| Primary Device ID | 05714880279993 |
| NIH Device Record Key | 7008ba52-4721-4d7d-b931-a6bef559f3a0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AudioService |
| Version Model Number | ITE 8.4 |
| Catalog Number | 21049466 |
| Company DUNS | 157412271 |
| Company Name | Ws Audiology Usa, Inc. |
| 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 | false |
| 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 | 17325626600 |
| consumerrelations@sivantos.com | |
| Phone | 17325626600 |
| consumerrelations@sivantos.com | |
| Phone | 17325626600 |
| consumerrelations@sivantos.com | |
| Phone | 17325626600 |
| consumerrelations@sivantos.com | |
| Phone | 17325626600 |
| consumerrelations@sivantos.com | |
| Phone | 17325626600 |
| consumerrelations@sivantos.com | |
| Phone | 17325626600 |
| consumerrelations@sivantos.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05714880279993 [Primary] |
| OSM | Hearing Aid, Air-Conduction With Wireless Technology, Prescription |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-12 |
| Device Publish Date | 2025-09-04 |
| 05714880280005 | C_ITE ITE TU 8 |
| 05714880279993 | C_ITE ITE 8.4 |
| 05714880279986 | C_ITE ITE 8.6 |
| 05714880279979 | C_ITE ITE 8.8 |
| 05714880279962 | C_ITE ITE 8.12 |
| 05714880279955 | C_ITE ITE 8.16 |
| 05714880279894 | C_ITE ITC TU 8 |
| 05714880279887 | C_ITE ITC 8.4 |
| 05714880279870 | C_ITE ITC 8.6 |
| 05714880279863 | C_ITE ITC 8.8 |
| 05714880279856 | C_ITE ITC 8.12 |
| 05714880279849 | C_ITE ITC 8.16 |