A new way to treat temporo-mandibular joint disorders (TMJDs) has been approved for use in the UK and Ireland. The Cerezen device comprises a pair of removable custom-made hollow inserts, which are placed within the ear canal to reduce the symptoms, pain and related conditions including grinding of teeth and headaches. A clinical study reports that 100% of patients are satisfied with these unique new ear canal inserts, which reduce TMJ pain.
Simply inserted in the ear, the nearest access point to the TMJ, the device works by exerting subtle pressure on the walls of the ear canal when the jaw is in the closed position. This encourages the patient to return to the ‘open bite’ position, minimising the tendency to clench the jaw and tense the surrounding muscles.
The Cerezen device was developed in the USA, has achieved USA FDA clearance and complies with the essential requirements of the relevant European Directives MDD93/42 (CE Mark). In addition, an A Level 1 Clinical Study showed that 100% of users indicated excellent (71%) or good (29%) overall satisfaction with the Cerezen device.
One reason for the effectiveness of the devices is that they can be worn 24 hours a day and are practically invisible, ensuring total discretion – another reason why compliance levels among users is also markedly higher than with intrusive bite splints.
The device is quick and simple to fit, requiring only around 15 minutes’ chair time plus 25 minutes for the ear impression by a trained professional such as an audiologist. Once the diagnosis is made and ear impressions taken and submitted, TMJ Health LLC produces the custom devices and supplies them in approximately two weeks.
According to the company, they are easy and convenient for the patient to insert and remove, offering a simple and safe reduction of TMJD symptoms without impacting the patient’s lifestyle – as speech, eating and drinking are unaffected. As the device is hollow, it does not affect hearing, and is fitted with small retraction posts to make it easy to remove – which is advised for bathing and swimming.
Dr Roger Wixtrom, who has 25 years of experience in the evaluation of the clinical performance and safety of a range of medical devices, was the Scientific Director of the pivotal clinical study of the Cerezen device. This compared its performance and safety to that of the most widely used current treatment, the bite splint and he commented: “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 Cerezen device offers a safe and effective option that patients should discuss with their dentist or ENT specialist”
Following regulatory approval, the Cerezen device can be seen at The Dentistry Show, Dentistry 15, the Irish Dental Association Show and Identex, where there will also be presentations for delegates about this innovative new device.