FDA Approves Marketing of New Hearing Aid with Laser Technology

The U.S. Food and Drug Administration (FDA) approved the marketing of a new hearing aid that utilizes laser technology.  The FDA review was part of a regulatory pathway that can be used for low- to moderate-risk medical devices that are not substantially equivalent to an already legally-marketed device.  While there are many hearing aids on the market, this new technology is a major advancement in hearing aids.

That’s good news for the over 35 million people in the United States that have some form of hearing loss.  Would you believe that only 30% of people over the age of 70 that could benefit from the use of hearing aids actually use them?

Laser Hearing Aid Technology

The newly approved hearing aid device is called the EarLens Contact Hearing Device.  It uses a laser diode and direct vibration of the eardrum to amplify sound. The combination of laser light pulses and a custom-fit component that comes in direct contact with the eardrum uses the patient’s own eardrum as a speaker. Because of this technology, the Contact Hearing Device can amplify a wide range of frequencies for some hearing-impaired persons. 

The EarLens Contact Hearing Device is indicated for use in adults with mild to severe sensorineural hearing impairment[K1] .  The EarLens is made by the EarLens Corporation of Menlo Park, California.

“For the millions of Americans with hearing impairment, hearing aids can significantly improve regular daily communications, as well as overall quality of life,” said William Maisel, M.D., M.P.H., Deputy Director for Science and Chief Scientist, in the FDA’s Press Release announcing the approval. “People with hearing impairment now have a new option that may help improve their hearing by amplifying sounds over a broad spectrum of frequencies.”

How Laser Hearing Aids Work

The EarLens, like most hearing aids, is made up of two parts.  The first part is a tympanic membrane transducer (TMT).  The TMT is non-surgically placed deeply into the ear canal directly on the eardrum.  The second part is a behind-the-ear (BTE) audio processor that sits on the outer ear and is connected to an ear tip placed in the ear canal.

Sound is received by the BTE processor and gets converted to electronic signals. This signal is digitally processed, then amplified and sent to the ear tip.  The ear tip contains the laser diode. The electronic signals of amplified sound get converted to pulses of light by the diode. The laser light pulses shine onto a photodetector in the TMT.  The TMT converts the light back into electronic signals and then transmits sound vibrations directly to the eardrum by direct contact.

The TMT component must be custom-molded to the wearer’s eardrum. The EarLens works differently from other hearing aids because it directly stimulates the eardrum. 

Effectiveness of the Technology

Studies on the safety and effectiveness of the EarLens included several assessments over a four-month period.  The assessments included:

• Stability of residual hearing
• Improvement in word recognition
• Functional amplification gain
• Ability to hear speech in background noise compared to listening without any amplification.

After 30 days of device use, the subjects had an average of a 33% improvement in word recognition. They also had functional gain of 30.5 decibels (dB) on average in the high-frequency range (2,000-10,000 Hz), with an average of 30-40 dB of functional gain noted at 6,000 Hz and above.

As for side-effects, some subjects experienced abrasions in the ear canal. This was mostly related to the ear tip use or abrasions caused during the impression-making procedure. There were no serious device-related “adverse events.”