Somnodent Fusion combines wing and screw calibration technology in a single device.
”This is one of the highest quality appliances available for use in treating obstructive sleep apnea,” said a dentist who described SomnoMed’s SomnoDent Fusion as much better than similar OSA devices. Rating all features as excellent, another evaluator shared the following feedback: “This appliance is so advanced [compared to] any other oral appliance on the market. It really shows that the company understands what dentists need in an appliance for the successful treatment of patients with obstructive sleep apnea.”
Twelve dentists evaluated SomnoDent Fusion, the latest innovation from SomnoMed featuring the fusion of wing and screw calibration technology in a single device.
Clinician Ease of Use
Manufacturer Description: SomnoDent Fusion features custom calibration with flexibility that reduces the frequency of resets that would leave patients without their appliances during manufacturer adjustments. Drop-in fit and fewer adjustments save dental practices both time and money.
Evaluator Feedback: Eight evaluators rated ease of use for the clinician as excellent and the remaining 4 rated it as very good. “It allows for greater advancement of the jaw without having to reset the appliance,” said an evaluator who reported that she would definitely purchase the device and recommend it to her colleagues. Rating all features as excellent, another evaluator noted that, “increased calibration capability is very welcome.”
Patient Ease of Titration
Manufacturer Description: Quick advancement with interchangeable wings and fine screw adjustments at 1 mm increments greatly enhance patient ease of use. The device’s 8.5 mm advancement is longer than that of most other dorsal fin oral devices.
Evaluator Feedback: “I love this appliance because of the ability to titrate it forward,” said a dentist who rated all features as excellent. When evaluators were asked what they liked most, responses included, “additional titration over the [SomnoDent] Flex,” “advancement range and precision,” “the ability to change the size of the wings,” and “extra advancement for large range-of-motion patients.” A dentist in practice for 32 years, who described the Fusion as much better than similar products said, “I like the ability to titrate beyond 5 mm.”
Patient Compliance: Comfort and Fit
Manufacturer Description: Designed to maximize compliance, 88% of patients have reported regular use of their SomnoDent devices. SomnoDent Fusion will be the first and only dorsal fin oral device with a micro-recorder that objectively records compliance data, including hours of wear and supine or non-supine head position. The device can be ordered with the proprietary SMH BFlex material, which enhances patient comfort and improves retention. The comfortable fi t allows patients to talk and open/close their mouths and lips during use. With device wings that are closer to the occlusal surface, patients feel more room in their mouths and less bulk.
Evaluator Feedback: Both patient compliance and comfort were rated as excellent or very good by all 12 evaluators. An evaluator who said she would definitely purchase the Fusion and recommend it to colleagues noted, “it allows the wings to be kept further back, which increases patient comfort.” Another evaluator noted, “Because the wings are changeable, lateral play in the appliance is minimized,” and that, “this also is reflected in a less bulky and slimmer appliance (width wise), and patients feel the difference.”
Efficacy: Systemic Health
Manufacturer Description: SomnoDent Fusion is an FDA 510(k)-cleared, class II medical device manufactured under 21 CFR 820 and ISO13485 standards. Significant clinical benefits have been demonstrated in 15 independent studies,1 with 91% of patients reporting improvement in sleep quality with SomnoDent.
Evaluator Feedback: Eight evaluators rated the Fusion’s ability to improve systemic health as excellent, and the remaining 4 rated it as very good or good. Referring to the device’s ISO medical grade manufacturing rating, a dentist in practice for 29 years said, “That is huge! This is what separates the SomnoDent from any other dental orthotic used for sleep apnea. When patients see that emblem they are so impressed.” The same evaluator went on to note that, “to have that quality assurance, unlike any other product on the market, is why they last longer, fi t better, work better. To me, that is a game-changer.”
Overall Satisfaction
Nine evaluators rated overall satisfaction as excellent and 3 rated it as very good. “It offers the best features of multiple designs in one device,” said a dentist who called it much better than similar products.
All 12 evaluators described the SomnoDent Fusion as much or somewhat better than similar products, with most (8) describing it as much better. Eleven evaluators said they would definitely purchase it, and 10 said they would definitely recommend it to colleagues. “It’s awesome,” said a Virginia dentist. “It was a well-thought-out improvement over the SomnoDent Flex.”
