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Sign in to claim this brandUnitron Hearing
US
Last updated May 23, 2026
What Unitron Hearing makes
Unitron Hearing manufactures air-conduction hearing aids in multiple form factors, including behind-the-ear, receiver-in-canal, in-the-ear, and canal styles. The company also produces hearing aid-enhanced audio devices designed for telecommunication and multimedia use.
The portfolio includes devices classified as Class I and Class II under FDA regulations, with all products listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in 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 manufacture?
Unitron Hearing specializes in air-conduction hearing aids, which come in various form factors such as behind-the-ear, receiver-in-canal, in-the-ear, and canal styles. Additionally, the company produces hearing aid-enhanced audio devices tailored for telecommunication and multimedia applications. These devices are designed to assist individuals with hearing impairments by amplifying sound in different environments and contexts.
Where is Unitron Hearing based?
Unitron Hearing is headquartered in the United States. The company’s location in the US influences its regulatory compliance, particularly with FDA requirements for medical devices.
Which regulatory registries list Unitron Hearing’s devices?
Unitron Hearing’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for air-conduction hearing aids and related products, allowing healthcare providers, regulators, and patients to verify device details and compliance.
How are Unitron Hearing’s devices classified under FDA regulations?
Unitron Hearing’s devices fall into two primary FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and benefits.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
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Catalogue (2169)
Page 35 of 44| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Unitron | 050-5621-D0 | FDA UDI | Class II | Active |
| Unitron | 050-5532-30 | FDA UDI | Class II | Active |
| Unitron | 063-5608-01 | FDA UDI | Class I | Active |
| Unitron | 050-5618-4144 | FDA UDI | Class II | Active |
| Unitron | 050-5579-06 | FDA UDI | Class II | Active |
| Unitron | 063-5444-01 | FDA UDI | Class I | Active |
| Unitron | 063-5617-01 | FDA UDI | Class II | Active |
| Unitron | 050-5732-S5 | FDA UDI | Class II | Active |
| Unitron | 063-5479-01 | FDA UDI | Class II | Active |
| Unitron | 050-5607-P8 | FDA UDI | Class II | Active |
| Unitron | 050-5615-68 | FDA UDI | Class II | Active |
| Unitron | 050-5691-S6 | FDA UDI | Class II | Active |
| Unitron | 050-5620-D0 | FDA UDI | Class II | Active |
| Unitron | 050-5604-P7 | FDA UDI | Class II | Active |
| Unitron | 050-6011-S544 | FDA UDI | Class II | Active |
| Unitron | 050-5538-05 | FDA UDI | Class II | Active |
| Unitron | 050-6016-S244 | FDA UDI | Class II | Active |
| Unitron | 050-5582-0344 | FDA UDI | Class II | Active |
| Unitron | 050-5680-P4 | FDA UDI | Class II | Active |
| Unitron | 050-5692-P8 | FDA UDI | Class II | Active |
| Unitron | 050-5624-S244 | FDA UDI | Class II | Active |
| Unitron | 050-5627-S5 | FDA UDI | Class II | Active |
| Unitron | 050-5535-01 | FDA UDI | Class II | Active |
| Unitron | 063-6022-01 | FDA UDI | Class II | Active |
| Unitron | 050-5720-P6 | FDA UDI | Class II | Active |
| Unitron | 050-5609-P7 | FDA UDI | Class II | Active |
| Unitron | 050-5535-3554 | FDA UDI | Class II | Active |
| Unitron | 050-5857-43 | FDA UDI | Class II | Active |
| Unitron | 050-5622-D644 | FDA UDI | Class II | Active |
| Unitron | 063-5322-01 | FDA UDI | Class I | Active |
| Unitron | 050-6020-S244 | FDA UDI | Class II | Active |
| Unitron | 050-5608-S7 | FDA UDI | Class II | Active |
| Unitron | 063-5682-01 | FDA UDI | Class I | Active |
| Unitron | 050-5580-41 | FDA UDI | Class II | Active |
| Unitron | 050-5581-03 | FDA UDI | Class II | Active |
| Unitron | 050-5571-60 | FDA UDI | Class II | Active |
| Unitron | 050-5721-S5 | FDA UDI | Class II | Active |
| Unitron | 063-5458-01 | FDA UDI | Class II | Active |
| Unitron | 050-5604-S3 | FDA UDI | Class II | Active |
| Unitron | 050-5524-12 | FDA UDI | Class I | Active |
| Unitron | 050-5582-0544 | FDA UDI | Class II | Active |
| Unitron | 050-5609-S6 | FDA UDI | Class II | Active |
| Unitron | 050-6010-P6 | FDA UDI | Class II | Active |
| Unitron | 063-5447-01 | FDA UDI | Class I | Active |
| Unitron | 050-5580-D0 | FDA UDI | Class II | Active |
| Unitron | 050-5723-S6 | FDA UDI | Class II | Active |
| Unitron | 050-5860-E2 | FDA UDI | Class II | Active |
| Unitron | 063-5423-01 | FDA UDI | Class I | Active |
| Unitron | 050-5610-S2 | FDA UDI | Class II | Active |
| Unitron | 050-5614-S7 | FDA UDI | Class II | Active |
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