FDA.reportPublic FDA data

STARKEY

Primary DI
00840388202241
Brand
STARKEY
Company
Starkey Laboratories, Inc.
Model
STARKEY SIGNATURE SERIES 20 CIC NW
Published
2025-06-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
ESDHearing Aid, Air-Conduction, Prescription
KLWMasker, tinnitus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ESDHearing Aid, Air-Conduction, PrescriptionEar, Nose, Throat1
KLWMasker, TinnitusEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840388202241PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840388202241008403882022418403882022410840388202241

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, canalA battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It typically consists of a miniature microphone, amplifier, and speaker (receiver) in a case that fits the ear canal [in-the-canal (ITC)] or in a case nearly hidden in the ear canal [completely-in-the-canal (CIC)]. 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. It is used for mild to moderately-severe 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
00840388220580Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220597Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220757Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220764Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220771Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220788Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220795Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220801Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220818Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220825Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220863Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220917Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220955Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220993Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221006Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221013Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221020Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221037Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221044Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221051Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221068Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221075Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221136Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221181Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221228Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221266Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221280Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221297Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221303Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221327Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04