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.
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.