| Primary Device ID | 00858177007144 |
| NIH Device Record Key | b7786c37-04de-4032-8608-f4ffa24632de |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | hiHealth Innovations |
| Version Model Number | hiHearing |
| Catalog Number | 22958 |
| 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 |
| 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 | |
| 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 | |
| Phone | +1-651-636-9770 |
| udi@intricon.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858177007144 [Primary] |
| OSM | Hearing Aid, Air Conduction With Wireless Technology |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-10-22 |
| Device Publish Date | 2018-08-21 |
| 00858177007892 - Audicus | 2022-11-18 Wireless Hearing Aid |
| 00858177007908 - Audicus | 2022-11-18 Wireless Hearing Aid |
| 00858177007915 - Audicus | 2022-11-18 Wireless Hearing Aid |
| 00858177007847 - Beurer | 2022-07-08 93532-005, Wireless Hearing Aid (Right); This version has no telecoil |
| 00858177007854 - Beurer | 2022-07-08 93532-006, Wireless Hearing Aid (Right); This version has no telecoil |
| 00858177007861 - Beurer | 2022-07-08 93532-007, Wireless Hearing Aid (Right); This version has no telecoil |
| 00858177007878 - Beurer | 2022-07-08 93532-008, Wireless Hearing Aid (Right); This version has no telecoil |
| 00858177007885 - Beurer | 2022-07-08 93532-009, Wireless Hearing Aid (Right); This version has no telecoil |