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Sign in to claim this brandOticon A/S
US
Last updated May 24, 2026
What Oticon A/S makes
Oticon A/S manufactures a range of air-conduction hearing aids, including receiver-in-the-ear, behind-the-ear, in-the-ear, and canal models. Their portfolio also includes audiometric/hearing device software, wireless-fitting computer-aided systems, remote controls for hearing aids, and wireless induction loops for hearing aid users.
The company’s devices are classified under FDA categories Class I and Class II, with products listed in the FDA’s Unique Device Identifier (UDI) database. Oticon A/S 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 Oticon A/S manufacture?
Oticon A/S specializes in air-conduction hearing aids, covering multiple form factors such as receiver-in-the-ear, behind-the-ear, in-the-ear, and canal models. Their portfolio also includes audiometric/hearing device software, wireless-fitting computer-aided systems, remote controls for hearing aids, and wireless induction loops designed to assist hearing aid users. These devices are developed to address various hearing loss needs and improve auditory access.
Where is Oticon A/S based, and does it operate internationally?
Oticon A/S is headquartered in the United States. While the company’s primary location is in the US, its devices are designed to meet global regulatory standards, including those in the FDA’s Unique Device Identifier (UDI) database. The company’s focus on hearing solutions suggests a broad market reach, though specific international operations or subsidiaries are not detailed in the available data.
Which regulatory registries list Oticon A/S’s devices?
Oticon A/S’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is used to track and identify medical devices in the United States, ensuring transparency and traceability for regulatory and market surveillance purposes. This listing applies to their air-conduction hearing aids and related accessories, as categorized under Class I and Class II devices.
How are Oticon A/S’s hearing aids classified by the FDA?
Oticon A/S’s hearing aids fall under two FDA device classes: Class I and Class II. Class I generally includes low-risk devices that pose minimal potential harm, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and benefits, as determined by regulatory authorities like the FDA.
What distinguishes Oticon A/S’s wireless-fitting computer-aided systems from other hearing aid technologies?
Oticon A/S’s wireless-fitting computer-aided systems are designed to streamline the customization and programming of hearing aids, enabling audiologists to adjust settings remotely and efficiently. These systems integrate with their air-conduction hearing aids to enhance fitting accuracy, user experience, and connectivity—such as pairing with smartphones or other devices—thereby improving accessibility and personalization for hearing aid users. This approach aligns with modern trends toward digital and wireless solutions in audiology.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- oticon.com
- —
- —
- [email protected]
- Phone
- +4539177100
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 305839946
Catalogue (7693)
Page 154 of 154| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Agxo | 126008 | FDA UDI | Class II | Active |
| Hhm | 115293 | FDA UDI | Class II | Active |
| Hhm | 201788 | FDA UDI | Class II | Active |
| Hhm | 201056 | FDA UDI | Class II | Active |
| Hhm | 193297 | FDA UDI | Class II | Active |
| Agxo | 155972 | FDA UDI | Class II | Active |
| Agxo | 176113 | FDA UDI | Class II | Active |
| Agxo | 174897 | FDA UDI | Class II | Active |
| Hhm | 193293 | FDA UDI | Class II | Active |
| Hhm | 104-37-132-00 | FDA UDI | Class II | Active |
| Agxo | 113340 | FDA UDI | Class I | Active |
| Agxo | 103-24-083-00 | FDA UDI | Class II | Active |
| Hhm | 115305 | FDA UDI | Class II | Active |
| Hhm | 193301 | FDA UDI | Class II | Active |
| Hhm | 155184 | FDA UDI | Class II | Active |
| Agxo | 126428 | FDA UDI | Class II | Active |
| Agxo | 133487 | FDA UDI | Class II | Active |
| Hhm | 103-39-212-00 | FDA UDI | Class II | Active |
| Agxo | 150876 | FDA UDI | Class II | Active |
| Hhm | 132404 | FDA UDI | Class II | Active |
| Agxo | 103-37-153-00 | FDA UDI | Class II | Active |
| Agxo | 216076 | FDA UDI | Class II | Active |
| Hhm | 101369 | FDA UDI | Class II | Active |
| Hhm | 119488 | FDA UDI | Class II | Active |
| Hhm | 101444 | FDA UDI | Class II | Active |
| EarQ | 176140 | FDA UDI | Class II | Active |
| Hhm | 150447 | FDA UDI | Class II | Active |
| Hhm | 207162 | FDA UDI | Class II | Active |
| Hhm | 103-24-123-00 | FDA UDI | Class II | Active |
| EarQ | 216249 | FDA UDI | Class II | Active |
| Hhm | 132276 | FDA UDI | Class II | Active |
| Hhm | 151066 | FDA UDI | Class II | Active |
| Hhm | 132281 | FDA UDI | Class II | Active |
| Agxo | 118721 | FDA UDI | Class II | Active |
| Agxo | 115254 | FDA UDI | Class II | Active |
| Hhm | 119486 | FDA UDI | Class II | Active |
| Hhm | 201807 | FDA UDI | Class II | Active |
| Hhm | 132402 | FDA UDI | Class II | Active |
| Hhm | 155880 | FDA UDI | Class II | Active |
| Hhm | 104-39-230-00 | FDA UDI | Class II | Active |
| Hhm | 216047 | FDA UDI | Class II | Active |
| Tinnitus Soundsupport | K133308 | FDA 510(k) | Class II | Active |
| Amendments To Multifocus | K951002 | FDA 510(k) | Class I | Active |
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