| Primary Device ID | 00858177007595 |
| NIH Device Record Key | b3021f2e-6101-4e6b-8a3f-6f2a596581ef |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lexie Hearing |
| Version Model Number | CM1 |
| Catalog Number | 93237-004 |
| 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 | false |
| OTC Over-The-Counter | true |
| Phone | +1-651-636-9770 |
| udi@intricon.com | |
| Phone | +1-651-636-9770 |
| udi@intricon.com | |
| Phone | +1-651-636-9770 |
| udi@intricon.com | |
| Phone | +1-651-636-9770 |
| udi@intricon.com | |
| Phone | +1-651-636-9770 |
| udi@intricon.com | |
| Phone | +1-651-636-9770 |
| udi@intricon.com | |
| Phone | +1-651-636-9770 |
| udi@intricon.com | |
| Phone | +1-651-636-9770 |
| udi@intricon.com | |
| Phone | +1-651-636-9770 |
| udi@intricon.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858177007595 [Primary] |
| OSM | Hearing Aid, Air Conduction With Wireless Technology |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-26 |
| Device Publish Date | 2020-10-16 |
| 00858177007540 | BTE Wireless Hearing Aid, Lumen 155i, Light Grey |
| 00858177007533 | BTEar Wireless Hearing Aid, Lumen 155i, Beige |
| 00858177007526 | BTE Wireless Hearing Aid, Lumen 155i, Metallic Black |
| 00858177007519 | BTE Wireless Hearing Aid, Lumen 155i, Bronze |
| 00858177007595 | Hearing Aid Accessory |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() LEXIE HEARING 98220205 not registered Live/Pending |
hearX USA Inc. 2023-10-12 |