FDA.reportPublic FDA data

Oticon

Primary DI
05707131357793
Brand
Oticon
Company
Oticon A/S
Model
204670
Device description
GENIE 2 2019.2 OTICON
Published
2019-08-22
Public version status
Update
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

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
05707131357793PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05707131357793057071313577935707131357793

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
+4539177100eand@demant.com

Regulatory Flags#

DUNS number
305839946
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
05707131329868Oticon1789432018-08-20
05707131329882Oticon1789452018-08-20
05707131329899Oticon1789462018-08-20
05707131329912Oticon1789482018-08-20
05707131331496Oticon1825732018-08-20
05707131331519Oticon1825752018-08-20
05707131331526Oticon1825762018-08-20
05707131331540Oticon1825782018-08-20
05707131331694Oticon1827252018-08-20
05707131331717Oticon1827272018-08-20
05707131331724Oticon1827282018-08-20
05707131331748Oticon1827302018-08-20
05707131339911Oticon1919072018-08-20
05707131339935Oticon1919092018-08-20
05707131339942Oticon1919102018-08-20
05707131339966Oticon1919122018-08-20
05707131340375Oticon1919402018-08-20
05707131340399Oticon1919422018-08-20
05707131340405Oticon1919432018-08-20
05707131340429Oticon1919452018-08-20

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