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flexTAP® Description

Product Description

myTAP is a precision-fit oral appliance for snoring and mild to moderate obstructive sleep apnea (OSA). The myTAP works by advancing and stabilizing the lower jaw so that the soft tissues of the throat and tongue do not collapse into the airway. myTAP is clinically proven to be an effective treatment option for those who try and fail CPAP.

  • - Boil and bite design with re-moldable trays
  • - Adjustable in ¼ mm increments to reduce jaw pain
  • - Thin, low-profile fit
  • - Easy patient adjustment while in the mouth

How It Works

The Adjustment Mechanism attached to the Lower Tray is threaded through the Adjustment Post of the Upper Tray. The Adjustment Dial is screwed onto the end of the Adjustment Mechanism allowing the patient to adjust the advancement of the lower jaw. The total adjustment range on the myTAP is 22mm and is adjusted in 1/4mm increments.

What’s Included in the myTAP Package?

  • 1. myTAP oral appliance
  • 2. Container
  • 3. Mouth Shield
  • 4. AM Aligner
  • 5. Instruction for use

What is the AM Aligner®?

The AM Aligner is a morning repositioner that comes with every myTAP. The purpose of the AM Aligner is to reposition the patient’s jaw after each use of the myTAP. It is made of a unique thermoplastic material and is used to take a registration of the patient’s normal, comfortable occlusion before the patient begins to use the myTAP. When fitting the AM Aligner, be sure the patient bites hard enough to cause translucency in contact areas when the Aligner is held up to a light.

Mandibular protrusion can move jaws forward permanently over a period of time if the patient doesn’t make sure that normal occlusion is reestablished each day.

How does the AM Aligner work

When the patient wakes up in the morning, their jaw will have been in an unnatural position all night so the bite will be off. The front teeth may hit together excessively and the back teeth may not hit at all. It is important for the patient to understand that this may become a permanent issue and getting their teeth back into proper occlusion is the patient’s responsibility. The AM Aligner is for getting the jaw back to the proper position, and is used each morning after removal of the myTAP

Daily use of the AM Aligner

When the myTAP is removed in the morning, first stretch your jaw aggressively. There may be pops and snaps from the jaw repositioning itself. After this exercise, the muscles will have relaxed somewhat and the jaw will begin to normalize

The AM Aligner should be then placed in the mouth, at least 15 to 30 minutes after the myTAP has been taken out. You should place the AM Aligner (previously fitted BEFORE initiation of therapy with the myTAP) in your mouth and bite into it, flexing the jaw a few times. This will force the jaw back, which may be uncomfortable if tried too soon after myTAP removal. As you wear the device, you will feel the muscles relaxing and very soon will notice that there is no stress in the jaw, with the teeth back in a comfortable, proper position. Some patients wear the AM Aligner while taking a shower or driving to work or reading emails. It is left to the discretion of the patient as to how long the aligner is worn and how often it is used. It is different for every patient. Some patients will find that they have no need for the aligner after a few weeks of wearing it because the muscles have learned to reposition the jaw on their own. If this is the case, the patient should keep the AM Aligner and check their bite periodically for as long as they are using the myTAP.

How to fit the AM Aligner

Click here for a step-by-step fitting video.

What is the Mouth Shield?

A Mouth Shield nasal breathing trainer comes with every myTAP. Patients using oral appliance therapy may complain of dry mouth or excess saliva. The myTAP Mouth Shield is designed to alleviate these side effects by sealing the mouth, providing greater comfort.

While comfort is the primary intended use, a secondary benefit to sealing the mouth is the promotion of nasal breathing. Research shows this is the best natural way to breathe.

A recent study showed better outcomes in patients treated with the myTAP with Mouth Shield versus patients treated with myTAP alone.

Intended Use

The myTAP is intended to be used by individuals who have been prescribed Oral Appliance therapy for snoring or mild to moderate sleep apnea. The myTAP is intended for single patient use in the home, hospital or other clinical setting.

This device is not advisable for patients with loose teeth, loose dental work, dentures, or other oral conditions, which would be adversely affected by wearing an oral appliance. In addition, the appliance is contraindicated in patients who have central sleep apnea, severe respiratory disorders or are under 18 years of age.

Do not use if any of the following apply:

  • • You are under active dental treatment.
  • • You are under active dental treatment.
  • • You have temporary crowns.
  • • You have temporary crowns.
  • • You have braces.
  • • You have less than 8 natural, healthy teeth in each arch.
  • • You have not seen a dentist within the last 12 months.
  • • You have a history of TMD, temporomandibular disorder.
  • • You have received dental implants in the past year.

When to seek dental consultation

In most cases you can fit the myTAP for most patients. However, seek consultation from a dentist if the following apply before or during treatment:

  • • You have pre-existing jaw issues.
  • • You experience continued jaw joint pain after use
  • • You experience tooth movement.
  • • You notice bite change.

Use of the AM Aligner after EACH use will significantly reduce the risk of bite change and tooth movement.

Possible Side Effects

There are possible side effects associated with the use of the myTAP:

  • • Sligh tooth or gingival discomfort due to pressure of the appliance.
  • • Excessive salivation initially. This should improve as the patient becomes accustomed to wearing the myTAP.
  • • Slight jaw soreness or tightness, initially and with adjustments
  • • Pain in the jaw joint.
  • • Temporary bite change. This may subside approximately 30 minutes after the myTAP is taken out of the mouth in the morning.
  • • Movement of teeth.
  • • Permanent bite change.
  • • Gagging and claustrophobia. This will improve as the patient becomes accustomed to wearing the myTAP.
  • • Unconsciously taking the myTAP out at night.
  • • Obstruction of oral breathing (possible with any oral appliance in the mouth).

When to contact your prescriber

  • • If symptoms of breathing difficulties or other respiratory disorders exist or persist, with or without the use of the device, contact the prescriber immediately.
  • • You may experience soreness or discomfort in your jaw or teeth. If discomfort persists, contact the prescriber.
  • • In the morning, you may sense a change in your bite. These changes should subside after the AM Aligner is used and as the day progresses. If the bite change continues, contact the prescriber.
  • • You should return to the prescriber at least yearly, or as often as necessary for re-evaluation. If the appliance becomes loose, damaged, or does not fit properly, contact the prescriber.

Warranty and Guarantee

We are pleased to offer a 30-day patient satisfaction guarantee and a 90-day warranty for myTAP. This does not include loss or damage to the appliance due to negligence on the part of the patient.