Audien Hearing

GUDID 00850065060002

Budget Hearing Aids, LLC

Air-conduction hearing aid, canal

• Primary Device ID: 00850065060002
• NIH Device Record Key: 5ad34e59-6f3d-482b-8647-9ef3aebfa3b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Audien Hearing
• Version Model Number: Atom One
• Company DUNS: 118027003
• Company Name: Budget Hearing Aids, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• 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	00850065060002 [Primary]

FDA Product Code

• QUF: Hearing Aid, Air-Conduction, 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: 2025-07-18
• Device Publish Date: 2025-07-10

On-Brand Devices [Audien Hearing]

• 00860003736159: Atom Pro
• 00860003736142: Atom
• 00860009028067: Audien ion
• 00860009028050: Audien BTE
• 00860009028043: Atom Pro 2
• 00860009028036: Atom 2
• 00860003736128: Atom One
• 00860003736135: ion pro
• 00850065060880: Atom X
• 00850065060194: ion pro 2
• 00850065060002: Atom One