AventaMed, a KARL STORZ Company, Receives Expanded Indication for Solo+ Tympanostomy Tube Device (TTD)

Business Wire

5 hours ago

EL SEGUNDO, Calif.--(BUSINESS WIRE)--KARL STORZ United States is proud to announce that the US 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+™ Tympanostomy Tube Device (TTD) has received expanded clearance from the FDA.
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, VP of Sales & 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.'
About Ear Infections
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 1 in every 15 children will have had ear tubes. 3
About KARL STORZ
Since its founding in Germany in 1945, KARL STORZ has grown to become a leading global supplier of endoscopy solutions, including imaging and integration across all sites of care. 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. For more information, visit www.karlstorz.com.
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.