| Primary Device ID | 00850046564017 | 
| NIH Device Record Key | 2ff1d920-5f75-483a-99d5-decfaf1d58e1 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Hearing Assist | 
| Version Model Number | CONNECT | 
| Company DUNS | 030980255 | 
| Company Name | Hearing Assist II, Inc. | 
| 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 | true | 
| Serial Number | true | 
| Manufacturing Date | false | 
| Expiration Date | true | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | false | 
| OTC Over-The-Counter | true | 
| Phone | 800-640-9695 | 
| CS@HearingAssist.com | |
| Phone | 800-640-9695 | 
| CS@HearingAssist.com | |
| Phone | 800-640-9695 | 
| CS@HearingAssist.com | |
| Phone | 800-640-9695 | 
| CS@HearingAssist.com | |
| Phone | 800-640-9695 | 
| CS@HearingAssist.com | |
| Phone | 800-640-9695 | 
| CS@HearingAssist.com | |
| Phone | 800-640-9695 | 
| CS@HearingAssist.com | |
| Phone | 800-640-9695 | 
| CS@HearingAssist.com | |
| Phone | 800-640-9695 | 
| CS@HearingAssist.com | |
| Phone | 800-640-9695 | 
| CS@HearingAssist.com | |
| Phone | 800-640-9695 | 
| CS@HearingAssist.com | |
| Phone | 800-640-9695 | 
| CS@HearingAssist.com | |
| Phone | 800-640-9695 | 
| CS@HearingAssist.com | |
| Phone | 800-640-9695 | 
| CS@HearingAssist.com | |
| Phone | 800-640-9695 | 
| CS@HearingAssist.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00850046564017 [Primary] | 
| GS1 | 20850046564011 [Package] Package: Case [4 Units] In Commercial Distribution | 
| QUG | Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2022-11-21 | 
| Device Publish Date | 2022-11-11 | 
| 00850046564048 | The Hearing Assist CONTROL is an air-conduction RIC hearing aid with Bluetooth adjustment of aco | 
| 00850046564024 | The Hearing Assist EAZE is an air-conduction RIC hearing aid with 4 presets for different enviro | 
| 00850046564017 | The Hearing Assist CONNECT is an air-conduction hearing aid with Bluetooth adjustment of acousti | 
| 00850046564000 | The Hearing Assist STREAM is an air-conduction RIC hearing aid with Bluetooth adjustment of acou | 
| 00850007148935 | The Hearing Assist CONNECT is an air-conduction hearing aid with Bluetooth adjustment of acousti | 
| 00850007148928 | The Hearing Assist STREAM is an air-conduction RIC hearing aid with Bluetooth adjustment of acou | 
| 00850007148911 | The Hearing Assist EAZE is an air-conduction RIC hearing aid with 4 presets for different enviro | 
| 00850007148904 | The Hearing Assist CONTROL is an air-conduction RIC hearing aid with Bluetooth adjustment of aco |