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Miracle-Ear

FDA UDI

Class II (US FDA UDI)

by Starkey Laboratories Inc.

Identity

Trade Name
MIRACLE-EAR FDA UDI
Generic Name
Tinnitus masking application software FDA UDI
Model / Reference
MIRACLE-EAR BLISS 3 RIC RT FDA UDI

Identifiers

Primary DI / UDI-DI
00842318198525 FDA UDI
FDA Product Code
OSM FDA UDI
KLW FDA UDI
GMDN Term
Tinnitus masking application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.3305 FDA UDI
874.3400 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Air-conduction hearing aid, receiver-in-canalTinnitus masking application software

Miracle-Ear by Starkey Laboratories Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tinnitus masking application software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Starkey Laboratories Inc.

Sources (1)

  • FDA UDI 6e0b4a3b-6e21-4d97-b527-29e692d7eeb4 33 fields · synced Jun 9, 2026