|By PR Newswire||
|August 13, 2014 01:08 PM EDT||
FARMINGTON HILLS, Mich., Aug. 13, 2014 /PRNewswire/ -- TMJ Health, LLC, today announced that TMJ NextGeneration™, a first-of-its-kind, FDA cleared medical device that is a safe and effective aid in reducing Temporomandibular Joint Disorder (TMJD) pain, is available nationwide. The device consists of two custom-made, hollow ear canal inserts that allow full passage of sound and are practically invisible from the outside.
TMJD are a group of painful conditions that affect the jaw joint and surrounding muscles and nerves. Although TMJD is not life threatening, it can be detrimental to quality of life since the symptoms--which include jaw pain, stiffness, clicking and locking, chewing difficulty, and migraines--can become chronic and difficult to manage. The National Institute of Health estimates that TMJD could afflict more than 35 million Americans, the majority of whom are women between 20 and 40 years of age.1
Traditionally, TMJD has been treated with bite splints--plastic mouthpieces that fit over the upper or lower teeth to prevent them from coming together and reduce the amount of clenching or grinding.
"While bite splints have helped to reduce pain associated with TMJD, there are drawbacks with these devices, said Dr. Roger Wixtrom, Ph.D. "For example, they cannot be worn while eating and they can also affect speech, and as such are typically only worn at night while sleeping."
The TMJ NextGeneration™ Device takes a different approach in treating TMJD. The ear canal is located very close to the temporomandibular joint (TMJ) and the volume of the ear canal increases when the jaw is opened through movements such as chewing, smiling, and speaking. The TMJ NextGeneration™ Device uses this anatomical change to provide a unique near field treatment for TMJD.
Patients wearing the devices in a three month clinical study experienced a significant reduction in the pain and dysfunction associated with TMJD, to an extent at least as much as that experienced by patients wearing a bite splint. In addition to the pain reduction, 100% of subjects indicated excellent (71%) or good (29%) overall satisfaction with the TMJ NextGeneration™ device.2
"The TMJ NextGeneration™ Device offers a safe and effective option that patients should discuss with their dentist or ENT," said Dr. Wixtrom.
About TMJ NextGeneration™
The TMJ NextGeneration™ device is an FDA cleared, safe and effective aid in reducing Temporomandibular Joint Disorder pain. TMJ NextGeneration's™ custom-made ear canal inserts are comfortable, discreet and can provide relief all day long. For more information, ask a dentist or ENT, or visit www.TMJNextGen.com to find a participating prescriber.
About Dr. Wixtrom
Dr. Roger Wixtrom is a board-certified toxicologist with more than 24 years of experience in the evaluation of the clinical performance and safety of a range of medical devices. He specifically served as the Scientific Director of the pivotal clinical study of the TMJ NextGeneration™ device that compared its performance and safety to that of the most widely used current treatment, the bite splint and continues to serve as a consultant for TMJ Health, LLC.
2 Tavera A, et al: Approaching Temporomandibular Disorders From a New Direction: A Randomized Controlled Clinical Trial of the TMDes Ear System. J. Craniomandibular Practice July 2012; Vol 30, No. 3, 172-181
Contact: Melissa Skabich
SOURCE TMJ Health, LLC
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