# Vestibular Implantation to Treat Adult-Onset Bilateral Vestibular Hypofunction

> **NIH NIH U01** · JOHNS HOPKINS UNIVERSITY · 2021 · $597,201

## Abstract

Project Summary
 Bilateral loss of vestibular sensation is disabling, with affected individuals suffering chronic disequilibrium,
increased risk of falls, and inability to maintain stable vision during head movements typical of daily life. While
most individuals with milder loss compensate through rehabilitative strategies enlisting other senses, those
with severe loss who fail to compensate have no good therapeutic options. When the vestibular nerves are
anatomically intact, as is true in most such cases, electrical stimuli encoding head rotation can drive nerve
activity and partially restore vestibular sensation, much as a cochlear implant partially restores auditory
sensation. In an on-going first-in-human early feasibility study of six adults disabled by bilateral vestibular
hypofunction after ototoxic hair cell injury, we found that vestibular implantation and motion-modulated
prosthetic stimulation targeting the implanted ear's three semicircular canals is a feasible, safe and effective
treatment for ototoxic loss, as evidenced by directionally-aligned vestibulo-ocular reflexes reliably elicited
during >3 years of continuous use, improvements in objective measures of posture and gait performance, and
improvement of patient-reported dizziness handicap and vestibular-related disability. On the strength of those
results, the United States Food & Drug Administration (FDA) has invited a request for humanitarian device
exemption for treatment of ototoxic loss; however, FDA advised that additional data would be required to
support expanding availability of this treatment to individuals with idiopathic loss, who make up the largest
proportion of bilateral vestibular hypofunction cases. Drawing on a well-established design, intact study team,
and protocol that yielded highly impactful results in the early feasibility study of subjects with ototoxic loss, the
proposed research program will extend this approach to adults disabled by idiopathic adult-onset bilateral
vestibular hypofunction. Results of this research are highly likely to yield broad, sustained impact, either
through support of early regulatory approval (if results of vestibular implantation for treatment of idiopathic loss
are as favorable as the results already obtained for ototoxic loss) or by providing the necessary foundational
data to support design of a subsequent, large-scale pivotal trial of vestibular implantation for idiopathic loss.

## Key facts

- **NIH application ID:** 10190477
- **Project number:** 1U01DC019364-01
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** Charles C Della Santina
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $597,201
- **Award type:** 1
- **Project period:** 2021-04-21 → 2026-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10190477

## Citation

> US National Institutes of Health, RePORTER application 10190477, Vestibular Implantation to Treat Adult-Onset Bilateral Vestibular Hypofunction (1U01DC019364-01). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10190477. Licensed CC0.

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