FDA.reportPublic FDA data

GN ReSound

Primary DI
05708296401017
Brand
GN ReSound
Company
Gn Hearing A/S
Model
23801377
Device description
HI,EIB998-DWHC,BTE,GRPH
Published
2026-08-21
Public version status
New
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
OSMHearing Aid, Air-Conduction with Wireless Technology, Prescription

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05708296401017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708296401017057082964010175708296401017

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, behind-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 microphone, an amplifier, and a speaker (receiver) contained in a case worn behind-the-ear (BTE). 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 through an earmould that fits inside the outer ear or a tube in the ear canal. 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
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
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
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
05708296401550GN ReSound238370752026-08-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974608620523PHONELUMShenzhen Eartech Co., Ltd.OSM2026-08-27
05708296400942GN ReSoundGn Hearing A/SOSM2026-08-21
05708296400959GN ReSoundGn Hearing A/SOSM2026-08-21
05708296400966GN ReSoundGn Hearing A/SOSM2026-08-21
05708296400973GN ReSoundGn Hearing A/SOSM2026-08-21
05708296400980GN ReSoundGn Hearing A/SOSM2026-08-21
05708296400997GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401000GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401024GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401031GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401048GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401055GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401062GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401079GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401086GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401093GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401109GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401116GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401123GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401130GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401550GN ReSoundGn Hearing A/SOSM2026-08-21
05708296435265GN ReSoundGn Hearing A/SOSM2026-08-21
05708296435272GN ReSoundGn Hearing A/SOSM2026-08-21
05708296435289GN ReSoundGn Hearing A/SOSM2026-08-21
05708296435296GN ReSoundGn Hearing A/SOSM2026-08-21
05708296435302GN ReSoundGn Hearing A/SOSM2026-08-21
05708296435319GN ReSoundGn Hearing A/SOSM2026-08-21
05708296435326GN ReSoundGn Hearing A/SOSM2026-08-21
05708296435333GN ReSoundGn Hearing A/SOSM2026-08-21
05708296435340GN ReSoundGn Hearing A/SOSM2026-08-21