Luco Hybrid OSA Appliance Inc. / Luco Hybrid OSA Inc.
Luco Hybrid OSA Appliance Inc. is a privately held Canadian company located in Kingston, Ontario, Canada. Luco Hybrid OSA Inc. the US subsidiary, is located in Clifton, New Jersey. The Luco Hybrid OSA Appliance is the result of over 25 years of clinical trials of various appliances in the treatment of patients with obstructive sleep apnea and over 29 years of clinical management of TMD cases (including severe TMD, trauma cases and TMD/orthodontic cases) and more than 4000 cases treated. It was found that although effective, the various appliances used had inherent problems: some would break or crack, some were hard to place into the mouth, some wore out prematurely requiring replacement after a short time and others left the teeth and jaws very sore. Some patients reported sores in their cheeks from bars, screws or wires and others complained that their tongues were sore upon waking due to screws in front of the mouth. All of these concerns were noted and, during the prototype stages of the appliance, each was addressed. The end result is very comfortable appliance that is very compatible with the oral tissues. This appliance was clinically designed by a practicing dentist on real patients, working with two sleep labs.
The breakages seen in some of the appliances was addressed with the patented cast chrome cobalt framework as the main structural component. This is the same material used in cast partial dentures, which last decades. The bulk of the material on the inside of the mouth was reduced as much as possible, maximizing the available space for the tongue (a welcome feature for those with a large tongue , a strong gag reflex or those who are claustrophobic). There are reflexes in the jaw muscles, similar to those when you tap your knee. This appliance was modified to activate these reflexes, which position the tongue and jaw forward naturally, and immediately the patients reported increased comfort.
All material from the front of the mouth was eliminated (where other appliances have screws, acrylic and adjustments) to accommodate mouth breathers and to allow the tongue to posture forward. The patented wing angle was modified to 90 degrees with a curved contact surface rather than a 70 degree angle. This patented innovation holds the jaw forward even when the mouth falls open whereas other appliances, with a 70 degree angle, actually allow the jaw to fall back. With the clinical background of using a multitude of orthodontic and TMD appliances, the information gained in this experience allowed modifications and enhancements to the design of the Luco Hybrid appliance that has proven to be not only very effective, but also very comfortable for the patients. This appliance is designed primary for patient comfort. After all, even if it the best treatment ever made, if it is not comfortable, patients will not wear it and the treatment will fail.
It was found that, in patients with TMJ problems or jaw muscle pain, that the symptoms were only partially controllable. In approximately 2006 the bite was shifted forward. The idea was to active pharyngeal reflexes to position the jaw forward more naturally. The results were nothing short of amazing. Case after case were returning in 10 -14 days symptom free. It was decided that this was significant enough to warrant a major change in the design of the appliance. This was the final change that resulted in the Luco Hybrid OSA Appliance.
The appliance has a reasonable lifespan. One concern expressed by patients is that appliances do not last and must be frequently repaired or replaced. With the Luco Hybrid OSA Appliance, the framework does not break down. As long as the patient’s teeth are maintained the appliance will continue to fit. There is acrylic over the teeth allowing adjustment for new fillings and crowns easily chair side by the dentist. Over time, the acrylic can be replaced re-using the framework inexpensively allowing the patient to continue using the same appliance (without having to get used to and paying for a new appliance every few years).
This appliance was developed and tested in conjunction with two sleep labs, supervised by board certified sleep specialists. It has been used to treat both civilian and military personnel with excellent results. The FDA has fully reviewed the design and data for this appliance and granted it market clearance (K130797) in the USA as a Class II medical device (December 2013). It is approved and registered in more than 55 countries as a Class I medical device including Canada, The UK, the European Union and others. As a class I appliance, it is approved also for Sleep Bruxism in these other regions. Very few OSA appliances achieve this level of recognition.
As the patient in need of treatment, you will find the Luco Hybrid OSA Appliance a comfortable, effective and very durable appliance that you will want to wear. As a prescribing dentist, you will find excellent compliance, and an appliance that is easy to place, easy to adjust and requires very little ongoing maintenance. As the referring sleep specialist, you will find that this appliance delivers the results you require in managing these cases consistently and reliably. Dental labs will find that this appliance is straight forward to manufacture allowing for consistent results and quality control in providing your doctors with the one of the newest, most advanced and most reliable appliances currently available. All the materials used in the appliance are FDA cleared, safe and have been used extensively in medicine and dentistry for decades.
Luco Hybrid OSA Appliance and Luco Hybrid OSA Inc. are offering to the USA, Canada, Great Britain, The European Union, Eurasia, Japan, Brazil, Russia, India and Australia a clinically proven appliance for treating OSA, snoring, sleep bruxism and TMD that can provide significant relief to theses diseases, and improve the quality of life to those affected. It is a durable, long lasting, comfortable design . It may also be used on severe OSA patients who tried and failed with CPAPs, are claustrophobic or travel a lot and may not always be able to use a CPAP.
This appliance is innovative, clinically verified by sleep studies, based on clinical trials and science, well constructed and designed to provide years of service to patients in need. It has many innovative advanced features not currently available in other appliances. This appliance truly is the next generation of OSA therapy.