RXEars

GUDID 00851362008063

Handheld (Bluetooth Low Energy protocol) personal wireless microphone to help hear companions easier in noisy or challenging listening environments. Used with RX8 Hearing aid(s) and controlled with RxEars APP as well as controls on the unit itself.

Persona Medical

Behind-the-ear air-conduction hearing aid

• Primary Device ID: 00851362008063
• NIH Device Record Key: 836d2463-f4ac-4662-a7c3-96b8dc29fe48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RXEars
• Version Model Number: Remote Microphone Wireless Streamer
• Company DUNS: 101877157
• Company Name: Persona Medical
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851362008063 [Primary]

FDA Product Code

• OSM: Hearing Aid, Air Conduction With Wireless Technology

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-03
• Device Publish Date: 2020-08-26

On-Brand Devices [RXEars]

• 00851362008025: IOS & Android based APP used to control RxEars RX7 BTE device.
• 00851362008018: Hearing Device incorporating Bluetooth Low Energy protocol to be controlled with RxEars APP for
• 00851362008063: Handheld (Bluetooth Low Energy protocol) personal wireless microphone to help hear companions ea
• 00851362008056: Hearing Device incorporating Bluetooth Low Energy protocol to be controlled with RxEars APP for
• 00851362008551: Hearing Device incorporating wireless protocol to be controlled with RxEars Pro APP for basic c
• 00851362008452: Hearing Device (RIC) incorporating wireless protocol to be controlled with RxEars Pro APP for b
• 00851362008438: Hearing Device incorporating an adjustable rocker volume control and memory control to fit mild
• 00851362008353: Hearing Device (RIC) incorporating wireless protocol to be controlled with RxEars Pro APP for b
• 00851362008346: Hearing Device incorporating wireless protocol to be controlled with RxEars Pro APP for basic c
• 00851362008339: This is a stock/universal fit hearing aid similar in size to a CIC (Custom In the Canal) . The d
• 00851362008322: Hearing Device incorporating an adjustable push-button volume control and memory control to fit