Important Safety and Risk Information
The Tula System is used by ENT doctors to insert ear tubes in an office setting using the Tula Tube Delivery System, the Tula Iontophoresis System and a numbing drug solution called TYMBION™. The Tula System can be used in children (6 months and older) and adults who need ear tubes.
Use of the Tula System may not be appropriate for all children. The Tula procedure should not be performed on children with certain abnormal ear anatomy, sensitivity/allergy to lidocaine or other numbing drugs, or reliance on electrically sensitive medical implants such as a pacemaker or cochlear implant.
The Tula System should be used by a physician who is trained on the use of the Tula System. Talk to your doctor for a full discussion of risks and benefits to determine whether Tula is appropriate for your child.
RISKS AND SIDE EFFECTS:
As with any surgical procedure, there are risks you should be aware of to help make your decision. The most common risks that occur with the Tula System include inability to complete the procedure due to insufficient numbing and/or dizziness during the procedure.
Patients may feel a sense of pressure, tingling, itching, or burning in the ear or at the location of an adhesive patch typically placed on the child’s shoulder during delivery of the numbing drug solution. The Tula System has settings that your doctor can control that may alleviate or reduce these sensations.
Temporary redness/irritation may occur at the site of the adhesive patch typically placed on the child’s shoulder during delivery of the numbing drug solution.
In rare cases, patients may experience temporary tongue numbness that should resolve within a few hours.
In rare cases, the ear tube may be unintentionally placed behind the eardrum during the procedure. Your doctor will discuss options with you which may include leaving the ear tube behind the eardrum, whether to attempt to remove the ear tube in the office or to remove the ear tube during a second procedure in the operating room.
OTHER POTENTIAL RISKS:
There are potential risks to ear tube placement that are the same whether your child’s ear tubes are placed with the Tula System or a procedure in the operating room. Please talk to your doctor to understand these risks and whether Tula may be the right option for your child.
The Tula System is intended to create a myringotomy and insert a tympanostomy tube using the Tula Tube Delivery System in pediatric (aged 6 months and older) and adult patients indicated to receive tympanostomy tubes. The Tula System is used to deliver a tympanostomy tube under local anesthesia induced using the Tula Iontophoresis System and TYMBION, a combination of an amide local anesthetic and an alpha and beta-adrenergic agonist. Contraindications include certain abnormal ear anatomy, sensitivity/allergy to lidocaine or other local anesthetics, and reliance on electrically sensitive medical implants such as a pacemaker. Risks may include, but are not limited to, inadequate local anesthesia, dizziness, and common tympanostomy procedure risks. For full prescribing information, see the Tula IFU and TYMBION Drug Package Insert at www.tulatubes.com/IFU. Rx only.