FDA.reportPublic FDA data

STARKEY

Primary DI
00840388200223
Brand
STARKEY
Company
Starkey Laboratories, Inc.
Model
STARKEY GENESIS AI 16 RIC 312
Published
2025-06-26
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, Prescription

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
00840388200223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840388200223008403882002238403882002230840388200223

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, receiver-in-canalA 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
00840388220580Starkey G Series AI63406-1312026-09-04
00840388220597Starkey G Series AI63406-1402026-09-04
00840388220757Starkey G Series AI63406-1412026-09-04
00840388220764Starkey G Series AI63407-1312026-09-04
00840388220771Starkey G Series AI63407-1402026-09-04
00840388220788Starkey G Series AI63407-1412026-09-04
00840388220795Starkey G Series AI63408-1312026-09-04
00840388220801Starkey G Series AI63408-1402026-09-04
00840388220818Starkey G Series AI63408-1412026-09-04
00840388220825Starkey G Series AI63400-1312026-09-04
00840388220863Starkey G Series AI63400-1402026-09-04
00840388220917Starkey G Series AI63400-1412026-09-04
00840388220955Starkey G Series AI63401-1312026-09-04
00840388220993Starkey G Series AI63401-1402026-09-04
00840388221006Starkey G Series AI63401-1412026-09-04
00840388221013Starkey G Series AI63402-1312026-09-04
00840388221020Starkey G Series AI63402-1402026-09-04
00840388221037Starkey G Series AI63402-1412026-09-04
00840388221044Starkey G Series AI63430-1312026-09-04
00840388221051Starkey G Series AI63430-1402026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714880270303WidexWidex A/SOSM2026-10-22
05708296447022GN HearingGn Hearing A/SOSM2026-10-21
05708296474998GN HearingGn Hearing A/SOSM2026-10-21
05708296475001GN HearingGn Hearing A/SOSM2026-10-21
05708296475025GN HearingGn Hearing A/SOSM2026-10-21
05708296475032GN HearingGn Hearing A/SOSM2026-10-21
05708296475049GN HearingGn Hearing A/SOSM2026-10-21
05708296485369GN HearingGn Hearing A/SOSM2026-10-21
05708296485529GN HearingGn Hearing A/SOSM2026-10-21
05708296249787BeltoneGn Hearing A/SKLW2022-08-24
05708296249787BeltoneGn Hearing A/SOSM2022-08-24
05708296249978BeltoneGn Hearing A/SOSM2022-08-24
05708296249978BeltoneGn Hearing A/SKLW2022-08-24
05708296226856GN HearingGn Hearing A/SKLW2021-06-11
05708296226856GN HearingGn Hearing A/SOSM2021-06-11
05708296226863GN HearingGn Hearing A/SOSM2021-06-11
05708296226863GN HearingGn Hearing A/SKLW2021-06-11
05708296227099GN HearingGn Hearing A/SOSM2021-06-11
05708296227099GN HearingGn Hearing A/SKLW2021-06-11
05708296220724GN HearingGn Hearing A/SKLW2021-06-07
05708296220724GN HearingGn Hearing A/SOSM2021-06-07
05708296221233GN HearingGn Hearing A/SOSM2021-06-07
05708296221233GN HearingGn Hearing A/SKLW2021-06-07
05708296221257GN HearingGn Hearing A/SKLW2021-06-07
05708296221257GN HearingGn Hearing A/SOSM2021-06-07
05708296221325GN HearingGn Hearing A/SKLW2021-06-07
05708296221325GN HearingGn Hearing A/SOSM2021-06-07
05708296221394GN HearingGn Hearing A/SKLW2021-06-07
05708296221394GN HearingGn Hearing A/SOSM2021-06-07
05708296221400GN HearingGn Hearing A/SKLW2021-06-07