AventaMed, a KARL STORZ Company, Gains FDA Clearance for Solo+^™ Ear-Tube Placement Device

TUTTLINGEN, Germany -Chronic ear infections are a leading reason for doctor visits and surgical procedures such as placement of ear tubes in young children.^1-3 Ear-tube placement has typically been performed in an operating room, requiring general anesthesia for children.

Introducing Solo+, a revolutionary advancement in pediatric care that emphasizes safety, overall patient satisfaction, and healthcare efficiency. Solo+ combines multiple steps into an all-in-one device, facilitating a simplified approach to enable office-based pediatric tympanostomies. Designed to eliminate the need for general anesthesia, single-pass devices, like the Solo+, significantly reduce the risks and side effects associated with general anesthesia during traditional tympanostomy tube insertion, offering a quicker recovery and minimizing disruption for young patients and their families.^4-7 Its ease of use and the comprehensive support system provided by KARL STORZ ensures a smooth transition for office staff, fostering an environment of excellence and innovation in patient care. For insurance payors, Solo+ represents a cost-effective solution that streamlines care delivery, improves access, and aligns with market trends toward minimally invasive procedures.^4,8,9

The US Food and Drug Administration (FDA) has given 510(k) clearance to the product for patients aged 6 months to 24 months old. In addition, Solo+ has attained certification in fulfilling the requirements of the European Medical Device Regulation (MDR). A full global launch is in preparation, and Solo+ will be available in targeted countries this year.

Ear-Tube Placement at the Press of a Button with Solo+

Otitis media may result in accumulation of fluid within the tympanic cavity, which can be painful and lead to a decrease in the ability to hear.³ Children are more prone to this condition.¹⁰ Persistent hearing loss may negatively influence language development, behavior, and progress in school.¹¹ When symptoms persist or worsen, tympanostomy tube (ear tube) insertion may be recommended. By the age of three, nearly 1 in every 15 children will have had ear tubes.³ With the innovative, single-use tympanostomy tube-placement system Solo+, Ear, Nose and Throat (ENT) specialists have the option to place the ear tube in the patient's eardrum by pressing a button using as little as topical anesthesia in alternative sites of care. The achievement of MDR certification and FDA 510(k) clearance reflects our commitment to innovating medical device solutions that address unmet needs to improve the patient experience.

ENT Product Portfolio Grows

AventaMed, the KARL STORZ company that developed Solo+, was created as a spinoff from Munster Technological University in 2015. It was acquired by KARL STORZ in January 2023 and has since enriched the already extensive ENT product portfolio of the family-owned MedTech company headquartered in Tuttlingen, Germany. “The Solo+ launch underpins our ambitious approach to continue to be the innovative partner of ENT surgery for state-of-the-art endoscopic treatments and to enable the different sites of care outside the operating theater to be offered more efficient solutions,” said Antonio Licata, Executive Director, Upper Endoscopy, at KARL STORZ.

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. Otolaryngology–Head and Neck Surgery. 2013;149:S1-S35. doi: 10.1177/0194599813487302.
⁴ Billings KR et al. Single Visit Evaluation and Tympanostomy Tube Placement for the Treatment of Acute Otitis Media in Children. Laryngoscope. 2021;131(12):2823-2829. doi: 10.1002/lary.29714.
⁵ Fournier I et al. Comparison of Tympanostomy Tubes Under Local Anesthesia Versus General Anesthesia for Children. Laryngoscope. 2023. doi:10.1002/lary.31095.
⁶ Davidson J et al. Cost and efficiency of myringotomy procedures in minor procedure rooms compared to operating rooms. Laryngoscope. 2020;130(1):242-246. doi: 10.1002/lary.27840.
⁷ Lustig LR et al. In-Office Tympanostomy Tube Placement in Children Using Iontophoresis and Automated Tube Delivery. Laryngoscope. 2020. doi: 10.1002/lary.28612.
⁸ Brodsky L et al. Office-Based Insertion of Pressure Equalization Tubes: The Role of Laser-Assisted Tympanic Membrane Fenestration. Laryngoscope. 1999;109(12):2009-2014. doi: 10.1097/00005537-199912000-00022.
⁹ Roy CF et al. Procedural Sedation in Minor Procedure Rooms for Pediatric Myringotomy and Tympanostomy: A Quality Improvement Initiative. Otolaryngol Head Neck Surg. 2022;167(6):979-984. doi: 10.1177/01945998211011066.
¹⁰ Bluestone CD, Swarts JD. Human evolutionary history: consequences for the pathogenesis of otitis media. Otolaryngol Head Neck Surg. 2010;143(6):739-44. doi: 10.1016/j.otohns.2010.08.015.
¹¹ Jamal A et al. Effect of Ear Infections on Hearing Ability: A Narrative Review on the Complications of Otitis Media. Cureus. 2022;14(7):e27400. doi: 10.7759/cureus.27400.

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