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Phonak

FDA UDI

Class II (US FDA UDI)

by Phonak, Inc.

Identity

Trade Name
Phonak FDA UDI
Generic Name
Air-conduction hearing aid, receiver-in-canal FDA UDI
Device Name
Audéo S SMART III (olive green) FDA UDI
Model / Reference
050-0941-G4 FDA UDI
Description
Audéo S SMART III (olive green) FDA UDI

Identifiers

Catalog Number
050-0941-G4 FDA UDI
Primary DI / UDI-DI
07612847859456 FDA UDI
FDA Product Code
OSM 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
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, receiver-in-canal

Phonak's Audéo S SMART III is a high-quality, programmable hearing aid designed for mild to profound hearing loss. This Air-Conduction With Wireless Technology (ACWT) device features an olive green case, allowing users to customize their fit and comfort. The Audéo S SMART III amplifies sound waves and converts them into increased sound pressure levels, making it an ideal solution for individuals with impaired hearing.

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Phonak, Inc.

Sources (1)

  • FDA UDI 9cc1bd05-0ad7-40a8-8888-0324f75e67f7 35 fields · synced Jul 26, 2026