FDA.reportPublic FDA data

Persona Medical

Primary DI
00851362008179
Brand
Persona Medical
Company
Persona Medical
Model
RxEars RX9
Device description
Hearing Device incorporating advanced algorithms and simple controls for volume & memory settings for different environments.
Published
2022-01-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00851362008179PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851362008179008513620081798513620081790851362008179

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, behind-the-earA 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

Regulatory Flags#

DUNS number
101877157
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
00851362008612Persona MedicalPersona Ri APP2025-11-17
00851362008605Persona MedicalPersona Ri APP2025-10-13
00851362008582Persona MedicalEvok Ri Glacier2025-10-13
00851362008599Persona MedicalEvok Ri Graphite2025-10-13
00851362008575Persona MedicalEvok Ri2025-09-19
00851362008162Persona MedicalClaret 400 OTE/BTE Hearing Aid2023-08-29
00851362008568Persona MedicalSombra 9P2023-08-10
00851362008322RXEars RXS2022-10-24
00851362008339RXEarsRXi2022-10-24
00851362008346RXEarsBT1S2022-10-24
00851362008353RXEarsBT2R2022-10-24
00851362008438RXEars RX42022-10-24
00851362008452RXEarsBT1R2022-10-24
00851362008551RXEarsBT2S2022-10-24
00851362008520Persona MedicalSombra 9R2022-10-10
00851362008537Persona MedicalSombra 9S2022-10-10
00851362008315Persona MedicalOle Deep CIC Custom Hearing Aid2022-10-06
00851362008407Persona MedicalEvok 900 Series Custom Hearing Aid2022-10-06
00851362008513Persona MedicalEvok 500 Series Custom Hearing Aid2022-10-06
00851362008544Persona MedicalClaret 300 Series Custom Hearing Aid2022-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714880286342CONNEXXWs Audiology Usa, Inc.OSM2026-10-01
05714880297584CONNEXXWs Audiology Usa, Inc.OSM2026-10-01
05708296253166GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253173GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253180GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253197GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253203GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253210GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253227GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253234GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253241GN ReSoundGn Hearing A/SOSM2026-09-21
05708296257966GN ReSoundGn Hearing A/SOSM2026-09-21
05708296257973GN ReSoundGn Hearing A/SOSM2026-09-21
05708296257980GN ReSoundGn Hearing A/SOSM2026-09-21
05708296257997GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258000GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258017GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258024GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258031GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258048GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258321GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258338GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258345GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258352GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258369GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258376GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258383GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258390GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258406GN ReSoundGn Hearing A/SOSM2026-09-21
05708296434602GN HearingGn Hearing A/SOSM2026-09-21