FDA.reportPublic FDA data

Miracle-Ear App

Primary DI
08059606110356
Brand
Miracle-Ear App
Company
AMPLIFON SPA
Model
5.0.2
Device description
Hearing device app
Published
2025-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OSMHearing Aid, Air-Conduction With Wireless Technology, Prescription

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08059606110356PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08059606110356080596061103568059606110356

GMDN Terms#

Term, Definition table
TermDefinition
Hearing aid/implant system remote controlA battery-powered device designed to be operated by the wearer of a hearing aid or a hearing implant system to enable discreet wireless (remote) adjustments to the device (e.g., volume and program changes). It is designed to be conveniently portable (e.g., carried in a pocket, handbag, or attached to a key ring).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
428013775
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860001471724Miracle Ear AppiOS v32021-03-31
00860001471731Miracle Ear AppAndroid v32021-03-31
08059300420010OtoPad 2.02023-06-26
00860001471700Miracle-Ear App2.0.12019-07-02
00860001471717Miracle-Ear App2.0.12019-07-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840388220580Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220597Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220757Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220764Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220771Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220788Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220795Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220801Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220818Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220825Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220863Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220917Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220955Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220993Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221006Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221013Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221020Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221037Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221044Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221051Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221068Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221075Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221136Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221181Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221228Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221266Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221280Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221297Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221303Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221327Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04