FDA.reportPublic FDA data

GN Hearing

Primary DI
05708296422326
Brand
GN Hearing
Company
Gn Hearing A/S
Model
23831676
Device description
PKG,JES M2,SPK SIL
Published
2026-08-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
QUHSelf-fitting Air-Conduction Hearing Aid, Over the Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QUHSelf-Fitting Air-Conduction Hearing Aid, Over The CounterEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05708296422326PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708296422326057082964223265708296422326

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.

Contacts#

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

Regulatory Flags#

DUNS number
306179227
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
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
05708296422043GN HearingGn Hearing A/SQUH2026-08-21
05708296422050GN HearingGn Hearing A/SQUH2026-08-21
05708296422067GN HearingGn Hearing A/SQUH2026-08-21
05708296422074GN HearingGn Hearing A/SQUH2026-08-21
05708296422081GN HearingGn Hearing A/SQUH2026-08-21
05708296422098GN HearingGn Hearing A/SQUH2026-08-21
05708296422104GN HearingGn Hearing A/SQUH2026-08-21
05708296422111GN HearingGn Hearing A/SQUH2026-08-21
05708296422128GN HearingGn Hearing A/SQUH2026-08-21
05708296422135GN HearingGn Hearing A/SQUH2026-08-21
05708296422142GN HearingGn Hearing A/SQUH2026-08-21
05708296422159GN HearingGn Hearing A/SQUH2026-08-21
05708296422166GN HearingGn Hearing A/SQUH2026-08-21
05708296422173GN HearingGn Hearing A/SQUH2026-08-21
05708296422180GN HearingGn Hearing A/SQUH2026-08-21
05708296422197GN HearingGn Hearing A/SQUH2026-08-21
05708296422203GN HearingGn Hearing A/SQUH2026-08-21
05708296422210GN HearingGn Hearing A/SQUH2026-08-21
05708296422227GN HearingGn Hearing A/SQUH2026-08-21
05708296422234GN HearingGn Hearing A/SQUH2026-08-21
05708296422241GN HearingGn Hearing A/SQUH2026-08-21
05708296422258GN HearingGn Hearing A/SQUH2026-08-21
05708296422265GN HearingGn Hearing A/SQUH2026-08-21
05708296422272GN HearingGn Hearing A/SQUH2026-08-21
05708296422289GN HearingGn Hearing A/SQUH2026-08-21
05708296422296GN HearingGn Hearing A/SQUH2026-08-21
05708296422302GN HearingGn Hearing A/SQUH2026-08-21
05708296422319GN HearingGn Hearing A/SQUH2026-08-21
05708296422333GN HearingGn Hearing A/SQUH2026-08-21
05708296422340GN HearingGn Hearing A/SQUH2026-08-21