Earflo

Basic Information

• Brand Name: Earflo
• Primary DI: 00860014369506
• Version / Model: EF001
• Company Name: EARFLO, INC.
• Labeler DUNS: 138345369
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-31
• Public Version: 1
• Public Version Date: 2026-04-08
• Public Version Status: New
• Public Device Record Key: 8eb5417c-9c28-4c89-95aa-cbdd9ae03f9d

Device Description

Earflo is a rechargeable, hand-held therapeutic device designed to provide treatment of negative middle ear pressure through a non-invasive method. Earflo functions by delivering controlled pressurized air into the nasal passages to ventilate the middle ear by momentarily increasing the air pressure in the nose and eustachian tubes. During use, the child drinks from the integrated sippy cup while the nose is sealed against the device’s mask. When liquid is swallowed, a puff of air is delivered into the nasal passage and eustachian tube, thereby opening the eustachian tube and equalizing pressure in the middle ear. Earflo is intended for use in children aged two years and older (under adult supervision) and adults to relieve negative middle ear pressure, prevent the accumulation of middle ear fluid, and prevent hearing loss.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MJV	Device, Inflation, Middle Ear	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
47542	Middle ear decompressor, positive pressure	A manual device intended to reduce the symptoms associated with negative air pressure in the middle ear by increasing air pressure in the Eustachian tube, to counter/prevent certain physical states or thick fluid accumulation behind the eardrum. It typically consists of a manually-operated deflator/inflator (e.g., balloon) connected to an applicator (e.g., nosepiece, mouthpiece, face mask). This is a reusable device typically used in the home.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860014369506	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K252751	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	72	Millimeter
Height	165	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -13 – 158 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: 41 – 104 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: 15 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal