Miracle-Ear App

GUDID 08059606110356

Hearing device app

AMPLIFON SPA

Hearing aid/implant system remote control

• Primary Device ID: 08059606110356
• NIH Device Record Key: 32cbf4fa-c0de-45af-a302-6b893322f954
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Miracle-Ear App
• Version Model Number: 5.0.2
• Company DUNS: 428013775
• Company Name: AMPLIFON SPA
• 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: false
• Manufacturing Date: true
• 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	08059606110356 [Primary]

FDA Product Code

• OSM: Hearing Aid, Air-Conduction With Wireless Technology, Prescription

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: 2025-07-04
• Device Publish Date: 2025-06-26

On-Brand Devices [Miracle-Ear App]

• 00860001471717: App Android 2.0.1. This database entry also covers the following minor software updates: v2.0.2
• 00860001471700: App IOS 2.0.1. This database entry also covers the following minor software updates: v2.0.2: (01
• 08059606110356: Hearing device app