KARL STORZ gains approval for Solo+^™ revolutionary ear tube placement device

Tuttlingen, June 3, 2024 – Chronic ear infections are a leading reason for doctor visits and surgical procedures such as placement of ear tubes in young children. Until recently, ear tube placement was typically performed in an operating room, requiring general anesthesia for children. The new Solo+^™ is an innovative, single-use ear tube device that enables patients and physicians to have a choice for the most frequently performed pediatric ENT surgery in a simple and quick manner. Solo+^™ has now attained certification in fulfilling the requirements of the European Medical Device Regulation (MDR). In addition, the Food and Drug Administration (FDA) in the US has given 510(k) clearance to the product for patients aged six months to 24 months old. A full global launch is in preparation and the Solo+^™ will be available in targeted countries this year.

Ear tube surgery by pressing a button
Otitis media results in accumulation of fluid within the tympanic cavity that can be painful and lead to a dramatic decrease in the ability to hear. Children are more prone to this condition. Fluid accumulation in the middle ear has also been linked to hearing loss. Persistent hearing loss may negatively influence language development, behavior, and progress in school. When symptoms persist or worsen, tympanostomy tube (ear tube) insertion is recommended. By the age of three, one in every 15 children will have had ear tubes. With the innovative, single-use, all-in-one hand-held tympanostomy tube device system Solo+^™, ear, nose and throat (ENT) specialists now 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 receiving the MDR certification and FDA 510(k) clearance reflects our commitment to innovating medical device solutions that address unmet needs to improve patient experience.

ENT product portfolio grows
AventaMed, the KARL STORZ company, which developed the Solo+^™, was created as a spin off 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, Senior Director ENT & Neuro & Spine Global Marketing at KARL STORZ.