hiHealth Innovations 22958

GUDID 00858177007144

Android App

INTRICON CORPORATION

Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software

• 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

Customer Support Contacts

• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com
• Phone: +1-651-636-9770
• Email: udi@intricon.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858177007144 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-10-22
• Device Publish Date: 2018-08-21

Devices Manufactured by INTRICON CORPORATION

• 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