FDA.reportPublic FDA data

Persona Medical

Primary DI
00851362008292
Brand
Persona Medical
Company
Persona Medical
Model
Evok 900 CIC Std/Pwr
Device description
8 Channel Programmable CIC faceplate module (Standard/Power) to be used to manufacture a custom hearing aid.
Published
2022-01-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LRBFace Plate Hearing Aid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRBFace Plate Hearing AidEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851362008292PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851362008292008513620082928513620082920851362008292

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714464167012BirdsongSbo Hearing A/SLRB2026-03-26
05714464167029BirdsongSbo Hearing A/SLRB2026-03-26
05714464167036BirdsongSbo Hearing A/SLRB2026-03-26
05714464167043BirdsongSbo Hearing A/SLRB2026-03-26
05714464167050BirdsongSbo Hearing A/SLRB2026-03-26
05714464167067BirdsongSbo Hearing A/SLRB2026-03-26
05714464167074BirdsongSbo Hearing A/SLRB2026-03-26
05714464167081BirdsongSbo Hearing A/SLRB2026-03-26
05714464167098BirdsongSbo Hearing A/SLRB2026-03-26
05714464167104BirdsongSbo Hearing A/SLRB2026-03-26
05714464167111BirdsongSbo Hearing A/SLRB2026-03-26
05714464167128BirdsongSbo Hearing A/SLRB2026-03-26
05714464167135BirdsongSbo Hearing A/SLRB2026-03-26
05714464167142BirdsongSbo Hearing A/SLRB2026-03-26
05714464167159BirdsongSbo Hearing A/SLRB2026-03-26
05714464148103PhilipsSbo Hearing A/SLRB2025-02-10
05714464148110PhilipsSbo Hearing A/SLRB2025-02-10
05714464148202OticonSbo Hearing A/SLRB2025-02-10
05714464148219OticonSbo Hearing A/SLRB2025-02-10
05714464148226OticonSbo Hearing A/SLRB2025-02-10
05714464148233OticonSbo Hearing A/SLRB2025-02-10
05714464148240OticonSbo Hearing A/SLRB2025-02-10
05714464148257OticonSbo Hearing A/SLRB2025-02-10
05714464148264OticonSbo Hearing A/SLRB2025-02-10
05714464148271OticonSbo Hearing A/SLRB2025-02-10
05714464148288BernafonSbo Hearing A/SLRB2025-02-10
05714464148295BernafonSbo Hearing A/SLRB2025-02-10
05714464148301BernafonSbo Hearing A/SLRB2025-02-10
05714464148318BernafonSbo Hearing A/SLRB2025-02-10
05714464148325BernafonSbo Hearing A/SLRB2025-02-10