A new medical device developed by Farmington Hills-based TMJ Health gives those with Temporomandibular Joint Disorder — which causes jaw stiffness, clicking, locking, chewing difficulty, or migraines — an alternative to the traditional treatment of bite splints.
Given the ear canal is located close to the temporomandibular joint, the new device, called TMJ NextGeneration, consists of hollow ear canal inserts that support the joint and related musculature, thereby reducing strain in the TMJ area.
The National Institute of Health estimates that TMJ afflicts more than 35 million Americans, the majority of whom are women between 20 and 40 years of age.
“While bite splints have helped to reduce pain associated with TMJ, there are drawbacks with these devices,” says Dr. Roger Wixtrom, who was the scientific director of the clinical study, which compared the performance of the ear canal inserts with that of a conventional mouthpiece. “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 three-month clinical study found that patients — who scored their level of pain each day on a scale of 0 to 10 — experienced a 58 percent drop in discomfort by the end of the study. Nearly 30 percent of participants rated their satisfaction with the device as good, while about 70 percent said it was excellent.
The device was recently approved by the U.S. Food and Drug Administration and is now available nationwide through participating prescribers.
Wixtrom, a board-certified toxicologist with more than 24 years of experience in the evaluation of the clinical performance and safety of numerous medical devices, serves as a consultant for TMJ Health.