Bringing Objective Insight to the Ear Exam

What if the ear exam could reveal more than what the eye can see?

OtoNexus is developing an ultrasound otoscope that combines proprietary through-air ultrasound with AI-assisted analysis to provide objective information about middle-ear conditions during the ear exam. The goal is to reduce diagnostic uncertainty, support more timely decisions, judicious antibiotic use, and help reduce unnecessary healthcare costs.

Explore the Technology

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

OtoNexus investigational ultrasound otoscope. Prototype render demonstrated

Key Highlights

Objective Middle-Ear Information

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

Diagnostic Confidence

  • Designed to support clinical decision-making by reducing uncertainty in evaluating middle ear infections.

Antibiotic Stewardship

  • Intended to support more informed treatment decisions and responsible antibiotic use.

Evidence and Development

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

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 regarding the presence and type of middle ear infection 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.
How Ultrasound Otoscopy Works

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.

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

Evidence and Regulatory Development

FDA STeP participation, ongoing clinical development, strategic relationships, and a growing intellectual property portfolio support advancement of the OtoNexus technology.

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.

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

OtoNexus investigational ultrasound otoscope. Prototype render shown.

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/EMED Care

Providing objective information during rapid, high-volume assessments.

For Clinicians

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. An accomplished board, advisory network, and industry leaders provide strategic oversight as the company advances clinical evidence generation, 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.

The OtoNexus Opportunity

OtoNexus is advancing an investigational AI-assisted ultrasound otoscope built on a proprietary through-air ultrasound platform. Learn more about our technology, development program, business model, and investment opportunity.

Investor Overview

Industry Awards and Recognition

Organizations across the medical technology, investment, and innovation communities have recognized OtoNexus.

OtoNexus 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 on our website NEWS.

Research, Innovation & Non-Dilutive Support

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