FDA.reportPublic FDA data

AUDIOSYNC

Primary DI
00842318173430
Brand
AUDIOSYNC
Company
Starkey Laboratories, Inc.
Model
AUDIOSYNC VIA AI CROSBICROS RIC 312
Catalog number
63085-J
Published
2019-04-12
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
00842318173430PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842318173430008423181734308423181734300842318173430

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
00840388220641NuEar NE NXG AI63197-N232026-07-02
00840388220689NuEar NE NXG AI63197-N402026-07-02
00840388220696NuEar NE NXG AI63197-N412026-07-02
00840388220702NuEar NE NXG AI63335-N412026-07-02
00840388220726NuEar NE Series AI63400-N402026-07-02
00840388220733NuEar NE Series AI63400-N412026-07-02
00840388220719NuEar NE Series AI63400-N232026-07-02
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974608620523PHONELUMShenzhen Eartech Co., Ltd.OSM2026-08-27
05708296400942GN ReSoundGn Hearing A/SOSM2026-08-21
05708296400959GN ReSoundGn Hearing A/SOSM2026-08-21
05708296400966GN ReSoundGn Hearing A/SOSM2026-08-21
05708296400973GN ReSoundGn Hearing A/SOSM2026-08-21
05708296400980GN ReSoundGn Hearing A/SOSM2026-08-21
05708296400997GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401000GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401017GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401024GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401031GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401048GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401055GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401062GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401079GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401086GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401093GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401109GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401116GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401123GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401130GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401550GN ReSoundGn Hearing A/SOSM2026-08-21
05708296435265GN ReSoundGn Hearing A/SOSM2026-08-21
05708296435272GN ReSoundGn Hearing A/SOSM2026-08-21
05708296435289GN ReSoundGn Hearing A/SOSM2026-08-21
05708296435296GN ReSoundGn Hearing A/SOSM2026-08-21
05708296435302GN ReSoundGn Hearing A/SOSM2026-08-21
05708296435319GN ReSoundGn Hearing A/SOSM2026-08-21
05708296435326GN ReSoundGn Hearing A/SOSM2026-08-21
05708296435333GN ReSoundGn Hearing A/SOSM2026-08-21