# Development of a Micro-Mechanical Insertion Tool with Intraoperative Real-Time Electrophysiological Sensing Control for Cochlear Implantation

> **NIH NIH R44** · IOTAMOTION, INC. · 2020 · $734,723

## Abstract

Project Summary/Abstract. 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 pre...

## Key facts

- **NIH application ID:** 10082146
- **Project number:** 2R44DC017640-03
- **Recipient organization:** IOTAMOTION, INC.
- **Principal Investigator:** Allan Henslee
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $734,723
- **Award type:** 2
- **Project period:** 2019-04-01 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10082146

## Citation

> US National Institutes of Health, RePORTER application 10082146, Development of a Micro-Mechanical Insertion Tool with Intraoperative Real-Time Electrophysiological Sensing Control for Cochlear Implantation (2R44DC017640-03). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10082146. Licensed CC0.

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