Phonak Brand

FDA UDI

Class II (US FDA UDI)

by Sonova AG

Identity

Trade Name: Phonak Brand FDA UDI
Generic Name: Air-conduction hearing aid, receiver-in-canal FDA UDI
Device Name: KS 11.0 T Kit Binaural SE (velvet black) FDA UDI
Model / Reference: 051-0050-P856 FDA UDI
Description: KS 11.0 T Kit Binaural SE (velvet black) FDA UDI

Identifiers

Primary DI / UDI-DI: 07613389585704 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

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

Phonak Brand hearing aids are advanced devices that provide enhanced sound quality and improved speech clarity for individuals with mild to profound hearing loss. These innovative devices utilize a combination of acoustic and wireless technologies to deliver tailored audio experiences, making everyday tasks more manageable. With their sleek design and user-friendly features, Phonak Brand hearing aids have become a trusted solution for those seeking to regain confidence in their communication abilities.

Similar devices

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

SET CROS PURE CHARGE&GO PRL — Signia GmbH · Class IIa
HA EVK E-FS-T USA 440 SLVGR — Widex A/S · Class IIa
AGXO — Sbo Hearing A/S · Class IIa
HA VIO E156 T BC LI GPH — WSAUD A/S · Class IIa
HANSATON — Hansaton Akustik GmbH · Class II
AMPLIFON — Starkey Laboratories Inc. · Class II
NUEAR — Starkey Laboratories Inc. · Class II
HA AMPLI-MINI R 3 AX 312 BLK — WSAUD A/S · Class IIa

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

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

Manufacturer

Manufacturer: Sonova AG

Sources (1)

FDA UDI 29cbefd7-4b3a-44e2-8e83-dc2c5731552f 33 fields · synced Jul 11, 2026