FDA.reportPublic FDA data

Phonak Audéo I90-Sphere

Primary DI
07613389686609
Brand
Phonak Audéo I90-Sphere
Company
Sonova AG
Model
(sandalwood)
Catalog number
050-1029-P3
Published
2024-05-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613389686609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613389686609076133896866097613389686609

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
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
06974608620523PHONELUMShenzhen Eartech Co., Ltd.OSM2026-08-27
05708296400942GN ReSoundGn Hearing A/SOSM2026-08-21
05708296400959GN ReSoundGn Hearing A/SOSM2026-08-21
05708296400966GN ReSoundGn Hearing A/SOSM2026-08-21
05708296400973GN ReSoundGn Hearing A/SOSM2026-08-21
05708296400980GN ReSoundGn Hearing A/SOSM2026-08-21
05708296400997GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401000GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401017GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401024GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401031GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401048GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401055GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401062GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401079GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401086GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401093GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401109GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401116GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401123GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401130GN ReSoundGn Hearing A/SOSM2026-08-21
05708296401550GN ReSoundGn Hearing A/SOSM2026-08-21
05708296435265GN ReSoundGn Hearing A/SOSM2026-08-21
05708296435272GN ReSoundGn Hearing A/SOSM2026-08-21
05708296435289GN ReSoundGn Hearing A/SOSM2026-08-21
05708296435296GN ReSoundGn Hearing A/SOSM2026-08-21
05708296435302GN ReSoundGn Hearing A/SOSM2026-08-21
05708296435319GN ReSoundGn Hearing A/SOSM2026-08-21
05708296435326GN ReSoundGn Hearing A/SOSM2026-08-21
05708296435333GN ReSoundGn Hearing A/SOSM2026-08-21