Eargo 8

GUDID 00850010429687

Eargo 8 Replacement Charger

Eargo, Inc.

Air-conduction hearing aid, in-the-ear

• Primary Device ID: 00850010429687
• NIH Device Record Key: e4923e1f-1a93-48f3-8cfc-7f3c370a8a52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eargo 8
• Version Model Number: 99-0182-001
• Company DUNS: 079865289
• Company Name: Eargo, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850010429687 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221698

FDA Product Code

• 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: 2025-05-21
• Device Publish Date: 2025-05-13

On-Brand Devices [Eargo 8]

• 00850010429809: Eargo 8 Charger, Power Cord & Adaptor
• 00850010429793: Eargo 8 Charger, Power Cord & Adaptor
• 00850010429724: Eargo Graphite Large Trumpets
• 00850010429717: Eargo Graphite Medium Trumpets
• 00850010429700: Eargo Graphite Small Trumpets
• 00850010429694: Eargo 8 Additional Charger
• 00850010429687: Eargo 8 Replacement Charger
• 00850010429540: Right Eargo 8 Hearing Device
• 00850010429328: Left Eargo 8 Hearing Device
• 00850010429304: Eargo 8 System