Persona Medical

Basic Information

• Brand Name: Persona Medical
• Primary DI: 00851362008049
• Version / Model: Voicepro Fitting Software NOAH
• Company Name: Persona Medical
• Labeler DUNS: 101877157
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-12
• Public Version: 2
• Public Version Date: 2020-10-06
• Public Version Status: Update
• Public Device Record Key: 4522df62-9d96-46d2-b9de-b7f42247290b

Device Description

Voicepro NOAH is fitting software with a NOAH Database used in conjunction with Persona Medical hearing instruments as a tool by Audiologists/Hearing Instrument Specialists to mitigate hearing loss. The Noah software system is designed specifically for the hearing care industry, providing hearing care professionals with a unified system for performing client-related tasks.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OSM	Hearing Aid, Air Conduction With Wireless Technology	Ear, Nose, Throat	874.3305	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57884	Hearing aid wireless-fitting computer-aided set	A 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.	No	Active
34671	Air-conduction hearing aid, behind-the-ear	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851362008049	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]