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, receiver-in-canal FDA UDI
Device Name: MEENERGY R 5 AX Graphite FDA UDI
Model / Reference: MEENERGY R 5 AX FDA UDI
Description: MEENERGY R 5 AX Graphite FDA UDI

Identifiers

Catalog Number: 21004017 FDA UDI
Primary DI / UDI-DI: 05714880135398 FDA UDI
FDA Product Code: OSM FDA UDI
KLW FDA UDI
GMDN Term: Air-conduction hearing aid, receiver-in-canal 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

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Lot / Batch Number

FDA UDI

Serial Number

Yes

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Expiration Date

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Manufacturing Date

FDA UDI

Category: Air-conduction hearing aid, receiver-in-canal

Miracle-Ear is a revolutionary new hearing aid designed to compensate for impaired hearing. This innovative device consists of a microphone and amplifier in a case behind-the-ear (BTE) connected via a wire, transmits amplified sound waves to the eardrum through air, and receives them electronically increased by an amplifier and sent as sound waves to the eardrum. For mild to profound hearing loss, Miracle-Ear is programmable to enable computerized adjustments for a patient's hearing loss and related factors.

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Also classified as Air-conduction hearing aid, receiver-in-canal.

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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 5b0169d3-7f00-4a90-8667-110b65bf8e2e 35 fields · synced Jul 24, 2026