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TransEar

FDA UDI

Class II (US FDA UDI)

by Ear Technology Corporation

Identity

Trade Name
TransEar FDA UDI
Generic Name
Auditory cranial bone vibrator FDA UDI
Device Name
bone conduction hearing aid - FDA UDI
Model / Reference
TE380 FDA UDI
Description
bone conduction hearing aid - FDA UDI

Identifiers

Catalog Number
none FDA UDI
Primary DI / UDI-DI
00810323003806 FDA UDI
510(k) Number
K050653 FDA UDI
FDA Product Code
LXB FDA UDI
GMDN Term
Auditory cranial bone vibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.3302 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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Auditory cranial bone vibrator

TransEar by Ear Technology Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Auditory cranial bone vibrator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ear Technology Corporation

Sources (1)

  • FDA UDI 4a7bd828-8373-45ac-afb4-462868bd7be1 35 fields · synced Jun 9, 2026