What is ear tube surgery?

Children can get middle ear infections (otitis media) when they have a cold or other respiratory infection. Recurrent ear infections (recurrent acute otitis media) and/or persistent fluid in the middle ear (otitis media with effusion) may become a chronic problem leading to other issues such as hearing loss, poor school performance, or behavior and speech problems. When this occurs, ear tube surgery, which is an insertion of ear tubes by an ENT doctor, may be considered.1,2

During an ear tube procedure, your child’s ENT doctor will create a small hole in the eardrum (also called the tympanic membrane) to allow fluids to drain out and to permit air to enter the ear to help drainage and healing. This first step is also called a myringotomy. The ENT doctor will then place the ear tubes, which are tiny cylinders, through the eardrum hole to maintain the opening and allow air into the middle ear. Ear tubes may also be called tympanostomy tubes, myringotomy tubes, ventilation tubes, or Pressure Equalization (PE) tubes.3,4

Ear tubes may reduce the risk of future ear infection, restore hearing loss caused by fluid in the ear, improve speech and balance problems, and improve behavior problems related to ear infections.5

Overview of ear tube procedures

  • In the Operating Room (OR)
  • In the Doctor’s Office (Tula)

2-3hours at the facility6

Traditionally, ear tube procedures take place in an operating room at a hospital or ambulatory surgery center while your child is under general anesthesia. After the surgical team has inserted the tubes, you are reunited with your child in the recovery area.3,4,7

  • Your child should fast before the procedure.8
  • Child goes into operating room. Parent goes into the waiting room.
  • Child is put under general anesthesia, then ear tubes are inserted.9
  • Child wakes up and is typically able to go home within a few hours.10

35minutes11

With the Tula System, special earplugs are used to push numbing drug solution into your child’s eardrum and ear tubes are inserted using a special Tula device. You can stay with your child during the entire procedure which typically lasts about 35 minutes.11,12

  • You are with your child in the procedure room.
  • Child wears special earplugs and plays quietly while the numbing drug solution works.
  • Child’s head is stabilized, and ear tubes are inserted.
  • Parent and child leave right after the procedure.

Compare ear tube placement in the operating room vs. in the office with Tula
Pros
Cons
OPERATING ROOM

  • Your child is asleep and immobile during the procedure

  • This surgery has historically been the standard of care

  • Possible side effects and complications of general anesthesia

  • Fasting is required prior to surgery

  • You will be separated from your child during the procedure
DOCTOR’S OFFICE WITH TULA

  • Avoid a trip to the operating room. No general anesthesia.

  • You can stay with your child.

  • Your child can likely return to normal activities immediately following procedure without grogginess.

  • No fasting. Your child can eat or drink during the procedure.

  • Your child must be willing to wear earplugs for about 10 minutes and sit still for ear tube insertion.

  • Your child may be rescheduled for a procedure in the Operating Room if the in-office procedure is not successful. Rescheduling may be necessary if the numbing medication is ineffective or if your child is unable to sit still.

Find out if Tula is right for your child.

Learn More

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.

  1. The Nemours Foundation. Middle Ear Infections (Otitis Media). KidsHealth. November 15, 2022. Updated November 15, 2022. Accessed January 30, 2023. https://kidshealth.org/en/parents/otitis-media.html
  2. American Academy of Otolaryngology–Head and Neck Surgery Foundation. Earaches. ENTHealth. September 20, 2018. Updated December 12, 2022. Accessed January 30, 2023. https://www.enthealth.org/conditions/earaches/
  3. The Nemours Foundation. Ear Tube Surgery. KidsHealth. October 12, 2021. Updated October 12, 2021. Accessed January 30, 2023. https://kidshealth.org/en/parents/ear-infections.html
  4. American Academy of Otolaryngology–Head and Neck Surgery Foundation. Ear Tubes. ENTHealth. September 26, 2018. Updated October 30, 2019. Accessed January 30, 2023. https://www.enthealth.org/be_ent_smart/ear-tubes/
  5. Rosenfeld RM, Tunkel DE, Schwartz SR, et al. Clinical Practice Guideline: Tympanostomy Tubes in Children (Update). Otolaryngology–Head and Neck Surgery. 2022;166(1_suppl):S1-S55.
  6. Cravero JP, Beach M, Dodge CP, Whalen K. Emergence characteristics of sevoflurane compared to halothane in pediatric patients undergoing bilateral pressure equalization tube insertion. J Clin Anesth. 2000;12(5):397-401.
  7. Hall MJ, Schwartzman A, Zhang J, Liu X. Ambulatory Surgery Data From Hospitals and Ambulatory Surgery Centers: United States, 2010. Natl Health Stat Report. 2017;(102):1-15.
  8. Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017;126(3):376-393.
  9. Hippard HK, Govindan K, Friedman EM, et al. Postoperative analgesic and behavioral effects of intranasal fentanyl, intravenous morphine, and intramuscular morphine in pediatric patients undergoing bilateral myringotomy and placement of ventilating tubes. Anesth Analg. 2012;115(2):356-363.
  10. Cravero JP, Beach M, Dodge CP, Whalen K. Emergence characteristics of sevoflurane compared to halothane in pediatric patients undergoing bilateral pressure equalization tube insertion. J Clin Anesth. 2000;12(5):397-401.
  11. Data on file. Tula Pivotal Study.
  12. Lustig LR, Ingram A, Vidrine DM, et al. In-Office Tympanostomy Tube Placement in Children Using Iontophoresis and Automated Tube Delivery. Laryngoscope. 2020;130 Suppl 4(Suppl 4):S1-S9.

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