FDA.report

Baha

Primary DI
09321502021012
Brand
Baha
Company
Cochlear Bone Anchored Solutions AB
Model
92575
Catalog number
92575
Device description
BP100 & Baha 4 Battery door Apple Green
Published
2016-11-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LXBHearing aid, bone conduction

Product Code Classifications

CodeDeviceSpecialtyClass
LXBHearing Aid, Bone ConductionEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
09321502021012PrimaryGS10
09321502039109Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
09321502021012093215020210129321502021012
09321502039109093215020391099321502039109

GMDN Terms

TermDefinition
Head-worn bone-conduction hearing aidAn electrically-powered acoustic device intended to compensate for impaired hearing by transmitting vibrations, from transduced sound waves, through the skull to the inner ear. It typically consists of a microphone, amplifier, and vibrator mounted or magnetically connected to a headband, spectacles or an implantable magnet; it may include positioning and protection devices. The microphone receives sound waves and converts them into electrical signals sent to the vibrator which transmits vibrations, typically through the mastoid bone, to the inner ears for hearing. This device is typically used to treat hearing impairment due to middle and/or outer ear obstructive pathologies.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)523-5798customer@cochlear.com

Regulatory Flags

DUNS number
559784736
Device count
2
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
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

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