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Unitron

FDA UDI

Class II (US FDA UDI)

by Unitron Hearing

Identity

Trade Name
Unitron FDA UDI
Generic Name
Air-conduction hearing aid, behind-the-ear FDA UDI
Device Name
TruHearing L16 HP Taupe FDA UDI
Model / Reference
050-5556-35 FDA UDI
Description
TruHearing L16 HP Taupe FDA UDI

Identifiers

Catalog Number
050-5556-35 FDA UDI
Primary DI / UDI-DI
00698764387255 FDA UDI
FDA Product Code
OSM FDA UDI
GMDN Term
Air-conduction hearing aid, behind-the-ear FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.3305 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

No

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

Yes

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, behind-the-ear

A comprehensive 2-3 paragraph SEO description written in clear, natural language. This device is a battery-powered acoustic hearing aid that uses sound waves to amplify sound for individuals with mild to profound hearing loss. It features an amplifier and speaker system, and can be programmed to adjust settings for individual patient needs.

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Unitron Hearing

Sources (1)

  • FDA UDI 51944031-b0a2-4796-8386-42ab418d83e6 35 fields · synced Jul 31, 2026