FDA.reportPublic FDA data

Persona Medical

Primary DI
00851362008315
Brand
Persona Medical
Company
Persona Medical
Model
Ole Deep CIC Custom Hearing Aid
Device description
This is a deep fitting In-The-canal (ITC) custom hearing aid. The device is used for mild to severe hearing loss; this is programmable to enable computerized adjustments for a patient's hearing loss and related factors.
Published
2022-10-06
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
ESDHearing Aid, Air Conduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ESDHearing Aid, Air-Conduction, PrescriptionEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851362008315PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851362008315008513620083158513620083150851362008315

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, in-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 miniature microphone, amplifier, and speaker (receiver) contained in a case that fits completely inside the outer ear (concha) [in-the-ear (ITE)]. 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 severe 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
00851362008179Persona MedicalRxEars RX92022-01-13
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
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
00840388201145STARKEYStarkey Laboratories, Inc.ESD2025-06-25
00840388201541STARKEYStarkey Laboratories, Inc.ESD2025-06-25
00840388201640AUDIBELStarkey Laboratories, Inc.ESD2025-06-25
07613389772838ampli-mini I 3 5P CIC-10 NWL PHSonova AGESD2024-11-12
07613389772845ampli-mini I 2 5P CIC-10 NWL PHSonova AGESD2024-11-12
07613389772920MEMINI I 4 5P CIC-10 NWL PHSonova AGESD2024-11-12
07613389772937MEMINI I 3 5P CIC-10 NWL PHSonova AGESD2024-11-12
16945936703773NewsoundXiamen New Sound Technology Co., Ltd.ESD2024-01-19
00810126191373AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191380AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191397AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191403AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191410AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191427AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191434AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191441AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191458AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191465AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191472AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191489AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191496AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191502AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191519AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191526AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191533AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191540AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191557AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191564AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191571AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191588AudinaAudina Hearing Instruments, Inc.ESD2023-01-31