# Supplement to Assess the MRI Safety of an Intracranial Auditory Nerve Implant

> **NIH NIH UG3** · UNIVERSITY OF MINNESOTA · 2020 · $108,320

## Abstract

Project Summary
The proposed ANI funded by the parent grant (1UG3NS107688-01) is a new central auditory prosthesis that
targets the auditory nerve to substantially improve hearing performance (tonal range and resolution) over the
current standard cochlear implant by interfacing directly with the auditory nerve.
The funded parent grant supports the development and all necessary biocompatibility, safety and functional pre-
clinical testing required to obtain an FDA Investigative Device Exemption (IDE) for the first in human
demonstration in the UH3 part of the project. Since the start of the project in October 2018 it has become clear
through discussions with the surgical team as part of the ongoing cadaver studies and a new FDA guidance on
MRI compatibility for implantable devices, that a) having the ability to carry out an MRI in a human subject without
the need to surgically remove the electrode would after all be highly desirable if not necessary, given the selected
patient group(s) and b) that third party safety testing according to the new guidance is required to satisfy the
need for highest possible safety for the study participants. These additional tasks were not anticipated or
budgeted for in the original proposal. While the majority of regulatory, GMP and fabrication costs can be
absorbed or are not affected by this additional task, the cost for the specific test devices and the third-party MRI
testing provider would need to be added to the current budget through an administrative supplement. The third-
party cost would be an overhead exempt pass through cost.
The supplement project will evaluate potential safety hazards in patients with ANI devices for 1.5 and 3 T MRI
systems through simulation and testing. This data will be provided to the FDA as part of the future IDE application
and to BfArM for approval for use in the ANI clinical trial in Hannover, Germany. Based on a preliminary
assessment, we anticipate that the generated data would support that the device can be considered conditionally
MRI safe. If the full system is considered not MRI safe, then we can cut the cable and remove the stimulator
module which only requires a superficial surgery and not the more invasive intracranial surgery to remove the
electrode and assembly, assuming that the latter is passing the MRI safety testing. It will however stop the ability
of patients to continue to participate in the study and to generate data. Only if the system and the electrode
assembly are both considered MRI unsafe, would a full removal surgery be required. Beyond the specific need
for this project, the supplement project will generate important safety, reliability and functionality data that can
properly inform the design of a future clinical ANI devices and products at an early stage in the development
cycle. The ability to allow MRI imaging in patients with chronic neuromodulation implants is seen as a critical
potential barrier to widespread use.

## Key facts

- **NIH application ID:** 10157112
- **Project number:** 3UG3NS107688-02S1
- **Recipient organization:** UNIVERSITY OF MINNESOTA
- **Principal Investigator:** Robert Kyle Franklin
- **Activity code:** UG3 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $108,320
- **Award type:** 3
- **Project period:** 2018-09-30 → 2022-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10157112

## Citation

> US National Institutes of Health, RePORTER application 10157112, Supplement to Assess the MRI Safety of an Intracranial Auditory Nerve Implant (3UG3NS107688-02S1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10157112. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*