EarLens wins FDA 510(k) for novel hearing aid
Submitted by kBLASTER Team on
by Fink Densford for Massdevice.com
EarLens said last Tuesday it won FDA 510(k) clearance for its laser diode-equipped direct vibration-based contact hearing device for use in adults with mild to severe sensorineural hearing impairment.
The device is designed to directly contact the patient’s eardrum and use it as a speaker and act as an amplifier for a wide range of frequencies, the Menlo Park, Calif.-based company said. It consists of a tympanic membrane transducer...