FDA.reportPublic FDA data

GN ReSound

Primary DI
05708296328871
Brand
GN ReSound
Company
Gn Hearing A/S
Model
22835170
Device description
HI,NX977-DWC,BTE,GLD
Published
2024-02-23
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, Prescription

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
05708296328871PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708296328871057082963288715708296328871

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
05708296485406GN Hearing243150002026-10-15
05708296485420GN Hearing243152002026-10-15
05708296485437GN Hearing243153002026-10-15
05708296485475GN Hearing243157002026-10-15
05708296485505GN Hearing243160002026-10-15
05708296253173GN ReSound223665712026-09-21
05708296253203GN ReSound223665742026-09-21
05708296253210GN ReSound223665752026-09-21
05708296253234GN ReSound223665772026-09-21
05708296258031GN ReSound224854772026-09-21
05708296257836GN ReSound224852752023-01-30
05708296258123GN ReSound224855772023-01-30
05708296258161GN ReSound224856722023-01-30
05708296258314GN ReSound224857782023-01-30
05708296260065BeltoneIMP6CIC-LP2022-12-08
05708296262311GN Hearing225027702022-12-08
05708296262496GN Hearing225029722022-12-08
05708296262533GN Hearing225029762022-12-08
05708296262625GN Hearing225030772022-12-08
05708296262649GN Hearing225031712022-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05708296249794BeltoneGn Hearing A/SOSM2022-08-24
05708296249794BeltoneGn Hearing A/SKLW2022-08-24
05708296249916BeltoneGn Hearing A/SOSM2022-08-24
05708296249916BeltoneGn Hearing A/SKLW2022-08-24
05708296250158GN ReSoundGn Hearing A/SKLW2022-08-24
05708296250158GN ReSoundGn Hearing A/SOSM2022-08-24
05708296250165GN ReSoundGn Hearing A/SKLW2022-08-24
05708296250165GN ReSoundGn Hearing A/SOSM2022-08-24
05708296228973GN ReSoundGn Hearing A/SOSM2021-08-31
05708296228973GN ReSoundGn Hearing A/SKLW2021-08-31
05708296229031BeltoneGn Hearing A/SKLW2021-08-31
05708296229031BeltoneGn Hearing A/SOSM2021-08-31
05708296227112GN HearingGn Hearing A/SKLW2021-06-11
05708296227112GN HearingGn Hearing A/SOSM2021-06-11
05708296227181GN HearingGn Hearing A/SKLW2021-06-11
05708296227181GN HearingGn Hearing A/SOSM2021-06-11
05708296227273GN HearingGn Hearing A/SKLW2021-06-11
05708296227273GN HearingGn Hearing A/SOSM2021-06-11
05708296227372GN HearingGn Hearing A/SKLW2021-06-11
05708296227372GN HearingGn Hearing A/SOSM2021-06-11
05708296227426GN HearingGn Hearing A/SKLW2021-06-11
05708296227426GN HearingGn Hearing A/SOSM2021-06-11
05708296222339GN HearingGn Hearing A/SOSM2021-06-07
05708296222339GN HearingGn Hearing A/SKLW2021-06-07
05708296222643GN HearingGn Hearing A/SKLW2021-06-07
05708296222643GN HearingGn Hearing A/SOSM2021-06-07
05708296222742GN HearingGn Hearing A/SKLW2021-06-07
05708296222742GN HearingGn Hearing A/SOSM2021-06-07
05708296222773GN HearingGn Hearing A/SOSM2021-06-07
05708296222773GN HearingGn Hearing A/SKLW2021-06-07