FDA.report

Bernafon

Primary DI
05714464159031
Brand
Bernafon
Company
Sbo Hearing A/S
Model
276897
Device description
BERNAFON ENTRA B 10 IIC
Published
2025-02-10
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
LRBFace plate hearing aid

Product Code Classifications

CodeDeviceSpecialtyClass
LRBFace Plate Hearing AidEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05714464159031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05714464159031057144641590315714464159031

GMDN Terms

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

Contacts

PhoneEmail
+4523648485succ@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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
05714464148103PhilipsSbo Hearing A/SLRB2025-02-10
05714464148202OticonSbo Hearing A/SLRB2025-02-10
05714464148219OticonSbo Hearing A/SLRB2025-02-10
05714464148226OticonSbo Hearing A/SLRB2025-02-10
05714464148233OticonSbo Hearing A/SLRB2025-02-10
05714464148240OticonSbo Hearing A/SLRB2025-02-10
05714464148257OticonSbo Hearing A/SLRB2025-02-10
05714464148271OticonSbo Hearing A/SLRB2025-02-10
05714464148295BernafonSbo Hearing A/SLRB2025-02-10
05714464148325BernafonSbo Hearing A/SLRB2025-02-10
05714464148332BernafonSbo Hearing A/SLRB2025-02-10
05714464148349BernafonSbo Hearing A/SLRB2025-02-10
05714464148363PhilipsSbo Hearing A/SLRB2025-02-10
05714464148370PhilipsSbo Hearing A/SLRB2025-02-10
05714464148431PhilipsSbo Hearing A/SLRB2025-02-10
05714464148837AGXOSbo Hearing A/SLRB2025-02-10
05714464148851AGXOSbo Hearing A/SLRB2025-02-10
05714464148875AGXOSbo Hearing A/SLRB2025-02-10
05714464148899AGXOSbo Hearing A/SLRB2025-02-10
05714464158911OticonSbo Hearing A/SLRB2025-02-10
05714464158935OticonSbo Hearing A/SLRB2025-02-10
05714464158973OticonSbo Hearing A/SLRB2025-02-10
05714464158980BernafonSbo Hearing A/SLRB2025-02-10
05714464158997BernafonSbo Hearing A/SLRB2025-02-10
05714464159024BernafonSbo Hearing A/SLRB2025-02-10
05714464159086PhilipsSbo Hearing A/SLRB2025-02-10
05714464159093PhilipsSbo Hearing A/SLRB2025-02-10
05714464159109PhilipsSbo Hearing A/SLRB2025-02-10
05714464159116PhilipsSbo Hearing A/SLRB2025-02-10
05714464159123PhilipsSbo Hearing A/SLRB2025-02-10