Good Sleep Co’s boil-and-bite device enters the market as a temporary mandibular advancement option for snoring, supporting referrals into custom oral-appliance pathways.
Key takeaways:
- Good Sleep Co’s Hushd Avera received FDA 510(k) clearance for adult snoring.
- The appliance is positioned for trial therapy, while patients await custom devices.
- The device uses a two-piece boil-and-bite design.
- Integration with Good Sleep Co’s digital ecosystem enables documentation, monitoring, and transition to custom-fabricated therapies.
The US Food and Drug Administration (FDA) has granted 510(k) clearance to the Hushd Avera oral appliance in adults, a temporary oral appliance by Good Sleep Co for trial therapy for the treatment of snoring in adults.
With FDA clearance now granted, Good Sleep Co is launching Hushd Avera as a temporary mandibular advancement device built for trial therapy, efficacy testing, and short-term gap management.
In addition to its clinical role, Hushd Avera is being deployed within Good Sleep Co’s ecosystem to intercept patients at the time of purchase—serving as an educational and therapeutic entry point that helps users understand the benefits of oral appliance therapy and guides them toward custom-fabricated devices and professional care pathways.
“Hushd Avera fills a critical gap in the patient pathway,” says Joel Simpson, founder and co-CEO of Good Sleep Co, in a release. “Clinicians can now test efficacy, titrate mandibular advancement, and keep patients treated while waiting for their custom Hushd Pro device—all without compromising comfort or care continuity. It’s an important addition to our connected ecosystem of oral-appliance and digital-health technologies.”
“What’s equally powerful is how Avera allows us to meet patients where they are—often online, exploring snoring solutions—and redirect them into a continuum of professionally managed OSA care. It acts as both a bridge and a compass, helping patients transition from self-directed solutions to the long-term, custom therapies they truly need.”
The two-piece boil-and-bite Hushd Avera was designed to function with the precision and reliability, according to Alwin Ngai, chief product officer of Good Sleep Co. “It required extensive materials-science testing, CAD-driven modelling, and thermal-form engineering to ensure consistent performance across variable bite registrations,” Ngai says in a release. “The Hushd Avera is the result of years of R&D, prototyping, and real-world validation by our engineering and clinical teams.”
“Many patients experiment with over-the-counter or online snoring devices that offer limited benefit or poor fit,” says Greg Goodman, Co-CEO and founder of Good Sleep Co, in a release. “Hushd Avera bridges the gap between self-treating patients and true, dentally prescribed oral-appliance therapy.”
Hushd Avera integrates into Good Sleep Co’s connected ecosystem—including the Hushd Pro Z-Link, Hushd Pro Avera, Hushd Sense AI-enabled monitoring system, and the ResDent SaaS clinical-workflow platform.
This ecosystem creates a closed-loop pathway for screening, diagnosis, therapy, and follow-up across dental and physician-based OSA care models. Clinicians can document trial outcomes, monitor progress via the ResDent platform, and transition patients into custom-manufactured devices with full data continuity.
