FDA Clears Oral Appliance with Tracking

SomnoMed developed an oral appliance that allowed doctors, insurers, and other interested parties to monitor how often a person with sleep apnea was using their device. Last week, the FDA decided the device could be sold in the US.

510(K) Clearance

SomnoDent FlexThe SomnoDent oral appliance with DentiTrac system was cleared through the FDA’s 510(k) system, which allows devices to avoid the formal approval process if they are “substantially equivalent” to devices already being marketed.

The oral appliance itself is basically the same SomnoDent appliance that has already been approved for sale as a sleep apnea treatment. Since the tracking system is similar to devices used in other disciplines, passage through this system was relatively straightforward for this device.

A Device That Is Hard to Fool

The DentiTrac component was developed not by SomnoMed, but by their partner, Braebon, a Canadian company based in Ontario. Chief technical office and co-founder of Braebon, Donald Bradley said of the device, “The challenge was to develop a measurement technology which could not be easily deceived.” He then referenced regulations that in the future might require more sleep apnea treatment for truck drivers, pilots, and others.

To protect the livelihood of these workers, there must be a sleep apnea treatment that patients can use that will meet the requirements of these regulations. FDA clearance for this device is a big first step, but we have yet to see whether regulatory agencies like the Federal Motor Safety Carrier Administration or the Federal Aviation Administration will accept this system as meeting their requirements.

Monitoring Shows Compliance Is Better with Oral Appliances

In response to the new clearance, SomnoMed Executive Chairman Dr. Peter Neustadt shared some evidence that has already been gathered by the monitoring device, comparing compliance for oral appliances with that of CPAP. The data showed that using an “all night/every night” standard of compliance, SomnoDent achieved a compliance rate of 84%.

However, using the same compliance standard commonly applied to CPAP (a minimum of 4 hours use a night for a minimum of 21 nights a month), oral appliances achieved a compliance rate of 95%, compared with the 60-70% common for CPAP.

This data shows how much likelier it is that people use oral appliances because they are more convenient and more comfortable. If you are tired of CPAP and are looking for a better sleep apnea treatment, please call (402) 493-4175 for an appointment with an Omaha sleep dentist at the Advanced Dental Sleep Treatment Center.