Persona Medical

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

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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 (ESD) (1) Hearing Aid, Air Conduction With Wireless Technology (OSM) (1)

Premarket Exempt

Yes

Clear

Persona Medical - 00851362008544 Catalog Number :

Device Description : These are a line of custom fitted hearing aids from Fullshell (In The Ear) to CI These are a line of custom fitted hearing aids from Fullshell (In The Ear) to CIC (Custom In the Canal) . The devices are used for mild to severe hearing loss; these are non-programmable in the field and adjustments ONLY made by the factory for a patient's hearing loss and related factors.

Device Class : 1

Duns Number: 101877157

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

RXEars - 00851362008551 Catalog Number :

Device Description : Hearing Device incorporating wireless protocol to be controlled with RxEars Pro Hearing Device incorporating wireless protocol to be controlled with RxEars Pro 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 : No

Device Count : 1

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