Lexie Hearing

FDA UDI

Class II (US FDA UDI)

by Hearx Group (pty) Ltd

Identity

Trade Name: Lexie Hearing FDA UDI
Generic Name: Air-conduction hearing aid, receiver-in-canal FDA UDI
Device Name: Lexie B1 Hearing Aids, powered by Bose. Self-fit, app-controlled hearing aids FDA UDI
Model / Reference: Lexie B1 Self-fitting OTC Hearing Aids Powered by Bose FDA UDI
Description: Lexie B1 Hearing Aids, powered by Bose. Self-fit, app-controlled hearing aids FDA UDI

Identifiers

Catalog Number: In-Store FDA UDI
Primary DI / UDI-DI: 00850022464577 FDA UDI
510(k) Number: K211008 FDA UDI
FDA Product Code: QDD FDA UDI
GMDN Term: Air-conduction hearing aid, receiver-in-canal FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.3325 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

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

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

Lexie Hearing by Hearx Group (pty) Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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

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AMPLIFON — Starkey Laboratories Inc. · Class II

Cleared under the same submission

K211008 also covers:

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: Hearx Group (pty) Ltd

Sources (1)

FDA UDI 8cbb8d69-50ff-408e-b6a8-fcdb7ebdc7d9 37 fields · synced May 31, 2026