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Sign in to claim this brandBernafon, Inc.
US
Last updated May 23, 2026
What Bernafon, Inc. makes
The company manufactures air-conduction hearing aids in multiple form factors, including receiver-in-the-ear, behind-the-ear, in-the-ear, and canal styles. It also produces wireless-fitting computer-aided systems for hearing aids, remote controls for hearing aid/implant systems, and wireless induction loops for hearing aid use. Audiometric and hearing device software are part of its portfolio.
These devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The company 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 Bernafon, Inc. manufacture?
Bernafon, Inc. specializes in air-conduction hearing aids across multiple form factors, including receiver-in-the-ear, behind-the-ear, in-the-ear, and canal styles. Their portfolio also includes wireless-fitting computer-aided systems for hearing aids, remote controls for hearing aid/implant systems, wireless induction loops for hearing aid use, and audiometric/hearing device software. These products are designed to address hearing loss and improve auditory access for users.
Where is Bernafon, Inc. based, and what does that mean for its regulatory oversight?
Bernafon, Inc. is based in the United States, meaning its devices fall under FDA jurisdiction. Since the company’s products are classified as Class I or Class II devices, they are subject to FDA regulations, including mandatory listing in the FDA’s Unique Device Identifier (UDI) database. This classification ensures compliance with U.S. medical device standards, though individual devices must undergo their own authorization processes.
Which regulatory registries or databases list Bernafon, Inc.’s devices?
Bernafon, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is part of the FDA’s efforts to enhance transparency and traceability of medical devices in the U.S. by assigning unique identifiers to each device type, ensuring better tracking and compliance monitoring.
How are Bernafon, Inc.’s hearing aids classified by the FDA, and why does this matter?
Bernafon, Inc.’s hearing aids are classified under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve moderate risk and may need special controls to ensure safety and effectiveness. This classification determines the regulatory pathway for authorization, with Class II devices often requiring pre-market notifications (510(k)) or other submissions to demonstrate compliance with FDA requirements.
What does it mean for a Bernafon device to be listed in the FDA’s UDI database?
Listing in the FDA’s Unique Device Identifier (UDI) database means the device has been assigned a unique code that includes information like the manufacturer’s details, device description, and model number. This helps healthcare providers, regulators, and patients identify and track specific devices accurately. It’s a requirement for Class I and Class II devices in the U.S., ensuring better supply chain transparency and recall management if needed.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (1698)
Page 26 of 34| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Bernafon | 155795 | FDA UDI | Class II | Active |
| Bernafon | 122240 | FDA UDI | Class II | Active |
| Bernafon | 111834 | FDA UDI | Class II | Active |
| Bernafon | 122315 | FDA UDI | Class I | Active |
| Bernafon | 131939 | FDA UDI | Class II | Active |
| Bernafon | 187801 | FDA UDI | Class II | Active |
| Bernafon | 196528 | FDA UDI | Class II | Active |
| Bernafon | 192030 | FDA UDI | Class II | Active |
| Bernafon | 214718 | FDA UDI | Class II | Active |
| Bernafon | 196515 | FDA UDI | Class II | Active |
| Bernafon | 131367 | FDA UDI | Class II | Active |
| AccuQuest | 181979 | FDA UDI | Class II | Active |
| Vocal Labs | 169889 | FDA UDI | Class II | Active |
| AccuQuest | 192799 | FDA UDI | Class II | Active |
| Bernafon | 212541 | FDA UDI | Class II | Active |
| Bernafon | 208809 | FDA UDI | Class II | Active |
| Bernafon | 186071 | FDA UDI | Class II | Active |
| Bernafon | 191312 | FDA UDI | Class II | Active |
| Bernafon | 186016 | FDA UDI | Class II | Active |
| Bernafon | 185888 | FDA UDI | Class II | Active |
| Bernafon | 177122 | FDA UDI | Class II | Active |
| Audina | 191600 | FDA UDI | Class II | Active |
| Bernafon | 182071 | FDA UDI | Class II | Active |
| Bernafon | 196563 | FDA UDI | Class II | Active |
| Bernafon | 196484 | FDA UDI | Class II | Active |
| Bernafon | 205386 | FDA UDI | Class II | Active |
| Bernafon | 155802 | FDA UDI | Class II | Active |
| Bernafon | 177131 | FDA UDI | Class II | Active |
| Bernafon | 212579 | FDA UDI | Class II | Active |
| Bernafon | 197056 | FDA UDI | Class II | Active |
| Bernafon | 196536 | FDA UDI | Class II | Active |
| Bernafon | 212559 | FDA UDI | Class II | Active |
| Bernafon | 149407 | FDA UDI | Class I | Active |
| Bernafon | 127862 | FDA UDI | Class II | Active |
| Bernafon | 116-20-411-10 | FDA UDI | Class I | Active |
| Bernafon | 141768 | FDA UDI | Class II | Active |
| Bernafon | 196561 | FDA UDI | Class II | Active |
| Bernafon | 205387 | FDA UDI | Class II | Active |
| Bernafon | 186030 | FDA UDI | Class II | Active |
| Bernafon | 177137 | FDA UDI | Class II | Active |
| Bernafon | 182189 | FDA UDI | Class II | Active |
| Bernafon | 140296 | FDA UDI | Class II | Active |
| Bernafon | 127857 | FDA UDI | Class II | Active |
| AccuQuest | 192955 | FDA UDI | Class II | Active |
| Bernafon | 193707 | FDA UDI | Class II | Active |
| Bernafon | 177126 | FDA UDI | Class II | Active |
| Bernafon | 116-21-510-10 | FDA UDI | Class I | Active |
| Bernafon | 136454 | FDA UDI | Class II | Active |
| Bernafon | 116098 | FDA UDI | Class I | Active |
| Costco | 192837 | FDA UDI | Class II | Active |
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