Eargo 7

GUDID 00850010429410

Left Eargo 7 Hearing Device

Eargo, Inc.

Air-conduction hearing aid, in-the-ear

• Primary Device ID: 00850010429410
• NIH Device Record Key: e3303e8b-c0d9-463c-b54a-4362d38bfcbb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eargo 7
• Version Model Number: 99-0157-001
• Company DUNS: 079865289
• Company Name: Eargo, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850010429410 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221698

FDA Product Code

• OSM: Hearing Aid, Air-Conduction With Wireless Technology, Prescription
• QUH: Self-Fitting Air-Conduction Hearing Aid, Over The Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-28
• Device Publish Date: 2023-03-20

On-Brand Devices [Eargo 7]

• 00850010429427: Right Eargo 7 Hearing Device
• 00850010429410: Left Eargo 7 Hearing Device
• 00850010429403: Eargo 7 System