FDA.reportPublic FDA data

GN ReSound

Primary DI
05708296174812
Brand
GN ReSound
Company
Gn Hearing A/S
Model
RE9ITC-DW-LP
Device description
HI,RE9ITC-DW-LP
Published
2019-08-28
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
05708296174812PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708296174812057082961748125708296174812

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
05708296447022GN Hearing238497002026-10-21
05708296474998GN Hearing243511002026-10-21
05708296475001GN Hearing243512002026-10-21
05708296475025GN Hearing243514002026-10-21
05708296475032GN Hearing243515002026-10-21
05708296475049GN Hearing243516002026-10-21
05708296485369GN Hearing243146002026-10-21
05708296485529GN Hearing243162002026-10-21
05708296221257GN HearingXC2ITE-DW-UP2021-06-07
05708296221325GN HearingXC3ITE-DW-HP2021-06-07
05708296221394GN HearingXC4ITC-DW-MP2021-06-07
05708296221400GN HearingXC4ITC-DW-UP2021-06-07
05708296221431GN HearingXC4ITE-DW-UP2021-06-07
05708296207435GN ReSoundKE2ITC-DW-UP2021-02-05
05708296207510GN ReSoundKE3ITC-DW-HP2021-02-05
05708296207534GN ReSoundKE3ITC-DW-UP2021-02-05
05708296207640GN ReSoundKE4ITE-DW-HP2021-02-05
05708296208050BeltoneRLY2ITC-DW-UP2021-02-05
05708296208210BeltoneRLY4CIC-W-MP2021-02-05
05708296174034BeltoneAMZ17MIH-W-HP2019-08-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714880270303WidexWidex A/SOSM2026-10-22
05708296447022GN HearingGn Hearing A/SOSM2026-10-21
05708296474998GN HearingGn Hearing A/SOSM2026-10-21
05708296475001GN HearingGn Hearing A/SOSM2026-10-21
05708296475025GN HearingGn Hearing A/SOSM2026-10-21
05708296475032GN HearingGn Hearing A/SOSM2026-10-21
05708296475049GN HearingGn Hearing A/SOSM2026-10-21
05708296485369GN HearingGn Hearing A/SOSM2026-10-21
05708296485529GN HearingGn Hearing A/SOSM2026-10-21
05708296249787BeltoneGn Hearing A/SKLW2022-08-24
05708296249787BeltoneGn Hearing A/SOSM2022-08-24
05708296249978BeltoneGn Hearing A/SOSM2022-08-24
05708296249978BeltoneGn Hearing A/SKLW2022-08-24
05708296226856GN HearingGn Hearing A/SKLW2021-06-11
05708296226856GN HearingGn Hearing A/SOSM2021-06-11
05708296226863GN HearingGn Hearing A/SOSM2021-06-11
05708296226863GN HearingGn Hearing A/SKLW2021-06-11
05708296227099GN HearingGn Hearing A/SOSM2021-06-11
05708296227099GN HearingGn Hearing A/SKLW2021-06-11
05708296220724GN HearingGn Hearing A/SKLW2021-06-07
05708296220724GN HearingGn Hearing A/SOSM2021-06-07
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
05708296221325GN HearingGn Hearing A/SKLW2021-06-07
05708296221325GN HearingGn Hearing A/SOSM2021-06-07
05708296221394GN HearingGn Hearing A/SKLW2021-06-07
05708296221394GN HearingGn Hearing A/SOSM2021-06-07
05708296221400GN HearingGn Hearing A/SKLW2021-06-07