FDA.reportPublic FDA data

Boots Hearingcare 3

Primary DI
07613389700725
Brand
Boots Hearingcare 3
Company
Sonova AG
Model
3.1
Catalog number
088-0025-00031
Published
2024-01-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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
07613389700725PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613389700725076133897007257613389700725

GMDN Terms#

Term, Definition table
TermDefinition
Audiometric/hearing device softwareA software program intended to assist with the evaluation of a patient’s hearing capability and/or evaluate and adjust the settings of a hearing assistive device. It may be used by healthcare professionals in a healthcare facility or by the patient in the home, and intended to be used on a non-medical computerized device (e.g., smartphone, tablet).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
480662550
Device count
1
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714880113778CONNEXXWs Audiology Usa, Inc.OSM2026-05-28
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05714880214369Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214376Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214383Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214390Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214413Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214420Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214543Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214567Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214574Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214581Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214598Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214611Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214628Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219425Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219432Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219449Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
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05714880219463Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219470Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219869Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219876Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219883Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219890Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219906Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219913Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219944Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219951Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880279566SigniaWs Audiology Usa, Inc.OSM2026-05-27