FDA.reportPublic FDA data

GN Hearing

Primary DI
05708296137107
Brand
GN Hearing
Company
Gn Hearing A/S
Model
20040900
Device description
CROS,SUREFIT,AUDIO SHOE,SM
Published
2017-03-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
OSMHearing aid, air conduction with wireless technology

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
05708296137107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708296137107057082961371075708296137107

GMDN Terms#

Term, Definition table
TermDefinition
Hearing aid enhanced audio attachmentA passive device intended to enable a wired audio transmission from a multimedia device (e.g., computer, phone, mp3 player) to a behind-the-ear (BTE) hearing aid, to enhance the sound quality received by the wearer of the hearing aid. Also known as an audioshoe, it consists of a hearing aid attachment which attaches/plugs directly into the hearing aid, making an electrical connection [e.g., direct audio input (DAI)], to receive power from and transmit the signal to the active hearing aid. A wire is used to connect the device to the multimedia 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
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05708296253166GN ReSound223665702026-09-21
05708296253173GN ReSound223665712026-09-21
05708296253180GN ReSound223665722026-09-21
05708296253197GN ReSound223665732026-09-21
05708296253203GN ReSound223665742026-09-21
05708296253210GN ReSound223665752026-09-21
05708296253227GN ReSound223665762026-09-21
05708296253234GN ReSound223665772026-09-21
05708296253241GN ReSound223665782026-09-21
05708296257966GN ReSound224854702026-09-21
05708296257973GN ReSound224854712026-09-21
05708296257980GN ReSound224854722026-09-21
05708296257997GN ReSound224854732026-09-21
05708296258000GN ReSound224854742026-09-21
05708296258017GN ReSound224854752026-09-21
05708296258024GN ReSound224854762026-09-21
05708296258031GN ReSound224854772026-09-21
05708296258048GN ReSound224854782026-09-21
05708296258321GN ReSound224858702026-09-21
05708296258338GN ReSound224858712026-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05708296253166GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253173GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253180GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253197GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253203GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253210GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253227GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253234GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253241GN ReSoundGn Hearing A/SOSM2026-09-21
05708296257966GN ReSoundGn Hearing A/SOSM2026-09-21
05708296257973GN ReSoundGn Hearing A/SOSM2026-09-21
05708296257980GN ReSoundGn Hearing A/SOSM2026-09-21
05708296257997GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258000GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258017GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258024GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258031GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258048GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258321GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258338GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258345GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258352GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258369GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258376GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258383GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258390GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258406GN ReSoundGn Hearing A/SOSM2026-09-21
05708296434602GN HearingGn Hearing A/SOSM2026-09-21
05708296434770GN HearingGn Hearing A/SOSM2026-09-21
05708296434794GN HearingGn Hearing A/SOSM2026-09-21