FDA.reportPublic FDA data

Phonak Brand

Primary DI
07613389402995
Brand
Phonak Brand
Company
Sonova AG
Model
088-0013-20
Catalog number
088-0013-20
Device description
myPhonak 4.0 app
Published
2020-07-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
OSMHearing aid, air conduction with wireless technology

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
07613389402995PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613389402995076133894029957613389402995

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 hearing assistive devices. It may be used by healthcare professionals in a healthcare facility or by the patient in the home, and usually runs on an off-the-shelf portable computerized device (e.g., smartphone, tablet).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+41589280101info@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
07613389927696Phonak CROS E-R(beige)050-1144-H0B32026-08-03
07613389927719Phonak CROS E-R(sand beige)050-1144-P1B32026-08-03
07613389927726Phonak CROS E-R(sandalwood)050-1144-P3B32026-08-03
07613389927733Phonak CROS E-R(chestnut)050-1144-P4B32026-08-03
07613389927740Phonak CROS E-R(champagne)050-1144-P5B32026-08-03
07613389927757Phonak CROS E-R(silver gray)050-1144-P6B32026-08-03
07613389927764Phonak CROS E-R(graphite gray)050-1144-P7B32026-08-03
07613389927771Phonak CROS E-R(velvet black)050-1144-P8B32026-08-03
07613389928181Phonak CROS E-R(sienna red)050-1144-8AB32026-08-03
07613389840599Moxi S9-RX(velvet black)050-6927-P82026-07-26
07613389840605Moxi S9-RX(sand)050-6927-R82026-07-26
07613389842012Moxi S7-RX(amber beige)050-6926-P22026-07-26
07613389842029Moxi S7-RX(chestnut)050-6926-P42026-07-26
07613389842036Moxi S7-RX(silver gray)050-6926-P62026-07-26
07613389842043Moxi S7-RX(graphite gray)050-6926-P72026-07-26
07613389842050Moxi S7-RX(velvet black)050-6926-P82026-07-26
07613389842067Moxi S7-RX(sand)050-6926-R82026-07-26
07613389842074Moxi S9-RX(amber beige)050-6927-P22026-07-26
07613389842081Moxi S9-RX(chestnut)050-6927-P42026-07-26
07613389842098Moxi S9-RX(silver gray)050-6927-P62026-07-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05708296253173GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253203GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253210GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253234GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258031GN ReSoundGn Hearing A/SOSM2026-09-21
05708296357796GN ReSoundGn Hearing A/SOSM2025-08-06
05708296357901GN ReSoundGn Hearing A/SOSM2025-08-06
05708296358144BeltoneGn Hearing A/SOSM2025-08-06
05708296358243BeltoneGn Hearing A/SOSM2025-08-06
05708296362196GN ReSoundGn Hearing A/SOSM2025-03-27
05708296362332GN ReSoundGn Hearing A/SOSM2025-03-27
05708296362431GN ReSoundGn Hearing A/SOSM2025-03-27
05708296362639GN ReSoundGn Hearing A/SOSM2025-03-27
05708296363087BeltoneGn Hearing A/SOSM2025-03-27
05708296364862GN ReSoundGn Hearing A/SOSM2025-03-27
05708296366118GN ReSoundGn Hearing A/SOSM2025-02-05
05708296366514GN ReSoundGn Hearing A/SOSM2025-02-05
05708296366545GN ReSoundGn Hearing A/SOSM2025-02-05
05708296366583GN ReSoundGn Hearing A/SOSM2025-02-05
05708296366750BeltoneGn Hearing A/SOSM2025-02-05
05708296366880BeltoneGn Hearing A/SOSM2025-02-05
05708296366903BeltoneGn Hearing A/SOSM2025-02-05
05708296366972BeltoneGn Hearing A/SOSM2025-02-05
05708296367481BeltoneGn Hearing A/SOSM2025-02-05
05708296355044GN HearingGn Hearing A/SOSM2024-08-09
05708296336173GN HearingGn Hearing A/SOSM2024-05-09
05708296335510GN ReSoundGn Hearing A/SOSM2024-05-08
05708296335527GN ReSoundGn Hearing A/SOSM2024-05-08
05708296335596GN ReSoundGn Hearing A/SOSM2024-05-08
05708296336227GN HearingGn Hearing A/SOSM2024-05-08