Persona Medical

Address:8531 154TH AVE NE,REDMOND,WA,98052,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Hearing Aid, Air Conduction With Wireless Technology (OSM) (10)

Premarket Exempt

Yes

Clear

Persona Medical - 00851362008001 Catalog Number :

Device Description : Wireless Hearing Aid

Device Class : 2

Duns Number: 101877157

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

RXEars - 00851362008018 Catalog Number :

Device Description : Hearing Device incorporating Bluetooth Low Energy protocol to be controlled with Hearing Device incorporating Bluetooth Low Energy protocol to be controlled with RxEars APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,.

Device Class : 2

Duns Number: 101877157

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

RXEars - 00851362008025 Catalog Number :

Device Description : IOS & Android based APP used to control RxEars RX7 BTE device.

Device Class : 2

Duns Number: 101877157

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Persona Medical - 00851362008032 Catalog Number :

Device Description : Voicepro is fitting software used in conjunction with Persona Medical hearing in Voicepro is fitting software used in conjunction with Persona Medical hearing instruments as a tool by Audiologists/Hearing Instrument Specialists to mitigate hearing loss.

Device Class : 2

Duns Number: 101877157

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

Persona Medical - 00851362008049 Catalog Number :

Device Description : Voicepro NOAH is fitting software with a NOAH Database used in conjunction with Voicepro NOAH is fitting software with a NOAH Database used in conjunction with Persona Medical hearing instruments as a tool by Audiologists/Hearing Instrument Specialists to mitigate hearing loss.The Noah software system is designed specifically for the hearing care industry, providing hearing care professionals with a unified system for performing client-related tasks.

Device Class : 2

Duns Number: 101877157

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

RXEars - 00851362008056 Catalog Number :

Device Class : 2

Duns Number: 101877157

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

RXEars - 00851362008063 Catalog Number :

Device Description : Handheld (Bluetooth Low Energy protocol) personal wireless microphone to help he Handheld (Bluetooth Low Energy protocol) personal wireless microphone to help hear companions easier in noisy or challenging listening environments. Used with RX8 Hearing aid(s) and controlled with RxEars APP as well as controls on the unit itself.

Device Class : 2

Duns Number: 101877157

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Persona Medical - 00851362008070 Catalog Number :

Device Description : Hearing Device incorporating Bluetooth Low Energy protocol to be controlled with Hearing Device incorporating Bluetooth Low Energy protocol to be controlled with Persona APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,.

Device Class : 2

Duns Number: 101877157

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Persona Medical - 00851362008087 Catalog Number :

Device Description : IOS & Android based APP used to control Evok 1600 OTE/BTE device.

Device Class : 2

Duns Number: 101877157

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Persona Medical - 00851362008094 Catalog Number :

Device Description : Hearing Device incorporating wireless protocol to be controlled with Persona APP Hearing Device incorporating wireless protocol to be controlled with Persona APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.

Device Class : 2

Duns Number: 101877157

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

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