| Primary Device ID | 00850007148935 |
| NIH Device Record Key | 5cf6d959-f2cb-4a60-9cbe-cc1f496aa81d |
| 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 | 00850007148935 [Primary] |
| GS1 | 10850007148932 [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 |