Temporomandibular Joint Dysfunction (TMJ)/Sinus Pain/Headaches

Temporomandibular joint disorders, or TMJD, are a group of painful conditions that affect the jaw joint and surrounding muscles and nerves.  People with TMJ disorders may exhibit a variety of symptoms including:

  • Pain in the chewing muscles and/or jaw joint
  • Radiating pain in the face, jaw or neck
  • Jaw muscle stiffness
  • Aching pain in and around ears
  • Difficulty chewing or discomfort while chewing
  • Limited movement or locking jaw
  • Painful clicking, popping or grinding in the jaw joint when opening or closing the mouth
  • Headaches or Migraines
  • A change in the way the upper and lower teeth fit together
  • Facial pain/Sinus Pain

What is the TMJ Next Generation?

  • The TMJ NextGeneration™ consists of a pair of prosthetic devices, with one device inserted in each of the ear canals, to reduce pain resulting from Temporomandibular Joint Disorder (TMJD)
  • The devices conform to the shape of the ear canal when the jaw is in an open position
  • The TMJ NextGeneration™ is hollow inside permitting full passage of sound

How does the TMJ Next Generation work?

The two mechanisms believed to be responsible for the clinically proven effectiveness of the TMJ NextGeneration™ involve: 1) “the ear insert supports the TMJ [Temporomandibular joint] and associated secondary musculature to reduce strain in the TMJ area” (as cited in the device patent); and 2) the device provides “cognitive awareness” (consciously or subconsciously) to the wearer regarding para-functional habits (e.g., jaw clenching) that contribute to TMJD pain and dysfunction. Both the support and cognitive awareness mechanisms are the direct result of the proximity of the ear canal to the TMJ, and the change in the shape and volume of the ear canal as the jaw opens and closes. As can be seen in the figure, the ear canal (external auditory meatus) is located immediately posterior to the condyle and disc of the TMJ:

What clinical study supported the FDA approval of this device?

The clinical trial of the TMJ NextGeneration™ (formerly known as the CID) was a prospective, open-label, three-arm, randomized, and un-blinded clinical trial with a pre-treatment screening phase, baseline visit and three-month treatment phase. The objective of the trial was to characterize the safety profile and assess the effectiveness of the TMJ NextGeneration™ in treating subjects with Temporomandibular disorders. Two comparison treatment groups were incorporated into the study, one with patients wearing an intraoral stabilization splint, and the other with patients implementing a jaw exercise regimen. There were 60 patients in the TMJ NextGeneration™ group, 64 in the stabilization splint group, and 28 in the jaw exercise regimen group. Subjects enrolled in the study were those who met the inclusion criteria of having an RDC/TMJD diagnoses that included at least one of the following: myofascial pain; arthralgia, or disc displacement with reduction; and a screening VAS pain score of >4. As mentioned previously, the distribution of these RDC/TMJD diagnoses was very similar in all 3 treatment groups: I: Myofascial Pain (97-100%); II-a: Disc Displacement with Reduction (45-48%); and III-a: Arthralgia (55-61%). The instruments used to assess TMJD in this study included the Craniomandibular Index (CMI-RDC), the Symptom Severity Index (SSI), the VAS (Visual Analog Scale for pain), and the TMJ Scale™. Following a one-month baseline evaluation period, patients initiated treatment and were followed for 3 months, with follow-up visits and data collection occurring at 1, 2, and 3 months. The primary efficacy endpoint was non-inferiority of the TMJ NextGeneration™ to the stabilization splint in the reduction of the Craniomandibular Index (CMI) score from baseline to 3 months. The primary safety endpoint was to characterize the safety profile of the TMJ NextGeneration™ by collecting and reporting study-related adverse events. With respect to statistical methods, the null hypotheses for primary effectiveness was that the TMJ NextGeneration™ results in a reduction in CMI score of less than 80% of the reduction in score with the stabilization splint. The statistic used to test the null hypothesis of inferiority1 was compared to the Student’s t distribution with 2n-2 degrees of freedom, at a significance level of α = 0.05.

What was patient satisfaction with the device?

Patient global satisfaction in the pivotal clinical trial was extremely high, with 100% of subjects in the TMJ NextGeneration™ group indicating excellent (71%) or good (29%) overall satisfaction with the device. A sampling of patient testimonials can be viewed on our website: www.TMJNextGen.com/testimonials

What is the process to get the device?

Please schedule a medical appointment with our Institute by calling (614) 867-3681.  We accept in-network insurance and charge $150 for patients not filing with insurance.  If the patient is an acceptable candidate for the TMJ NextGeneration, we then charge $975 for prostheses for both ears.  For patients who purchase the TMJ Next Generation and paid $150 for the evaluation, we will credit the evaluation fee towards the purchase of the prostheses.  Unfortunately, due to insurance rules, we can not credit any insurance payments or deductibles with the purchase of the prostheses.  After payment is received, we create a customized mold of your ear canals.  This mold is shipped to the company. After 1-2 weeks, customized prostheses are returned back to our Institute. We then make sure these molds fit your ear canals appropriately, and then have patients followup with us on an as needed basis.  Please call us with any questions.

 

Where can I find more information?

Please visit http://tmjnextgen.com/product_information/the_better_solution for more information.