Periodic Reporting for period 1 - OptoWavePro (Near natural hearing restoration through waveguide-based optical cochlear implants)
Berichtszeitraum: 2024-04-01 bis 2025-03-31
The OptoWavePro project aims to develop an optical cochlear implant (oCI) that can restore near-natural hearing in profoundly hearing-impaired and deaf patients. This innovative technology has the potential to significantly improve the quality of life for millions of people worldwide. The project builds on the results of the ERC-funded OptoHear research, which demonstrated the feasibility and efficacy of optogenetic stimulation applied to spiral ganglion neurons.
The oCI technology uses a combination of micro-scale light emitter technology and expression of channelrhodopsins (ChRs), light-gated ion channels, in the auditory nerve to directly stimulate the auditory nerve through focused light. This approach bypasses the dysfunctional or absent sensory hair cells, allowing for precise neural control and near-natural hearing restoration. The project's objectives are to increase the optical channel count to 64, improve the laser diode array, and develop a transparent sapphire window for hermetic sealing.
The OptoWavePro project will contribute to the development of a revolutionary new technology that has the potential to transform the lives of millions of people worldwide. The project's impact will be significant, as it will provide a new treatment option for profoundly hearing-impaired and deaf patients. The oCI technology has the potential to restore near-natural hearing, improving the quality of life for patients and their families.
The oCI technology uses a combination of micro-scale light emitter technology and expression of channelrhodopsins (ChRs), light-gated ion channels, in the auditory nerve to directly stimulate the auditory nerve through focused light. This approach bypasses the dysfunctional or absent sensory hair cells, allowing for precise neural control and near-natural hearing restoration. The project's objectives are to increase the optical channel count to 64, improve the laser diode array, and develop a transparent sapphire window for hermetic sealing.
The OptoWavePro project will contribute to the development of a revolutionary new technology that has the potential to transform the lives of millions of people worldwide. The project's impact will be significant, as it will provide a new treatment option for profoundly hearing-impaired and deaf patients. The oCI technology has the potential to restore near-natural hearing, improving the quality of life for patients and their families.
The core technical objective of OptoWavePro is to create a fully functional prototype of an optical cochlear implant that can restore more natural hearing in people with severe hearing loss. The work focuses on integrating three key components into a compact implant: a high-density laser diode array, custom microlens arrays for directing laser beams, and biomedical-grade polymer waveguides that deliver light to targeted neurons in the cochlea. These are assembled into a robust hermetic titanium package designed to meet clinical and surgical requirements.
Modulight leads development of custom flip-chip laser arrays, each with up to 64 emitters spaced at 100 micrometers. The design ensures efficient coupling into optical channels, producing narrow beams while minimizing heat and stray light. Alternative top-side mounting options have been explored to improve reproducibility and reduce fabrication risks.
Efficient light delivery requires advanced incoupling optics. The team designed fused silica microlens arrays, each lens paired with a laser diode to collimate and focus light into millimeter-scale waveguides. A bi-convex geometry optimizes alignment and minimizes crosstalk. Automated alignment tools enable micron-level precision during assembly. Optical simulations confirmed the chosen setup balances efficiency, uniformity, and manufacturability.
Polymer waveguide development centers on biocompatible Parylene, suited for long-term implantation. Researchers used both direct patterning and wafer-scale casting to enable mass production. The waveguides incorporate features like slanted mirrors and total internal reflection prisms to redirect red light along the cochlea toward optogenetically sensitized neurons. Early process optimization included material testing, surface roughness analysis, and refractive index measurements to ensure optical clarity, mechanical resilience, and reliable channel isolation.
Integrating the optical and electronic components into a clinical-grade device required extensive engineering. The titanium case incorporates a sapphire window, gold-brazed to a titanium flange, ensuring both high light transmission and hermetic sealing. Its design includes a flat return, step structure, and dimensional tolerances to support automated assembly. Hermeticity and photometry tests validated the feedthrough, while internal titanium posts protect sensitive optical components from shock and vibration.
In summary, OptoWavePro has achieved major milestones: Validated laser arrays, microlens systems, and high-performance waveguides, all integrated into a sealed clinical package. Combined with preclinical validation, digital quality control, and ongoing regulatory planning, the project is well positioned to move toward clinical translation and market impact.
Modulight leads development of custom flip-chip laser arrays, each with up to 64 emitters spaced at 100 micrometers. The design ensures efficient coupling into optical channels, producing narrow beams while minimizing heat and stray light. Alternative top-side mounting options have been explored to improve reproducibility and reduce fabrication risks.
Efficient light delivery requires advanced incoupling optics. The team designed fused silica microlens arrays, each lens paired with a laser diode to collimate and focus light into millimeter-scale waveguides. A bi-convex geometry optimizes alignment and minimizes crosstalk. Automated alignment tools enable micron-level precision during assembly. Optical simulations confirmed the chosen setup balances efficiency, uniformity, and manufacturability.
Polymer waveguide development centers on biocompatible Parylene, suited for long-term implantation. Researchers used both direct patterning and wafer-scale casting to enable mass production. The waveguides incorporate features like slanted mirrors and total internal reflection prisms to redirect red light along the cochlea toward optogenetically sensitized neurons. Early process optimization included material testing, surface roughness analysis, and refractive index measurements to ensure optical clarity, mechanical resilience, and reliable channel isolation.
Integrating the optical and electronic components into a clinical-grade device required extensive engineering. The titanium case incorporates a sapphire window, gold-brazed to a titanium flange, ensuring both high light transmission and hermetic sealing. Its design includes a flat return, step structure, and dimensional tolerances to support automated assembly. Hermeticity and photometry tests validated the feedthrough, while internal titanium posts protect sensitive optical components from shock and vibration.
In summary, OptoWavePro has achieved major milestones: Validated laser arrays, microlens systems, and high-performance waveguides, all integrated into a sealed clinical package. Combined with preclinical validation, digital quality control, and ongoing regulatory planning, the project is well positioned to move toward clinical translation and market impact.
OptoWavePro has reached key technical and scientific milestones that position it at the forefront of next-generation hearing restoration. A major achievement is the design and testing of a 64-channel optical waveguide, ready for integration with laser diode and microlens arrays. The system is housed in a hermetically sealed titanium package with a sapphire optical feedthrough, ensuring safety and long-term stability for potential human implantation.
These early results suggest strong potential to transform cochlear implants, enabling more natural hearing—especially in noisy environments or with complex sounds like music. This could improve rehabilitation speed and quality of life for the deaf or severely hearing-impaired, while also laying the foundation for broader neuroprosthetic applications.
To realise clinical and commercial impact, larger-scale and long-term preclinical trials are needed to confirm safety and efficacy. Human studies will require improved device reliability, surgical handling, and rehabilitation protocols. Substantial public and private funding will be critical for further development, regulatory approval, and market entry.
Success also depends on engaging healthcare authorities, payers, and cochlear implant manufacturers, and aligning with regulatory and standardisation frameworks for combined device and gene therapy products.
IP protection efforts are underway, with the first patent filed on waveguide lenses. Maintaining international IP rights will support competitiveness, investor confidence, and cross-border collaboration.
In summary, OptoWavePro is demonstrating technical feasibility and regulatory readiness. Continued research, partnerships, and investment are essential for scaling up and reaching the market.
These early results suggest strong potential to transform cochlear implants, enabling more natural hearing—especially in noisy environments or with complex sounds like music. This could improve rehabilitation speed and quality of life for the deaf or severely hearing-impaired, while also laying the foundation for broader neuroprosthetic applications.
To realise clinical and commercial impact, larger-scale and long-term preclinical trials are needed to confirm safety and efficacy. Human studies will require improved device reliability, surgical handling, and rehabilitation protocols. Substantial public and private funding will be critical for further development, regulatory approval, and market entry.
Success also depends on engaging healthcare authorities, payers, and cochlear implant manufacturers, and aligning with regulatory and standardisation frameworks for combined device and gene therapy products.
IP protection efforts are underway, with the first patent filed on waveguide lenses. Maintaining international IP rights will support competitiveness, investor confidence, and cross-border collaboration.
In summary, OptoWavePro is demonstrating technical feasibility and regulatory readiness. Continued research, partnerships, and investment are essential for scaling up and reaching the market.