← Back to catalogue

Audiosync

FDA UDI

Class II (US FDA UDI)

by Starkey Laboratories Inc.

Identity

Trade Name
AUDIOSYNC FDA UDI
Generic Name
Air-conduction hearing aid, in-the-ear FDA UDI
Model / Reference
AUDIOSYNC VIA AI 1200 ITE R FDA UDI

Identifiers

Catalog Number
63223-ASY FDA UDI
Primary DI / UDI-DI
00842318180315 FDA UDI
FDA Product Code
KLW FDA UDI
OSM FDA UDI
GMDN Term
Air-conduction hearing aid, in-the-ear FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.3400 FDA UDI
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

Yes

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
MRI Safety
MR Unsafe FDA UDI

Category: Air-conduction hearing aid, in-the-earTinnitus masking application software

Audiosync by Starkey Laboratories Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tinnitus masking application software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Starkey Laboratories Inc.

Sources (1)

  • FDA UDI 64db05ae-bea6-4066-adcf-16f13f758202 34 fields · synced Jun 9, 2026