FDA.reportPublic FDA data

Sonova Brand (multiple brand)

Primary DI
07613389564228
Brand
Sonova Brand (multiple brand)
Company
Sonova AG
Model
051-5046-AB
Device description
All-Day Clear ADC1 (US)
Published
2022-12-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
OTC
true

Product Codes#

Code, Name table
CodeName
QUHSelf-Fitting Air-Conduction Hearing Aid, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QUHSelf-Fitting Air-Conduction Hearing Aid, Over The CounterEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613389564228PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613389564228076133895642287613389564228

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, receiver-in-canalA battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It consists of a microphone and an amplifier in a case behind-the-ear (BTE) connected, via a wire, to a receiver (speaker) in the ear canal [receiver-in-canal (RIC)]. 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. 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

Regulatory Flags#

DUNS number
480662550
Device count
1
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
05708296422043GN HearingGn Hearing A/SQUH2026-08-21
05708296422050GN HearingGn Hearing A/SQUH2026-08-21
05708296422067GN HearingGn Hearing A/SQUH2026-08-21
05708296422074GN HearingGn Hearing A/SQUH2026-08-21
05708296422081GN HearingGn Hearing A/SQUH2026-08-21
05708296422098GN HearingGn Hearing A/SQUH2026-08-21
05708296422104GN HearingGn Hearing A/SQUH2026-08-21
05708296422111GN HearingGn Hearing A/SQUH2026-08-21
05708296422128GN HearingGn Hearing A/SQUH2026-08-21
05708296422135GN HearingGn Hearing A/SQUH2026-08-21
05708296422142GN HearingGn Hearing A/SQUH2026-08-21
05708296422159GN HearingGn Hearing A/SQUH2026-08-21
05708296422166GN HearingGn Hearing A/SQUH2026-08-21
05708296422173GN HearingGn Hearing A/SQUH2026-08-21
05708296422180GN HearingGn Hearing A/SQUH2026-08-21
05708296422197GN HearingGn Hearing A/SQUH2026-08-21
05708296422203GN HearingGn Hearing A/SQUH2026-08-21
05708296422210GN HearingGn Hearing A/SQUH2026-08-21
05708296422227GN HearingGn Hearing A/SQUH2026-08-21
05708296422234GN HearingGn Hearing A/SQUH2026-08-21
05708296422241GN HearingGn Hearing A/SQUH2026-08-21
05708296422258GN HearingGn Hearing A/SQUH2026-08-21
05708296422265GN HearingGn Hearing A/SQUH2026-08-21
05708296422272GN HearingGn Hearing A/SQUH2026-08-21
05708296422289GN HearingGn Hearing A/SQUH2026-08-21
05708296422296GN HearingGn Hearing A/SQUH2026-08-21
05708296422302GN HearingGn Hearing A/SQUH2026-08-21
05708296422319GN HearingGn Hearing A/SQUH2026-08-21
05708296422326GN HearingGn Hearing A/SQUH2026-08-21
05708296422333GN HearingGn Hearing A/SQUH2026-08-21