FDA.report

Oticon

Primary DI
05707131329752
Brand
Oticon
Company
Oticon A/S
Model
178968
Device description
OPN 1, KIT 312 NFM 90 PB L C001
Published
2018-08-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KLWMasker, tinnitus

Product Code Classifications

CodeDeviceSpecialtyClass
KLWMasker, TinnitusEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05707131329752PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05707131329752057071313297525707131329752

GMDN Terms

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

Contacts

PhoneEmail
+4539177100hama@oticon.com

Regulatory Flags

DUNS number
305839946
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
05707131379399Oticon2148162020-05-20
05707131357588Oticon2044522019-08-22
05707131357595Oticon2044532019-08-22
05707131357601Oticon2044542019-08-22
05707131357618Oticon2044552019-08-22
05707131357793Oticon2046702019-08-22
05707131357809Oticon2046712019-08-22
05707131357847Oticon2046752019-08-22
05707131399724Oticon2251192020-12-17
05707131399731Oticon2251202020-12-17
05707131399748Oticon2251212020-12-17
05707131399755Oticon2251222020-12-17
05714464006847Oticon2218752020-12-17
05714464006854Oticon2218842020-12-17
05714464006861Oticon2218932020-12-17
05714464007189Oticon2218672020-12-17
05714464007196Oticon2218682020-12-17
05714464007202Oticon2218692020-12-17
05714464007219Oticon2218702020-12-17
05714464007226Oticon2218712020-12-17

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05714880295061SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
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05714880295689SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295764SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295771SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295825SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295832SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295887SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295894SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295948SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295955SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
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05714880296006SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880296037SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880296068SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880296099SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
07613389834147Phonak Audéo E90-Sphere Sonova AGKLW2026-03-17
07613389860498Phonak Audéo E30-Sphere Sonova AGKLW2026-03-17
07613389891171Phonak Audéo E90-RSonova AGKLW2026-03-16
05714464175529BernafonSbo Hearing A/SKLW2026-02-25
05714464175567NeutralSbo Hearing A/SKLW2026-02-25
05714464175598PhilipsSbo Hearing A/SKLW2026-02-25
05714464175628OticonSbo Hearing A/SKLW2026-02-25
05714464176151PhilipsSbo Hearing A/SKLW2026-02-25
05714464176168PhilipsSbo Hearing A/SKLW2026-02-25
05714464176335OticonSbo Hearing A/SKLW2026-02-25
05714464176359OticonSbo Hearing A/SKLW2026-02-25
05714464182848OticonSbo Hearing A/SKLW2026-02-25