RXEars

GUDID 00851362008339

This is a stock/universal fit hearing aid similar in size to a CIC (Custom In the Canal) . The device is used for mild to moderate hearing loss. This is non-programmable in the field and adjustments ONLY made by the factory for a patient's hearing loss and related factors.

Persona Medical

Air-conduction hearing aid, in-the-ear

• Primary Device ID: 00851362008339
• NIH Device Record Key: 09afaf13-eb52-43a4-b574-8f3112b86335
• Commercial Distribution Discontinuation: 2022-10-24
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: RXEars
• Version Model Number: RXi
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851362008339 [Primary]

FDA Product Code

• ESD: Hearing Aid, Air Conduction

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: 2022-11-01
• Device Publish Date: 2022-10-24

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