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Sign in to claim this brandUnitron Hearing Division
US
Last updated May 26, 2026
What Unitron Hearing Division makes
The company manufactures air-conduction hearing aids in multiple form factors, including receiver-in-canal, behind-the-ear, in-the-ear, and canal styles. It also produces noninvasive battery chargers designed for these devices.
These products are classified as Class II devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Unitron Hearing Division manufacture?
Unitron Hearing Division specializes in air-conduction hearing aids, offering multiple form factors such as receiver-in-canal, behind-the-ear, in-the-ear, and canal styles. They also produce noninvasive battery chargers designed specifically for these hearing aid devices. These products are tailored to address hearing loss by amplifying sound for better auditory clarity.
Where is Unitron Hearing Division based?
Unitron Hearing Division operates from the United States. This location allows the company to align its manufacturing and regulatory processes with FDA standards, ensuring compliance with U.S. medical device regulations.
Which regulatory registries list Unitron Hearing Division’s devices?
Unitron Hearing Division’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry provides a standardized way to identify medical devices, ensuring traceability and transparency in the healthcare system.
How are Unitron Hearing Division’s devices classified under FDA regulations?
Unitron Hearing Division’s air-conduction hearing aids and battery chargers fall under Class II classification according to FDA regulations. This classification typically applies to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- unitron.com
- —
- —
- [email protected]
- Phone
- +1 519 895 0100
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 243202080
Catalogue (1869)
Page 21 of 38| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Unitron | 050-6063-P7 | FDA UDI | Class II | Active |
| Unitron | 050-5752-S5 | FDA UDI | Class II | Active |
| Unitron | 050-5750-Q9 | FDA UDI | Class II | Active |
| Unitron | 050-6051-0144 | FDA UDI | Class II | Active |
| Unitron | 050-6031-01 | FDA UDI | Class II | Active |
| Unitron | 050-5794-P765 | FDA UDI | Class II | Active |
| Unitron | 050-5761-P7 | FDA UDI | Class II | Active |
| Unitron | 050-6269-P444 | FDA UDI | Class II | Active |
| Unitron | 050-6259-P665 | FDA UDI | Class II | Active |
| Unitron | 050-6258-P744 | FDA UDI | Class II | Active |
| Unitron | 063-6283-01 | FDA UDI | Class II | Active |
| Unitron | 050-6033-P474 | FDA UDI | Class II | Active |
| Unitron | 050-6246-P4 | FDA UDI | Class II | Active |
| Unitron | 050-6047-P4 | FDA UDI | Class II | Active |
| Unitron | 050-6269-S265 | FDA UDI | Class II | Active |
| Unitron | 050-6448-P8 | FDA UDI | Class II | Active |
| Unitron | 063-6219-01 | FDA UDI | Class II | Active |
| Unitron | 050-6050-0174 | FDA UDI | Class II | Active |
| Unitron | 050-6395-P744 | FDA UDI | Class II | Active |
| Unitron | 050-6013-P462 | FDA UDI | Class II | Active |
| Unitron | 050-6390-P765 | FDA UDI | Class II | Active |
| Unitron | 050-6246-S544 | FDA UDI | Class II | Active |
| Unitron | 050-6031-P674 | FDA UDI | Class II | Active |
| Unitron | 063-6207-01 | FDA UDI | Class I | Active |
| Unitron | 050-5791-S3 | FDA UDI | Class II | Active |
| Unitron | 050-5881-P4 | FDA UDI | Class II | Active |
| Unitron | 050-5794-S3 | FDA UDI | Class II | Active |
| Unitron | 063-6222-01 | FDA UDI | Class II | Active |
| Unitron | 050-6391-P644 | FDA UDI | Class II | Active |
| Unitron | 050-6061-P6 | FDA UDI | Class II | Active |
| Unitron | 050-5771-S2 | FDA UDI | Class II | Active |
| Unitron | 050-6035-P244 | FDA UDI | Class II | Active |
| Unitron | 050-5791-P744 | FDA UDI | Class II | Active |
| Unitron | 050-6192-S544 | FDA UDI | Class II | Active |
| Unitron | 050-6030-P644 | FDA UDI | Class II | Active |
| Unitron | 050-6271-P244 | FDA UDI | Class II | Active |
| Unitron | 050-5762-S5 | FDA UDI | Class II | Active |
| Unitron | 050-5881-S265 | FDA UDI | Class II | Active |
| Unitron | 063-6201-01 | FDA UDI | Class I | Active |
| Unitron | 050-6062-P244 | FDA UDI | Class II | Active |
| Unitron | 050-6045-P8 | FDA UDI | Class II | Active |
| Unitron | 063-6289-01 | FDA UDI | Class I | Active |
| Unitron | 050-5873-P8 | FDA UDI | Class II | Active |
| Unitron | 050-5764-P7 | FDA UDI | Class II | Active |
| Unitron | 050-5770-01 | FDA UDI | Class II | Active |
| Unitron | 050-5772-P4 | FDA UDI | Class II | Active |
| Unitron | 050-6045-S344 | FDA UDI | Class II | Active |
| Unitron | 050-6033-S3 | FDA UDI | Class II | Active |
| Unitron | 050-6191-S344 | FDA UDI | Class II | Active |
| Unitron | 050-6047-P444 | FDA UDI | Class II | Active |
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