Objective Ear Infection Detection at the Point of Care.
OtoNexus is developing an AI-enabled ultrasound otoscope designed to reduce diagnostic uncertainty, support antibiotic stewardship, and improve clinical decision-making during ear infection evaluations.
Key Highlights
Selected for U.S. FDA Safer Technologies Program (STeP) Learn more.
2-second scan workflow for frontline settings
Razor/razorblade economics: Device + single-use tips.
Early clinical work at leading institutions supports ongoing development.
The OtoNexus Solution
Unmet Need:
Diagnosing middle ear infections remains challenging because clinicians often rely on subjective visual assessment, which can contribute to diagnostic variability.
Clinical Value:
Provides objective assessment of middle ear conditions at the point of care to support clinical decision-making, improve diagnostic confidence, and promote the judicious use of antibiotics.
System Value:
Objective ear infection assessment can help address diagnostic uncertainty, support antibiotic stewardship, improve clinical decision-making, and reduce the healthcare burden associated with otitis media.
How the Technology Works
The OtoNexus ultrasound otoscope is designed to provide objective information about middle ear conditions during a routine ear examination. Using proprietary through-air ultrasound technology and AI-assisted analysis, the system is intended to help clinicians better evaluate middle ear effusion and support more informed treatment decisions in seconds.
Frequently Asked Questions
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An ultrasound otoscope is a diagnostic device that uses ultrasound technology to evaluate conditions within the middle ear. Unlike traditional otoscopy, which relies primarily on visual inspection of the eardrum, ultrasound can provide objective information about the presence and characteristics of middle ear fluid.
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Diagnosing middle ear infections often depends on visual examination of the eardrum and interpretation of clinical symptoms. This process can be subjective and may vary among healthcare providers, contributing to diagnostic uncertainty and differences in treatment decisions.
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Middle ear effusion is the presence of fluid behind the eardrum. It commonly occurs during or after ear infections and can be an important factor in determining appropriate patient management and treatment.
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The OtoNexus ultrasound otoscope uses proprietary through-air ultrasound technology to assess middle ear conditions. Advanced algorithms analyze the collected data and return objective information during the patient visit to support clinical decision-making.
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The OtoNexus system is designed to provide objective information within seconds as part of a routine ear examination workflow.
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Objective assessment of middle ear conditions may help clinicians make more informed treatment decisions. Improved diagnostic confidence can support the judicious use of antibiotics and broader antibiotic stewardship efforts.
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Objective assessment may support healthcare professionals who diagnose and manage patients with suspected middle ear infections, including pediatricians, family medicine physicians, urgent care clinicians, and other frontline healthcare providers.
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Traditional ear examinations primarily rely on visual assessment. OtoNexus is developing technology designed to provide additional objective information about middle ear conditions, helping clinicians evaluate patients with greater confidence.
Evidence & Validation
FDA Safer Technologies Program (STeP)
The OtoNexus ultrasound otoscope has been selected for the U.S. Food and Drug Administration's (FDA) Safer Technologies Program (STeP), which facilitates the development and review of certain medical devices that may offer meaningful safety advantages over existing treatment or diagnostic approaches.
Participation in the STeP program supports earlier and more frequent interaction with the FDA, helping align development activities, evidence generation, and regulatory planning throughout the product development process.
For OtoNexus, this designation provides an opportunity to work closely with FDA as we advance technology designed to reduce diagnostic uncertainty in the evaluation of middle ear infections and support more informed treatment decisions.
STeP designation does not represent FDA clearance or approval.
Clinical Significance
Recognition of the technology's potential to address an important healthcare need
Enhanced opportunities for engagement with FDA during development
Improved alignment on clinical evidence and regulatory expectations
Support for a more efficient and predictable development pathway
Key Highlights and Benefits:
Accuracy and clinical insight
Designed to detect the presence of middle ear effusion and help characterize infection type to support appropriate management.
Speed and efficiency at the point of care
Designed to return results in seconds through a simplified, one-button workflow—reducing exam time and supporting timely decision-making during the visit.
Antibiotic stewardship
Intended to help clinicians distinguish cases where antibiotics may be appropriate versus cases more consistent with non-bacterial presentations—reducing avoidable prescribing and improving precision in antibiotic use.
Learn more about our new technology here.
Product Development Achievements:
Patented Technology: Our proprietary application of through-air ultrasound, miniaturized to fit within the tip of an ear speculum, is patented, providing a competitive edge in the market.
Clinical Validation: We have conducted successful clinical studies demonstrating the ultrasound otoscope's high accuracy and reliability, validating its effectiveness.
Strategic Partnerships: We have established collaborations with leading healthcare institutions and organizations to further our development and enhance our market reach.
Market Opportunity
Addressing a Significant Healthcare Need
Otitis media is one of the most common childhood illnesses and a leading reason for pediatric healthcare visits and antibiotic prescriptions. Despite its prevalence, diagnosis often relies on subjective assessment, contributing to diagnostic uncertainty and variation in treatment decisions.
As healthcare systems increasingly prioritize diagnostic accuracy, antibiotic stewardship, and efficient care delivery, there is growing demand for technologies that provide objective information at the point of care.
Opportunity Areas
Improving diagnostic confidence
Supporting more informed treatment decisions
Promoting responsible antibiotic use
Reducing unnecessary follow-up care
Enhancing efficiency in frontline healthcare settings.
Scalable Commercial Model
OtoNexus is developing a device-and-consumable business model in which recurring disposable tip usage scales alongside adoption of the ultrasound otoscope platform.
Team & Governance
OtoNexus is led by an experienced team with backgrounds across medical device development, research and engineering, clinical and regulatory execution, and commercialization. The leadership team is focused on advancing the program through key development and market-readiness milestones and building the organizational capabilities required to support adoption and scale. Learn more about our team here.
Company Focus
OtoNexus is developing a point-of-care approach intended to improve identification and management of middle ear infections by reducing diagnostic uncertainty in frontline settings.
Antibiotic resistance is a significant public health and economic issue, and avoidable antibiotic prescribing remains a meaningful contributor. OtoNexus is focused on addressing one upstream driver—diagnostic ambiguity at the point of care.
For more information, please explore our investor information page or complete the form below to contact us directly.
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Call Us
You can also call us directly at (206) 330-0610.
OtoNexus Medical Technologies is more than just a promising investment; it’s an opportunity to be part of a groundbreaking innovation in medical diagnostics with global implications. Our medical device company is based just outside of Seattle, Washington.
Industry Awards and Recognition
OtoNexus Medical Technologies is honored to have received awards and recognition from Keiretsu Capital (Most Valued Company), Keiretsu Forum MidAtlantic (Most Valued Company), Keiretsu Forum Northwest (Most Valued Company), Red Herring (Top 100 North America) Angel Capital Association (Most Investable Company), Puget Sound Business Journal (Washington’s 100 Best Workplaces), MedTech Outlook (Top 10 Infection Control Solution Providers), MedTech Outlook (Top Provider 2024), MedTech Strategist (Startups to Watch), Silicon Review (Innovative Companies to Watch) and Women Corporate Directors (Winner Launch Zone). Please see the full details in our website NEWS.
Support and Non-Dilutive Funding
OtoNexus Medical Technologies has received grants and/or support from the following institutions and groups: National Institutes of Health, National Science Foundation, State of Washington, Life Sciences Discovery Fund, Southwest Pediatric Device Consortium, Philadelphia Pediatric Medical Device Consortium, MedTech Innovator, Advanced Medical Technology Association, Future in Review, Consortium for Technology and Innovation in Pediatrics
