KARL STORZ United States is proud to announce that the U.S. Food and Drug Administration (FDA) has cleared an expanded indication for the AventaMed Solo+™ Tympanostomy Tube Device (TTD), allowing its use in pediatric patients aged 6 months and older. This expanded clearance builds on the 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. 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. 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 that 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 and marketing, head & neck division, at KARL STORZ US. “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.”
