FDA.reportPublic FDA data

GN ReSound

Primary DI
05708296207534
Brand
GN ReSound
Company
Gn Hearing A/S
Model
KE3ITC-DW-UP
Device description
HI,KE3ITC-DW-UP
Published
2021-02-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
05708296207534PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708296207534057082962075345708296207534

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.

Contacts#

Phone, Email table
PhoneEmail
+1-888-735-4327consumerhelp@gnresound.com

Regulatory Flags#

DUNS number
306179227
Device count
1
DM exempt
false
Premarket exempt
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05708296394029Beltone237358702026-10-05
05708296394036Beltone237358712026-10-05
05708296394098Beltone237358772026-10-05
05708296394104Beltone237358782026-10-05
05708296394111Beltone237358792026-10-05
05708296394128Beltone237359702026-10-05
05708296394135Beltone237359712026-10-05
05708296394197Beltone237359772026-10-05
05708296394203Beltone237359782026-10-05
05708296394210Beltone237359792026-10-05
05708296394487Beltone237366702026-10-05
05708296394494Beltone237366712026-10-05
05708296394555Beltone237366772026-10-05
05708296394562Beltone237366782026-10-05
05708296394579Beltone237366792026-10-05
05708296394586Beltone237367702026-10-05
05708296394593Beltone237367712026-10-05
05708296394654Beltone237367772026-10-05
05708296394661Beltone237367782026-10-05
05708296394678Beltone237367792026-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05708296220724GN HearingGn Hearing A/SKLW2021-06-07
05708296220724GN HearingGn Hearing A/SOSM2021-06-07
05708296207435GN ReSoundGn Hearing A/SOSM2021-02-05
05708296207435GN ReSoundGn Hearing A/SKLW2021-02-05
05708296207442GN ReSoundGn Hearing A/SKLW2021-02-05
05708296207442GN ReSoundGn Hearing A/SOSM2021-02-05
05708296207510GN ReSoundGn Hearing A/SOSM2021-02-05
05708296207510GN ReSoundGn Hearing A/SKLW2021-02-05
05708296207572GN ReSoundGn Hearing A/SOSM2021-02-05
05708296207572GN ReSoundGn Hearing A/SKLW2021-02-05
05708296207589GN ReSoundGn Hearing A/SOSM2021-02-05
05708296207589GN ReSoundGn Hearing A/SKLW2021-02-05
05708296207596GN ReSoundGn Hearing A/SKLW2021-02-05
05708296207596GN ReSoundGn Hearing A/SOSM2021-02-05
05708296207640GN ReSoundGn Hearing A/SKLW2021-02-05
05708296207640GN ReSoundGn Hearing A/SOSM2021-02-05
05708296208050BeltoneGn Hearing A/SKLW2021-02-05
05708296208050BeltoneGn Hearing A/SOSM2021-02-05
05708296208067BeltoneGn Hearing A/SKLW2021-02-05
05708296208067BeltoneGn Hearing A/SOSM2021-02-05
05708296208081BeltoneGn Hearing A/SKLW2021-02-05
05708296208081BeltoneGn Hearing A/SOSM2021-02-05
05708296208159BeltoneGn Hearing A/SKLW2021-02-05
05708296208159BeltoneGn Hearing A/SOSM2021-02-05
05708296208180BeltoneGn Hearing A/SOSM2021-02-05
05708296208180BeltoneGn Hearing A/SKLW2021-02-05
05708296208203BeltoneGn Hearing A/SKLW2021-02-05
05708296208203BeltoneGn Hearing A/SOSM2021-02-05
05708296208210BeltoneGn Hearing A/SOSM2021-02-05
05708296208210BeltoneGn Hearing A/SKLW2021-02-05