Medical Doctors

The following links provide information of interest to medical doctors and sleep specialists. Click on each to view this information:

IFU

Reg

Data

Features

Sleep apnea is a growing concern in most countries. As you are aware, the list of diseases and risks associated to untreated OSA is growing quite long. Oral appliance therapy is recognized by the American Academy of Sleep Medicine as a primary treatment for mild to moderate obstructive sleep apnea and primary snoring and as the treatment choice in CPAP failure cases (studies have shown up to 47% of patients treated with CPAPs do not use them as directed, if at all). What makes the Luco Hybrid OSA Appliance unique is that it is also very effective at treating sleep related bruxism, alleviating the pain, TMJ problems and other symptoms associated with oral appliance therapy.

The Luco Hybrid OSA Appliance is innovative and unique:

  • It has a cast metal framework that provides comfort, strength and safety for the patients and reduces the bulk of the appliance. All materials used in the appliance are FDA approved and proven safe. The appliance is one of the smallest on the market and very well tolerated by patients, even gaggers.
  • The framework can last in excess of 20 years and the acrylic can be replaced as needed (usually around 5 years), which reduces the cost of the appliance and provides the patient with a long term appliance they can rely on. Almost all of the appliances currently available only last 3-4 years.
  • It is adjustable up to 6 mm In 1/4 increments from the initial position. If they gain weight it is easily adjusted in the dental office.
  • It is very effective in treating Sleep-Related Bruxism, which occurs in up to 30% of OSA patients and respects all the reflexes of the masticatory muscles. It is one of the few appliances currently where this is not a contraindication for use and actually approved for this treatment.
  • It has been clinically tested for more than 10 years with excellent results (before and after sleep studies) – the compliance level is very high and patients tolerate the design very well as they are custom made for each patient. And it lasts.
  • It can be used on mouth breathers and gaggers with no problems.
  • If a patient has to evacuate as in illness, it can be done quickly as the appliance does not need to be removed. This reduces the risk of aspiration.
  • The design can be modified for patients who mouth breath, have strong gag reflexes, or have not been able to wear other appliance designs. As stated, each is custom made, from start to finish resulting in a very well fit appliance leading to improved compliance and treatment success.

The Luco Hybrid OSA Appliance is very effective in treating mild and moderate and severe patients who have tried and failed with CPAPs. As noted, there have been no TMJ concerns to date and many patients report improved TMJ health, decreased muscle pain and a marked decrease in headaches, both on waking and during the day.

On this website you will find data for 30 patients for your viewing. This data was reviewed by the FDA in the application process and accepted (K130797). The results are impressive and speak for themselves. These patients were assessed by the same sleep lab using the same equipment and interpreted by the same sleep specialist for consistency.

This appliance is registered currently by Health Canada (MDEL 5315), the MHRA (European Union including the UK), the Ministry of Health (India) and the TGA (Australia) for the treatment of mild to moderate sleep apnea, primary snoring and sleep-related bruxism. As of December 18, 2013, this appliance has received market clearance by the FDA (K130797) as a Level 2 Medical Device for the treatment of mild to moderate sleep apnea and primary snoring in adults.

Features of the Luco Hybrid OSA Appliance