QuietLab Pro

The QuietLab Pro is a reusable, over-the-counter oral appliance designed to reduce or eliminate snoring in adults aged 18 and older. It works by gently repositioning the lower jaw forward during sleep to maintain an open upper airway and reduce tissue vibration that causes snoring.

QuietLab Pro features an expanded 9 mm mandibular advancement range using a 25-position micro-adjustment mechanism for fine-tuned customization. It is constructed from biocompatible medical-grade materials (PC, TPU, TPE), requires no boil-and-bite fitting, and includes an Adaptive Fit system with anatomically pre-contoured trays. A 30-subject usability study validated safe and effective self-use without clinical supervision.

Biocompatibility testing per ISO 10993-1 evaluated acute systemic toxicity, cytotoxicity (extract and indirect), oral mucosa irritation, and skin sensitization. Usability validation was conducted per IEC 62366.

QuietLab Pro is substantially equivalent to legally marketed predicates (ZQuiet OTC, ZQuiet Advance, Vital Sleep, SomnoGuard SP Soft) because it shares identical indications for use, the same fundamental mechanism of mandibular advancement via mechanical means, and consistent intended use as an over-the-counter intraoral appliance. Enhanced technological features such as improved adjustment range and materials do not raise new safety or effectiveness questions and are consistent with predicate device performance.