Otolith Labs

What Otolith Labs does

Otolith Labs, Inc. is a privately held medical device company founded in 2015 and headquartered in Washington, D.C., that is developing a non-invasive prescription wearable headband for the treatment of chronic vertigo and vestibular migraine. The company's core product is built on patented non-invasive Vestibular Resonance Therapy (nVRT) technology, which uses precisely calibrated bone-conducted vibrations to deliver localized mechanical stimulation to the inner ear's vestibular system. Founder Sam Owen, the first-named inventor on nine U.S. patent publications, discovered a narrow range of therapeutic signals interacting with the vestibular system in 2015, and the company has been granted multiple patents covering both the signal range and the wearable device design. The device has been tested on over 600 subjects with zero reportable serious device-related adverse events, and in one clinical study 87.5% of 40 participants reported vertigo symptom reduction within five minutes of activation.

The company is pursuing a hardware-sales business model as a prescription-only medical device distributed through physicians; it received FDA Breakthrough Device Designation in June 2021, ISO 13485 certification in 2022, and is preparing for FDA De Novo filing and U.S. commercial launch in 2025. Otolith is pre-revenue with respect to product sales; the only disclosed income to date is approximately $2 million in non-sales Department of Defense research grants. The company has raised approximately $23.3 million in venture funding across a seed round (June 2021, $3.3M led by Mark Cuban's Radical Investments) and a Series A (September 2022, $20M led by Morningside Ventures). Go-to-market is being built around an enterprise field-sales motion targeting prescribers, supported by a medical advisory board spanning leading vestibular programs at UCSF, Stanford, Duke, University of Miami, and the University of Kansas, with the company currently raising a new financing round to fund launch.

Adjacent use cases are being validated beyond the core vestibular migraine indication: the technology was validated by Land Rover Jaguar in 2018 for motion sickness, has been studied with the U.S. Air Force and Ford, and a February 2025 peer-reviewed publication in Frontiers demonstrated effectiveness for cybersickness from virtual reality. Strategic and clinical partners include VeDA (Industry Advisory Council), Georgetown University, MUSC, and the University of Newcastle. The current executive team — comprising CEO Dan Wagner (formerly CCO at Olympus, Spark Biomedical, HeartSciences, and Signature Biologics), Chief Clinical Officer Kevin Franck (formerly SVP at Frequency Therapeutics, head of marketing at Bose Hear, faculty at Harvard Medical School), CTO/Co-Founder Jon Akers, and CSO/Co-Founder Didier Depireux — reflects a build-out for commercial scale rather than continued research-only operations.

Name

Otolith Labs

Legal name

Otolith Labs, Inc.

Website

https://otolithlabs.com

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

11–50 employees

Short description

Otolith Labs is a Washington, D.C.-based medical device company developing a patented, non-invasive wearable headband (nVRT technology) that uses bone-conducted vibrations to treat chronic vertigo and vestibular migraine, with FDA Breakthrough Device Designation and a planned 2025 U.S. commercial launch via physician prescription.

Ownership category

akta.pro rank

Product category

Vestibular Medical Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

Electromedical & Electrotherapeutic Apparatus (3845)

akta.pro primary industry

Vestibular Rehabilitation & Balance Therapy (HSADAIAF)

Keywords

• Vestibular medical devices
• Vertigo treatment devices
• Wearable therapeutic devices
• Vestibular migraine therapy
• Bone conduction therapy

Headquarters

HQ city

Washington

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Others

Revenue model

1. Medical Device Sales: Otolith Labs is developing a prescription wearable medical device for treating chronic vertigo. The company has generated nearly $2 million in revenue to date from Department of Defense Research Grants, but this is non-sales related. The primary revenue model will be hardware sales of the wearable device upon FDA approval and commercial launch.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels8 records

Core offering

Otolith Labs develops a prescription wearable medical headband device that delivers non-invasive Vestibular Resonance Therapy (nVRT) through precisely calibrated bone conduction vibrations to stimulate the vestibular system. The device is intended to provide acute treatment for chronic vertigo and vestibular migraine, and is being prepared for U.S. commercial launch in 2025 following FDA Breakthrough Device Designation.

Product overview

Otolith Labs offers a single core product: the Otolith Device, a wearable medical headband that utilizes patented nVRT (non-invasive Vestibular Resonance Therapy) technology. The device provides precision signals through calibrated bone conduction vibrations to the vestibular system, designed to reduce symptoms of chronic vertigo and vestibular migraine. The company has received FDA Breakthrough Device Designation and is pursuing De Novo marketing approval as a prescription device.

Differentiator

Problem solved

Functional benefit

Products and services

• Otolith Device A noninvasive wearable medical headband that delivers non-invasive Vestibular Resonance Therapy (nVRT) through precisely calibrated bone conduction vibrations to stimulate the vestibular system. It is intended as a prescription device for physicians to prescribe for adult patients with chronic vertigo and vestibular migraine. The device has been used on over 600 subjects in clinical studies with zero reportable serious device-related adverse events.

Quantifiable outcome

• 87.5% of 40 participants reported reduction in vertigo symptoms within 5 minutes of turning on the device
• +2 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Eight partnerships are on record, tiered core and minor.

• VeDA (Vestibular Disorder Association)coreStrategic or Co-development Partner · 1 October 2024Otolith joined VeDA's Industry Advisory Council, which brings together organizations that support vestibular healthcare. The IAC offers strategic advice to VeDA's leadership to enhance patient care and advocacy efforts. Otolith is also a proud sponsor of VeDA.
• University of NewcastleminorStrategic or Co-development Partner · 1 January 2020Collaborative research partnership for exploratory study on vestibular stimulation to reduce cybersickness from virtual reality. The study was conducted by Shamus Smith et al. between 2020 and 2021 with 30 healthy individuals recruited.
• FordminorStrategic or Co-development PartnerClinical study partner that has worked with Otolith Labs, demonstrating validation of the technology for motion-related applications.
• U.S. Air ForceminorStrategic or Co-development PartnerClinical study partner collaborating with Otolith Labs on vestibular and motion sensitivity research.
• Land Rover JaguarminorStrategic or Co-development PartnerIn 2018, Land Rover Jaguar validated Otolith's technology in the treatment of motion sickness, demonstrating the technology's applicability for automotive and motion sensitivity applications.
• Georgetown UniversityminorStrategic or Co-development PartnerAcademic partner collaborating with Otolith Labs on vestibular research and clinical studies.
• MUSC (Medical University of South Carolina)minorStrategic or Co-development PartnerAcademic medical center partner working with Otolith Labs on vestibular clinical research.
• UCSF (University of California San Francisco)minorStrategic or Co-development PartnerMedical advisory board member Jeffrey D. Sharon, MD is Director of the Balance and Falls Center at UCSF and has served as principal investigator for vestibular clinical trials.

Scale indicators9 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• Eargo: Hearing health wearables company (first hearing aid to IPO in the U.S.). Board member Raphael Michel co-founded Eargo, providing direct adjacency in ear-related prescription wearables and consumer-driven medical device commercialization.
• Signia (WS Audiology): Major hearing aid manufacturer under WS Audiology. Relevant incumbent adjacent in ear-worn medical devices, with growing focus on integrated balance and fall-detection features that overlap with vestibular care.
• Demant (Oticon): Global hearing healthcare group (Oticon, Bernafon, Sonic, Philips Hearing). Comparable as an incumbent ear-worn medical device incumbent, with vestibular diagnostics and balance-related solutions in portfolio.
• Cochlear Ltd. Global leader in implantable hearing solutions addressing inner-ear disorders. Compares as an incumbent in the inner-ear medical device category where Otolith's leadership has prior experience (Franck at Cochlear).

Others

• Onera Health: Sleep diagnostics and wearable health-tech company co-founded by Board member Raphael Michel. Indirect peer given shared founder-advisor network and overlapping wearable diagnostic medical device space.

Direct peers

• Scion NeuroStim: Develops wearable neurostimulation devices targeting ear-related neurological conditions (notably tinnitus). Most direct functional peer given the shared wearable, non-invasive stimulation approach to inner-ear disorders.
• Neurovalens: Develops non-invasive vestibular and trigeminal nerve stimulation devices for medical conditions including vestibular disorders. Comparable in approach (non-invasive neuro-vestibular stimulation) and in stage (pre-commercial/early commercial).

Emerging players

• Sound Pharmaceuticals: Clinical-stage biopharma developing treatments for inner-ear disorders including hearing loss and tinnitus. Relevant adjacent player addressing the same patient population and unmet need in inner-ear therapeutics.
• Frequency Therapeutics: Clinical-stage inner-ear regenerative therapeutics company. Direct adjacency in treating hearing/vestibular loss; Chief Clinical Officer Kevin Franck was SVP of Strategic Marketing and New Product Planning at Frequency.
• Spark Biomedical: Early-stage neurostimulation medical device company (focused on opioid withdrawal and neonatal abstinence). Both are pre-commercial wearable neurostim developers with analogous fundraising and commercialization profiles; CCO Dan Wagner previously led commercial at Spark.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

• Facebookfacebook.com/otolithlabs
• LinkedInlinkedin.com/company/otolith-labs
• Xx.com/OtolithLabs

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Funding overview

Funding rounds6 records

Investors2 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Otolith Labs