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Sign in to claim this brandSonic Innovations, Inc.
US
Last updated May 27, 2026
What Sonic Innovations, Inc. makes
Sonic Innovations, Inc. 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 wireless-fitting computer-aided systems, remote controls for hearing aid/implant use, audiometric/hearing device software, and wireless induction loops for hearing assistance.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Sonic Innovations, Inc. 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 Sonic Innovations, Inc. manufacture?
Sonic Innovations, Inc. 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 complementary devices like wireless-fitting computer-aided systems, remote controls for hearing aid/implant compatibility, audiometric/hearing device software, and wireless induction loops designed to enhance hearing assistance. These products cater to users requiring tailored hearing solutions.
Where is Sonic Innovations, Inc. based?
Sonic Innovations, Inc. is headquartered in the United States. This location aligns with regulatory frameworks governing medical devices in the country, including FDA compliance requirements for classification and listing.
Which regulatory registries list Sonic Innovations, Inc.’s devices?
Sonic Innovations, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system standardizes identification for medical devices, ensuring traceability and regulatory transparency. This listing helps healthcare providers and regulators verify device details, such as classification and compliance status.
How are Sonic Innovations, Inc.’s devices classified under FDA regulations?
Sonic Innovations, Inc.’s devices fall under FDA’s Class I and Class II categories. Class I generally includes low-risk devices requiring general controls, while Class II involves additional performance standards or special controls due to moderate risk. The classification depends on factors like device purpose, potential risks, and intended use, ensuring appropriate regulatory oversight.
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
- 968696919
Catalogue (941)
Page 19 of 19| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Sonic | 215359 | FDA UDI | Class II | Active |
| Sonic | 201920 | FDA UDI | Class II | Active |
| Sonic | 192149 | FDA UDI | Class II | Active |
| Sonic | 162546 | FDA UDI | Class II | Active |
| Sonic | 159220 | FDA UDI | Class II | Active |
| Sonic | 156067 | FDA UDI | Class II | Active |
| Sonic | 192096 | FDA UDI | Class II | Active |
| Sonic | 186167 | FDA UDI | Class II | Active |
| Sonic | 186292 | FDA UDI | Class II | Active |
| Sonic | 192092 | FDA UDI | Class II | Active |
| Sonic | 165808 | FDA UDI | Class II | Active |
| Sonic | 186264 | FDA UDI | Class II | Active |
| Sonic | 192129 | FDA UDI | Class II | Active |
| Sonic | 192133 | FDA UDI | Class II | Active |
| Sonic | 119294 | FDA UDI | Class II | Active |
| Sonic | 197295 | FDA UDI | Class II | Active |
| Sonic | 176980 | FDA UDI | Class II | Active |
| Sonic | 159270 | FDA UDI | Class II | Active |
| Sonic | 159241 | FDA UDI | Class II | Active |
| Sonic | 196476 | FDA UDI | Class II | Active |
| Sonic | 102304 | FDA UDI | Class II | Active |
| Sonic | 186153 | FDA UDI | Class II | Active |
| Sonic | 159177 | FDA UDI | Class II | Active |
| Sonic | 208814 | FDA UDI | Class II | Active |
| Sonic | 192140 | FDA UDI | Class II | Active |
| Sonic | 215339 | FDA UDI | Class II | Active |
| Sonic | 192093 | FDA UDI | Class II | Active |
| Sonic | 177118 | FDA UDI | Class II | Active |
| Sonic | 186282 | FDA UDI | Class II | Active |
| Sonic | 151474 | FDA UDI | Class II | Active |
| Sonic | 124928 | FDA UDI | Class I | Active |
| Sonic | 186191 | FDA UDI | Class II | Active |
| Sonic | 159091 | FDA UDI | Class II | Active |
| Sonic | 186201 | FDA UDI | Class II | Active |
| Sonic | 149020 | FDA UDI | Class II | Active |
| Sonic | 161182 | FDA UDI | Class II | Active |
| Sonic | 186313 | FDA UDI | Class II | Active |
| Sonic | 114709 | FDA UDI | Class II | Active |
| Sonic | 193704 | FDA UDI | Class II | Active |
| Sonic | 177144 | FDA UDI | Class II | Active |
| Sonic Innovations Completely-In-The-Canal Dsp Hearing Aid With Soft Shell | K984518 | FDA 510(k) | Class I | Active |
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