On Oct. 27, 2025, Good Sleep Co announced that the Hushd Pro Z-Link has received FDA 510(k) clearance. It is a precision-engineered mandibular advancement device intended to reduce or alleviate snoring and mild-to-moderate obstructive sleep apnea in adults.
About the Hushd Pro Z-Link
The Hushd Pro Z-Link is a prescription oral appliance for sleep apnea that combines advanced materials and digital manufacturing. Each device is custom-manufactured using medical-grade polyamide type 12 nylon and state-of-the-art CAD/CAM and SLS 3D-printing technology. A vapor-smoothed finish gives the appliance a low-profile, comfortable fit designed to promote long-term compliance.
The device features separate maxillary and mandibular splints, linked by connectors on each side. These splints are custom-designed for each patient and are integrated with twin-mated studs positioned around the canines and first molars. The assembly functions as a mandibular repositioner, holding the lower jaw forward to help maintain an open airway during sleep.
A key feature of the Hushd Pro Z-Link is its modular advancement system, which allows dentists to fine-tune mandibular positioning with millimeter precision. Using interchangeable Z-Links on each side, clinicians can incrementally adjust the appliance to achieve optimal therapeutic outcomes while preserving comfort and device integrity.
Good Sleep Co is now distributing the Hushd Pro Z-Link across the U.S. through licensed dental sleep medicine professionals.
About oral appliance therapy
Oral appliance therapy is a non-invasive treatment for snoring and sleep apnea, involving the use of a removable device worn in the mouth during sleep. These appliances, varying in appearance, are favored by some patients for their ease of use and portability, as they are smaller and more travel-friendly compared to traditional CPAP machines, taking a few weeks for most individuals to adapt to sleeping with them.
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