FDA Allows Marketing of New EarLens Laser-based Hearing Aid
The US Food and Drug Administration (FDA) announced that it is allowing the marketing of a new hearing aid that uses a laser diode and direct vibration of the eardrum to amplify sound: the EarLens Contact Hearing Device (CHD), which is manufactured by EarLens Corporation of Menlo Park, Calif.
The FDA reports that the combination of laser light pulses and a custom-fit device component that comes in direct contact with the eardrum is designed to use the patient’s own eardrum as a speaker and enables amplification over a wider range of frequencies for some hearing impaired persons. The EarLens CHD is indicated for use by adults with mild to severe sensorineural hearing impairment.
The EarLens CHD consists of two parts: a tympanic membrane transducer (TMT), which is non-surgically placed deeply into the ear canal on the eardrum, and a behind-the-ear (BTE) audio processor that sits on the outer ear and is connected to an ear tip that is placed in the ear canal. External sound waves received by the BTE processor are converted to electronic signals, digitally processed, amplified and sent to the ear tip, which contains a laser diode. There, the electronic signals of amplified sound are converted to pulses of light. The laser light pulses then shines onto a photodetector in the TMT, which converts the light back into electronic signals, transmitting sound vibrations directly to the eardrum by direct contact.
The EarLens CHD differs from traditional air conduction hearing aids in several ways. The TMT component is custom-molded to the patient’s eardrum and contains a driver mechanism that directly stimulates the eardrum, enabling efficient amplification of sound.
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