The TMJ NextGeneration™ Device is a medical device that treats the TM joint at its nearest access point - the ear canal. It consists of two custom-made, hollow ear canal inserts that fit in the ear canals. Because they are hollow, the inserts permit full passage of sound. When in place, the devices rest in the outer part of the ear canal and have small retraction posts that allow for easy removal. The device is easy for the patient to insert and remove. When inserted in the ear it is practically invisible from the outside.
TMJ NextGeneration's™ custom-fit ear canal inserts are comfortable, discreet and can provide you with relief all day long.
In addition to the pain reduction, 100% of subjects indicated good (29%) or excellent (71%) overall satisfaction with the TMJ NextGeneration™ Device. Patients wearing the devices in a three month clinical study experienced a significant reduction in the pain and dysfunction associated with Temporomandibular Joint Disorders (TMJD), to an extent at least as much as that experienced by patients wearing a basic bite splint or following a specified jaw exercise regimen. No unexpected or serious adverse events were reported and a comparable safety profile to the bite splint was observed.
Mechanism of Action:
Two mechanisms believed to be responsible for the clinically proven effectiveness of the TMJ NextGeneration™ device involve:
the ear insert supports the TMJ [Temporomandibular joint] and associated secondary musculature to reduce strain in the TMJ area and
the device provides "cognitive awareness" (consciously or subconsciously) to the wearer regarding para-functional habits (e.g., jaw clenching) that contribute to TMJD pain, relieving strain in the TMJ area. Both mechanisms function because of the proximity of the ear canal to the TMJ, and the ear inerts maintain the shape and volume of the ear canal as the jaw opens and closes.
Safety and effectiveness of the TMJ NextGeneration™ device has not been established for people:
Who have been diagnosed with rheumatoid arthritis, osteoarthritis, osteoarthrosis or another connective tissue disorder
Who have had direct trauma to the jaw; or
Who have had prior Temporomandibular Joint Disorders (TMJ) surgery or ear surgery
When the Device Should Not Be Used (Contraindications)
You should not be fitted for a TMJ NextGeneration™ device if:
You have active ear drainage, swelling or redness
You have an unresolved history of ear pain unrelated to TMJD; or
Your ear canal anatomy does not allow for fit of the device (e.g., too narrow or prolapsed [fallen] canal, or previous mastoid surgery)