FDA approves ear inserts to reduce TMJ pain

TMJ NextGeneration has been granted FDA approval to treat temporomandibular joint pain.--Courtesy of TMJ Health

Chronic pain is a difficult development area for both drug and device developers; creating a product that effectively reduces pain and is sufficiently tolerable over long periods remains a challenge. Now sufferers with temporomandibular joint (TMJ) disorder pain have a new device option that has proven more effective than the most common treatment.

The FDA has approved TMJ NextGeneration, custom ear canal inserts that increase the volume of the ear canal when the jaw is closed, thereby discouraging the user from clenching the jaw and the surrounding muscles.

In a clinical trial, the device proved noninferior to a stabilization splint, an oral appliance otherwise known as a bite guard that fits over the upper or lower teeth. These splints are the most widely used TMJ disorder treatment, according to the U.S. National Institute of Dental and Craniofacial Research. But studies of their efficacy are inconclusive and the NIDCR recommends their use only for a short period of time.

"While bite splints have helped to reduce pain associated with TMJD, there are drawbacks with these devices," Dr. Roger Wixtrom, the lead researcher on the trial, said in a statement. "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."

TMJ NextGeneration provided a 46% reduction in TMJD pain at one month in a clinical trial, with a 58% reduction in pain at three months. The device expands the ear canal by around 20%. The process is a fairly simple one. An audiologist or other healthcare provider must make a mold of each ear, which takes about 20 minutes. Then the company, TMJ Health, creates the custom inserts, which are received by the provider within two to three weeks.

More than 35 million Americans have TMJD and most of these are women between 20 and 40 years old, according to the U.S. National Institutes of Health.

Michigan-based TMJ Health was founded in 2013 and raised $2 million from a single investor in January, according to an SEC filing.

- here is the release
- and the SEC filing

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