sivantos.comTRUHEARING - C_ITE TH PREMIUM 7 CIC LI
2026-01-20
WS Audiology USA, Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2430101 | 2430101 | WS Audiology USA, Inc. | 1 | Y | 2026-01-01 | 185 Commerce Dr Hauppauge NY US 11788 |
| 3025495169 | 3025495169 | WS Audiology USA, Inc. | 1 | Y | 2026-01-01 | 101 Wood Avenue South 7th Floor Iselin NJ US 08830 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 05714880250695 | Audio Service - HA R LI 4.6 Z BG | 17325626600 | consumerrelations@sivantos.com |
| 05714880250701 | Audio Service - HA R LI 4.6 Z BLK | 17325626600 | consumerrelations@sivantos.com |
| 05714880250718 | Audio Service - HA R LI 4.6 Z DBR | 17325626600 | consumerrelations@sivantos.com |
| 05714880250725 | Audio Service - HA R LI 4.6 Z GNT | 17325626600 | consumerrelations@sivantos.com |
| 05714880250732 | Audio Service - HA R LI 4.6 Z GR | 17325626600 | consumerrelations@sivantos.com |
| 05714880291278 | TRUHEARING - C_ITE TH PREMIUM 7 CIC LI | 17325626600 | consumerrelations@sivantos.com |
| 05714880291285 | TRUHEARING - C_ITE TH ADVANCED 7 CIC LI | 17325626600 | consumerrelations@sivantos.com |
| 05714880291292 | TRUHEARING - C_ITE TH STANDARD 7 CIC LI | 17325626600 | consumerrelations@sivantos.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 7005 | 1002902577 | K110973 | IE-ZEN (IN CLEAR SERIES HEARING AID) | KLW | 2011-05-05 |
| 7005 | 1480860186 | K080955 | ZEN PROGRAM (MIND 440 HEARING AID) | KLW | 2008-06-27 |
| 7005 | 1002902577 | ||||
| 7005 | 1152327925 | ||||
| 7005 | 1230565953 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| KLW | 2 | 2011-05-05 |
GUDID#
TRUHEARING - C_ITE TH ADVANCED 7 CIC LI
2026-01-20
TRUHEARING - C_ITE TH STANDARD 7 CIC LI
2026-01-20
Audio Service - HA R LI 4.6 Z BG
2026-09-18
Audio Service - HA R LI 4.6 Z BLK
2026-09-18
Audio Service - HA R LI 4.6 Z DBR
2026-09-18
Audio Service - HA R LI 4.6 Z GNT
2026-09-18
Audio Service - HA R LI 4.6 Z GR
2026-09-18
SIGNIA - SET PORTABLE CHARGER STYLETTO
2026-08-21
SIGNIA - SET PTBL CHGR STYLETTO USKA
2026-08-21
SIGNIA - SET SIGNIA REMOTE CONTROL
2026-08-21
Sony - KIT CRE-C20
2024-07-18
Sony - CRE-C20 L BLK
2024-07-01
Sony - CRE-C20 R BLK
2024-07-01
Sony - Sony CRE-E10 Hearing Aid
2023-05-30
Sony - Sony CRE-C10 Hearing Aid
2022-09-12
MIRACLE EAR - C_ITE MEMINI I 4 5W CIC-R
2026-07-29
MIRACLE EAR - C_ITE MEMINI I 5 5W CIC-R
2026-07-29
MIRACLE EAR - C_ITE MEMINI I 3 5W CIC-R
2026-07-29
MIRACLE EAR - C_ITE MEMINI I 2 5W CIC-R
2026-07-29
SIGNIA - KIT SILK C&G 7IX RB BLK TR
2026-07-22
SIGNIA - KIT SILK C&G 7IX RB MOC TR
2026-07-22
SIGNIA - KIT SILK C&G 5IX RB BLK TR
2026-07-22
SIGNIA - KIT SILK C&G 5IX RB MOC TR
2026-07-22
SIGNIA - KIT SILK C&G 3IX RB BLK TR
2026-07-22
SIGNIA - KIT SILK C&G 3IX RB MOC TR
2026-07-22
SIGNIA - KIT SILK C&G 2IX RB BLK TR
2026-07-22
SIGNIA - KIT SILK C&G 2IX RB MOC TR
2026-07-22
SIGNIA - KIT SILK C&G 1IX RB BLK TR
2026-07-22
SIGNIA - KIT SILK C&G 1IX RB MOC TR
2026-07-22
SIGNIA - KIT SILK C&G SD IX RB BLK TR
2026-07-22
SIGNIA - KIT STYLETTO SD DIX RB BLK-SLV
2026-07-22
SIGNIA - KIT STYLETTO 1IX RB BLK-SLV
2026-07-22
SIGNIA - KIT STYLETTO 1IX RB SNW-SLV
2026-07-22
SIGNIA - KIT STYLETTO 2IX RB BLK-SLV
2026-07-22
SIGNIA - KIT STYLETTO 2IX RB SNW-SLV
2026-07-22
SIGNIA - KIT STYLETTO 3IX RB BLK-BLKG
2026-07-22
SIGNIA - KIT STYLETTO 3IX RB BLK-GPH
2026-07-22
SIGNIA - KIT STYLETTO 3IX RB BLK-SLV
2026-07-22
SIGNIA - KIT STYLETTO 3IX RB COS-RGD
2026-07-22