FDA.reportPublic FDA data

Phonak

Primary DI
07612847817555
Brand
Phonak
Company
Phonak AG
Model
050-0905-70
Catalog number
050-0905-70
Device description
Phonak Ambra microM (palladium/black)
Published
2016-09-12
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
07612847817555PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07612847817555076128478175557612847817555

GMDN Terms#

Term, Definition table
TermDefinition
Behind-the-ear air-conduction hearing aidA 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
+41589280101contact@phonak.com

Regulatory Flags#

DUNS number
480089517
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
07613275528884Phonak058-0125-050058-0125-0502016-09-12
07612847809260Phonak050-0905-01050-0905-012016-09-12
07612847809277Phonak050-0906-01050-0906-012016-09-12
07612847809284Phonak050-0907-01050-0907-012016-09-12
07612847817517Phonak050-0905-13050-0905-132016-09-12
07612847817524Phonak050-0905-33050-0905-332016-09-12
07612847817531Phonak050-0905-34050-0905-342016-09-12
07612847817548Phonak050-0905-38050-0905-382016-09-12
07612847817562Phonak050-0905-B3050-0905-B32016-09-12
07612847817579Phonak050-0905-B4050-0905-B42016-09-12
07612847817586Phonak050-0905-F0050-0905-F02016-09-12
07612847817609Phonak050-0905-F7050-0905-F72016-09-12
07612847817630Phonak050-0905-G1050-0905-G12016-09-12
07612847817647Phonak050-0905-G2050-0905-G22016-09-12
07612847817654Phonak050-0905-G3050-0905-G32016-09-12
07612847817661Phonak050-0905-G4050-0905-G42016-09-12
07612847817678Phonak050-0905-G5050-0905-G52016-09-12
07612847818477Phonak050-0906-13050-0906-132016-09-12
07612847818484Phonak050-0906-33050-0906-332016-09-12
07612847818491Phonak050-0906-34050-0906-342016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613389927696Phonak CROS E-RSonova AGOSM2026-08-03
07613389927719Phonak CROS E-RSonova AGOSM2026-08-03
07613389927726Phonak CROS E-RSonova AGOSM2026-08-03
07613389927733Phonak CROS E-RSonova AGOSM2026-08-03
07613389927740Phonak CROS E-RSonova AGOSM2026-08-03
07613389927757Phonak CROS E-RSonova AGOSM2026-08-03
07613389927764Phonak CROS E-RSonova AGOSM2026-08-03
07613389927771Phonak CROS E-RSonova AGOSM2026-08-03
07613389928181Phonak CROS E-RSonova AGOSM2026-08-03
05714878800291MIRACLE EARWs Audiology Usa, Inc.OSM2026-07-29
05714878800307MIRACLE EARWs Audiology Usa, Inc.OSM2026-07-29
05714878800314MIRACLE EARWs Audiology Usa, Inc.OSM2026-07-29
05714878800352MIRACLE EARWs Audiology Usa, Inc.OSM2026-07-29
07613389840599Moxi S9-RXSonova AGOSM2026-07-26
07613389840605Moxi S9-RXSonova AGOSM2026-07-26
07613389842012Moxi S7-RXSonova AGOSM2026-07-26
07613389842029Moxi S7-RXSonova AGOSM2026-07-26
07613389842036Moxi S7-RXSonova AGOSM2026-07-26
07613389842043Moxi S7-RXSonova AGOSM2026-07-26
07613389842050Moxi S7-RXSonova AGOSM2026-07-26
07613389842067Moxi S7-RXSonova AGOSM2026-07-26
07613389842074Moxi S9-RXSonova AGOSM2026-07-26
07613389842081Moxi S9-RXSonova AGOSM2026-07-26
07613389842098Moxi S9-RXSonova AGOSM2026-07-26
07613389842104Moxi S9-RXSonova AGOSM2026-07-26
07613389842111Moxi S-RX FLEX:TRIALSonova AGOSM2026-07-26
07613389843682Relate5.0 Platinum RIC RXSonova AGOSM2026-07-26
07613389843699Relate5.0 RIC RX DEMOSonova AGOSM2026-07-26
07613389844627Relate5.0 Gold RIC RXSonova AGOSM2026-07-26
07613389844634Relate5.0 Gold RIC RXSonova AGOSM2026-07-26