FDA.reportPublic FDA data

AUDIGY

Primary DI
00842318115157
Brand
AUDIGY
Company
Starkey Laboratories, Inc.
Model
AGXSP 2 I1200 RIC 13
Catalog number
64121-A
Published
2016-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
KLWMasker, tinnitus
OSMHearing aid, air conduction with wireless technology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLWMasker, TinnitusEar, Nose, Throat2
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842318115157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842318115157008423181151578423181151570842318115157

GMDN Terms#

Term, Definition table
TermDefinition
Receiver-in-canal air-conduction hearing aidA battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It consists of a microphone and an amplifier in a case behind-the-ear (BTE) connected, via a wire, to a receiver (speaker) in the ear canal [receiver-in-canal (RIC)]. The microphone receives sound waves and converts them into electrical signals which are increased by the amplifier and sent as sound waves, by the speaker, to the eardrum. The device is used for mild to profound hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.

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
Serial number
true
Manufacturing date on label
true

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
05714880288117SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880288124SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880288131SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880288148SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880288155CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880288162CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880288179CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880288186CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880297508SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880297515CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880297522CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880297539CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880297546CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880297553SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880297560SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880297577SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880297928SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880297935SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880297942SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880297959SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880297966CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880297973CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880297980CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880297997CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
07613389915006SilentCloud Mobile AppSonova AGKLW2026-06-24
07613389938531SilentCloud Web AppSonova AGKLW2026-06-24
06945936705701QuietlyBoldXiamen New Sound Technology Co., Ltd.OSM2026-06-09
05714880295719SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295719SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295726SIGNIAWs Audiology Usa, Inc.KLW2026-06-08