Custom Oral Appliances Comparison Guide

Company: Aiomega LLC Airway Management Inc Dream Systems Dental
Sleep Lab Good Sleep Co Great Lakes Dental
Technologies Open Airway
Dental Solutions Ltd Panthera Dental Panthera Dental ProSomnus Sleep
Technologies ProSomnus Sleep
Technologies ProSomnus Sleep
Technologies SICAT GmbH & Co KG Slow Wave Inc Slow Wave Inc SomnoMed Appliance: AIO Breathe flexTAP O2 OASYS Oral / Nasal Airway
System (Optional Tongue
Dilators & Tongue Repositioning Buttons) hushdPRO Avera Nylon Sleep Herbst O2Vent Optima Panthera D-SAD Classic Panthera D-SAD X3 ProSomnus EVO ProSomnus EVO [PH] ProSomnus EVO SELECT OPTISLEEP Slow Wave DS8 BROSA SomnoDent Herbst Advance Elite Website: aiomd.com tapintosleep.com dreamsystemsdentallab.com us.goodsleepco.health gldt.com openairway.com pantherasleep.com pantherasleep.com prosomnus.com prosomnus.com prosomnus.com sicat.com slowwave.net slowwave.net somnomed.com/en/dentists/products Warranty (days): 365 1,095 730 1,095 730 1,095 1,095 1,095 1,095.75 1,095 (+730 for Medicare beneficiaries) 1,095.75 730 1,095 1,095 730 Indications: Mild-Moderate OSA, Snoring Mild-Moderate OSA, Snoring Mild-Moderate OSA, Snoring Mild-Moderate OSA Mild-Moderate OSA, Snoring Mild-Moderate OSA, Snoring Mild-Moderate OSA, Snoring Mild-Moderate OSA, Snoring Mild-Moderate OSA, Snoring Mild-Moderate OSA, Snoring Mild-Moderate OSA, Snoring Mild-Moderate OSA, Snoring Mild-Moderate OSA, Snoring Bruxism Mild-Moderate OSA, Snoring Materials: Biocompatible polymer (ISO 10993 for perpetual use in oral cavity) Thermal Acrylic, Laminate, Nylon, no metal parts Biocompatible Polymer, Cobalt-Chromium Alloys, Stainless Steel, Hard Acrylic, Laminate, Thermal Acrylic Nylon (no BPAs, no phthalates, no PFAS, no gluten) Nylon Nylon, 3D printed Biocompatible Polymer, Nylon Biocompatible Polymer, Nylon Biocompatible Polymer, Medical grade class VI Biocompatible Polymer, Stainless Steel, Medical grade class VI Biocompatible Polymer, Medical grade class VI Biocompatible
Polymer, Hard Acrylic, Nylon Hard Acrylic, BioMed Clear Hard Acrylic Biocompatible
Polymer, Cobalt-Chromium Alloys, Stainless Steel, Hard Acrylic PDAC Verified: No Yes Yes No Yes Yes Yes Yes Yes Yes No No Yes Yes Yes How Does the Oral
Appliance Work?: Individually customizable interactive flange technology has a connected-arc-of-motion that provides increasing revive-on-demand airflow through incremental 3D increase in airway size beyond the natural airway size of a person. This Antero-Vertical-Mandibular-Lingual Repositioning raises the hyoid bone antero-superiorly and predictably achieves desired oxygenation. FlexTAP advances the lower jaw with a single point midline advancement. Self-titratable adjustments in 1/3 mm increments aid in easier, faster, and better treatment outcomes. The Oasys Simplicity provides mandibular advancement. The standard Oasys with Nasal Dilators improves nasal breathing and adding Tongue Lifters improves forward tongue positioning. A series of upper and lower trays are provided that gently repositions the jaw and tongue to maintain an open airway. Simple advancement with a change of the tray. Mandibular advancement in 1 mm increments ranging from +0 – 5mm. Mandibular position is set to open the airway and hold this position while sleeping. O2Vent Optima has two mechanisms of action that add stability to the airway. 1. A mechanism of advancing the jaw forward encouraging a more open airway. 2. Incorporates an airway channel that further stabilizes the airway. Traction appliance design, in line with the occlusal plane, promoting nasal breathing, minimizing stress on the TMJ and allowing more space for the tongue. A single set of upper and lower splints are connected through a patented rod titration system.  Low profile and lightweight dorsal fin appliance. Maximizes tongue space and avoids soft tissue contact. A single set of durable upper and lower splints are adjusted using an interchangeable clip system. ProSomnus EVO uses vertically mated buccal posts to advance and hold the mandible forward to open the airway.  he ProSomnus [PH] uses a continuous advancement protocol. Upper arch connects via Herbst Arm  to lower arch with an adjustment nut. ProSomnus EVO SELECT uses vertically mated buccal posts to advance and hold the mandible forward to open the airway. The airway is kept open by protrusion of the mandible with a 2-part appliance. It allows for lateral movement and mouth opening. Incorporates a vertical opening and makes more room for the tongue. Also stimulates the user’s brain to naturally migrate the tongue forward during sleep. Incorporates a vertical opening and makes more room for the tongue. Also relaxes the jaw during sleep treating bruxism the disease, not just teeth grinding. The device functions as a mandibular repositioner, which acts to increase the patient’s pharyngeal space during sleep. Intraoral-Scan Impression Compatible: Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Max Protrusion/
Max Retrusion/Adjustment Increment (mm): Anterior: 15, Vertical: 36/
5/
0.06. Anterior for 0.1 deg mouth opening 17/
2/
0.333 15/
5/
1 5/
2/
1 4/
1
/<0.25 6/
2/
1 N/A/
N/A/
0.5 5/
-1/
0.5 unlimited/
customizable/
1 12/
-1/
 0.1  unlimited/
customizable/
1 9/
9/
1 2/
2/
N/A (no adjustments needed) 2/
2/
N/A (no adjustments needed) 8/
-1/
0.1 Upper-Lower Connection: Not connected Connected Not connected Not connected Connected. Connected Connected Not connected Not connected Connected Not connected Connected Not connected Not connected Connected Custom Accessories Available: Mandibular plateaus can be built into the device to provide enhanced anterior airway opening to achieve desired degrees of minimum mouth opening. Mouth Shield nasal breathing trainer, AM Aligner morning repositioner. Retention clasps, hooks & elastics, in combination with Invisalign.  Hooks and elastics. Advancement shims, ‘C’ cut shims, elastics, telescopic hardware. Connector bands, biteforks. Pairs of interchangeable elongation-proof rods allow for a titration range from 16 mm to 34 mm in 0.5 mm increments. Titration clips (allow adjustment from -1 mm to +5 mm in 0.5 mm increments). Monogram customization options. Monogram customization options. Monogram customization options. None. None. None. Distal wrap, breathing hole, edentulous, cheek protector option, discluding element. Supporting Study: None tapintosleep.com/peer-reviewed-studies Shrivastava D, Bixby JK,
Livornese DS, et al. Efficacy of oral appliance therapy in the treatment of severe OSA in CPAP-resistant cases. Sleep Vigilance. 2018. Not provided. Not provided. openairway.com/pages/clinical-resources Not provided. Not provided. Mosca E, Remmers J. Precision vs traditional oral appliance therapy: A comparison of therapeutic efficacy. JDSM 10.2. Abstract #006. (https://aadsm.org/journal/abstracts_issue_102.php) Not provided. Not provided. Not provided. Not provided. Not provided. Phillips CL, Grunstein RR, Darendeliler MA, et al. Health outcomes of continuous positive airway pressure versus oral appliance treatment for obstructive sleep apnea: a randomized controlled trial. Am J Respir Crit Care Med. 2013 Apr 15;187(8):879-87. Features: Elevation and anterior displacement of hyoid bone increases entire cross-sectional area of the narrowest spot in airway and drops airflow resistance, facilitating massive tidal volumes at low effort. No need for built-in anterior advancement mitigates against TMJ dysfunction. A CAD/CAM process uses robotics, AI, and proprietary software to custom-make these nylon appliances from intraoral scans or physical impressions. High manufacturing precision, with numerous customization options and an exclusive polishing process. Unique applications with upper denture, minimal dentition upper or lower, nasal obstruction or resistance, in combination with Invisalign. 3D printed nylon, virtually indestructible, customizable, with an emphasis on comfort and ease of use. Allows lateral and vertical movement without disengaging the appliance. Made less than 1 mm thick, retains durability and retention while maintaining appropriate flexibility. The O2Vent Optima products are OADS’ latest offering in the O2Vent oral appliance range. The lower jaw can be moved forward to a comfortable range while also allowing the integrated airway channel to bypass nasal congestion and other areas of airway collapse, such as from the tongue, soft palate, and lateral walls. A CAD/CAM process uses robotics, AI, and proprietary software to custom-make these nylon appliances from intraoral scans or physical impressions. High manufacturing precision, with numerous customization options and an exclusive polishing process. A CAD/CAM process uses robotics, AI, and proprietary software to custom-make these nylon appliances from intraoral scans or physical impressions. High manufacturing precision, with numerous customization options and an exclusive polishing process. Incorporates advanced materials, manufacturing robotics, and AI to advance the treatment of OSA using a precision platform. In a controlled IRB study (2021), 100% of patients preferred EVO over previous devices and CPAP; 100% of providers would recommend EVO; and 100% of providers stated EVO was easy to deliver. Features MG6 technology. ProSomnus EVO [PH], FDA cleared and Medicare E0486 verified. EVO [PH] is the only dual arm advancement device with innovative materials, manufacturing robotics and artificial intelligence designed to provide a better experience for all patients. Engineered for performance, biocompatibility and the greatest comfort. A signature variation of the ProSomnus EVO device, EVO SELECT is optimized for patients who may benefit from a more compact, effective, and easy to use precision OAT medical device using the most innovative materials. Not provided. No need for morning repositioner. 3D printed. Accurate to within 1/100th of a mm. 100-day money back guarantee. Infinitely adjustable ramp system allows the brain to locate perfect jaw resting spot for each patient. Individually milled from one piece of pre-cured PMMA for greater flexural strength. All the patented strength improvements in the Herbst Advance are also found in the Herbst Advance Elite. SomnoMed will replace it for free if it breaks, no questions asked, for 3 years. The Herbst Advance Elite is only supplied with a Bflex soft inner liner for increased comfort and retention.