FDA.reportPublic FDA data

GN Hearing

Primary DI
05708296422074
Brand
GN Hearing
Company
Gn Hearing A/S
Model
23831275
Device description
HI,M3,RIE,N-BOX,SAND
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
05708296422074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708296422074057082964220745708296422074

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
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
05708296400942GN ReSound238013702026-08-21
05708296400959GN ReSound238013712026-08-21
05708296400966GN ReSound238013722026-08-21
05708296400973GN ReSound238013732026-08-21
05708296400980GN ReSound238013742026-08-21
05708296400997GN ReSound238013752026-08-21
05708296401000GN ReSound238013762026-08-21
05708296401017GN ReSound238013772026-08-21
05708296401024GN ReSound238013782026-08-21
05708296401031GN ReSound238013792026-08-21
05708296401048GN ReSound238014702026-08-21
05708296401055GN ReSound238014712026-08-21
05708296401062GN ReSound238014722026-08-21
05708296401079GN ReSound238014732026-08-21
05708296401086GN ReSound238014742026-08-21
05708296401093GN ReSound238014752026-08-21
05708296401109GN ReSound238014762026-08-21
05708296401116GN ReSound238014772026-08-21
05708296401123GN ReSound238014782026-08-21
05708296401130GN ReSound238014792026-08-21

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
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
05708296422326GN HearingGn Hearing A/SQUH2026-08-21
05708296422333GN HearingGn Hearing A/SQUH2026-08-21
05708296422340GN HearingGn Hearing A/SQUH2026-08-21