| Primary Device ID | 00846430006034 |
| NIH Device Record Key | 6f833e83-7d7a-48b2-b754-56024d0337f7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LucidHearing |
| Version Model Number | BHA-Tala-Android-OTC |
| Company DUNS | 115380859 |
| Company Name | ETYMOTIC RESEARCH, 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 | (800) 492-4515 |
| customerservice@budgethearingaids.com | |
| Phone | (800) 492-4515 |
| customerservice@budgethearingaids.com | |
| Phone | (800) 492-4515 |
| customerservice@budgethearingaids.com | |
| Phone | (800) 492-4515 |
| customerservice@budgethearingaids.com | |
| Phone | (800) 492-4515 |
| customerservice@budgethearingaids.com | |
| Phone | (800) 492-4515 |
| customerservice@budgethearingaids.com | |
| Phone | (800) 492-4515 |
| customerservice@budgethearingaids.com | |
| Phone | (800) 492-4515 |
| customerservice@budgethearingaids.com | |
| Phone | (800) 492-4515 |
| customerservice@budgethearingaids.com | |
| Phone | (800) 492-4515 |
| customerservice@budgethearingaids.com | |
| Phone | (800) 492-4515 |
| customerservice@budgethearingaids.com | |
| Phone | (800) 492-4515 |
| customerservice@budgethearingaids.com | |
| Phone | (800) 492-4515 |
| customerservice@budgethearingaids.com | |
| Phone | (800) 492-4515 |
| customerservice@budgethearingaids.com | |
| Phone | (800) 492-4515 |
| customerservice@budgethearingaids.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00846430006034 [Primary] |
| QUG | Hearing Aid, Air-Conduction With Wireless Technology, 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 | 2025-04-17 |
| Device Publish Date | 2025-04-09 |
| 00846430006034 | BHA-Tala-Android-OTC 20138-BHA |
| 00846430006027 | BHA-Tala-MFI-OTC 20128-BHA |