FDA.reportPublic FDA data

STARKEY HEARING TECHNOLOGIES

Primary DI
00842318168528
Brand
STARKEY HEARING TECHNOLOGIES
Company
Starkey Laboratories, Inc.
Model
STARKEY HEARING TECHNOLOGIES TV
Catalog number
43005-100
Published
2018-08-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842318168528PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842318168528008423181685288423181685280842318168528

GMDN Terms#

Term, Definition table
TermDefinition
Television set listening aidA device used by a person that is hard of hearing to listen to a television (TV) set. It takes the sound output from a TV, either by a direct electrical connection or by means of a microphone placed close to the TV loudspeaker, amplifies the signal which is then fed to the user by means of an earphone or an induction loop in conjunction with an appropriate hearing aid.

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
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
05708296253166GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253173GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253180GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253197GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253203GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253210GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253227GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253234GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253241GN ReSoundGn Hearing A/SOSM2026-09-21
05708296257966GN ReSoundGn Hearing A/SOSM2026-09-21
05708296257973GN ReSoundGn Hearing A/SOSM2026-09-21
05708296257980GN ReSoundGn Hearing A/SOSM2026-09-21
05708296257997GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258000GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258017GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258024GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258031GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258048GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258321GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258338GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258345GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258352GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258369GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258376GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258383GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258390GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258406GN ReSoundGn Hearing A/SOSM2026-09-21
05708296434602GN HearingGn Hearing A/SOSM2026-09-21
05708296434770GN HearingGn Hearing A/SOSM2026-09-21
05708296434794GN HearingGn Hearing A/SOSM2026-09-21