FDA.reportPublic FDA data

Oticon

Primary DI
05714464175444
Brand
Oticon
Company
Sbo Hearing A/S
Model
286069
Device description
OTICON GENIE 2 2026.1 VA
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
05714464175444PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05714464175444057144641754445714464175444

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
05708296434688GN HearingGn Hearing A/SOSM2026-09-18
05708296434701GN HearingGn Hearing A/SOSM2026-09-18
05708296434718GN HearingGn Hearing A/SOSM2026-09-18
05708296477159GN ReSoundGn Hearing A/SOSM2026-09-18
05708296477166BeltoneGn Hearing A/SOSM2026-09-18
05708296477173GN ReSoundGn Hearing A/SOSM2026-09-18
05708296477180BeltoneGn Hearing A/SOSM2026-09-18
05714880250695Audio ServiceWs Audiology Usa, Inc.KLW2026-09-18
05714880250695Audio ServiceWs Audiology Usa, Inc.OSM2026-09-18
05714880250701Audio ServiceWs Audiology Usa, Inc.KLW2026-09-18
05714880250701Audio ServiceWs Audiology Usa, Inc.OSM2026-09-18
05714880250718Audio ServiceWs Audiology Usa, Inc.KLW2026-09-18
05714880250718Audio ServiceWs Audiology Usa, Inc.OSM2026-09-18
05714880250725Audio ServiceWs Audiology Usa, Inc.KLW2026-09-18
05714880250725Audio ServiceWs Audiology Usa, Inc.OSM2026-09-18
05714880250732Audio ServiceWs Audiology Usa, Inc.KLW2026-09-18
05714880250732Audio ServiceWs Audiology Usa, Inc.OSM2026-09-18
00840388220580Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220580Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220597Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220597Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220757Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220757Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220764Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220764Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220771Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220771Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220788Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220788Starkey G Series AIStarkey Laboratories, Inc.OSM2026-09-04
00840388220795Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04