hi Health 93299-000, 001

GUDID 00858177007090

Wireless Hearing Aid

INTRICON CORPORATION

Behind-the-ear air-conduction hearing aid Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear

• Primary Device ID: 00858177007090
• NIH Device Record Key: 0103ec7e-47cb-49f6-bdab-c8069910063e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: hi Health
• Version Model Number: BTE Wireless
• Catalog Number: 93299-000, 001
• 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: 651-636-9770
• Email: udi@intricon.com
• Phone: 651-636-9770
• Email: udi@intricon.com
• Phone: 651-636-9770
• Email: udi@intricon.com
• Phone: 651-636-9770
• Email: udi@intricon.com
• Phone: 651-636-9770
• Email: udi@intricon.com
• Phone: 651-636-9770
• Email: udi@intricon.com
• Phone: 651-636-9770
• Email: udi@intricon.com
• Phone: 651-636-9770
• Email: udi@intricon.com
• Phone: 651-636-9770
• Email: udi@intricon.com
• Phone: 651-636-9770
• Email: udi@intricon.com
• Phone: 651-636-9770
• Email: udi@intricon.com
• Phone: 651-636-9770
• Email: udi@intricon.com
• Phone: 651-636-9770
• Email: udi@intricon.com
• Phone: 651-636-9770
• Email: udi@intricon.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858177007090 [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: 2018-05-14
• Device Publish Date: 2018-04-13

On-Brand Devices [hi Health]

• 00858177007106: Wireless Hearing Aid
• 00858177007090: Wireless Hearing Aid