Indications For Use

 

The Luco Hybrid OSA Appliance is the first treatment market cleared by the FDA for the treatment of sleep bruxism. Many pharmaceuticals have been tried but, although some were effective, their side effects rendered them unsafe to use. Because sleep bruxism originates deep within the brain, psychotherapy, hypnotherapy and acupuncture have all failed in clinical trials to control sleep bruxism. The Luco Hybrid OSA Appliance is clinically proven and FDA cleared for this treatment.

With sleep bruxism occurring in 8-12% of the population and OSA at 16%, sleep bruxism occurs in over 30% of OSA patients. in fact, 80% of sleep bruxism occurs concurrently with sleep apnea.

The Luco Hybrid OSA Appliance is the only treatment available for 30% of OSA patients.

The research required by the FDA for this clearance demonstrated:

  • A reduction in mean jaw muscle pain overall by 95.08%
  • A reduction in mean TMJ palpation pain of 94.45%
  • An 87.38% reduction in the number of sleep bruxism events
  • A 91.2% reduction in the mean duration of bruxism events
  • A 92.5% reduction of the mean Bruxism Index (hourly rate)
  • A 25.6% reduction in heart rate associated with sleep bruxism events

A VAS (Visual Analog Scale) completed by the subjects demonstrated:

  • a 92.8% decrease in TMJ pain on waking and later in the day
  • A 93.85% reduction in jaw muscle pain in waking and later in the day
  • A 91.4% reduction in reported tooth sensitivity to extreme temperatures
  • A 96.83% reduction in tension/migraine type headaches on waking and later into the day
  • A 94.7$ reduction in neck and shoulder pain on waking and later in the day

These results will be published shortly now that the data has been released by the FDA. The data clearly shows that this device is effective in the treatment of sleep bruxism and associated tension migraine headaches resulting in a significant improvement in quality of life. 

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