FDA.reportPublic FDA data

GN Hearing

Primary DI
05708296485420
Brand
GN Hearing
Company
Gn Hearing A/S
Model
24315200
Device description
SW,FSW SOLUS MAX 2.4,UP1
Published
2026-10-15
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
05708296485420PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708296485420057082964854205708296485420

GMDN Terms#

Term, Definition table
TermDefinition
Audiometric/hearing device softwareA software program intended to assist with the evaluation of a patient’s hearing capability and/or evaluate and adjust the settings of a hearing assistive device. It may be used by healthcare professionals in a healthcare facility or by the patient in the home, and intended to be used on a non-medical computerized device (e.g., smartphone, tablet).

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
true
Serial number
false
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
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
05708296262656GN Hearing225031722022-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05708296253173GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253203GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253210GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253234GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258031GN ReSoundGn Hearing A/SOSM2026-09-21
05708296357796GN ReSoundGn Hearing A/SOSM2025-08-06
05708296357901GN ReSoundGn Hearing A/SOSM2025-08-06
05708296358144BeltoneGn Hearing A/SOSM2025-08-06
05708296358243BeltoneGn Hearing A/SOSM2025-08-06
05708296362196GN ReSoundGn Hearing A/SOSM2025-03-27
05708296362332GN ReSoundGn Hearing A/SOSM2025-03-27
05708296362431GN ReSoundGn Hearing A/SOSM2025-03-27
05708296362639GN ReSoundGn Hearing A/SOSM2025-03-27
05708296363087BeltoneGn Hearing A/SOSM2025-03-27
05708296364862GN ReSoundGn Hearing A/SOSM2025-03-27
05708296366118GN ReSoundGn Hearing A/SOSM2025-02-05
05708296366514GN ReSoundGn Hearing A/SOSM2025-02-05
05708296366545GN ReSoundGn Hearing A/SOSM2025-02-05
05708296366583GN ReSoundGn Hearing A/SOSM2025-02-05
05708296366750BeltoneGn Hearing A/SOSM2025-02-05
05708296366880BeltoneGn Hearing A/SOSM2025-02-05
05708296366903BeltoneGn Hearing A/SOSM2025-02-05
05708296366972BeltoneGn Hearing A/SOSM2025-02-05
05708296367481BeltoneGn Hearing A/SOSM2025-02-05
05708296355044GN HearingGn Hearing A/SOSM2024-08-09
05708296336173GN HearingGn Hearing A/SOSM2024-05-09
05708296335510GN ReSoundGn Hearing A/SOSM2024-05-08
05708296335527GN ReSoundGn Hearing A/SOSM2024-05-08
05708296335596GN ReSoundGn Hearing A/SOSM2024-05-08
05708296336227GN HearingGn Hearing A/SOSM2024-05-08