Earflo

What Earflo does

Earflo Inc. is a privately held medical device company that has developed an FDA-cleared, non-invasive at-home treatment for negative middle ear pressure in children ages two and older. The company's core product is a child-friendly device disguised as a sippy cup that uses sensors to detect swallowing and deliver precisely controlled bursts of air through the nose synchronized with the natural opening of the eustachian tube. This swallow-synchronized autoinflation mechanism is positioned as an alternative to ear tube surgery during the standard three-month watchful waiting period for otitis media with effusion, with clinical studies reporting 89% surgery avoidance and 86% hearing improvement after four weeks of use.

The device is sold direct-to-consumer through the company's e-commerce website at $279 per unit with free shipping, supported by a gamified companion mobile app available on iOS and Android that motivates pediatric compliance and logs treatment sessions for parents and clinicians. Earflo targets two customer segments: parents of children ages 2+ experiencing chronic ear pressure or fluid buildup (the paying consumer), and pediatric healthcare providers including pediatricians and ENT specialists who can recommend the device during watchful waiting. Distribution is currently limited to the United States, with explicit plans to expand through pediatric healthcare provider channels.

Earflo originated from the Stanford Biodesign program and is incorporated in California with headquarters in San Carlos. Research and development is led by Dr. Peter Santa Maria at the University of Pittsburgh through the UPMC CREATES Lab, with additional ties to Perth Biodesign and the University of Western Australia. The founding team comprises Dr. Intan Oldakowska (CEO), Dr. Matthew Oldakowski, Dr. Peter Santa Maria (CMO), and Dr. Stephen Kargotich. The company received FDA 510(k) clearance in April 2026 and has secured funding from the Richard King Mellon Foundation ($415,000 in November 2025), METS Ignited ($188,820 in October 2023), the Eye and Ear Foundation of Pittsburgh, and Australian Medical Angels.

Name

Earflo

Legal name

Earflo Inc.

Website

https://earflocare.com

Company type

Private

Founded year

2020

Operating status

Operating

Headcount range

1–10 employees

Short description

Earflo is a medical device company that has developed an FDA-cleared, sippy cup-styled swallow-synchronized autoinflation device to treat negative middle ear pressure in children ages two and older, offering a non-surgical at-home alternative to ear tube surgery.

Ownership category

akta.pro rank

Headquarters

HQ city

San Carlos

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2C

Offering type

Hardware or Manufacturing

Cost components

Personnel, Supply Chain, Technology or R&D, Marketing or Sales, Operations

Revenue model

1. Medical Device Sales: Earflo sells its FDA-cleared medical device directly to consumers through its e-commerce website at $279 per unit. The device is available for purchase online with free shipping included. The companion app is available for free download and the device does not require app usage to operate. The company also offers a 1-year limited warranty covering manufacturing defects.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels7 records

Core offering

Earflo designs, manufactures, and sells an FDA-cleared medical device that delivers swallow-synchronized autoinflation to treat negative middle ear pressure in children ages 2 and older. The device is shaped like a child-friendly sippy cup, uses built-in sensors to detect swallowing, and delivers a precisely controlled puff of air through the nose to open the eustachian tube and equalize middle ear pressure. The product is sold directly to parents through the company's e-commerce website at $279 per unit, with a free companion gamified mobile app available on iOS and Android to encourage pediatric compliance and log treatment sessions.

Product overview

Earflo offers a two-component product system consisting of the Earflo Device and Earflo Companion App. The Earflo Device is an FDA-cleared medical device that serves as the core treatment product—a sippy-cup-shaped device that delivers controlled air pressure through the nose during swallowing to treat negative middle ear pressure in children ages 2 and older. The Earflo Companion App is a gamified mobile application available on iOS and Android that pairs with the device to motivate children through game-based treatment sessions and enables parents and clinicians to track treatment progress. Together, these products provide a non-invasive, at-home alternative to ear tube surgery for pediatric ear pressure issues.

Differentiator

Problem solved

Functional benefit

Products and services

• Earflo Device An FDA-cleared medical device priced at $279 that treats negative middle ear pressure in children ages 2 and older. Designed to look and feel like a child's sippy cup, it delivers a precisely controlled puff of air through the nose synchronized with swallowing to open the eustachian tube and equalize middle ear pressure. Sold directly to consumers through earflocare.com with free shipping, a 1-year limited warranty, and bundled access to the companion gamified app. Clinical outcomes: 86% immediate pressure improvement, 86% improved hearing after 4 weeks, 89% avoided ear-tube surgery. Currently available in the US only.
• Earflo Companion App A free gamified mobile application available on iOS (App Store) and Android (Google Play) that turns Earflo treatment into a space-adventure game where children launch a rocket ship, collect rewards and alien friends to stay motivated. The app logs every treatment session and provides a dashboard for parents and clinicians to track usage and progress over time. Not required for device operation but included free with device purchase.

Quantifiable outcome

• 89% of children indicated for ear tube surgery avoided surgery after 4 weeks of Earflo use
• +5 more outcomes

Named customers1 record

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration4 records

Feature4 records

Partnerships

Four partnerships are on record, tiered core and minor.

• Stanford BiodesigncoreStrategic or Co-development PartnerEarflo was developed through the Stanford Biodesign program. Dr. Matthew Oldakowski was training as a Global Faculty at Stanford Biodesign when he initiated Earflo. The Stanford Biodesign methodology was part of his current role with Perth Biodesign.
• University of Pittsburgh / UPMCcoreStrategic or Co-development PartnerDr. Peter Santa Maria serves as Director of SPARK Global and co-leads the UPMC CREATES Lab at the University of Pittsburgh. Clinical studies were conducted through UPMC. The company was developed with academic, industry and start-up experience from this institution.
• Perth Biodesign / Biodesign AustraliacoreStrategic or Co-development PartnerDr. Intan Oldakowska helps future medtech entrepreneurs through her involvement with Perth Biodesign and Biodesign Australia. Dr. Matthew Oldakowski teaches the Biodesign methodology as part of his role with Perth Biodesign. Earflo was initiated at Stanford Biodesign.
• Fogarty InnovationminorStrategic or Co-development PartnerListed as an advisor to Earflo, providing guidance and support for the company's development and commercialization efforts.

Scale indicators6 records

Recent moves5 records

Expansion highlights4 records

Broad incumbents

• Sonova: Sonova (parent of Phonak and Unitron) is a global hearing healthcare leader with products spanning hearing aids, cochlear implants, and wireless communications. While focused on hearing loss rather than middle ear pressure, Sonova's hearing health franchise makes it a relevant comparable for ear-related medical device companies.
• Stryker (ENT division): Stryker's ENT and surgical divisions produce instruments used in ear tube surgery and related otology procedures. As a broad medical device incumbent, Stryker competes in the broader ear care treatment pathway and has the resources to enter the non-surgical autoinflation market.
• Demant: Demant (parent of Oticon, Bernafon, and Sonic) is a major hearing healthcare company with global reach in hearing aids, hearing implants, and diagnostic audiology equipment. As a broad incumbent in hearing and ear health, Demant represents a comparable established player in the broader ear care ecosystem.
• Acclarent (Johnson & Johnson): Acclarent, a Johnson & Johnson MedTech subsidiary, is a leading manufacturer of ENT surgical devices for sinus and ear conditions. As a broad incumbent in ENT medical devices, Acclarent represents the type of larger player that could enter the pediatric autoinflation space or acquire Earflo's technology.
• Smith+Nephew: Smith+Nephew acquired Tusker Medical in 2020 to enter the pediatric ear tube delivery space. As a broad incumbent that has already made strategic moves into pediatric ENT, Smith+Nephew represents a potential acquirer or competitor for Earflo.
• Medtronic: Medtronic is one of the largest medical device manufacturers globally, with a presence in ENT surgical instruments, hearing implants, and related otology products. As a broad incumbent, Medtronic could potentially enter or acquire into the pediatric autoinflation category.

Emerging players

• Eargo: Eargo is a direct-to-consumer hearing aid company that pioneered online hearing aid sales with a focus on consumer-friendly design. While Eargo targets adult hearing loss rather than pediatric ear pressure, it shares Earflo's DTC distribution model, premium pricing strategy, and design-forward approach to ear-related medical devices.

Direct peers

• EarPopper: The EarPopper by Micromedical is a medical device that delivers controlled air pressure through the nose to open the eustachian tube and treat middle ear pressure problems. It is a direct competitor to Earflo, serving similar patient populations with the same core mechanism (nasal air delivery for eustachian tube opening), but lacks Earflo's swallow-synchronization and child-friendly design.
• Preceptis Medical: Preceptis Medical developed the Hummingbird device, an in-office pediatric ear tube delivery system designed as an alternative to operating-room ear tube surgery under general anesthesia. It targets the same pediatric OME patient population as Earflo, but via a procedural rather than at-home autoinflation approach.
• Otovent: Abigo Medical's Otovent is a balloon-based autoinflation device used to treat middle ear pressure and otitis media with effusion. It is the closest direct competitor to Earflo in the autoinflation category, though Otovent uses a Valsalva-style balloon method that is harder for young children compared to Earflo's swallow-synchronized delivery.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/channel/UCnZ5eH8lqGxI
• LinkedInlinkedin.com/company/earflo
• Instagraminstagram.com/earflocare

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Funding overview

Funding rounds2 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 Earflo