Persona Medical

GUDID 00851362008100

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.

Persona Medical

Air-conduction hearing aid, behind-the-ear
Primary Device ID00851362008100
NIH Device Record Keyc1518f48-a87e-4ba6-a898-7137a02e64cf
Commercial Distribution StatusIn Commercial Distribution
Brand NamePersona Medical
Version Model NumberSombra XR
Company DUNS101877157
Company NamePersona Medical
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100851362008100 [Primary]

FDA Product Code

OSMHearing Aid, Air Conduction With Wireless Technology

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-09
Device Publish Date2021-03-01

On-Brand Devices [Persona Medical]

00851362008049Voicepro NOAH is fitting software with a NOAH Database used in conjunction with Persona Medical
00851362008032Voicepro is fitting software used in conjunction with Persona Medical hearing instruments as a t
00851362008001Wireless Hearing Aid
00851362008131Handheld (Bluetooth Low Energy protocol) personal wireless microphone to help hear companions ea
00851362008070Hearing Device incorporating Bluetooth Low Energy protocol to be controlled with Persona APP for
00851362008087IOS & Android based APP used to control Evok 1600 OTE/BTE device.
00851362008148Windows Desktop based APP used to control Evok 1600 OTE/BTE device. A USB Bluetooth dongle will
00851362008124Hearing Device incorporating wireless protocol to be controlled with Persona APP for basic chang
00851362008117Hearing Device incorporating wireless protocol to be controlled with Persona APP for basic chang
00851362008100Hearing Device incorporating wireless protocol to be controlled with Persona APP for basic chang
00851362008094Hearing Device incorporating wireless protocol to be controlled with Persona APP for basic chang
00851362008186Handsfree (Bluetooth) use of hearing aids with TV or other devices with AUX output. Also, can be
00851362008179Hearing Device incorporating wireless protocol to be controlled with RxEars APP for basic chang
008513620083084 Channel Programmable CIC faceplate module (Standard/Power) to be used to manufacture a custom
008513620082928 Channel Programmable CIC faceplate module (Standard/Power) to be used to manufacture a custom
008513620082852 Channel Programmable CIC faceplate module (Standard/Power) to be used to manufacture a custom
008513620082788 Channel Programmable, Directional, MM button Thintube/BTE Hearing Aid
008513620082618 Channel Programmable, Rocker Volume Control, Directional & Tele-coil Thintube/BTE Hearing Aid
008513620082544 Channel Programmable, Rocker Volume Control, Directional & Tele-coil Thintube/BTE Hearing Aid
008513620082478 Channel Programmable, Rocker Volume Control, Directional & Tele-coil BTE Hearing Aid
008513620082304 Channel Programmable, Rocker Volume Control, Directional & Tele-coil BTE Hearing Aid
008513620082234 Channel Programmable, Rocker VC, Directional, Thintube/BTE Hearing Aid
008513620082168 Channel Programmable, Rocker VC, Directional, Thintube/BTE Hearing Aid
008513620082094 Channel Programmable, Rocker VC, Directional, RIC/BTE Hearing Aid
008513620081938 Channel Programmable, Rocker VC, Directional, RIC/BTE Hearing Aid
00851362008544These are a line of custom fitted hearing aids from Fullshell (In The Ear) to CIC (Custom In the
00851362008513These are a line of custom fitted hearing aids from Fullshell (In The Ear) to CIC (Custom In the
00851362008407These are a line of custom fitted hearing aids from Fullshell (In The Ear) to CIC (Custom In the
00851362008315This is a deep fitting In-The-canal (ITC) custom hearing aid. The device is used for mild to sev
00851362008537OTE/BTE Programmable Hearing Aid with Rocker VC, Directional and Telecoil features. It is used
00851362008520RIC/BTE Programmable Hearing Aid with Rocker VC, Directional and Telecoil features. It is used
00851362008568OTE/BTE Programmable Hearing Aid with Rocker VC, Directional and Telecoil features. It is used
00851362008162These are a line of Behind-the-Ear Thintube/Earhook hearing instruments. The devices are used fo

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.