“Sleeping in Complete Comfort”
INDICATIONS FOR USE:
Medical: (FDA Clearance K130797)
- For the treatment of mild to moderate obstructive sleep apnea
- For the treatment of primary snoring
Dental: (FDA Clearance K160477)
- For the treatment of sleep bruxism
- To aid in the treatment of associated tension/migraine type headaches
This device is the first treatment the FDA has cleared for the treatment of sleep bruxism of any kind. Various medications have been studied, but to date, all have failed in treating sleep bruxism or the side effects were very severe. Similarly, because sleep bruxism does not have a psychological component, psychotherapies are ineffective at treating it.
This is the only dental device with both medical and dental uses and the only device FDA recognized for the treatment of patients who suffer from one or more of these diseases.
Also of note, the FDA has also cleared this device to aid in the treatment of the tension/migraine type headaches that often accompany sleep bruxism. No other OSA appliance can make that claim. Standard single arch (upper and lower) night guards only protect the teeth. They do nothing to treat the underlying sleep bruxism (and associated problems such as increased heart rate and blood pressure). Upper night guards may actually affect the airway.
The Luco Hybrid OSA Appliance is unique in that it actually significantly reduces the number and the duration of sleep bruxism events that occur. It also significantly reduces the heart rate associated with each event, reducing the strain on the heart. This is while opening the airway and reducing snoring.
It has a cast metal framework made from the same material as a cast partial denture and metal hip replacements. The acrylic allows for simple adjustments chairside for dental work that may be needed at a later date, should dental work be required. Figures 1 and 2 show the framework. Due to the strength of the cast framework, the appliance size is quite small and very comfortable to wear.
There is no material in the front to allow mouth breathing as needed. Many people suffer from allergies or have chronic stuffy noses. By eliminating all the material in the front, there is no restriction of mouth breathing. If you are claustrophobic, you will certainly appreciate this design!
The Luco Hybrid OSA Appliance is clinically proven and FDA cleared as the only true treatment of sleep bruxism. If you suffer from OSA and sleep bruxism, this is the only device that can treat both conditions together. And, if you wear a CPAP and suffer from sleep bruxism, we have very successfully used this device with CPAP therapy (by simply having a mask fitted to the device jaw positioning).
And as sleep bruxism falls under dental uses, any dentist can order this treatment as it is currently available in the US and Canada.
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