FDA.reportPublic FDA data

Oticon

Primary DI
05714464148226
Brand
Oticon
Company
Sbo Hearing A/S
Model
271193
Device description
OTICON OWN SI 2 IIC
Published
2025-02-10
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
LRBFace plate hearing aid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLWMasker, TinnitusEar, Nose, Throat2
LRBFace Plate Hearing AidEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05714464148226PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05714464148226057144641482265714464148226

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, canalA 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) in a case that fits the ear canal [in-the-canal (ITC)] or in a case nearly hidden in the ear canal [completely-in-the-canal (CIC)]. 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. It is used for mild to moderately-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
+4523648485succ@demant.com

Regulatory Flags#

DUNS number
306018410
Device count
1
DM exempt
true
Serial number
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
05714880299359AudioServiceWs Audiology Usa, Inc.KLW2026-10-28
05714880299403AudioServiceWs Audiology Usa, Inc.KLW2026-10-28
05714880299410AudioServiceWs Audiology Usa, Inc.KLW2026-10-28
05714880299427AudioServiceWs Audiology Usa, Inc.KLW2026-10-28
05714880299564REXTONWs Audiology Usa, Inc.KLW2026-10-28
05714880299571REXTONWs Audiology Usa, Inc.KLW2026-10-28
05714880299588REXTONWs Audiology Usa, Inc.KLW2026-10-28
05714880299595REXTONWs Audiology Usa, Inc.KLW2026-10-28
05714880299601REXTONWs Audiology Usa, Inc.KLW2026-10-28
05714880299618REXTONWs Audiology Usa, Inc.KLW2026-10-28
05714880299625REXTONWs Audiology Usa, Inc.KLW2026-10-28
05714880299632REXTONWs Audiology Usa, Inc.KLW2026-10-28
05714880299649REXTONWs Audiology Usa, Inc.KLW2026-10-28
05714880299656REXTONWs Audiology Usa, Inc.KLW2026-10-28
05714880299663REXTONWs Audiology Usa, Inc.KLW2026-10-28
05714880299670REXTONWs Audiology Usa, Inc.KLW2026-10-28
05714880299687REXTONWs Audiology Usa, Inc.KLW2026-10-28
05714880299694REXTONWs Audiology Usa, Inc.KLW2026-10-28
05714880299991MIRACLE EARWs Audiology Usa, Inc.KLW2026-10-27
05714880300000MIRACLE EARWs Audiology Usa, Inc.KLW2026-10-27
05714880300017MIRACLE EARWs Audiology Usa, Inc.KLW2026-10-27
05714880300024MIRACLE EARWs Audiology Usa, Inc.KLW2026-10-27
05714880300031MIRACLE EARWs Audiology Usa, Inc.KLW2026-10-27
05714880300048MIRACLE EARWs Audiology Usa, Inc.KLW2026-10-27
05714880300055MIRACLE EARWs Audiology Usa, Inc.KLW2026-10-27
05714880300062MIRACLE EARWs Audiology Usa, Inc.KLW2026-10-27
05714880300079MIRACLE EARWs Audiology Usa, Inc.KLW2026-10-27
05714880300086MIRACLE EARWs Audiology Usa, Inc.KLW2026-10-27
05714880300093MIRACLE EARWs Audiology Usa, Inc.KLW2026-10-27
05714880300109MIRACLE EARWs Audiology Usa, Inc.KLW2026-10-27