The 3D-printed oral appliance is indicated for the treatment of snoring and mild to moderate obstructive sleep apnea.


Summary: GoodSleepCo, an Australian medical device company, has received FDA 510(k) clearance for its hushd Pro Avera oral appliance, which treats snoring and mild to moderate obstructive sleep apnea. Custom-made splints reposition the lower jaw to prevent airway blockage during sleep. The device allows for patient-specific adjustments using CAD/CAM technology, providing a range of advancements.

Key Takeaways:

  • The hushd Pro Avera oral appliance has received 510(k) clearance from the FDA for treating snoring and mild to moderate obstructive sleep apnea.
  • The device is fabricated with medical-grade nylon and combined with an AI-enabled 3D-printed manufacturing process.
  • Utilizing CAD/CAM technology, the appliance allows for a range of advancements tailored to each patient’s prescribed mandibular positions.

GoodSleepCo, an Australian medical device company, announced the US Food and Drug Administration (FDA) has granted 510(k) clearance to its hushd Pro Avera oral appliance for the treatment of snoring and mild to moderate obstructive sleep apnea.

Hushd Pro Avera is designed using 3D printing technology and medical-grade nylon, coupled with automation and artificial intelligence-enabled processes. 

“This FDA clearance marks a significant milestone for GoodSleepCo,” says Joel Simpson, founder of GoodSleepCo, in a release. “It not only paves the way for Avera’s introduction into the United States’ market but also signifies a leap forward in our commitment to enhancing patient care and practitioner efficiency.”

Hushd Pro Avera Design

The device includes custom-made splints for the upper and lower teeth. When connected, these splints reposition the lower jaw forward during sleep, preventing the tongue and throat tissues from blocking the airway. 

The hushd Pro Avera device series consists of one or more maxillary device(s) and one or more mandibular device(s) that join together. Sequential devices are designed and manufactured using CAD/CAM technology to match the mandibular advancement positions prescribed by the dentist or physician, according to the FDA’s summary

This process allows for a range of advancements tailored to the patient’s comfort and needs. As such, prescribed advancements can be achieved by removing the current maxillary or mandibular device and inserting the next device in the series.

“We are particularly excited about the expansion of our product portfolio with Avera. By offering a comprehensive suite of devices and apps, we empower healthcare providers to deliver personalized, value-based care that prioritizes patient experience and clinical outcomes,” says Greg Goodman, co-founder of GoodSleepCo, in a release. 

Photo caption: hushd Pro Avera

Photo credit: GoodSleepCo