FDA.reportPublic FDA data

STARKEY

Primary DI
00842318109552
Brand
STARKEY
Company
STARKEY LABORATORIES, INC.
Model
MUSE I1200 ITC
Catalog number
CK3I
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
KLWMasker, tinnitus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLWMasker, TinnitusEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842318109552PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842318109552008423181095528423181095520842318109552

GMDN Terms#

Term, Definition table
TermDefinition
Tinnitus masking application softwareAn individual software application program or group of programs, routines or algorithms designed for use in, or together with, other devices such as a computer, a digital hearing aid, or formated into a compact disc read-only memory (CD-ROM) or an MP3 format to enable it to provide generated noise of sufficient intensity and bandwidth to mask (make less noticeable and provide temporary relief from) tinnitus (a ringing sound in the ear or internal head noises). The basic set of applications programs and routines can be upgraded to add new system capabilities. Application program packages are typically identified by a proprietary name and "version" or "upgrade" number.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
055461479
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840388213773OUIEZENOuieZen SL2 Charger RIC R/RT 2026-02-13
00840388213780OUIEZENOuieZen SL2 Prm Charger RIC R/RT2026-02-13
00840388213797NUEARNUEAR NE SERIES AI P BTE 132026-02-13
00840388213803NUEARNUEAR NE SERIES AI UP BTE 132026-02-13
00840388207161KINDKINDviano 3 RIC R2026-02-11
00840388210024OUIEZENOuieZen 24 OM CIC2026-02-11
00840388210246OUIEZENOuieZen 16 OM CIC2026-02-11
00840388210505OUIEZENOuieZen 16 OM mRIC R2026-02-11
00840388211908STARKEYStarkey G Series AI 24 UP BTE 132026-02-08
00840388211915STARKEYStarkey G Series AI 20 UP BTE 132026-02-08
00840388211922STARKEYStarkey G Series AI 16 UP BTE 132026-02-08
00840388211939STARKEYStarkey G Series AI 12 UP BTE 132026-02-08
00840388211946STARKEYStarkey G Series AI 10 UP BTE 132026-02-08
00840388211953STARKEYStarkey G Series AI UP BTE 132026-02-08
00840388211960STARKEYStarkey G Series AI 24 UP BTE 13 (DEMO)2026-02-08
00840388211977STARKEYStarkey G Series AI UP BTE 13 (TIER DEMO)2026-02-08
00840388211991STARKEYStarkey G Series AI 24 UP BTE 13 (GS DEMO)2026-02-08
00840388212004AUDIBELAudibel A Series AI 24 UP BTE 132026-02-08
00840388212011AUDIBELAudibel A Series AI 20 UP BTE 132026-02-08
00840388212028AUDIBELAudibel A Series AI 16 UP BTE 132026-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714880295054SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295061SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295078SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295689SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295764SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295771SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295825SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295832SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295887SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295894SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295948SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295955SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295962SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295979SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880296006SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880296037SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880296068SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880296099SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
07613389834147Phonak Audéo E90-Sphere Sonova AGKLW2026-03-17
07613389860498Phonak Audéo E30-Sphere Sonova AGKLW2026-03-17
07613389891171Phonak Audéo E90-RSonova AGKLW2026-03-16
05714464175529BernafonSbo Hearing A/SKLW2026-02-25
05714464175567NeutralSbo Hearing A/SKLW2026-02-25
05714464175598PhilipsSbo Hearing A/SKLW2026-02-25
05714464175628OticonSbo Hearing A/SKLW2026-02-25
05714464176151PhilipsSbo Hearing A/SKLW2026-02-25
05714464176168PhilipsSbo Hearing A/SKLW2026-02-25
05714464176335OticonSbo Hearing A/SKLW2026-02-25
05714464176359OticonSbo Hearing A/SKLW2026-02-25
05714464182848OticonSbo Hearing A/SKLW2026-02-25