The device, cleared for mild to moderate OSA, is available immediately. PDAC coverage is pending.

The US Food and Drug Administration has cleared Airway Management’s Nylon flexTAP, a digitally printed single-point midline oral appliance device for mild to moderate obstructive sleep apnea (OSA). Manufactured in the United States, the device is now available through Airway Labs, with PDAC coverage (E0486) pending.

According to Airway Management, key features include:

• Digitally-printed medical-grade nylon: Utilizes advanced digital printing for a precise, custom-fit design that prioritizes patient comfort.
• Patented Vertex Technology: Enables dual-axis (vertical and horizontal) movement to maximize airway space, reducing the need for excessive protrusion—ideal for patients with larger tongues or narrow airways.
• 17 mm range of advancement: Features precise 1/3 mm increment adjustments for optimal mandibular protrusion, improving airway patency.
• Ultra-thin custom TAP trays: The thinnest custom TAP yet.
• BPA-free and metal-free: Crafted with biocompatible materials.
• No bite registration required: Simplifies the fitting process.
• Included a mouth shield to promote nasal breathing and an AM Aligner.
• 4-year warranty.

“We are thrilled to introduce the Nylon flexTAP, a game-changer in oral appliance therapy,” says Charles Collins, CEO of Airway Management, in a release. “Feedback from key opinion leaders in our TAP Sleep Care system highlights its superior effectiveness and patient comfort. Peer-reviewed studies also confirm that our patented mouth shield, which promotes nasal breathing, significantly improves treatment outcomes. This innovation underscores our commitment to advancing sleep health.”

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