EAR, NOSE & THROAT

Tula® Tympanostomy System

An in-office alternative to traditional tympanostomy for patients aged 6-months and older, utilising revolutionary, child-friendly, local anaesthesia and insertion technology designed specifically to address the challenge of tube insertion in an awake child without using mechanical restraints.1,2 95% of parents were very satisfied with the Tula procedure2

Tula Tympanostomy Kit

Procedure Overview

The Tula Iontophoresis System applies a low-level electrical charge to the TYMBION™ ionic local anaesthetic, accelerating drug uptake into the tympanic membrane. The child may play quietly, watch videos or snack during the process.

The Tula Tube Delivery System allows a physician to create a myringotomy and insert a 1.14 mm inner diameter grommet in less than half a second, minimising the amount of time the child needs to remain still.3 The Tula System is supported by an educational and training program designed with input from experts in paediatric psychology, medical stress and pain management.



Product Features

The Procedure

Recovery Information

Risks



Disclaimer

The Tula System is intended to create a myringotomy and insert a tympanostomy tube using the Tula Tube Delivery System in paediatric (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 anaesthesia induced using the Tula Iontophoresis System and TYMBION, a combination of an amide local anaesthetic and an alpha and beta-adrenergic agonist. Contraindications include certain abnormal ear anatomy, sensitivity/allergy to lidocaine or other local anaesthetics, and reliance on electrically sensitive medical implants such as a pacemaker. Risks may include, but are not limited to, inadequate local anaesthesia, 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.

Citations
  1. IFU007011, available at www.tulatubes.com/IFU
  2. Lustig LR, Ingram A, Vidrine M, et al. In‐office tympanostomy tube placement in children using iontophoresis and automated tube delivery. Laryngoscope. 2020; 130: S1-S9. Satisfaction results from parents of children who participated in the Tula pivotal clinical study, n=201.
  3. Procedure typically lasts about 35 minutes. Tula Pivotal Study. Data on file.
  4. Data on file. Tula Pivotal Study. Results from office lead-in and pivotal cohorts combined.
  5. Kay et al. Meta-analysis of tympanostomy tube sequelae. Otol Head Neck Surg 124: 374-80 2001.
  6. Probable date of extrusion was calculated as the midpoint between the date when tube position across the tympanic membrane was last confirmed and the date when the tube was first noted to be extruded. Mean 95% Confidence Interval [CI]: 15.41-19.05, Median 95% CI: 16.16-17.42. Data on file. Tula Pivotal Study. Results from all cohorts combined.
  7. Waldman, E. H., Ingram, A., Vidrine, M., Gould, A. R., Zeiders, J. W., & Lustig, L. R. (2022, September 10–14). Two-Year Outcomes After Pediatric In-Office Tympanostomy [Oral presentation]. AAO-HNSF 2022 Annual Meeting, Philadelphia, PA, United States.
  8. Lindstrom DR, Reuben B, Jacobson K, Flanary VA, Kerschner JE. Long-term results of Armstrong beveled grommet tympanostomy tubes in children. Laryngoscope. 2004;114(3):490-494. 
  9. Weigel MT, Parker MY, Goldsmith MM, Postma DS, Pillsbury HC. A prospective randomized study of four commonly used tympanostomy tubes. Laryngoscope. 1989;99(3):252-256.
  10. April MM, Portella RR, Orobello PW Jr, Naclerio RM. Tympanostomy tube insertion: anterosuperior vs. anteroinferior quadrant. Otolaryngol Head Neck Surg. 1992;106(3):241-242. 
  11. Klingensmith MR, Strauss M, Conner GH. A comparison of retention and complication rates of large-bore (Paparella II) and small-bore middle ear ventilating tubes. Otolaryngol Head Neck Surg. 1985;93(3):322-330.
  12. Moon IS, Kwon MO, Park CY, et al. When should retained Paparella type I tympanostomy tubes be removed in asymptomatic children?. Auris Nasus Larynx. 2013;40(2):150-153.
  13. Walker P. Ventilation tube duration versus site of placement. Aust N Z J Surg. 1997;67(8):571-572.

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