Assure®

Basic Information

• Brand Name: Assure®
• Primary DI: 00812944021153
• Version / Model: 4360 WL
• Catalog Number: HLT-SIE96WL-B
• Company Name: HEARING LAB TECHNOLOGY, LLC
• Labeler DUNS: 827693503
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-10
• Public Version: 6
• Public Version Date: 2020-10-06
• Public Version Status: Update
• Public Device Record Key: a7b179be-5fae-4b39-87b0-a506541ee436
• Distribution End Date: 2019-05-20

Device Description

Assure Speaker-In-Ear 96WL Style Beige

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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	Ear, Nose, Throat	874.3305	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56736	Air-conduction hearing aid, receiver-in-the-ear	A battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It consists of a microphone or microphones and an amplifier in a case behind-the-ear (BTE) connected, via a wire, to a receiver (speaker) in the outer ear [receiver-in-the-ear (RITE)]. The microphone(s) 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. The device is used for mild to profound 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	00812944021153	GS1

Customer Contacts

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