FDA Registration
Active
🇨🇦 Canada
Unitron Hearing, a division of National Hearing Services Inc.
Reg #: 3002808415
·
FEI: 3002808415
·
Expires 2026
Products
5
Proprietary Names
156
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Unitron Hearing, a division of National Hearing Services Inc.
- Registration Number
- 3002808415
- FEI Number
- 3002808415
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 20 BEASLEY DRIVE
- City
- KITCHENER Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K123450
Owner / Operator
- Firm Name
- Sonova AG
- Operator Number
- 9028479
- Address
- Laubisruetistrasse 28
- City
- Staefa
- State
- Zurich
- Postal Code
- 8712
- Country
- CH
US Agent
- Business Name
- Sonova USA Inc.
- Contact Name
- Syed Farhan
- Address
- 444 Commerce Street
- City
- Aurora
- State
- IL
- ZIP
- 60504
- Country
- US
- [email protected]
- Phone
- 331 2781926
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Masker, Tinnitus | KLW | Class 2 | Ear, Nose, Throat | No | 2014-01-06 |
| Hearing Aid, Air-Conduction, Prescription | ESD | Class 1 | Ear, Nose, Throat | No | 2006-09-14 |
| Device, Assistive Listening | LZI | Class 2 | Ear, Nose, Throat | No | 2020-06-05 |
| Self-Fitting Air-Conduction Hearing Aid, Over The Counter | QUH | Class 2 | Ear, Nose, Throat | No | 2023-06-19 |
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | OSM | Class 2 | Ear, Nose, Throat | No | 2011-08-09 |
Proprietary Names
ampli-connect R L PH
MEMINI E D 5P R-R AI PH
Phonak Audeo L
Phonak Virto P
MECHARGE RIC 5P FP
Unitron Charger RIC S
Vista B
T Stride
Au V
Phonak Naida L
T Max
Moxi S
Unitron Charger ITE
Aura:fit AudioNova
Sennheiser Sonite R
Sonite R Kit
Phonak Audeo P-RL
AudioNova B
Hearing Remote
Easy Line Charger RIC 3
ampli-mini I 5P CIC-10 NWL PH
Phonak Audeo I
Remote Control Easy Line
Phonak Virto M
Easy Line ChargerGo RIC S
HelloGO
Phonak Target
AudioNova V charger
Relate3
Phonak Bolero M
ampli-charge R AI 3 5P FP
Unitron ChargerGo RIC S
Stride B
Phonak Audeo M
Easy Line Charger RIC S
Moxi V
Insera S-10 NW O
Charger Easy Line
MEMINI I 5P CIC-10 NWL PH
Phonak RemoteControl
Phonak Brio 5 Move
myPhonak
Phonak Charger Virto I
Easy Line ChargerCombi BTE2
Star Evolution
Vista V
Moxi RS charger
DX Insera
Phonak Audeo L-R Fit
T Insera
Vista S
Easy Line Charger ITE
ampli-energy R Trial 5P
MEMINI E 5 P R-R AI PH
Aura:fit
Phonak Audeo I-Sphere
Remote Control AudioNova
Insera B
Relate5 ITE R
Phonak ChargerGo RIC I
ampli-connect R Trial L
ampli-mini E 5P R-R AI PH
ampli-mini R L PH
ampli-mini E D 5P R-R AI PH
Au B
Moxi V-R/RT charger
Sonite Rise
DX Stride P R
Phonak Naida M
HANSATON stream remote
Phonak Audeo P-R Fit
MEMINI E P R-R PH
ampli-charge R 3
AudioNova V
Easy Line RS charger
Phonak Naida L-M
Phonak Brio 5 I
DX Stride M
Unitron Remote Plus
MECHARGE RIC 5P
Unitron Charger Combi BTE 2
Phonak Naida P
Relate4
Unitron Charger Moxi R 3
Relate3.1
ampli-energy B Trial L
Insera S-R
Sennheiser S Charger R
Unitron TrueFit
ampli-energy R 5P R PH
Easy Line Remote
Au 3
Phonak Audeo P
Vista DX
Vista T
AudioNova S
Roger X
Au Basic+
Stride V
AudioNova DX
AudioNova T
Relate 5
Phonak ChargerGo RICSPH I
RELATE 2
Phonak Virto I
Phonak Charger RIC I
Moxi B
T Moxi
Aura:fit Relate
ampli-energy B L RP PH
Easy Line V charger
Sonite Rise Charger Go
EasyView Otoblock
Lyric SoundLync kit
Lyric sizing and fitting kit
Titanium FitGuide
Phonak Lyric4
Relate5 ITE 10 NW O
Star Eclipse
Roger 20
Roger 21
Unitron Shine Rev
Lyric programming wand
Lyric insertion tool
Roger Focus II
All-Day Clear ADC1 Hearing Aid
All-Day Clear Slim ADCS1 Hearing Aid
Moxi S-RX
Unitron ChargerGO RIC S-RX
Easy Line ChargerGO RIC S-RX
Terra+ RIC-R
Terra BTE-SP
Phonak Slim L-R
Roger Neckloop
Sennheiser Sonite Rise Charger Go
Phonak Sky L
Phonak Sky M
Terra+ RIC-312
Phonak CROS P
Phonak Naida Link CROS
Terra+ BTE-M
Terra RIC-312
Phonak CROS L
Terra BTE-M
Terra+ BTE-UP
Phonak Naida Link
Terra+ BTE-SP
myPhonak Junior
Phonak CROS I
Au A
Naida CI Connect
Terra BTE-UP
MEMINI E 5P R-R PH
Phonak Slim P-R
Phonak Sky Link M
Phonak Naida Link M
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility