ELEHEAR

GUDID 06977352080438

Hearing aids

ELEHEAR Inc.

Air-conduction hearing aid, in-the-ear

• Primary Device ID: 06977352080438
• NIH Device Record Key: 7dc4a54f-b779-4fa2-86ec-e10e029c18b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELEHEAR
• Version Model Number: FC04
• Company DUNS: 699441039
• Company Name: ELEHEAR Inc.
• Device Count: 1
• DM Exempt: false
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06977352080438 [Primary]

FDA Product Code

• QUG: Hearing Aid, Air-Conduction With Wireless Technology, 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: 2026-01-08
• Device Publish Date: 2025-12-31

On-Brand Devices [ELEHEAR]

• 06977352080070: RIC 03
• 06977352080124: Hearing aids, Champagne Gold
• 06977352080308: Hearing aids, champagne
• 06977352080292: Hearing Aids, silver gray
• 06977352080148: Hearing aids, champagne
• 06977352080131: Hearing aids, silver gray
• 06977352080438: Hearing aids