Now Made in the US. Local manufacturing. Faster turnaround. Same trusted quality. Now Made in the US. Local manufacturing. Faster turnaround. Same trusted quality.

PRO PRODUCT RANGE

Hushd Pro Z-Link

Custom fitted Strut style Mandibular Advancement Device

The Hushd Pro Z-Link is a precision-engineered oral appliance, clinically prescribed for the treatment of snoring and/or mild to moderate obstructive sleep apnea. The two-arch design features a ‘Z’ shaped patent-pending hinge mechanism on each side which connects the arches. The Z-Link connectors are made of the same durable lightweight nylon polyamide 12 as the arches, and allow for controlled mandibular advancement. Not only is this effective for the treatment of OSA, but the strut design means it can be adjusted asymmetrically for individual comfort to cater for lateral deviations, without compromising the mandibular position.

Fabricated with medical grade nylon, combined with an AIenabled 3D printed manufacturing process, the Hushd Pro Z-Link is a solution for patients who are CPAP intolerant or desire an alternative. The superior quality of the nylon construction means the profile of the arches is very thin, and means the Z-Link connectors sit comfortably within the mouth. The unique Z-Link design also offers for minor lateral jaw movement found only in strut type oral appliances, which helps accommodate mandibular deviation associated with tempromendibular joint disorders.

Reach out to see if this product is available in your country.

Oral Appliance Therapy as part of an ecosystem of support

Hushd Pro Z-Link provides a treatment option for those suffering from sleep apnea.

MANUFACTURING TECHNOLOGY

CAD/CAM technology for premium device fit, comfort, efficacy and durability.

Computer-aided Design Process

Thanks to advanced CAD software, our experts optimize key features of each device based on the individual patient’s mandible trajectory. This means that our devices are able to titrate smoothly over its entire range of adjustment. At the same time, our patient specific adaptation protocol improves the fit of our devices, enhancing patient comfort while ensuring a reliable and predictable result.

Computer-aided 3D Manufacturing Process

Hushd Pro devices are manufactured with industrial SLS 3D printers. The caliber of our digital machines combined with our operator quality control process ensures precision for each device.

Medical Grade Nylon

Made from medical-grade polyamide type 12 nylon, our custom oral appliances meet TGA standards, with rigorous mechanical and biocompatibility testing for safety and reliability. In the USA the Hushd Pro Avera and Hushd Pro Z-Link are cleared by the FDA, and Hushd Pro Avera has received PDAC K1027 determination.

HUSHD PRO Z-LINK

What it does

The Hushd Pro Z-Link device is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults, by titrating the mandible forward during sleep.

Each Hushd Pro Z-Link consists of an Upper and Lower dental splint with a patent-pending hinge mechanism featuring interchangeable Z-Link connectors. The connectors fit to each side of the arches to dictate the titration level of the mandible. Incremental forward positioning of the mandible is achieved by connecting the supplied Z-link connectors to each side of the arches. For example +1 Z-Link connectors fitted on each side of the arch, protrude the mandible by 1mm. +2 connectors on each sides protrude by 2mm and so on.

Indications for use

The Hushd Pro Z-Link is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

Ordering process

Patients who are identified as benefiting from the device, have an intra-oral scan or physical impression taken by a dentist. The data is submitted to the Good Sleep Co. lab for device production. A custom-made Hushd Pro Z-Link is then delivered as a ready-to-use package, to the desired location of the patient. (Optional ‘fitting’ of the device involves a dentist checking that the device fits perfectly and is ready for use.)

How it works

Using the device

Patients use the device overnight (or when sleeping) by placing the Upper and Lower splints (or arches) onto the respective teeth, with Z-Link connectors fitted to either side of the arches to dictate the level of titration. (The Z-Link connectors are designed to minimise the risk of disengagement during normal use while still being easy to swap for the purpose of titration.)

After use, the device is removed carefully one arch at a time. Once cleaned, it should be stored safely in the supplied storage dish. (Precautions and Contraindications are listed in the device IFU.)

Mandibular Advancement

There are 6 advancement positions or ‘combinations’ as standard for the Hushd Pro Z-Link. Adjusting the combinations (to progressively move the lower jaw further forward) is called Titration or Mandibular Advancement. Connecting the Uppler and Lower arches using R0 and L0 begins the treatment as prescribed by the treating clinician. To advance the combination, the Z-Links are swapped incrementally (from 0 to +1 and so on). If required and as directed by the practitioner, the Z-Link connectors can be used in an asymmetrical configuration (for example +1 on the right side & +2 on the left).

A unique feature of the Hushd Pro Z-Link strut style oral appliance is that it allows greater lateral freedom to accommodate mandibular deviation or deflection, while still holding the mandible forward in the required titration position.

Advancement Sequence
Z-Link Connector Sequence

7 pairs of connectors come with every Z-Link device allowing titration from -1mm to +5mm. Each connector increases advancement by 1.0mm

Monitoring Sleep

To assess a patient’s sleep quality, feedback from a sleep monitoring device like the Good Sleep Test, provides real-time feedback, and the option to generate a Specialist Report. The benefit of the Good Sleep Test is that it’s unobtrusive and can be used at home with ease. Patient sleep data is shared directly from the device to the practitioner, making it a practical sleep-review option for both patient and practitioner.

PACKAGING

What’s in the box?

Hushd Pro Z-Link box includes:
  • The custom made device, consisting of an Upper and Lower arch
  • A set of Z-Link connectors (from -1mm to +5mm)
  • A mold of the patients’ teeth
  • Instructions for use
  • A quality storage dish with mirror
  • Cleaner solution
  • A Morning Aligner if it has been ordered

Grow your sleep care offering with Good Sleep Co.

Support better patient outcomes with connected dental sleep medicine solutions designed to simplify workflows, improve treatment visibility, and enhance the patient experience.

Better sleep for better health

Did you know the Good Sleep Co. aims to add 1 million years* to patients’ lives over the next 5 years by providing the best in class treatment of patients with obstructive sleep apnea? We care about innovation because we care about patients’ health.

*Based on peer reviewed evidence, treating patients with obstructive sleep apnea
on average increases their life expectancy by 10 years.

Talk to us

Good Sleep Co. brings OAT, monitoring, and clinical insights together in one connected solution. We can answer all your questions. Let’s chat.