Tula™ – Tympanostomy System

Procedure Summary

The Tula™ System is FDA-approved for patients aged 6 months and older.

The Tula™ Iontophoresis System accelerates the delivery of the TYMBION™ ionic local anesthetic to the tympanic membrane by applying a low-level electrical current. During the procedure, children can remain calm and engaged, playing quietly, watching videos, or having a snack.

The Tula™ Tube Delivery System allows the physician to perform the myringotomy and place a 1.14 mm inner-diameter grommet in less than half a second, minimizing the time the child must remain still.³

The Tula™ System is supported by a structured training and education program, developed with input from experts in pediatric psychology, medical stress, and pain management.

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Product Features

87% success rate in office-based procedures
In the Tula™ pivot study, procedural success was defined as the successful placement of tubes in both ears for bilateral cases.

The success rate of the Tula™ procedure was 86% in children under 5 years and 89% in children aged 5–12 years.²

Patients were treated in the office without sedation, anxiolytics, or papoose boards.²
95% tube patency at 3-week follow-up
The functional patency rates of Tula™ tubes placed in the office are comparable to those reported in the literature for conventionally placed operating-room tubes.⁴
95% of parents reported high satisfaction with the Tula™ procedure
Parental satisfaction was recorded at the 3-week follow-up. 95% of parents responded either “Strongly Agree” (82%) or “Agree” (13%) to the statement:

“Overall, I am very satisfied with the office-based ear tube procedure.”

A total of 201 parent surveys were completed.²
Mean time from tube placement to extrusion: 16.8 months
In the Tula™ pivot study, the mean time from tube placement to extrusion across all cohorts was 16.8 months (median 15.8 months), consistent with the ranges reported in the literature for similarly placed operating-room tubes.⁶–¹³

References

1. IFU007011. Available at: www.tulatubes.com/IFU
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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. 2001;124:374–380.
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 months; Median 95% CI: 16.16–17.42 months. Data on file. Tula Pivotal Study. Results from all cohorts combined.
7. Waldman EH, Ingram A, Vidrine M, Gould AR, Zeiders JW, Lustig LR. Two-Year Outcomes After Pediatric In-Office Tympanostomy [Oral presentation]. AAO-HNSF 2022 Annual Meeting, Philadelphia, PA, United States; September 10–14, 2022.
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.

DISCLAIMER

The Tula™ System is designed for the creation of a myringotomy and placement of tympanostomy tubes in pediatric patients (6 months and older) and adult patients requiring ear tube placement using the Tula™ Tube Placement System.

The system is used under local anesthesia administered via the Tula™ Iontophoresis System with TYMBION™, a combination of amide local anesthetic and alpha/beta-adrenergic agonists.

Contraindications include certain abnormal ear anatomies, hypersensitivity or allergy to lidocaine or other local anesthetics, and dependence on electrically sensitive medical implants such as pacemakers.

Potential risks include inadequate local anesthesia, dizziness, and risks associated with standard tympanostomy procedures, though these are not exhaustive.

For complete prescribing information, please refer to the Tula IFU and TYMBION™ Drug Package Insert at www.tulatubes.com/IFU
. Prescription only.

Tula™ – Tympanostomy System

Procedure Summary

Product Features

87% success rate in office-based procedures

95% tube patency at 3-week follow-up

95% of parents reported high satisfaction with the Tula™ procedure

Mean time from tube placement to extrusion: 16.8 months

References

DISCLAIMER

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