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Starkey

FDA UDI

Class II (US FDA UDI)

by Starkey Laboratories Inc.

Identity

Trade Name
STARKEY FDA UDI
Generic Name
Air-conduction hearing aid, receiver-in-canal FDA UDI
Model / Reference
MUSE IQ 1200 RIC 312 FDA UDI

Identifiers

Catalog Number
64325-7 FDA UDI
Primary DI / UDI-DI
00842318128720 FDA UDI
FDA Product Code
KLW FDA UDI
OSM FDA UDI
GMDN Term
Air-conduction hearing aid, receiver-in-canal 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, receiver-in-canalTinnitus masking application software

A battery-powered, behind-the-ear (BTE) acoustic device designed to compensate for impaired hearing by amplifying sound waves to the eardrum through air. The STARKEY device is intended for mild to profound hearing loss and offers programmable adjustments for computerized relief. It is also a software application program that provides tinnitus masking capabilities.

Similar devices

Also classified as Tinnitus masking application software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Starkey Laboratories Inc.

Sources (1)

  • FDA UDI 0224bee0-67a8-4097-91f8-f44ab47913ab 34 fields · synced Jul 21, 2026