on their custom sleep devices.

Sleep Device Manufacturing: Answering the Frequently Asked Questions

Q: What do you need from the office to start a case?

 A: Many believe that laboratories need more information than usual to design obstructive sleep apnea devices. The good news is this is not the case! As your custom sleep device manufacturer, DynaFlex® only needs a completed Rx form, your patient’s models or scans, and a bite record of where you would like our team to build the appliance. You or the patient can titrate the device to protrude the mandible forward from the start position. Keep in mind: most of these devices do not go backwards; it is always best to be conservative in the starting position. If the bite is too protrusive to start, and the patient cannot tolerate it, you will typically have to send the case back to the lab for a “Bite Reset”.

Milled DynaFlex Adjustable Herbst®

Q: How do I get my case back from the lab faster?

 A: Most importantly, make sure your Rx is filled out completely and properly. While this may seem obvious, it’s one of the major causes of delay/case to be put on hold. Secondly, please make sure the scans/models are not distorted, and the bite has not shifted. We recommend verifying scans/models while the patient is in office. Calling the patient back to the office for new records takes up valuable time and delays the case even further. These digital issues are easily avoidable with some simple checks in place. Most labs offer rush services to create devices faster for patients who need theirs quickly.

Q: What if my patient needs to go further protrusive than their sleep device will allow?

A: Many labs offer a “Bite Reset” service, which requires the device to be sent to the lab. They will mount it to its current position, then reset the hardware so that the patient can go further forward. This usually adds strength to the device, which is essential for heavy bruxers.

Have more questions on starting a case for oral appliance therapy? Worried about the details when it comes to a more complex case for edentulous patients? Give our laboratory a call at 1-800-489-4020 and speak to a dental sleep medicine expert – we are here to help!

For more information on our products and services, please visit https://www.dynaflex.com/dental-sleep-laboratory-devices/.

Top 5 Questions About EVO Answered

Thank you to Dental Sleep Practice magazine for the opportunity to have ProSomnus answer the five most common questions about ProSomnus® EVO™. Counting down from number five.

  1. Is ProSomnus EVO Medicare approved?

EVO is PDAC verified. The issue is that it is PDAC verified for code K1027, not E0486. CMS is in the process of developing a coverage policy for K1027. A growing number of insurance payors are beginning to cover K1027 as a benefit. We’ll know more later this year. Many of our customers are using a low cost PDAC approved appliance to fulfill the CMS rules and sign the POD for this. They then sell the patient a backup device like ProSomnus EVO, and then execute an ABN for that.

  1. Why those 90-degree posts?

With a 70-degree post/strap/arm or similar mechanism that replicates mandibular rotation, you will lose 1.8mm of advancement if the patient opens 5.0mm. That means, with 70-degree posts you would need more dose/advancement and that could mean less comfort, more side effects and loss of some efficacy.

  1. How do you advance/adjust it?

With Iterative Advancement like this, the numbers on the post indicate where you are at precisely. U0 + L0, is exactly where you took your bite. By trading out the other arches in any combination, the numbers add up to where you are in relation to that point. U0 + L1, would be forward 1.0mm, U2 + L0 would be forward 2.0mm, U2 + L1 would be 3.0mm, and so forth. You can even move backward if you accidentally started too far forward or if the patient develops muscle or ligament discomfort. U-2 + L0 would be 2.0mm more retruded, then U-2 + L1 would be 1.0mm retruded. All very precisely.

  1. ProSomnus EVO is comparable to other premium priced devices…but you say it can save me money?

EVO saves delivery time, has fewer side effects, less breakage/repair, better compliance, and best-in-class outcomes. Precision solutions like this have the potential to save your practice so much TIME, they can be considered the LEAST expensive device solution. ProSomnus takes great pride in being a Class II Medical Device Manufacturer. We accept the additional regulatory, testing and reporting requirements that accompany that responsibility. We invest in making devices with bite transfer precision (articulator mounting), accuracy in advancement, and with the smallest volume. We utilize best-in-class materials, including MG6™ Technology for our ProSomnus EVO products that are stronger, safer, and more biocompatible. All this serves our customers and patients with the best efficacy and adherence. Plus, we want to delight physicians and payers, so they appreciate the value of better, more efficacious, and adherent OAT with precision devices. Lower dose, fewer side effects and first-time fit saves our customers time and money. Other manufactures do not do the amount of research that we do. We are investing in the future of DSM in a way that results in better treatment experiences for the benefit of patients and our dentist customers. We are proud of our fees, they represent the investment in precision, technology, and better outcomes that our customers have come to expect from us. Not to mention, that patients deserve; physicians will trust, and payers will reimburse better.

  1. What is EVO made of?

If we told you…we would have to, you know. The MG6 Technology is proprietary material resourced and designed using Artificial Intelligence and Robotic Manufacturing in such a way that it provides the most precise fit, bite transfer, and biocompatibility of any material used today. The great success we continue to enjoy with the milled PMMA material is even better with the slightly flexible, more forgiving, most biocompatible material. In the FDA MAUDE database (Manufacturer and User Facility Device Experience Complaint Database), 95% of the complaints were from 8 other manufacturers. 59% of those complaints are traceable to biocompatibility/hypersensitivity/allergic/inflammatory reactions. None of those were ProSomnus materials. In fact, 100% of them were cold cured/bench acrylics, Thermacryl, and soft liner materials.

For more information on ProSomnus precision oral appliances, please visit ProSomnus.com or email Info@ProSomnus.com.

 

Have some FAQs about sleep and fetal maternal health? Read “Sleep Related Breathing Disorders During Pregnancy: The Impact of Intervention on Maternal and Fetal Health Outcomes,” and take the quiz to receive 2 CE credits!  https://dentalsleeppractice.com/ce-articles/sleep-related-breathing-disorders-during-pregnancy-the-impact-of-intervention-on-maternal-and-fetal-health-outcomes/
 

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