| Primary Device ID | 00810153660040 | 
| NIH Device Record Key | 9f7761d5-a127-4443-9d12-f50980e98507 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Go Prime | 
| Version Model Number | Go Hearing | 
| Catalog Number | GHPS00003BL | 
| Company DUNS | 539177681 | 
| Company Name | HEARX GROUP (PTY) LTD | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| MRI Safety Status | MR Unsafe | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | false | 
| 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 | 
| Phone | +1 302 754 3190 | 
| support@gohearing.com | |
| Phone | +1 302 754 3190 | 
| support@gohearing.com | |
| Phone | +1 302 754 3190 | 
| support@gohearing.com | |
| Phone | +1 302 754 3190 | 
| support@gohearing.com | |
| Phone | +1 302 754 3190 | 
| support@gohearing.com | |
| Phone | +1 302 754 3190 | 
| support@gohearing.com | |
| Phone | +1 302 754 3190 | 
| support@gohearing.com | |
| Phone | +1 302 754 3190 | 
| support@gohearing.com | |
| Phone | +1 302 754 3190 | 
| support@gohearing.com | |
| Phone | +1 302 754 3190 | 
| support@gohearing.com | |
| Phone | +1 302 754 3190 | 
| support@gohearing.com | |
| Phone | +1 302 754 3190 | 
| support@gohearing.com | |
| Phone | +1 302 754 3190 | 
| support@gohearing.com | |
| Phone | +1 302 754 3190 | 
| support@gohearing.com | |
| Phone | +1 302 754 3190 | 
| support@gohearing.com | |
| Phone | +1 302 754 3190 | 
| support@gohearing.com | |
| Phone | +1 302 754 3190 | 
| support@gohearing.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00810153660040 [Primary] | 
| QUF | Hearing Aid, Air-Conduction, Over The Counter | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2023-12-26 | 
| Device Publish Date | 2023-12-18 | 
| 00810153660811 - Lexie Hearing | 2025-08-08 Lexie B2 Powered by Bose (AARP) | 
| 00850022464621 - hearX Group | 2025-03-12 The hearOAE (otoacoustic emission device) is a portable, handheld, battery-operated device that can detect hearing loss using Ot | 
| 00810153660217 - Go Prime - Black | 2024-08-27 Go Prime - Black - Amazon | 
| 00810153660187 - Go Prime - Beige | 2024-05-27 Go Prime - Beige - In-store | 
| 00810153660149 - Lexie Hearing | 2024-03-15 | 
| 00810153660156 - Lexie Hearing | 2024-03-15 | 
| 00810153660163 - Lexie Hearing | 2024-03-15 | 
| 00850022464591 - Go Prime - Beige | 2024-02-20 Go Prime - Beige - In-store | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  GO PRIME  97760222  not registered Live/Pending | hearX USA Inc. 2023-01-19 | 
|  GO PRIME  87634066  not registered Live/Pending | J.F.J Disc Repair Inc. 2017-10-04 |