AventaMed, a KARL STORZ Company, Receives Expanded Indication for Solo+ Tympanostomy Tube Device (TTD)
Clearance Makes Office-Based Procedure Available to a Wider Range of Patients
EL SEGUNDO, Calif., June 18, 2025--(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+ 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.
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Contacts
Susan ManciaMobile: 562-841-1515E-mail: susan.mancia@karlstorz.com
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