Product Information

Precautions for prescribing Cerezen™ ear canal inserts

Cerezen™ ear canal inserts

 

It is not recommended that your patients wear their Cerezen™ ear canal inserts while showering, swimming or in a heated moist environment such as a steam bath or sauna. If the patient wil be participating in any contact sports, the Cerezen™ ear canal inserts should be removed and stored in the pouch provided. Significant weight gain or loss may affect the fit of the Cerezen™ inserts within the ear and may require your patients to be refitted with new inserts.

Warnings:

If your patients experience some initial discomfort, it may simply represent a brief adjustment period of the ears as they adapt to the ear canal inserts.

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

The safety and effectiveness of Cerezen™ ear canal inserts have not been established for people:

  • Who have had prior temporomandibular joint disorder (TMJD) surgery or ear surgery.
  • Who have been diagnosed with rheumatoid arthritis, osteoarthritis, osteoarthrosis or another connective tissue disorder; or
  • Who have had direct trauma to the jaw

When the Inserts Should Not Be Used (Contraindications)
Your patients should not be fitted for Cerezen™ inserts if:

  • They have an unresolved history of ear pain unrelated to TMJ disorder; or
  • They have active ear drainage, swelling or redness; or
  • Their 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 Cerezen™ inserts in a three-month clinical study experienced a significant reduction in the pain and dysfunction associated with TMJ disorder, 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 in regards to reducing their TMJ pain.

Contact us to learn more about Cerezen™ inserts.