Its upper and lower splints can be incrementally adjusted with interchangeable Z-Links on each side.
The US Food & Drug Administration (FDA) has cleared Good Sleep Co’s Hushd Pro Z-Link, a mandibular advancement oral appliance, for the treatment of snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
“Achieving FDA clearance for the Hushd Pro Z-Link is a pivotal moment for Good Sleep Co and for patients and clinicians in dental sleep medicine,” says Joel Simpson, Good Sleep co-CEO and founder, in a release.
Hushd Pro Z-Link Features
According to Good Sleep Co, highlights of the Hushd Pro Z-Link include:
- The device is custom-manufactured using medical-grade polyamide type 12 nylon and CAD/CAM and SLS 3D-printing technology with Vapour smoothed finishing, enabling a precise, low-profile fit.
- Includes a modular advancement system with upper and lower splints that can be incrementally adjusted by the treating dentist using interchangeable Z-Links on each side. This allows for precise mandibular advancement to achieve therapeutic outcomes while maintaining patient comfort and appliance integrity.
“The Hushd Pro Z-Link represents the culmination of years of engineering refinement and user-centred design,” says Alwin Ngai, chief product officer and inventor of the Hushd Pro Z-Link, in a release. “Our goal was to create an oral appliance that offers precision, strength, and comfort in equal measure—something that clinicians can trust and patients actually want to wear. The side-mounted Z-Link mechanism allows controlled advancement with millimeter accuracy, reducing complexity for the dentist while maintaining the smallest profile in its class. This device embodies the fusion of biomechanics, materials science, and manufacturing innovation that defines Good Sleep Co.”
New Oral Appliance Enters US Market
With FDA 510(k) clearance secured, Good Sleep Co is now positioned to offer the Hushd Pro Z-Link regionally across the US through licensed dental sleep medicine providers.
“This clearance validates our investment in advanced manufacturing, precision fit, and clinical efficacy—and it significantly expands our ability to support dental and medical professionals in the US who are committed to delivering high-quality oral-appliance therapy,” says Greg Goodman, Good Sleep Co co-CEO and founder, in a release.
