TRUHEARING 21043117

GUDID 05714880264685

C_ITE TH STANDARD 7 IIC

Ws Audiology Usa, Inc.

Air-conduction hearing aid, in-the-ear

• Primary Device ID: 05714880264685
• NIH Device Record Key: b769daaf-e2fb-4b0c-aa4d-4939fb3e6a02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRUHEARING
• Version Model Number: TH Standard 7 IIC
• Catalog Number: 21043117
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05714880264685 [Primary]

FDA Product Code

• OSM: Hearing Aid, Air Conduction With Wireless Technology

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-30
• Device Publish Date: 2024-10-22

On-Brand Devices [TRUHEARING]

• 05714880175950: TH Advanced 6 Custom LI
• 05714880175943: TH Premium 6 Custom LI
• 05714880174977: TH PREMIUM 6 RIC Sandy Brown(31)
• 05714880174960: TH PREMIUM 6 RIC Granite(2)
• 05714880174953: TH PREMIUM 6 RIC Deep Brown(72)
• 05714880174946: TH PREMIUM 6 RIC Black(5)
• 05714880174939: TH PREMIUM 6 RIC Beige(1)
• 05714880174922: TH ADVANCED 6 RIC Beige(1)
• 05714880174915: TH ADVANCED 6 RIC Black(5)
• 05714880174908: TH ADVANCED 6 RIC Deep Brown(72)
• 05714880174892: TH ADVANCED 6 RIC Granite(2)
• 05714880174885: TH ADVANCED 6 RIC Sandy Brown(31)
• 05714880123593: TH Premium 5 SP BTE LI Sandy Brown
• 05714880123586: TH Premium 5 SP BTE LI Granite
• 05714880123579: TH Premium 5 SP BTE LI Deep Brown
• 05714880123562: TH Premium 5 SP BTE LI Black
• 05714880123555: TH Premium 5 SP BTE LI Beige
• 05714880174823: SET TH CROS 6 RIC Sandy Brown(31)
• 05714880174816: SET TH CROS 6 RIC Granite(2)
• 05714880174809: SET TH CROS 6 RIC Deep Brown(72)
• 05714880174793: SET TH CROS 6 RIC Black(5)
• 05714880174786: SET TH CROS 6 RIC Beige(1)
• 05714880174779: TH Premium 6 SR LI Black-Silver
• 05714880174762: TH Premium 6 SR LI Black-Black Gloss
• 05714880174755: TH Premium 6 SR LI Snow White-Rose Gold
• 05714880174748: TH Premium 6 SR LI Snow White-Snow White Gloss
• 05714880174731: TH Premium 6 SR LI Cosmic Blue-Rose Gold
• 05714880150933: HA TH DEMO 6 RIC LI Granite(2)
• 05714880147032: HA TH ADVANCED 6 RIC LI T Sandy Brown(31)
• 05714880147025: HA TH ADVANCED 6 RIC LI T Granite(2)
• 05714880147018: HA TH ADVANCED 6 RIC LI T Deep Brown(72)
• 05714880147001: HA TH ADVANCED 6 RIC LI T Black(5)
• 05714880146998: HA TH ADVANCED 6 RIC LI T Beige(1)
• 05714880146981: HA TH PREMIUM 6 RIC LI T Sandy Brown(31)
• 05714880146974: HA TH PREMIUM 6 RIC LI T Granite(2)
• 05714880146967: HA TH PREMIUM 6 RIC LI T Deep Brown(72)
• 05714880146950: HA TH PREMIUM 6 RIC LI T Black(5)
• 05714880146943: HA TH PREMIUM 6 RIC LI T Beige(2)
• 05714880146936: SET TH CROS 6 RIC LI Sandy Brown(31)
• 05714880146929: SET TH CROS 6 RIC LI Granite(2)
• 05714880146912: SET TH CROS 6 RIC LI Deep Brown(72)
• 05714880146905: SET TH CROS 6 RIC LI Black(5)
• 05714880146899: SET TH CROS 6 RIC LI Beige(1)
• 05714880146882: HA TH ADVANCED 6 RIC LI Sandy Brown(31)
• 05714880146875: HA TH ADVANCED 6 RIC LI Granite(2)
• 05714880146868: HA TH ADVANCED 6 RIC LI Deep Brown(72)
• 05714880146851: HA TH ADVANCED 6 RIC LI Black(5)
• 05714880146844: HA TH ADVANCED 6 RIC LI Beige(1)
• 05714880146837: HA TH PREMIUM 6 RIC LI Sandy Brown(31)
• 05714880146820: HA TH PREMIUM 6 RIC LI Granite(2)