Device is ready for use by commercial partners
CAMBRIDGE, MA – Approximately 15 percent of U.S. adults suffer from hearing loss; its impact can be devastating. In addition to trouble communicating and enjoying daily life, those who deal with the condition commonly report difficulty focusing and making decisions, anxiety that people are talking behind their back, and loss of self-esteem. While researchers are developing drugs potentially capable of treating hearing loss, they often encounter difficulty demonstrating preclinical efficacy due to uncertainty regarding concentration of the medication at the intended delivery site to prove that it is responsible for observed changes in hearing.
Draper engineers, in collaboration with clinicians and scientists at Massachusetts Eye and Ear, have developed a device capable of delivering drugs directly to the cochlea—an area of the inner ear difficult to reach with injections and systemic drug delivery—that also can be used to sample drug concentration in the cochlea, a key step toward securing FDA approval.
“Hearing loss drugs hold the potential to restore the natural sense of hearing, but preclinical measurements of drug concentrations in the inner ear will be critical in demonstrating that the drug is responsible for observed hearing changes prior to human trials,” said Jeff Borenstein, Draper’s principal investigator for the intracochlear drug delivery device.
Other approaches generally deliver drugs to treat hearing loss through the middle ear, which relies on indirect transport to the inner ear and may require repeat injections. Draper’s device, developed with funding from the NIH through its National Institute on Deafness and Other Communication Disorders (NIDCD), builds on the company’s expertise in precision instrumentation and microsystems in concert with Mass. Eye and Ear’s world-leading expertise in the molecular biology and clinical aspects of hearing loss. The device is capable of delivering one or more drugs in an automated, timed sequence directly into the fluid of the inner ear. Draper’s device also features a reciprocating delivery cycle that keeps the volume of inner ear fluid constant while mixing in the drug, which is intended to increase the treatment’s safety and efficacy.
“Ultimately, this device should be useful for delivering drugs where and when they are needed, in a concentration where they can be effective, and without unwanted systemic side effects,” said Sharon Kujawa, director of audiology research at Mass. Eye and Ear. “Some of the most promising future treatments may require the delivery of combinations of drugs in a timed and sequenced manner to be effective, and these requirements will not easily be met with systemic delivery. With the local, intracochlear delivery provided by this device, it should be possible to take advantage of present and future breakthroughs in hearing loss treatment and prevention with the potential to benefit our patients with hearing loss.”
During recent testing designed and executed in collaboration with Mass. Eye and Ear, Draper replaced the commercially available actuator used in earlier tests with custom designed hardware that is more precise and smaller, making it simpler to implement in animal models. Borenstein and his Mass. Eye and Ear colleagues including Kujawa published results of their recent work in the peer-reviewed journal Lab on a Chip.
In addition to improving confidence in results from preclinical trials, a wearable version of the device could be available in the near future to treat patients who experience hearing loss as a side effect to medications like cisplatin, a chemotherapy drug, or tobramycin, which is used to treat cystic fibrosis, Borenstein said.
Draper continues to develop its expertise in designing, characterizing and processing materials at the macro-, micro- and nanoscales. Understanding the physical properties and behaviors of materials at these various scales is vital to exploit them successfully in designing components or systems. This enables the development and integration of biomaterials, 3D printing and additive manufacturing, wafer fabrication, chemical and electrochemical materials and structural materials for application to system-level solutions required of government and commercial sponsors.
Draper’s Biomedical Solutions capability centers on the application of microsystems, miniaturized electronics, computational modeling, algorithm development and image and data analytics applied to a range of challenges in healthcare and related fields. Draper fills that critical engineering niche that is required to take research or critical requirements and prototype or manufacture realizable solutions. Some specific examples are MEMS, microfluidics and nanostructuring applied to the development of wearable and implantable medical devices, organ-assist devices and drug-delivery systems. Novel neural interfaces for prosthetics and for treatment of neurological conditions are being realized through a combination of integrated miniaturized electronics and microfabrication technologies.
Draper has designed and developed microelectronic components and systems going back to the mid-1980s. Our integrated, ultra-high density (iUHD) modules of heterogeneous components feature system functionality in the smallest form factor possible through integration of commercial-off-the-shelf (COTS) technology with Draper-developed custom packaging and interconnect technology. Draper continues to pioneer custom Microelectromechanical Systems (MEMS), Application-Specific Integrated Circuits (ASICs) and custom radio frequency components for both commercial (microfluidic platforms organ assist, drug development, etc.) and government (miniaturized data collection, new sensors, Micro-sats, etc.) applications. Draper features a complete in-house iUHD and MEMS fabrication capability and has existing relationships with many other MEMS and microelectronics fabrication facilities.
Draper develops precision instrumentation systems that exceed the state-of-the-art in key parameters (input range, accuracy, stability, bandwidth, ruggedness, etc.) that are designed specifically to operate in our sponsor’s most challenging environments (high shock, high temperature, radiation, etc.). As a recognized leader in the development and application of precision instrumentation solutions for platforms ranging from missiles to people to micro-Unmanned Aerial Vehicles (UAVs), Draper finds or develops state-of-the-art components (gyros, accelerometers, magnetometers, precision clocks, optical systems, etc.) that meet the demanding size, weight, power and cost needs of our sponsors and applies extensive system design capabilities consisting of modeling, mechanical and electrical design, packaging and development-level testing to realize instrumentation solutions that meet these critical and demanding needs.