America Hears®

Basic Information

• Brand Name: America Hears®
• Primary DI: 00810068831634
• Version / Model: ITC64-A
• Catalog Number: HLT-CUSITC64-A
• Company Name: HEARING LAB TECHNOLOGY, LLC
• Labeler DUNS: 827693503
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-16
• Public Version: 1
• Public Version Date: 2023-06-26
• Public Version Status: New
• Public Device Record Key: 3a206e59-aad3-4b37-ac7c-26ee19fb0254

Device Description

Custom 64 Channel ITE Wireless MFI

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OSM	Hearing Aid, Air-Conduction with Wireless Technology, Prescription	Ear, Nose, Throat	874.3305	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41209	Air-conduction hearing aid, canal	A battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It typically consists of a miniature microphone, amplifier, and speaker (receiver) in a case that fits the ear canal [in-the-canal (ITC)] or in a case nearly hidden in the ear canal [completely-in-the-canal (CIC)]. The microphone receives sound waves and converts them into electrical signals which are increased by the amplifier and sent as sound waves, by the speaker, to the eardrum. It is used for mild to moderately-severe hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810068831634	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]