Today, congenital or acquired hearing loss affects around 5% (360 million people, of which 32 million are children, WHO, 2015) of the world population and presents significant impact on people’s social, emotional, and economic wellbeing. Deafness is a partial or total inability to hear, and classified as conductive, sensorineural, and mixed deafness. Sensorineural impairment, which represents the majority of the profound deafness, can be restored using cochlear implants (CIs), which electrically stimulate the auditory nerve to repair hearing in people with severe-to-profound hearing loss (>90 dB sound pressure level in both ears). CIs are used for more than 40 years and today implanted in around 500.000 individuals worldwide. However, conventional CIs have major drawbacks such as replacing the entire natural hearing mechanism with electronic hearing, even though most parts of the hearing system (such as the eardrum and ossicles) are operational. Moreover, daily battery recharge/replacement requirement, damage risk of external components especially if exposed to water (shower, rain, swimming, perspiration etc.), aesthetic concerns particularly for children and young adults, limitation in access to some medical examinations and treatments, personal safety and interrupted communication during night time are other critical drawbacks. Therefore, researchers in this area try to eliminate these problems via fully implantable, self-powered, and stand-alone cochlear implants.
FLAMENCO project was aimed to develop a fully implantable, low-power, energy harvesting, next generation CI mimicking the natural hearing mechanism of the ear. Fully Implantable Cochlear Implant (FICI) proposed by FLAMENCO has a ground-breaking nature as it revolutionizes the operation principle of the conventional CIs.
In this respect, we developed novel transducers for sound sensing and energy harvesting, and interface electronics for processing the signals generated by these transducers. In parallel, packaging and interconnects were implemented, followed by the integration of sub-units for mechanical, electronic and in-vivo tests. These tests on the sub-units and integrated systems of FICI revealed the achievement of the highest efficiency energy harvesting IC, lowest power consuming sound processing IC; and minimum mass sound sensor achieving the highest voltage output in the literature. We also succeeded in; stimulating auditory system of a deafened guinea pig; and generating intelligible outputs during speech tests. All of these achievements are considered to be significant results for advancing to preclinical validation and performing further R&D aiming at commercialization of FLAMENCO FICI Concept.
In conclusion, we are confident that FLAMENCO has the potential to eliminate the aforementioned concerns for actual CI technology and improve the lives of people with sensorineural impairment by recovering their hearing as good as healthy individuals.