When was the last time any manufacturer tried to change the mechanics of hearing aid technology non-surgically before Earlens developed its light-driven hearing solution? The last major advance in hearing technology may have been the integration of digital signal processing. Since then, manufacturers have been tweaking ever-more sophisticated algorithms to deliver the level of sound quality that consumers have always hoped for.
Unfortunately, those efforts will all ultimately face limitations in the quality of sound and audibility that they can provide because every acoustic hearing aid is constrained by hearing aid receiver technology. That’s why Earlens developed a new way to create sound without an acoustic signal. In 2016, Earlens released a new light-driven approach to treating hearing loss. The original Earlens worked by converting sound into light, which contained an encoded audio signal and powered a tiny custom lens to drive the eardrum.
While patients often raved about the sound quality with the first generation of Earlens technology, some patients also noticed sound variability, which most often occurred with jaw movements like smiling, or chewing. This sound variability was a challenge to overcome with a light-based system: ear canal movements caused changes in the alignment between the emitter on the Light Tip and the tiny solar panel on the Lens that captured the light energy. The system required perfect alignment between these components to offer optimal sound quality. Thus, Earlens set out to create a new platform that would enable the same great benefits of direct drive—without the sensitivity to shifts in alignment.
After over 50,000 hours of research and development, Earlens created a novel resonant inductive coupling technology that received FDA clearance in January 2019. This new method of data and power transfer from the Ear Tip to the Lens drastically reduces the sensitivity to misalignment between the Ear Tip and Tympanic Lens components. In an IRB approved human factors study of forty-eight (48) adult users of the existing Earlens Light-Driven Hearing Aid, participants who had reported sound variability with the Photonic system confirmed subjectively that sound variability had been eliminated or significantly improved with use of the Inductive system. Aided gain and word recognition testing results additionally confirmed that the new inductive Earlens Contact Hearing Solution provided the same effectiveness of amplification as the light-driven approach, thus preserving the advantage of direct drive technology.
For data and further discussion of the new inductive technology, read Levy and Dundas, “Clinical Study Functional Comparison of Earlens Contact Hearing Solution with Inductive vs. Light-Driven Coupling.”
Earlens is a privately held medical technology company committed to transforming the hearing experience for millions of people who suffer from hearing loss. The Earlens® Contact Hearing Solution, which uses a small lens placed directly on the eardrum to vibrate and activate a person’s natural hearing system, originally received FDA clearance following a De Novo submission in 2015. Additional FDA clearances were granted in 2016 for wireless streaming to an Apple device, and in 2019 for the second generation of the Earlens technology that utilizes resonant inductive coupling to transmit power and data to the Lens.