FDA.report

Oticon

Primary DI
05714464101672
Brand
Oticon
Company
Sbo Hearing A/S
Model
259448
Device description
OTICON REAL 1 MINIBTE R C079
Published
2023-03-16
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
OSMHearing Aid, Air-Conduction with Wireless Technology, Prescription

Product Code Classifications

CodeDeviceSpecialtyClass
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05714464101672PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05714464101672057144641016725714464101672

GMDN Terms

TermDefinition
Air-conduction hearing aid, behind-the-earA 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 microphone, an amplifier, and a speaker (receiver) contained in a case worn behind-the-ear (BTE). 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 through an earmould that fits inside the outer ear or a tube in the ear canal. The device is used for mild to profound hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.

Sterilization Methods

Method

Contacts

PhoneEmail
+4539177100loek@demant.com

Regulatory Flags

DUNS number
306018410
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
05714464170876Oticon2856352026-02-25
05714464175512Bernafon2860762026-02-25
05714464175529Bernafon2860772026-02-25
05714464175536Bernafon2860782026-02-25
05714464175543Bernafon2860792026-02-25
05714464175550Neutral2860802026-02-25
05714464175567Neutral2860812026-02-25
05714464175598Philips2860842026-02-25
05714464175604Philips2860852026-02-25
05714464175611Oticon2860862026-02-25
05714464175628Oticon2860872026-02-25
05714464176120Philips2861372026-02-25
05714464176137Philips2861382026-02-25
05714464176144Philips2861392026-02-25
05714464176151Philips2861402026-02-25
05714464176168Philips2861412026-02-25
05714464176311Oticon2861562026-02-25
05714464176328Oticon2861572026-02-25
05714464176335Oticon2861582026-02-25
05714464176342Oticon2861592026-02-25

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