FDA.reportPublic FDA data

GN Hearing

Primary DI
05708296391240
Brand
GN Hearing
Company
Gn Hearing A/S
Model
23685775
Device description
PKG,JES 700,RTL,SAND
Published
2025-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QUGHearing Aid, Air-Conduction with Wireless Technology, Over the Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QUGHearing Aid, Air-Conduction With Wireless Technology, Over The CounterEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05708296391240PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708296391240057082963912405708296391240

GMDN Terms#

Term, Definition table
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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
306179227
Device count
1
Premarket exempt
true
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05708296253166GN ReSound223665702026-09-21
05708296253173GN ReSound223665712026-09-21
05708296253180GN ReSound223665722026-09-21
05708296253197GN ReSound223665732026-09-21
05708296253203GN ReSound223665742026-09-21
05708296253210GN ReSound223665752026-09-21
05708296253227GN ReSound223665762026-09-21
05708296253234GN ReSound223665772026-09-21
05708296253241GN ReSound223665782026-09-21
05708296257966GN ReSound224854702026-09-21
05708296257973GN ReSound224854712026-09-21
05708296257980GN ReSound224854722026-09-21
05708296257997GN ReSound224854732026-09-21
05708296258000GN ReSound224854742026-09-21
05708296258017GN ReSound224854752026-09-21
05708296258024GN ReSound224854762026-09-21
05708296258031GN ReSound224854772026-09-21
05708296258048GN ReSound224854782026-09-21
05708296258321GN ReSound224858702026-09-21
05708296258338GN ReSound224858712026-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979809410003Hearing AidsShenzhen Anker Medical Devices Co., Ltd.QUG2026-09-22
06943786094839AUDIENAustar Hearing Science & Technology (Xiamen) Co., Ltd men) Co., Ltd.QUG2026-09-20
06977352080612ELEHEARELEHEAR Inc.QUG2026-09-05
06977352080629ELEHEARELEHEAR Inc.QUG2026-09-05
06977352080681ELEHEARELEHEAR Inc.QUG2026-09-05
06977352080698ELEHEARELEHEAR Inc.QUG2026-09-05
06974608620523PHONELUMShenzhen Eartech Co., Ltd.QUG2026-08-27
00850080488577flysoundShenzhen Flysounds Medical Technology Co.,Ltd.QUG2026-08-25
00850080488584flysoundShenzhen Flysounds Medical Technology Co.,Ltd.QUG2026-08-25
00850065321967CeretoneAudicon CorporationQUG2026-08-14
06943786094846AUSTARAustar Hearing Science & Technology (Xiamen) Co., Ltd men) Co., Ltd.QUG2026-08-14
08056262819890nuance audioLUXOTTICA GROUP SPAQUG2026-07-31
08056262856789nuance audioLUXOTTICA GROUP SPAQUG2026-07-31
06980305290013CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290020CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290037CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290044CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290068CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290082CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290099CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290105CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290112CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290129CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980134820016n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820023n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820030n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820047n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820054n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820061n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820078n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09