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Myerson EMA Sleep Apnea & Snoring Device.

FDA Approved
Food & Drug Administration Document information number FDA 510k #K971794 (Approved 09/29/1997)

Click here for Instructions and FDA approval on page 2

Click here for Insurance Reimbursement Codes

The EMA Device is a simple, patient-friendly oral appliance created for noninvasive treatment of Sleep Apnea and Snoring.  The primary treatment mechanism of opening the bite and gently moving the mandible forward is achieved with the use of interchangeable elastic straps that offer varying degrees of mandibular advancement.

 

The EMA appliance uses 9 different lengths of elastic straps to gradually and incrementally advance the mandible forward.
 
  • Four different strengths of elastic straps match the strength of the pull to the musculature of the patient.
  • The EMA's patented design allows freedom of lateral mandibular movement.
  • Air flow through the oral pharynx is increased either through the advancement of the mandible, increased vertical opening, or both.
  • Thermoformed custom trays limit tooth movement.

 

Pretreatment Screening

 

  • Basic physical assessment primarily involves measuring the patient?s range of mandibular motion and quality of jaw movement. If the patient can open smoothly to 40 millimeters intrinsically and protrude the jaw 5 millimeters comfortably, and these movements can be performed without significant TMJ clicking or crepitus, it is reasonably likely that the appliance will be tolerated comfortably.
 
  • Adequate dental retention is essential. The EMA can only be used over intact, nonmobile teeth without periodontal involvement. Dental restorations must be secure, as any removable oral appliance can displace loose crowns, inlays, onlays, or veneers. Having adequate numbers of secure teeth for retention of the EMA is particularly important in the maxillary anterior and premolar region and in the mandibular premolar and molar areas.
 
Impressions & Bite Registration

 

  • Take upper and lower dental impressions.  The extension of the impressions should go to the height of contour of the gingiva on all sides of the teeth.
  • Take a wax bite with the patient in an un-protruded centric occlusion with the bite open 8 to 10 mm in the anterior region.
  • Send models and wax bite to Oral Arts Lab.
  •  
Delivery to the Patient
 
  • Fit the upper and lower appliances without the EMA elastic straps to check for comfort and to make sure there is no gingival impingement.  The EMA may feel snug to the patient for the first five to ten minutes.  Remove upper and lower.
  • Wet two EMA elastic straps of the same color and length, then attach each to the lower appliance, rotating the strap on the button hook to seat.  EMA logo on strap should face the appliance.  Repeat for upper.
  • Seat the upper first and have the patient move the mandible forward while pushing down on the anterior portion of the lower appliance until it snaps into place.  Question the patient for comfort of the appliance on the teeth and TMJ comfort.
  • Check the posterior bite pads for even occlusion.  If either side is high, conservatively grind the high side until both sides occlude evenly in the protruded position with straps in place.
  • To avoid unnecessary office visits, you may send extra straps with the patient to use in advancing the mandible further or to replace stretched straps.
  • Instruct the patient to chew sugar free gum every morning after wearing the appliance to help return condyles to normal position.
  •  
Patient Follow Up
 
  • If the patient has discomfort in one TMJ, adjust the bite pads as necessary (pain usually is on the side where the bite pad is high).
  • If an elastic strap is 1/8 inch longer than a new strap or the hole becomes oval, then it should be replaced with a new strap of same color and length.
  • If patient reports there has been no significant lessening of apneic episodes or snoring, and if the patient feels the mandible could be moved further forward without TMJ pain then this can be addressed in three ways:
    • Replace straps with new straps of same color but one size shorter.
    • Replace with new firmer straps of a different color that are one size longer.
    • Increase vertical opening by adding up to 3-4mm of acrylic or light cure composite to the occlusal surfaces of the bite pads.
 
Further Strap Progression Instructions
 
  • Myerson's approach is gradual advancement of the mandible, until maximum efficacy and comfort is achieved.
  • There are nine different lengths, 21mm  through 13mm.  1 are the longest, 5 are the shortest.  The shorter the strap, the greater the mandibular advancement.
  • All strap lengths come in four different degrees of elasticity, denoted by the color.
    White: soft
    Yellow:  medium
    Blue:  Firm
    Clear:  Extra firm
    The firmer the strap, the greater the mandibular advancement.
  • A strap should last at least a month to 6 weeks; if they are wearing out sooner than that, we recommend moving to a firmer strap.  However, when doing so, we recommend switching to one size longer (for example, from a #17mm yellow to a #18mm blue).
  • The most conservative approach is to begin the patient with the #21mm yellow strap, then move to a shorter straps (19mm, 18mm, etc.) as necessary until symptoms are significantly reduced or eliminated. If any TMJ discomfort is felt on both sides, switch to the white.

 

 

     

 
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