Miracle-Ear

FDA UDI

Class II (US FDA UDI)

by WS Audiology USA, Inc.

Identity

Trade Name: Miracle-Ear FDA UDI
Generic Name: Air-conduction hearing aid, in-the-ear FDA UDI
Device Name: S_ITE MEENERGY2RFR5WSR BLK BLK FDA UDI
Model / Reference: MEENERGY 2 RF R 5w FDA UDI
Description: S_ITE MEENERGY2RFR5WSR BLK BLK FDA UDI

Identifiers

Catalog Number: 21035461 FDA UDI
Primary DI / UDI-DI: 05714880224320 FDA UDI
FDA Product Code: OSM FDA UDI
KLW FDA UDI
GMDN Term: Air-conduction hearing aid, in-the-ear 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Air-conduction hearing aid, in-the-ear

Miracle-Ear by WS Audiology USA, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Air-conduction hearing aid, in-the-ear.

Bernafon — Bernafon, Inc. · Class II
AUDIBEL — Starkey Laboratories Inc. · Class II
Unitron — Unitron Hearing · Class I
AGX — Widex A/S · Class II
Widex — Widex A/S · Class II
Ceretone — AUDICON CORPORATION · Class I
Bernafon — Bernafon, Inc. · Class II
AUDIGY — Starkey Laboratories Inc. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: WS Audiology USA, Inc.

Sources (1)

FDA UDI a53f4022-084d-4943-b5d4-e7ff6c4035ac 35 fields · synced Jun 8, 2026