After receiving approval from the Food and Drug Administration (FDA) late last year, hearing device maker Earlens raised $51 million in debt and equity to back the launch of its light-driven hearing aid. The FDA cleared it via its de novo premarket review pathway last September; that route is reserved for low- to moderate-risk medical devices that do not have a substantially equivalent marketed device.
According to the website FierceMedicalDevices, which covers the medical devices and diagnostics industries, hearing aids are challenging to market for several reasons, including the fact that hearing aids are typically an out-of-pocket expense for US consumers. Earlens is reportedly aiming to offer its novel technology at a cost that may be slightly higher than existing options.
For more details, see the full report on the FierceMedicalDevices website.
Image credit: Earlens; FierceMedicalDevices