The FDA published a draft rule on Oct. 19 for over-the-counter hearing aids, four years after the Food and Drug Administration Reauthorization Act (FDARA) had directed the agency to do so by 2020. One of the potentially more problematic aspects of the draft is that the rule would be preemptive of state law on several points, including consumer protections, a consideration that could serve as a flashpoint in future litigation.
Innerscope Hearing Technologies Inc. acquired the assets and operations of Ihear Medical Inc. for an undisclosed amount. The deal significantly boosts Innerscope’s position in the emerging market of direct-to-consumer and over-the-counter hearing products, an important development in the run-up to the FDA’s expected release next month of new regulations for hearing aids that can be sold in stores without a prescription.
Medtronic plc reported it will acquire Intersect ENT, a deal that represents a major expansion of Medtronic’s footprint in the ear/nose/throat (ENT) space. Intersect’s products for chronic rhinosinusitis will give Medtronic access to a medical market said to be among the top 10 most expensive conditions for employers, with a potential patient population of 35 million in the U.S. alone.
Advanced Bionics LLC heard good news from the U.S. FDA, which granted approval for the company’s Marvel cochlear implant (CI) platform and the first-ever sound processor designed specifically for children. The development brings the Marvel platform, initially created for hearing aids produced by Advanced Bionics' sister company, Phonak AG, to the sound processor for CIs for the first time.
Eargo Inc., a medical device company specializing in hearing aids, reported $18.2 million in third quarter revenue, driven by sales of the company’s Neo Hifi hearing aid system and a decrease in the sales return accrual rate. Revenue was up 135% over the third quarter of 2019.
PARIS – Med-El Elektromedizinische Geräte GmbH has reported the first successful procedure in Europe for a totally implantable cochlear implant (TICI). The surgery was performed at Liège University Hospital in Belgium. “This TICI is a major step in cochlear implant technology. It has been the aim since the beginning of cochlear implants to be able to integrate all the components into a single internal device,” Philippe Lefebvre, head of the otorhinolaryngology department at Liège University Hospital, told BioWorld.
Sinusitis implant company Intersect ENT Inc. has agreed to acquire Fiagon AB Medical Technologies, a manufacturer of electromagnetic surgical navigation systems, for €60 million (US$71.1 million). Under the terms of the agreement, Intersect ENT will pay €15 million at the time of the closing and €15 million annually for the ensuing three years.
Photonicare Inc., which has developed the Tomi Scope for noninvasive imaging of the middle ear, has attracted the attention of investors. It has reported an oversubscribed $5.2 million series A financing led by I2e Management Co. Inc., with OSF Ventures, Sony Innovation Fund and Dreampact Ventures also participating.
PERTH, Australia – Sydney-based Cochlear Ltd. reported its first loss in 25 years due to the COVID-19 pandemic and a patent battle loss in the U.S. For fiscal year 2020, which ended June 30, Cochlear reported a AU$238 million (US$170 million) loss in sales, down 186% from last year’s profit of AU$276 million.
Months after revealing a U.S. FDA nod for the Rhinaer Stylus to treat chronic rhinitis, Aerin Medical Inc. reported the closing of a $48 million equity financing. In addition, the company revealed that Matt Brokaw, who has deep experience in the ear, nose and throat (ENT) space, has come on board as president and CEO.