US-based TMJ Health has launched TMJ NextGeneration, a FDA-cleared medical device that will be used to reduce temporomandibular joint disorder (TMJD) pain.
The two custom-made, hollow ear canal inserts featured in the device enable the full passage of sound, and are said to be invisible from the outside.
TMJD, which is a group of painful conditions, affects the jaw joint and surrounding muscles and nerves.
Even though TMJD is not life threatening, the disorder can be detrimental to quality of life and the symptoms can become chronic and difficult to manage, the company said.
The symptoms of TMJD include jaw pain, stiffness, clicking and locking, chewing difficulty, and migraines.
According to the National Institute of Health, TMJD could afflict more than 35 million people in the US, the majority of whom are women aged between 20 and 40.
TMJD has often been treated with bite splints, which are plastic mouthpieces that fit over the upper or lower teeth to prevent them from coming together and reduce the amount of clenching or grinding.
LSCI president and board-certified toxicologist Roger Wixtrom said: "While bite splints have helped to reduce pain associated with TMJD, there are drawbacks with these devices.
"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 offers a safe and effective option that patients should discuss with their dentist or ENT."
The TMJ NextGeneration hollow ear canal inserts are located very close to the temporomandibular joint, and the volume of the ear canal increases when the jaw is opened through movements such as chewing, smiling and speaking.
The device uses this anatomical change to provide a unique near-field treatment for TMJD.
In a three-month clinical study, patients wearing the device 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, the company claimed.
Image: TMJ NextGeneration is a first-of-its-kind, FDA-cleared medical device that is a safe and effective aid in reducing TMJD pain. Photo: courtesy of TMJ Health, LLC.