FDA.reportPublic FDA data

Vista V9-M

Primary DI
07613389732610
Brand
Vista V9-M
Company
Sonova AG
Model
espresso
Catalog number
050-6864-P444
Published
2024-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OSMHearing Aid, Air-Conduction With Wireless Technology, Prescription

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613389732610PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613389732610076133897326107613389732610

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
0589280101info@sonova.com

Regulatory Flags#

DUNS number
480662550
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613389540031Sonova Brand (multiple brand)051-5047-AB2022-12-12
07613389564228Sonova Brand (multiple brand)051-5046-AB2022-12-12
07613389619621Sonova Brand (multiple brand)051-5107-AB2022-12-12
07613389557930All-Day Clear 1.0 app088-5015088-50152023-02-16
07613389771831MEMINI E D 6P R-R PH (silver gray)050-1145-P6B12026-03-26
07613389771855MEMINI E D 6P R-R AI PH (silver gray)050-1147-P6B12026-03-26
07613389772012ampli-mini E 2 6P R-R PH (velvet black)050-1137-P8672026-03-26
07613389772401MEMINI E 2 6P R-R PH (silver gray)050-1137-P6B12026-03-26
07613389772418MEMINI E 2 6P R-R PH (velvet black)050-1137-P8B12026-03-26
07613389772548MEMINI E 5 6P R-R AI PH (sand beige)050-1141-P1B12026-03-26
07613389772555MEMINI E 5 6P R-R AI PH (sandalwood)050-1141-P3B12026-03-26
07613389772562MEMINI E 5 6P R-R AI PH (silver gray)050-1141-P6B12026-03-26
07613389772579MEMINI E 5 6P R-R AI PH (velvet black)050-1141-P8B12026-03-26
07613389772586MEMINI E 4 6P R-R AI PH (sand beige)050-1142-P1B12026-03-26
07613389772593MEMINI E 4 6P R-R AI PH (sandalwood)050-1142-P3B12026-03-26
07613389772609MEMINI E 4 6P R-R AI PH (silver gray)050-1142-P6B12026-03-26
07613389772616MEMINI E 4 6P R-R AI PH (velvet black)050-1142-P8B12026-03-26
07613389772623MEMINI E 3 6P R-R AI PH (sand beige)050-1143-P1B12026-03-26
07613389772630MEMINI E 3 6P R-R AI PH (sandalwood)050-1143-P3B12026-03-26
07613389772647MEMINI E 3 6P R-R AI PH (silver gray)050-1143-P6B12026-03-26

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Primary DI, Brand, Company table
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