TMJ NextGen Pilot Study to Treat Subjects With Bruxism

Inclusion Criteria: 1. Subjects at least 18 years of age; 2. Subject has had a diagnosis of sleep bruxism confirmed within the past 30 days; 3. Subject has an average of ≥ 1.25 bruxism episodes per hour of sleep based on two nights of screening Bruxoff™ evaluations; 4. Subject is able to read and understand the ICF and has voluntarily provided written informed consent; 5. Subject has a minimum of 26 remaining teeth; 6. Subject has an average of ≥ 1.25 bruxism episodes per hour of sleep based on the single-night screening sleep PSG evaluations. Exclusion Criteria: 1. Subjects with any physical or behavioral disorder, which, in the opinion of the Principal Investigator, may interfere with the use of the device or compliance with the study protocol; 2. Subject has a significant respiratory disease that actively requires treatment; 3. Subject is taking antidepressant medication; 4. Subject has a significant sleep disorder that actively requires treatment, in addition to bruxism; 5. Subject is undergoing treatment for sleep apnea; 6. Subjects diagnosed with rheumatoid arthritis, osteoarthritis, osteoarthrosis, or another connective tissue disorder of the head/neck region; 7. Subjects who have had direct trauma to the jaw; 8. Subjects who have used an occlusal appliance to treat a TMD within the previous six months; 9. Subjects who have had prior TMJ or ear surgery; 10. Subjects who have a narrow ear canal or impression of the ear canal, which is prolapsed due to an anatomical shift or failure of the ear canal wall structure, or a canal that does not allow for the ear canal second turn to be identified; 11. Subjects with visible or congenital ear deformity as observed on targeted physical exam that does not allow for fitting of the study device; 12. Subjects who have taken a narcotic pain medication in the last seven days prior to Day 1 of the study; 13. Subjects who have a history of chronic ear pain unrelated to TMJ; 14. Subjects who have a history of ear drainage in the past six months; 15. Subjects who have active ear drainage, swelling, or redness as observed on targeted physical exam; 16. Subjects whom the investigator believes may not be an appropriate candidate for an intra-oral splint due to missing or poor quality dentition or untreated pain of dental origin (pulpal pain, pericoronitis of wisdom teeth, or similar conditions).