Bringing Objective Insight to the Ear Exam

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.

Investigational device. Not cleared by the FDA. Not available for commercial sale.

Child getting his ears examined by a medical professional in a clinic setting.

Key Highlights

Objective Ear Infection Assessment

  • Designed to provide objective information about middle ear fluid conditions during the patient visit.

Diagnostic Confidence

  • Supports clinical decision-making by reducing uncertainty in evaluating middle ear infections.

Antibiotic Stewardship

  • Promotes more informed treatment decisions and responsible antibiotic use.

Evidence and Validation

  • FDA STeP designation, clinical validation efforts, strategic partnerships, and a growing intellectual property portfolio support the development of objective diagnostic technology.

Addressing the Information Gap in the Ear Exam

The Challenge:

Visual examination provides limited information about conditions behind the eardrum.

The Information Gap:

Clinicians need additional objective information during the examination.

The OtoNexus Approach:

OtoNexus is developing through-air ultrasound and AI-assisted analysis to supplement the ear exam.

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.

A step-by-step infographic explaining the process of using an ear otoscope for diagnosis. Step 1: Position - the clinician places the otoscope into the ear canal during a routine exam. Step 2: Scan - a quick, non-invasive ultrasound scan is done using proprietary through-air ultrasound technology. Step 3: Analyze - advanced algorithms evaluate the collected data and assess inner ear characteristics. Step 4: Inform - objective information is returned in seconds to aid clinical decision-making and antibiotic use.

Frequently Asked Questions

  • 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.

  • The middle ear is located behind the eardrum and cannot be examined directly using conventional visual otoscopy. Clinicians must combine the appearance of the eardrum with symptoms and other clinical findings. This can contribute to uncertainty and variability in assessment.

  • Middle-ear effusion is fluid located behind the eardrum. It may occur with acute otitis media or remain after an infection has resolved. Determining whether fluid is present is an important part of evaluating middle-ear conditions.

  • The investigational OtoNexus ultrasound otoscope is designed to collect through-air ultrasound signals during a routine ear examination. Proprietary algorithms are being developed to analyze these signals and provide objective information intended to supplement the clinician’s assessment.

  • OtoNexus is developing AI-assisted algorithms to identify relevant patterns in the ultrasound signal. The resulting information is intended to support—not replace—clinical judgment.

  • The OtoNexus system is being designed to provide information during the patient visit as part of the routine examination workflow. Final performance and workflow claims will be established through product development, clinical evaluation and applicable FDA review.

  • Additional objective information about middle-ear conditions could help clinicians make more informed treatment decisions. OtoNexus is evaluating its technology as a potential tool for supporting diagnostic confidence and antibiotic stewardship objectives.

  • The OtoNexus platform is being developed for healthcare professionals who evaluate patients with suspected middle-ear conditions, including pediatricians, family medicine clinicians, urgent care clinicians and otolaryngologists.

  • No. The OtoNexus ultrasound otoscope is investigational, has not been cleared by the FDA and is not currently available for commercial sale.

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

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.

An illustration of a female doctor examining a young child's ear with the Novoscop ultrasound otoscope.

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.

Who We Serve

Supporting Ear Infection Evaluation Across Frontline Healthcare

OtoNexus is developing objective diagnostic technology to support clinicians in evaluating and managing patients with suspected middle ear infections. The platform is intended to integrate into routine workflows across a variety of healthcare settings.

The clinicians who would benefit from using the OtoNexus Novoscope - pediatricians, family medicine, urgent care, and ENT specialists.

Pediatricians

Supporting evaluation of one of childhood's most common infections.

Family Medicine

Designed to fit within routine patient encounters and support clinical decision-making.

Urgent Care

Providing objective information during rapid, high-volume assessments.

ENT Specialists

Supporting physicians who manage complex or recurrent middle ear disease..

Leadership Team & Governance

OtoNexus is led by an experienced team with expertise across business development, medical device innovation, clinical research, regulatory strategy, artificial intelligence, and commercialization. Supported by an accomplished board, advisory network, and industry leaders who provide strategic oversight as the company advances clinical validation, regulatory milestones, and commercialization readiness. Meet the team.  

Company Mission

Advancing a New Standard in Ear Infection Care

OtoNexus is developing objective diagnostic technology designed to improve the evaluation of middle ear infections, support antibiotic stewardship, and help clinicians make more informed treatment decisions at the point of care.

For more information, please explore our investor information page or complete the form below to contact us directly.

Investment Opportunity

OtoNexus is advancing an investigational AI-enabled ultrasound otoscope designed to provide objective information about middle-ear conditions during routine ear examinations. The development program is supported by proprietary through-air ultrasound technology, an established intellectual property portfolio, participation in the FDA Safer Technologies Program, and ongoing clinical research.

The company is pursuing a planned capital-equipment and recurring-consumable business model, initially focused on pediatric, family medicine, urgent care, and otolaryngology settings. Current investment will support the clinical, regulatory, engineering, and commercialization-readiness milestones required to advance the technology toward future FDA review and market introduction.

Qualified investors are invited to complete the form below to request additional information about the company, development program, and investment opportunity.

The OtoNexus ultrasound otoscope is investigational, has not been cleared by the FDA, and is not currently available for commercial sale.

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You can also call us directly at (206) 330-0610.

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

 
Support and Non Dilutive Funding Sponsor OtoNexus Medical Technologies