We talked recently about how insurance companies often require tracking of your CPAP usage as a condition of coverage. For some people, this can be a real barrier to using oral appliances, especially if you have to use CPAP as a pilot or truck driver due to DOT regulations. That may soon be changing, now that the FDA has cleared oral appliances that can also track your usage.
Something Old, Something New
SomnoMed married tracking technology and oral appliance therapy in their newest product. Somnomed is a well-established manufacturer of oral appliances for sleep apnea treatment. It’s basically their SomnoDent oral appliance, but now it includes a DentiTrac system.
The Dentitrac system was developed by SomnoMed’s partner, Braebon. Braebon’s chief technical officer and co-founder Donald Bradley said he was thinking about pilots and drivers who would soon be subject to more sleep apnea-related regulations. Therefore, he said, “the challenge was to develop a measurement technology which could not be easily deceived.” That way, they knew it would have the best likelihood of being acceptable to people in this situation.
The device worked well enough to get FDA clearance for marketing in the US. However, it should be noted that the device was cleared through the 510(k) system, which allows devices to be marketed if they are “substantially equivalent” to one or more devices on the market.
This means the appliance didn’t go through rigorous testing, but considering that the SomnoDent appliance is already approved, and the tracking device is similar to other ones in use, it seems a reasonable decision.
Monitoring Shows Compliance Is Better with Oral Appliances
The research data from this new tracking gives great support for the use of oral appliances. SomnoMed Executive Chairman Dr. Peter Neustadt presented evidence from trials showing how much more likely people were to use oral appliances. Using SomnoMed’s ideal standard “all night/every night” compliance with oral appliances was 84%. That’s much better than the CPAP compliance rate of 60-70%. And CPAP compliance is measured with a much weaker standard: it only requires a minimum of 4 hours a night, 21 days a month. Measured at that standard, the compliance rate for oral appliances is a whopping 95%.
If you are looking for a sleep apnea treatment that is more comfortable and convenient, please call (361) 851-8274 for an appointment with Corpus Christi sleep dentist Dr. Don H. Lowrance.