FDA.reportPublic FDA data

GN Hearing

Primary DI
05708296221325
Brand
GN Hearing
Company
Gn Hearing A/S
Model
XC3ITE-DW-HP
Device description
HI,XC3ITE-DW-HP
Published
2021-06-07
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
05708296221325PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708296221325057082962213255708296221325

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, in-the-earA 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) contained in a case that fits completely inside the outer ear (concha) [in-the-ear (ITE)]. 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 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
05708296249787Beltone221740722022-08-24
05708296249978Beltone221742732022-08-24
05708296226856GN Hearing220194042021-06-11
05708296226863GN Hearing220194052021-06-11
05708296227099GN Hearing220199022021-06-11
05708296220724GN Hearing218128202021-06-07
05708296221233GN HearingXC2ITE-DW-HP2021-06-07
05708296221257GN HearingXC2ITE-DW-UP2021-06-07
05708296221394GN HearingXC4ITC-DW-MP2021-06-07
05708296221400GN HearingXC4ITC-DW-UP2021-06-07
05708296221431GN HearingXC4ITE-DW-UP2021-06-07
05708296222261GN Hearing220057082021-06-07
05708296222278GN Hearing220057202021-06-07
05708296222346GN Hearing220059042021-06-07
05708296222704GN Hearing220066052021-06-07
05708296222711GN Hearing220066082021-06-07
05708296222797GN Hearing220068042021-06-07
05708296223039GN Hearing220073022021-06-07
05708296221998GN Hearing220158772021-05-14
05708296222070GN Hearing220163772021-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05708296249787BeltoneGn Hearing A/SOSM2022-08-24
05708296249787BeltoneGn Hearing A/SKLW2022-08-24
05708296249978BeltoneGn Hearing A/SKLW2022-08-24
05708296249978BeltoneGn Hearing A/SOSM2022-08-24
05708296226856GN HearingGn Hearing A/SOSM2021-06-11
05708296226856GN HearingGn Hearing A/SKLW2021-06-11
05708296226863GN HearingGn Hearing A/SKLW2021-06-11
05708296226863GN HearingGn Hearing A/SOSM2021-06-11
05708296227099GN HearingGn Hearing A/SKLW2021-06-11
05708296227099GN HearingGn Hearing A/SOSM2021-06-11
05708296220724GN HearingGn Hearing A/SOSM2021-06-07
05708296220724GN HearingGn Hearing A/SKLW2021-06-07
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
05708296221394GN HearingGn Hearing A/SKLW2021-06-07
05708296221394GN HearingGn Hearing A/SOSM2021-06-07
05708296221400GN HearingGn Hearing A/SOSM2021-06-07
05708296221400GN HearingGn Hearing A/SKLW2021-06-07
05708296221431GN HearingGn Hearing A/SKLW2021-06-07
05708296221431GN HearingGn Hearing A/SOSM2021-06-07
05708296222261GN HearingGn Hearing A/SKLW2021-06-07
05708296222261GN HearingGn Hearing A/SOSM2021-06-07
05708296222278GN HearingGn Hearing A/SOSM2021-06-07
05708296222278GN HearingGn Hearing A/SKLW2021-06-07
05708296222346GN HearingGn Hearing A/SOSM2021-06-07
05708296222346GN HearingGn Hearing A/SKLW2021-06-07
05708296222704GN HearingGn Hearing A/SKLW2021-06-07
05708296222704GN HearingGn Hearing A/SOSM2021-06-07