FDA.reportPublic FDA data

Persona Medical

Primary DI
00851362008032
Brand
Persona Medical
Company
Persona Medical
Model
Voicepro Fitting Software
Device description
Voicepro is fitting software used in conjunction with Persona Medical hearing instruments as a tool by Audiologists/Hearing Instrument Specialists to mitigate hearing loss.
Published
2018-12-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
00851362008032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851362008032008513620080328513620080320851362008032

GMDN Terms#

Term, Definition table
TermDefinition
Hearing aid wireless-fitting computer-aided setA collection of devices designed to work in conjunction with a computer to transmit wireless data to a hearing aid for computer-aided adjustment of the hearing aid while it is being fitted to a patient by healthcare personnel. It primarily consists of computer application software and a neck loop to establish the wireless link (the radio link protocol) with the hearing aid. The hearing aid must be compatible for wireless data reception and may be behind-the-ear (BTE), in-the-ear (ITE) and completely-in-the-canal (CIC) types.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4073392422sagarc@personamedical.com

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
05714880296440SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296464SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296488SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296501SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296525SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296549SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296563SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296587SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296600SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296624SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296648SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296679SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296709SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296716SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296747SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296754SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296853SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296860SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296877SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296884SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296891SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296907SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296914SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880297010SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880297027SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880297034SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880297041SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880297058SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880297065SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880297072SIGNIAWs Audiology Usa, Inc.OSM2026-07-22