SBIR-STTR Award

While the Cochlear Implant (CI) has traditionally been used to treat patients with severe to complete hearing loss, recent advances have now made the CI a treatment option for people with moderate hearing levels who previously did not qualify for a traditional CI. These hearing preservation approaches attempt to preserve the patient's residual hearing following CI surgery. However, studies have suggested that trauma to the cochlea during electrode insertion results in damage to delicate inner ear structures, and up to 50% of patients experience delayed hearing loss following surgery that results in a diminished quality of life.1 Additionally, recent studies suggest that trauma to the cochlea occurring during electrode insertion may be correlated with changes in Electrocochleography (ECochG) readings taken from the cochlea. In this SBIR, iotaMotion aims to develop an insertion tool that couples cochlear implant ECochG measurements to a micromechanical control system that will assist the surgeon to sense, predict, and mitigate cochlear insertion trauma in real-time during electrode insertion. The anticipated impact of this technology will be to improve short and long-term hearing outcomes for CI patients by enhancing “hearing preservation” cochlear implantation. The project will develop a functional prototype with insertion control algorithms for a “smart” insertion tool and then evaluate the system's feasibility in a pilot animal study via the following three aims:1) Develop a Working Benchtop Prototype of a Real-Time Intracochlear Damage Monitoring and Insertion Tool. The first stage of development will comprise the design, fabrication, and testing of the device in a laboratory setting; demonstrating that the insertion tool can be controlled and regulated by the novel hardware and software inputs. 2) Evaluate the control system EcochG feedback sensitivity and reliability with motion control algorithms that utilize real-time feedback to prevent intracochlear damage. Aim 2 will develop several firmware control algorithms that detect ECochG changes with a feedback loop to the control console and motor unit for micromechanical motion adjustments. This will help determine the relationship between ECochG readings and electrode movement within the cochlea. 3) Demonstrate proof of concept capability to assist the surgeon during electrode insertion based on real time ECochG feedback in pilot large animal study. The final specific aim will evaluate the prototype device in vivo with a pilot animal model. The ability of the device to sense and mitigate ECochG changes through motion adjustments will be validated. Ultimately, the success of Phase I will allow development of this insertion system to progress to a second iteration of the design (based on the knowledge gained in Phase I) and further in vivo testing to establish the efficacy of the device as compared to the current gold standard of implantations. SBIR funding will help secure additional outside investment and bring us closer to commercializing this much needed treatment for people suffering from disabling hearing loss.

Public Health Relevance Statement:


Project narrative:
Despite the many advances in cochlear implant technology, recent clinical trials have found that up to 50% of patients who undergo “hearing preservation” cochlear implant surgery can experience continued hearing decline after surgery; likely due to intracochlear trauma experienced during electrode insertion. To address this issue, iotaMotion aims to develop an insertion tool that couples cochlear implant ECochG measurements to a micromechanical control system to aid the surgeon in sensing, predicting, and mitigating cochlear insertion trauma in real-time during electrode insertion. This SBIR Phase I project will develop a working prototype and demonstrate the capability of the device in an in vivo model; thereby establishing the feasibility for continued development and commercialization to eventually reduce the incidence of residual hearing loss for the millions who are candidates for receiving cochlear implants.

Project Terms:
Address; Algorithms; Animal Model; Animals; base; Clinical Trials; Cochlea; Cochlear implant procedure; Cochlear Implants; commercialization; Complete Hearing Loss; Computer software; Couples; design; Development; Devices; Electrocochleographies; Electrodes; Electrophysiology (science); experience; Feedback; Funding; Goals; Gold; Grant; Hearing; hearing impairment; hearing preservation; Implant; implantation; improved; in vivo; in vivo evaluation; in vivo Model; Incidence; interest; Investments; Knowledge; Laboratories; Labyrinth; Manuals; Measurement; Measures; Mechanics; Molecular; Monitor; Motion; Motor; Movement; novel; Operative Surgical Procedures; Outcome; Patients; Performance; Phase; preservation; prevent; Privatization; prototype; Quality of life; Reading; Residual state; Resistance; robot control; Secure; Sheep; Signal Transduction; Small Business Innovation Research Grant; Structure; success; Surgeon; System; Technology; Testing; Time; tool; Trauma

One of the more recent goals of cochlear implant (CI) surgery is the preservation of residual hearing to improve overall patient outcomes. Unfortunately, up to 50% of patients experience delayed residual hearing loss following cochlear implant surgery, resulting in a diminished quality of life. To address this issue, iotaMotion is developing an insertion system to assist surgeons in performing controlled and consistent CI electrode insertions as well as to monitor the electrocochleography (ECochG) readings taken from the cochlea during CI electrode insertion, which have been shown to indicate cellular damage and residual hearing loss. The system controls the rate of electrode array insertion and responds in real time to ECochG feedback received from the cochlear tissues via a feedback loop. In Phase I, a working benchtop prototype was developed and the system response to ECochG signals was demonstrated in both benchtop and large animal in vivo proof-of-concept studies. Control algorithms were also developed as part of the feedback loop to the insertion system’s motor unit. Continuing with these results, the goals of this proposed Phase II SBIR project are to: 1) Improve System Usability and Enhance Use Features. With the goal of continuing to improve the prototype developed in Phase I, Aim 1 work will improve system fidelity, incorporate real-time impedance checks, integrate the system into an easy-to-use tablet for use in the OR, and evaluate usability. 2) Establish Manufacturing and Quality Controls. The supply chain and manufacturing and quality procedures to verify/validate system safety and reliability will be implemented using relevant standards and FDA guidance to define testing procedures. The electrical safety, sterility, biocompatibility, functionality, and data security testing of production-level devices that will be used for pre-clinical studies and commercialization will be performed. 3) Evaluate In Vivo Efficacy of the Combined System. The system will be evaluated in an acute in vivo model of cochlear implantation. By comparing usage of the system to the current gold standard of manual CI electrode insertions, iotaMotion will evaluate the system’s ability to monitor ECochG signals from the cochlea and will confirm that the system induces no increases in scalar translocations or OSL fractures when compared to manual insertions as assessed by 3D X-ray microscopy. 4) Perform Observational Clinical Study. As part of the regulatory strategy, the ability of the ECochG monitoring system to collect reliable and significant ECochG signals in an observational clinical study will be evaluated. Completion of these Phase II Aims will set the stage for the development and production of the system in a GMP environment and execution of a prospective clinical trial designed to establish safety and efficacy in humans. We envision the data collected to comprise the basis for the Device History Record that will be used to prepare for first-in-man studies. This Phase II funding will help secure additional company investment and will move us much closer to commercializing this much-needed treatment for people suffering from disabling hearing loss.

Public Health Relevance Statement:
Project Narrative Despite the many advances in cochlear implant technology, recent clinical trials have found that up to 50% of patients who undergo “hearing preservation” cochlear implant surgery can experience continued hearing decline after surgery—likely due to intracochlear trauma experienced during electrode insertion. To address this issue, iotaMotion has developed an insertion tool that couples cochlear implant ECochG measurements to a micromechanical control system to aid the surgeon in sensing, predicting, and mitigating insertion trauma during an electrode insertion. This SBIR Phase II project will allow major further advances to be made with this novel tool that, when commercialized, will significantly reduce the incidence of residual hearing loss for the millions who are candidates for receiving cochlear implants.

Project Terms:
3-Dimensional; Acoustic Stimulation; Acute; Address; Algorithms; Animals; base; biomaterial compatibility; cell injury; Clinical Research; Clinical Trials; Clinical Trials Design; Cochlea; Cochlear implant procedure; Cochlear Implants; commercialization; Computer software; Couples; Data; Data Security; design; Development; Devices; electric impedance; Electrocochleographies; Electrodes; Electrophysiology (science); Environment; experience; Feedback; first-in-human; Floor; Fracture; Funding; Goals; Gold; Hearing; hearing impairment; hearing preservation; Human; Implant; Implanted Electrodes; improved; in vivo; in vivo Model; Incidence; Investments; Labyrinth; Letters; Manuals; manufacturability; Measurement; Mechanics; microphone; Modeling; Monitor; Motion; Motor; Noise; novel; Operative Surgical Procedures; Patient-Focused Outcomes; Patients; Performance; Phase; preclinical study; preservation; Procedures; Production; prospective; prototype; Quality Control; Quality of life; Reading; Recording of previous events; Residual state; response; Safety; Secure; Sheep; Signal Transduction; Small Business Innovation Research Grant; Sterility; Structure; Surgeon; System; Tablets; Techniques; Technology; Testing; Time; Tissues; tool; Trauma; usability; Validation; Wireless Technology; Work; X ray microscopy