FDA.reportPublic FDA data

GN Hearing

Primary DI
05708296419142
Brand
GN Hearing
Company
Gn Hearing A/S
Model
23850500
Device description
FITTING KIT,ALLFIT DOMES,10PC
Published
2026-01-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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
05708296419142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708296419142057082964191425708296419142

GMDN Terms#

Term, Definition table
TermDefinition
Earmould, preformedA preformed device designed to fit in an ear canal and through which the acoustic output from a hearing aid is conveyed to the eardrum. It is made of soft synthetic polymer materials and may have various forms (e.g., plug-like, ear shape). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
306179227
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true

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
00840388220580Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220597Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220757Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220764Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220771Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220788Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220795Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220801Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220818Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220825Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220863Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220917Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220955Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220993Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221006Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221013Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221020Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221037Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221044Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221051Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221068Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221075Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221136Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221181Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221228Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221266Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221280Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221297Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221303Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388221327Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04