Hearing Help Express 93334-000, -001, -002, -003, -004

GUDID 00858177007250

Directional 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: 00858177007250
• NIH Device Record Key: 6bea53c2-2ff8-4a21-923b-611859d9699c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hearing Help Express
• Version Model Number: Felix-8730
• Catalog Number: 93334-000, -001, -002, -003, -004
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858177007250 [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: 2019-04-11
• Device Publish Date: 2019-02-28

On-Brand Devices [Hearing Help Express]

• 00858177007250: Directional Wireless Hearing Aid
• 00858177007243: Matched Pair Directional Wireless Hearing Aid
• 00858177007236: Fitting Software
• 00858177007137: Hearing Aid Accessory
• 00858177007120: Wireless Hearing Aid
• 00858177007113: iOS App
• 00858177007359: Lumen 155i Behind-the-Ear Air-Conduction Hearing Aid.
• 00858177007489: L155i Behind-the-Ear Air-Conduction Hearing Aid.
• 00858177007472: Lumen 155i Behind-the-Ear Air-Conduction Hearing Aid, Metallic Black
• 00858177007335: Android App
• 00858177007311: Companion Microphone
• 00858177007571: Sentibo OTC BTE Wireless Hearing Aid, Right, Beige
• 00858177007564: Sentibo OTC BTE Wireless Hearing Aid, Left, Beige
• 00858177007557: BTE Wireless, Directional Hearing Aid, Beige
• 00858177007502: BTE Wireless Directional Hearing Aid, Beige
• 00858177007496: BTE Wireless Directional Hearing Aid, Metallic Black