FDA.reportPublic FDA data

Beltone

Primary DI
05708296239139
Brand
Beltone
Company
Gn Hearing A/S
Model
22223600
Device description
USB,FSW SM1.14,SP1,US
Published
2022-07-08
Public version status
Update
Distribution status
Not 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
05708296239139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708296239139057082962391395708296239139

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 hearing assistive devices. It may be used by healthcare professionals in a healthcare facility or by the patient in the home, and usually runs on an off-the-shelf portable computerized device (e.g., smartphone, tablet).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1-888-235-8663marketing@beltoneapps.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05708296447022GN Hearing238497002026-10-21
05708296474998GN Hearing243511002026-10-21
05708296475001GN Hearing243512002026-10-21
05708296475025GN Hearing243514002026-10-21
05708296475032GN Hearing243515002026-10-21
05708296475049GN Hearing243516002026-10-21
05708296485369GN Hearing243146002026-10-21
05708296485529GN Hearing243162002026-10-21
05708296221257GN HearingXC2ITE-DW-UP2021-06-07
05708296221325GN HearingXC3ITE-DW-HP2021-06-07
05708296221394GN HearingXC4ITC-DW-MP2021-06-07
05708296221400GN HearingXC4ITC-DW-UP2021-06-07
05708296221431GN HearingXC4ITE-DW-UP2021-06-07
05708296207435GN ReSoundKE2ITC-DW-UP2021-02-05
05708296207510GN ReSoundKE3ITC-DW-HP2021-02-05
05708296207534GN ReSoundKE3ITC-DW-UP2021-02-05
05708296207640GN ReSoundKE4ITE-DW-HP2021-02-05
05708296208050BeltoneRLY2ITC-DW-UP2021-02-05
05708296208210BeltoneRLY4CIC-W-MP2021-02-05
05708296174034BeltoneAMZ17MIH-W-HP2019-08-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714880270303WidexWidex A/SOSM2026-10-22
05708296447022GN HearingGn Hearing A/SOSM2026-10-21
05708296474998GN HearingGn Hearing A/SOSM2026-10-21
05708296475001GN HearingGn Hearing A/SOSM2026-10-21
05708296475025GN HearingGn Hearing A/SOSM2026-10-21
05708296475032GN HearingGn Hearing A/SOSM2026-10-21
05708296475049GN HearingGn Hearing A/SOSM2026-10-21
05708296485369GN HearingGn Hearing A/SOSM2026-10-21
05708296485529GN HearingGn Hearing A/SOSM2026-10-21
05708296394029BeltoneGn Hearing A/SOSM2026-10-05
05708296394036BeltoneGn Hearing A/SOSM2026-10-05
05708296394098BeltoneGn Hearing A/SOSM2026-10-05
05708296394104BeltoneGn Hearing A/SOSM2026-10-05
05708296394111BeltoneGn Hearing A/SOSM2026-10-05
05708296394128BeltoneGn Hearing A/SOSM2026-10-05
05708296394135BeltoneGn Hearing A/SOSM2026-10-05
05708296394197BeltoneGn Hearing A/SOSM2026-10-05
05708296394203BeltoneGn Hearing A/SOSM2026-10-05
05708296394210BeltoneGn Hearing A/SOSM2026-10-05
05708296394487BeltoneGn Hearing A/SOSM2026-10-05
05708296394494BeltoneGn Hearing A/SOSM2026-10-05
05708296394555BeltoneGn Hearing A/SOSM2026-10-05
05708296394562BeltoneGn Hearing A/SOSM2026-10-05
05708296394579BeltoneGn Hearing A/SOSM2026-10-05
05708296394586BeltoneGn Hearing A/SOSM2026-10-05
05708296394593BeltoneGn Hearing A/SOSM2026-10-05
05708296394654BeltoneGn Hearing A/SOSM2026-10-05
05708296394661BeltoneGn Hearing A/SOSM2026-10-05
05708296394678BeltoneGn Hearing A/SOSM2026-10-05
05708296397877BeltoneGn Hearing A/SOSM2026-10-05