hearX 93336-005, 006, 007, 008, 009
GUDID 00858177007342
Behind-the-Ear Wireless Hearing Aid
INTRICON CORPORATION
Behind-the-ear air-conduction hearing aid| Primary Device ID | 00858177007342 |
| NIH Device Record Key | 0839d046-cea2-413f-97d0-3e341c144427 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | hearX |
| Version Model Number | Lexie Lumen |
| Catalog Number | 93336-005, 006, 007, 008, 009 |
| Company DUNS | 002345767 |
| Company Name | INTRICON CORPORATION |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858177007342 [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 | 2020-08-05 |
| Device Publish Date | 2020-07-28 |
On-Brand Devices [hearX]
| 00858177007465 | Android Hearing Aid Programming App |
| 00858177007458 | IOS Hearing Aid Programming App |
| 00858177007342 | Behind-the-Ear Wireless Hearing Aid |
Trademark Results [hearX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEARX 88603544 not registered Live/Pending |
hearX IP (Pty) Ltd. 2019-09-04 |
 HEARX 73636421 1471748 Live/Registered |
HEARX LTD. 1986-12-22 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.