America Hears® HLT-CUSITC128-I

GUDID 00810068831610

Custom 128 Channel ITE Wireless MFI

HEARING LAB TECHNOLOGY, LLC

Air-conduction hearing aid, canal

• Primary Device ID: 00810068831610
• NIH Device Record Key: d7801f59-41e9-4ed6-b527-a25158cd54b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: America Hears®
• Version Model Number: ITC128-I
• Catalog Number: HLT-CUSITC128-I
• Company DUNS: 827693503
• Company Name: HEARING LAB TECHNOLOGY, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• 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: +1(800)492-4515
• Email: ahwebmail@americahears.com
• Phone: +1(800)492-4515
• Email: ahwebmail@americahears.com
• Phone: +1(800)492-4515
• Email: ahwebmail@americahears.com
• Phone: +1(800)492-4515
• Email: ahwebmail@americahears.com
• Phone: +1(800)492-4515
• Email: ahwebmail@americahears.com
• Phone: +1(800)492-4515
• Email: ahwebmail@americahears.com
• Phone: +1(800)492-4515
• Email: ahwebmail@americahears.com
• Phone: +1(800)492-4515
• Email: ahwebmail@americahears.com
• Phone: +1(800)492-4515
• Email: ahwebmail@americahears.com
• Phone: +1(800)492-4515
• Email: ahwebmail@americahears.com
• Phone: +1(800)492-4515
• Email: ahwebmail@americahears.com
• Phone: +1(800)492-4515
• Email: ahwebmail@americahears.com
• Phone: +1(800)492-4515
• Email: ahwebmail@americahears.com
• Phone: +1(800)492-4515
• Email: ahwebmail@americahears.com
• Phone: +1(800)492-4515
• Email: ahwebmail@americahears.com
• Phone: +1(800)492-4515
• Email: ahwebmail@americahears.com
• Phone: +1(800)492-4515
• Email: ahwebmail@americahears.com
• Phone: +1(800)492-4515
• Email: ahwebmail@americahears.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810068831610 [Primary]

FDA Product Code

• OSM: Hearing Aid, Air-Conduction with Wireless Technology, Prescription

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: 2023-06-26
• Device Publish Date: 2023-06-16

On-Brand Devices [America Hears®]

• 00812944026769: 128ch WL Pearl White
• 00812944026752: 128ch WL Black
• 00812944026745: 128ch WL Brown
• 00812944026738: 128ch WL Gray
• 00812944026721: 128ch WL Beige
• 00812944025359: Freedom 96 WL Dark Brown
• 00812944025342: Freedom 96 WL Pearl White
• 00812944025335: Freedom 96 WL Light Brown
• 00812944025328: Freedom 96 WL Grey
• 00812944025311: Freedom 96 WL Black
• 00812944025304: Freedom 96 WL Beige
• 00812944025083: Ezairo RITE64/SIE64 gray
• 00812944025076: Custom ITCD 96
• 00812944025069: Custom IIC 96
• 00812944025045: Ezairo RITE64/SIE64 beige
• 00812944024604: Ezairo RITE64/SIE64 brown
• 00812944024598: Ezairo RITE64/SIE64 Pearl White
• 00812944024581: Ezairo RITE64/SIE64 LT BR
• 00812944024574: Ezairo RITE64/SIE64 Black
• 00812944023935: Custom Full Shell 64
• 00812944023928: Custom Full Shell PLD 32
• 00812944023911: Custom Half Shell 64
• 00812944023904: Custom Half Shell PLD 32
• 00812944023898: Custom Canal 64
• 00812944023881: Custom Canal PLD 32
• 00812944023874: Custom Micro Canal 64
• 00812944023867: Micro Canal - 32 Ch - PLD
• 00812944023850: Custom Comp Canal 64
• 00812944023843: Cust Comp in the Canal PLD 32
• 00812944021856: Ezairo RITE32/SIE32 beige
• 00812944021849: Ezairo RITE32/SIE32 brown
• 00812944021832: Ezairo RITE32/SIE32 gray
• 00812944028084: Universal 64ch WL Beige
• 00812944027506: Universal 32ch WL Pearl White
• 00812944027490: Universal 32ch WL Black
• 00812944027483: Universal 32ch WL Brown
• 00812944027476: Universal 32ch WL Grey
• 00812944027469: Universal 32ch WL Beige
• 00812944027452: Universal 16ch WL Pearl White
• 00812944027445: Universal 16ch WL Black
• 00812944027438: Universal 16ch WL Brown
• 00812944027421: Universal 16ch WL Grey
• 00812944027414: Universal 16ch WL Beige
• 00812944027209: Universal 128ch WL Beige
• 00812944023980: Ezairo OF 8 ch Beige
• 00810068830422: Custom Elite CIC HA Package
• 00810068830415: Custom Elite Micro Canal HA Package
• 00810068830408: Custom Elite Canal HA Package
• 00810068830392: Custom Elite Half Shell HA Package
• 00810068830385: Custom Elite Full Shell HA Package