FDA.reportPublic FDA data

Oticon

Primary DI
05707131331748
Brand
Oticon
Company
Oticon A/S
Model
182730
Device description
OPN 3, KIT 10 85 PB C001
Published
2018-08-20
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLWMasker, TinnitusEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133308000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133308000TINNITUS SOUNDSUPPORTOticon A/S2014-03-18KLW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05707131331748PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05707131331748057071313317485707131331748

GMDN Terms#

Term, Definition table
TermDefinition
In-the-ear air-conduction hearing aidA battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It typically consists of a miniature microphone, amplifier, and speaker (receiver) contained in a case that fits completely inside the outer ear (concha) [in-the-ear (ITE)]. The microphone receives sound waves and converts them into electrical signals which are increased by the amplifier and sent as sound waves, by the speaker, to the eardrum. The device is used for mild to severe hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4539177100hama@oticon.com

Regulatory Flags#

DUNS number
305839946
Device count
1
DM exempt
true
Serial number
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
05707131339911Oticon1919072018-08-20
05707131339935Oticon1919092018-08-20
05707131339942Oticon1919102018-08-20
05707131339966Oticon1919122018-08-20
05707131340375Oticon1919402018-08-20
05707131340399Oticon1919422018-08-20
05707131340405Oticon1919432018-08-20
05707131340429Oticon1919452018-08-20
05707131379399Oticon2148162020-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840388220580Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220597Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220757Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220764Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220771Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220788Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220795Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220801Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220818Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220825Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220863Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220917Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220955Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220993Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221006Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221013Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221020Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221037Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221044Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221051Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221068Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221075Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221136Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221181Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221228Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221266Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221280Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221297Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221303Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221327Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04