| Primary Device ID | 00851362008315 |
| NIH Device Record Key | 65fa4422-7788-44e9-ac28-494b8b7d8a11 |
| Commercial Distribution Discontinuation | 2022-10-10 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Persona Medical |
| Version Model Number | Ole Deep CIC Custom Hearing Aid |
| Company DUNS | 101877157 |
| Company Name | Persona Medical |
| 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 | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| 00851362008049 | Voicepro NOAH is fitting software with a NOAH Database used in conjunction with Persona Medical |
| 00851362008032 | Voicepro is fitting software used in conjunction with Persona Medical hearing instruments as a t |
| 00851362008001 | Wireless Hearing Aid |
| 00851362008131 | Handheld (Bluetooth Low Energy protocol) personal wireless microphone to help hear companions ea |
| 00851362008070 | Hearing Device incorporating Bluetooth Low Energy protocol to be controlled with Persona APP for |
| 00851362008087 | IOS & Android based APP used to control Evok 1600 OTE/BTE device. |
| 00851362008148 | Windows Desktop based APP used to control Evok 1600 OTE/BTE device. A USB Bluetooth dongle will |
| 00851362008124 | Hearing Device incorporating wireless protocol to be controlled with Persona APP for basic chang |
| 00851362008117 | Hearing Device incorporating wireless protocol to be controlled with Persona APP for basic chang |
| 00851362008100 | Hearing Device incorporating wireless protocol to be controlled with Persona APP for basic chang |
| 00851362008094 | Hearing Device incorporating wireless protocol to be controlled with Persona APP for basic chang |
| 00851362008186 | Handsfree (Bluetooth) use of hearing aids with TV or other devices with AUX output. Also, can be |
| 00851362008179 | Hearing Device incorporating wireless protocol to be controlled with RxEars APP for basic chang |
| 00851362008308 | 4 Channel Programmable CIC faceplate module (Standard/Power) to be used to manufacture a custom |
| 00851362008292 | 8 Channel Programmable CIC faceplate module (Standard/Power) to be used to manufacture a custom |
| 00851362008285 | 2 Channel Programmable CIC faceplate module (Standard/Power) to be used to manufacture a custom |
| 00851362008278 | 8 Channel Programmable, Directional, MM button Thintube/BTE Hearing Aid |
| 00851362008261 | 8 Channel Programmable, Rocker Volume Control, Directional & Tele-coil Thintube/BTE Hearing Aid |
| 00851362008254 | 4 Channel Programmable, Rocker Volume Control, Directional & Tele-coil Thintube/BTE Hearing Aid |
| 00851362008247 | 8 Channel Programmable, Rocker Volume Control, Directional & Tele-coil BTE Hearing Aid |
| 00851362008230 | 4 Channel Programmable, Rocker Volume Control, Directional & Tele-coil BTE Hearing Aid |
| 00851362008223 | 4 Channel Programmable, Rocker VC, Directional, Thintube/BTE Hearing Aid |
| 00851362008216 | 8 Channel Programmable, Rocker VC, Directional, Thintube/BTE Hearing Aid |
| 00851362008209 | 4 Channel Programmable, Rocker VC, Directional, RIC/BTE Hearing Aid |
| 00851362008193 | 8 Channel Programmable, Rocker VC, Directional, RIC/BTE Hearing Aid |
| 00851362008544 | These are a line of custom fitted hearing aids from Fullshell (In The Ear) to CIC (Custom In the |
| 00851362008513 | These are a line of custom fitted hearing aids from Fullshell (In The Ear) to CIC (Custom In the |
| 00851362008407 | These are a line of custom fitted hearing aids from Fullshell (In The Ear) to CIC (Custom In the |
| 00851362008315 | This is a deep fitting In-The-canal (ITC) custom hearing aid. The device is used for mild to sev |
| 00851362008537 | OTE/BTE Programmable Hearing Aid with Rocker VC, Directional and Telecoil features. It is used |
| 00851362008520 | RIC/BTE Programmable Hearing Aid with Rocker VC, Directional and Telecoil features. It is used |
| 00851362008568 | OTE/BTE Programmable Hearing Aid with Rocker VC, Directional and Telecoil features. It is used |
| 00851362008162 | These are a line of Behind-the-Ear Thintube/Earhook hearing instruments. The devices are used fo |