KARL STORZ Wins Expanded FDA Indication for Solo+ Tympanostomy Tube Device

The U.S. Food and Drug Administration (FDA) has cleared an expanded indication for KARL STORZ’s AventaMed Solo+ Tympanostomy Tube Device (TTD), allowing its use in pediatric patients aged 6 months and older. This expanded clearance builds on the device’s previous 510(k) clearance, which was indicated for patients 6 to 24 months old.

The Solo+ device represents a significant advancement in pediatric ENT care, according to the company. It is intended to deliver a tympanostomy tube (also known as a ventilation tube) into a patient’s tympanic membrane, or eardrum, to treat problems arising from ear infections. Traditionally, this procedure would be performed in an operating room under general anesthesia but the Solo+ device offers a convenient alternative. Using as little as a topical anesthetic, the Solo+ device integrates multiple functions into a single, user-friendly instrument, deploying the tube with the press of a button. As a result, it enables tympanostomies to be performed in an office setting.

New clinical findings support the safe and effective use of the Solo+ device, showing physicians were consistently able to complete the procedure in the office as intended—without needing to move to the operating room.

The Solo+ Tympanostomy Tube Device demonstrated consistent, reliable performance across pediatric age groups, with strong follow-up outcomes. These results provide both guardians and physicians with greater confidence in selecting an office-based approach to ear tube placement for a wider range of children.

“On behalf of patients and their families, we are excited by this expanded indication,” said Chris Smith, vice president of Sales & Marketing, Head & Neck Division, at KARL STORZ U.S. “This makes it possible to offer this effective treatment to a broad population. With clear advantages like avoiding general anesthesia, reducing total procedural costs, and delivering high patient satisfaction, the Solo+ device will benefit doctors and patients alike. It’s part of our commitment to provide technology that addresses real-world needs.”

Chronic ear infections are a leading reason for doctor visits among young children.^1-3 Children are more susceptible to this potentially painful condition, which can adversely affect the ability to hear.¹ Treatment often involves procedures known as myringotomy and tympanostomy.

Myringotomy involves making an incision in the eardrum to drain excess fluid from the middle ear. It is sometimes performed as a standalone treatment, but is often combined with tympanostomy, in which a tiny tube is inserted in the eardrum to alleviate pressure and allow fluid to drain. The procedure is common: by the age of three, nearly one in every 15 children will have had ear tubes.³

Since its founding in Germany in 1945, KARL STORZ has grown to become a global supplier of endoscopy solutions, including imaging and integration across all care sites. Now in its third generation, the family-owned company employs 9,400 people in more than 40 countries worldwide. The company acquired the Solo+ technology through the acquisition of AventaMed, which was spun off from Munster Technological University in 2015.

References
¹ Ahmed S et al. Incremental health care utilization and costs for acute otitis media in children. Laryngoscope. 2014;124(1):301-5. doi: 10.1002/lary.24190.
² Bhattacharyya N, Shay SG. Epidemiology of Pediatric Tympanostomy Tube Placement in the United States. Otolaryngol Head Neck Surg. 2020;163(3):600-602. doi: 10.1177/0194599820917397.
³ Rosenfeld RM et al. Clinical Practice Guideline: Tympanostomy Tubes in Children. Otolaryngol Head Neck Surg. 2013;149:S1-S35. doi: 10.1177/0194599813487302.