FDA.reportPublic FDA data

Oticon

Primary DI
05714464175468
Brand
Oticon
Company
Sbo Hearing A/S
Model
286071
Device description
OTICON GENIE 2 2026.1
Published
2026-01-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

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
05714464175468PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05714464175468057144641754685714464175468

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).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4523648485succ@demant.com

Regulatory Flags#

DUNS number
306018410
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05714464175659Maico2860902026-04-10
05714464175666Maico2860912026-04-10
05714464175673Maico2860922026-04-10
05714464175680Maico2860932026-04-10
05714464175697Maico2860942026-04-10
05714464175703Oticon2860952026-04-10
05714464175710Oticon2860962026-04-10
05714464175727Oticon2860972026-04-10
05714464175734Oticon2860982026-04-10
05714464175741Oticon2860992026-04-10
05714464175857Oticon2861102026-04-10
05714464175864Oticon2861112026-04-10
05714464175871Oticon2861122026-04-10
05714464175888Oticon2861132026-04-10
05714464175895Oticon2861142026-04-10
05714464175963Oticon2861212026-04-10
05714464176175Bernafon2861422026-04-10
05714464176182Bernafon2861432026-04-10
05714464176199Bernafon2861442026-04-10
05714464176205Bernafon2861452026-04-10

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