Mechanism:

• M1 is an FDA-approved Entry-level Mandibular Repositioning Device (MRD) that holds the lower jaw in a forward position during sleep, preventing the collapse of the tongue and soft tissues in the back of the throat.
• The small plastic device fits over the teeth and helps stop snoring and teeth grinding at night.

Safety and Side Effects:

• M1 is made of FDA-approved food-grade silicone material, which is softer and less likely to cause irritation or obstruction.
• It is designed to protect the teeth and jaw while providing a comfortable sleep experience.
• No reported side effects with the use of M1 MRD.

Patient Eligibility:

• M1 can be used by individuals who experience snoring and teeth grinding during sleep.
• It is suitable for those who prefer a non-invasive solution.
• Patients should check with their physician for diagnosis and treatment of OSA before using this device.

Clinical Data:

• A randomized crossover trial compared the effectiveness of custom-made (MRDc) and ready-made (MRDr) mandibular repositioning devices in managing obstructive sleep apnea (OSA).
• The study showed that the MRDc achieved a complete treatment response in 64% of participants, compared to 24% with the MRDr, demonstrating significant clinical effectiveness and improved patient compliance and tolerance.

Cost:

• $26.90.