FDA.report

STARKEY

Primary DI
00840388209646
Brand
STARKEY
Company
STARKEY LABORATORIES, INC.
Model
Starkey G Series AI 16 RIC R
Published
2025-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KLWMasker, tinnitus

Product Code Classifications

CodeDeviceSpecialtyClass
KLWMasker, TinnitusEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840388209646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840388209646008403882096468403882096460840388209646

GMDN Terms

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

TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius60 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
055461479
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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 DIBrandCompanyProduct codePublished
07613389834147Phonak Audéo E90-Sphere Sonova AGKLW2026-03-17
07613389860498Phonak Audéo E30-Sphere Sonova AGKLW2026-03-17
07613389891171Phonak Audéo E90-RSonova AGKLW2026-03-16
05714464175529BernafonSbo Hearing A/SKLW2026-02-25
05714464175567NeutralSbo Hearing A/SKLW2026-02-25
05714464175598PhilipsSbo Hearing A/SKLW2026-02-25
05714464175628OticonSbo Hearing A/SKLW2026-02-25
05714464176151PhilipsSbo Hearing A/SKLW2026-02-25
05714464176168PhilipsSbo Hearing A/SKLW2026-02-25
05714464176335OticonSbo Hearing A/SKLW2026-02-25
05714464176359OticonSbo Hearing A/SKLW2026-02-25
05714464182848OticonSbo Hearing A/SKLW2026-02-25
05714464182855OticonSbo Hearing A/SKLW2026-02-25
05714464182879OticonSbo Hearing A/SKLW2026-02-25
05714464182893OticonSbo Hearing A/SKLW2026-02-25
05714464182916OticonSbo Hearing A/SKLW2026-02-25
05714464182985OticonSbo Hearing A/SKLW2026-02-25
05714464183005OticonSbo Hearing A/SKLW2026-02-25
05714464183050OticonSbo Hearing A/SKLW2026-02-25
05714464183074OticonSbo Hearing A/SKLW2026-02-25
05714464183081OticonSbo Hearing A/SKLW2026-02-25
05714464183098OticonSbo Hearing A/SKLW2026-02-25
05714464183104OticonSbo Hearing A/SKLW2026-02-25
05714464183111OticonSbo Hearing A/SKLW2026-02-25
05714464183142OticonSbo Hearing A/SKLW2026-02-25
05714464183180OticonSbo Hearing A/SKLW2026-02-25
05714464183203OticonSbo Hearing A/SKLW2026-02-25
05714464183227OticonSbo Hearing A/SKLW2026-02-25
05714464183234OticonSbo Hearing A/SKLW2026-02-25
05714464183241OticonSbo Hearing A/SKLW2026-02-25