Miracle-Ear App

GUDID 00860001471717

App Android 2.0.1. This database entry also covers the following minor software updates: v2.0.2: (01)00860001471717(11)190807(10)202; v2.0.3: (01)00860001471717(11)190927(10)203; v2.0.4: (01)00860001471717(11)191014(10)204; v2.0.5: (01)00860001471717(11)191218(10)205; v2.0.6: (01)00860001471717(11)200227(10)206

AMPLIFON SPA

Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control Hearing aid/implant system remote control

• Primary Device ID: 00860001471717
• NIH Device Record Key: f7d15688-c993-4c69-b09e-bab96c2044d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Miracle-Ear App
• Version Model Number: 2.0.1
• 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: true
• 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

Customer Support Contacts

• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com
• Phone: 866-396-3749
• Email: app@miracle-ear.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860001471717 [Primary]

FDA Product Code

• OSM: Hearing Aid, Air Conduction With Wireless Technology

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 8
• Public Version Date: 2020-02-28
• Device Publish Date: 2019-07-02

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