SBIR-STTR Award

For many years cochlear devices were primarily powered by zinc-air hearing-aid batteries. However, given the inconvenience, cost and environmental impact due to the replacement and disposal of non-rechargeable zinc-air batteries, the cochlear industry recently introduced rechargeable Li-ion battery powered cochlear devices. While Li-ion battery provides advantages over non-rechargeable zinc-air battery, it is not capable of meeting the demanding requirements of the newest and next generation Behind-the-Ear (BTE) cochlear implants. When powered with Li-ion, these devices would need to be frequently recharged (often more than once a day) and the battery would need to be replaced every year (average battery life of only one year). The cochlear industry is seeking a higher energy density battery (>300 Wh/L) with sufficient charge to power the next generation cochlear device for 1-3 days without recharging, with recharge capability in 5 to 10 minutes and with at least a five year life. FET submits this application to NIH for to develop a 120-mAh rechargeable BTE cochlear battery that will meet these requirements. It will be based on FET's high energy density NanoEnergy(R) thin-film battery technology. In Phase I, we will fabricate individual battery cells and modules (stack of 5 cells) and conduct tests to demonstrate their performance. In Phase II, we will complete the battery by stacking modules and will produce a sufficient quantity of batteries for extensive in-house testing and evaluation by our partner in this effort - a major cochlear device manufacturer. Proposed Commercial Applications: Our initial battery will be designed for BTE cochlear devices, which generate current annual sales of approximately $ 425 million and expected to grow by approximately 20 percent annually. Upon completion of the cochlear demonstration battery, we will pursue other implantable neuromodulation applications, which have current annual sales of $1.6 billion and expected to grow to $10 billion in 10 to 15 years. In addition to neuromodulation applications, our battery technology will be suitable for developing rechargeable batteries for hearing aids, currently estimated to be a $5 billion dollar industry.

Thesaurus Terms:
Medical device power source, thin-film battery, lithium battery, cochlear implant, neurostimulator power source, neuromodulation battery, hearing aid battery.

Public Health Relevance:
The energy-density and life of currently-available rechargeable batteries are inadequate to meet the challenging power requirements of next generation cochlear implants, hearing aids and neuromodulation systems. NanoEnergy(R), Front Edge Technology's (FET) rechargeable, thin-film, lithium battery technology is enabling technology for meeting these demanding power requirement.

Public Health Relevance Statement:
Project Narrative The energy-density and life of currently-available rechargeable batteries are inadequate to meet the challenging power requirements of next generation cochlear implants, hearing aids and neuromodulation systems. NanoEnergy(R), Front Edge Technology's (FET) rechargeable, thin-film, lithium battery technology is enabling technology for meeting these demanding power requirement.

NIH Spending Category:
Assistive Technology; Bioengineering; Prevention; Rehabilitation.

Project Terms:
Air; Arts; base; Cells; Charge; Cochlear Implants; commercial application; Consensus; cost; Custom; design; Development; Devices; Dimensions; Ear structure; energy density; Environmental Impact; Evaluation; evaluation/testing; Film; Funding; Generic Drugs; Goals; Government; Hearing Aids; Hour; Housing; improved; Individual; Industry; Ions; Letters; Life; Life Cycle Stages; Lithium; Manufacturer Name; Marketing; Medical Device; meetings; neuroregulation; next generation; Performance; Persons; Phase; Power Sources; public health relevance; Relative (related person); Research; Sales; solid state; System; Technology; Testing; Thesauri; Thick; Time; United States National Institutes of Health; Work; Zinc

Hearing loss is the number one disability in the world. There are currently over eight million Americans that wear hearing aids and approximately 200,000 cochlear implants in use worldwide. For many years, hearing aids and cochlear devices were primarily powered by disposable zinc-air batteries. However, given the inconvenience, cost and environmental impact due to the replacement and disposal of non-rechargeable zinc-air batteries, the cochlear industry and hearing aid industry are actively developing rechargeable battery powered devices. Front Edge Technology is proposing to develop a new type of rechargeable battery for Behind-the-Ear (BTE) cochlear implants and for BTE hearing aids. Compared to the existing state-of-the-art products, the proposed battery has twice the energy density, three times the battery life, and one quarter of the recharge time. More importantly, the proposed battery will have the highest safety standard, which is crucial to a head-worn hearing device. In the Phase I work, FET has demonstrated a 12-mAh battery with a footprint suitable for BTE devices. Phase I results also demonstrated greater than 500 Wh/L in energy density, recharge in one hour, and good capacity retention after cycling. In Phase II, we will further develop a 110-mAh battery in the same footprint. This battery will have innovative safety structures integrated at the cell level so that in any abusive conditions, the battery surface temperature will not exceed 50oC. Phase II work will also demonstrate a 12.5-mAh hearing aid battery with the same dimensions as a size-13 Zn-air battery. Successful development of the proposed batteries will have major contributions in the development of smaller and better next generation cochlear implant BTE devices and hearing aids. The high expected maturity of the battery at the end of the Phase II program will facilitate a quick commercialization of the new batteries.

Public Health Relevance:
The energy-density, service life, and safety of currently available rechargeable batteries are inadequate in meeting the challenging power requirements of next generation cochlear implants and hearing aids. Front Edge Technology's proposed high-energy thin-film battery will enable the development of smaller and better hearing devices.

Thesaurus Terms:
Adopted;Air;American;Auditory Prosthesis;Calendar;Caliber;Cells;Characteristics;Charge;Cochlear Implants;Cochlear Prosthesis;Contracting Opportunities;Contracts;Development;Devices;Diameter;Dimensions;Ear;Ear Structure;Ecological Impact;Environmental Impact;Explosion;Film;Goals;Head;Hearing;Hearing Aids;Hearing Loss;Hour;Hypoacuses;Hypoacusis;Impact, Environmental;Industry;Ions;Letters;Li+ Element;Life;Life Cycle;Life Cycle Stages;Lithium;Nih;National Institutes Of Health;National Institutes Of Health (U.S.);Phase;Programs (Pt);Programs [publication Type];Sbir;Sbirs (R43/44);Safety;Services;Small Business Innovation Research;Small Business Innovation Research Grant;Structure;Surface;Technology;Temperature;Thick;Thickness;Time;United States National Institutes Of Health;Work;Zinc;Zn Element;Commercialization;Cost;Disability;Energy Density;Hearing Impairment;Hearing Perception;Improved;Innovate;Innovation;Innovative;Life Course;Meetings;Next Generation;Programs;Solid State;Sound Perception