Product Information

Precautions for patients using Cerezen™ ear canal inserts

Cerezen™ ear canal inserts for TMJ disorder

 

It is not recommended that you wear your Cerezen™ ear canal inserts while showering, swimming or in a heated, moist environment such as a steam bath or sauna. It is recommended when participating in any contact sports that you remove your Cerezen™ ear canal inserts and store them in the pouch provided. Significant weight gain or loss may affect the fit of the Cerezen™ inserts within your ears and may require you to be refitted.

Warnings:

If you experience some initial discomfort, it may simply represent a brief adjustment period of the ear as it adapts to the inserts.

If, however, soreness, swelling, itchiness, or drainage occurs in either one or both the ears, then you should remove your Cerezen™ inserts and call your health care practitioner to discuss your condition.

The safety and effectiveness of the Cerezen™ ear canal inserts have 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 disorder (TMJD) surgery or ear surgery.

When the Cerezen™ Ear Canal Inserts Should Not Be Used (Contraindications)
You should not be fitted for the Cerezen™ ear inserts for TMJ pain 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 inserts (e.g., too narrow or prolapsed [fallen] canal, or previous mastoid surgery).

Risks and Benefits:

Patients wearing the Cerezen™ ear canal inserts in a three month clinical study experienced a significant reduction in the pain and dysfunction associated with TMJD, to an extent at least as much as that experienced by patients wearing a stabilization splint (mouth splint) or following a specified jaw exercise regimen. No unexpected or serious adverse events were reported and a comparable safety profile to the stabilization splint (mouth splint) was observed. Patients in the study reported very high levels of satisfaction.

For more information about Cerezen™ear canal inserts, contact us today.