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Sign in to claim this brandPhonak, Inc.
US
Last updated May 23, 2026
What Phonak, Inc. makes
Phonak, Inc. manufactures air-conduction hearing aids in multiple form factors, including behind-the-ear, receiver-in-canal, canal, and in-the-ear designs. The company also produces hearing aid enhanced audio devices tailored for teaching environments. These devices are intended to amplify sound for individuals with hearing loss.
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 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 Phonak, Inc. manufacture?
Phonak, Inc. specializes in air-conduction hearing aids, which come in various form factors such as behind-the-ear, receiver-in-canal, canal, and in-the-ear designs. Additionally, they produce hearing aid enhanced audio devices specifically designed for teaching environments. These devices are intended to amplify sound for individuals experiencing hearing loss.
Where is Phonak, Inc. based?
Phonak, Inc. is headquartered in the United States. This location is relevant for regulatory purposes, as it may influence the jurisdiction under which their devices are authorized and monitored.
Which regulatory registries or databases list Phonak, Inc.’s devices?
Phonak, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for authorized products, allowing stakeholders to verify specific device details and compliance information.
How are Phonak, Inc.’s devices classified under FDA regulations?
Phonak, Inc.’s devices fall into two classification categories under FDA regulations: Class I and Class II. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional controls due to moderate risk. The classification determines the regulatory oversight and requirements for each device type.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (3047)
Page 61 of 61| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Phonak | 050-0447-F0 | FDA UDI | Class II | Active |
| Phonak | 050-0328-P1 | FDA UDI | Class II | Active |
| Phonak | 050-0330-Q3 | FDA UDI | Class II | Active |
| Phonak | 050-0136-P8 | FDA UDI | Class II | Active |
| Phonak | 050-0327-P3 | FDA UDI | Class II | Active |
| Phonak | 050-0941-G3 | FDA UDI | Class II | Active |
| Phonak | 050-0113-P2 | FDA UDI | Class II | Active |
| Phonak | 050-0988-06 | FDA UDI | Class I | Active |
| Phonak Microvox Resonal Fm System | K941768 | FDA 510(k) | Class II | Active |
| Phonak Pico-Forte Pp-C-P Bte Hearing Instrument | K913503 | FDA 510(k) | Class I | Active |
| Phonak Novo Forte E3 | K972106 | FDA 510(k) | Class I | Active |
| Phonak 9900 Cic | K953921 | FDA 510(k) | Class I | Active |
| Phonak Pico-Forte Sc-D-2 | K932735 | FDA 510(k) | Class I | Active |
| Phonak Pico-Forte C-2 Bte Hearing Instrument | K924912 | FDA 510(k) | Class I | Active |
| Phonak Phonica Model 312-C Ite Hearing Instrument | K912570 | FDA 510(k) | Class I | Active |
| Phonak Microzoom P 2 | K972097 | FDA 510(k) | Class I | Active |
| Phonak Piconet2 P2 Az | K961622 | FDA 510(k) | Class I | Active |
| Bte Pico Scd, Pico Sc | K900831 | FDA 510(k) | Class I | Active |
| Phonak Pico-Forte Ppc-L-P-2 Bte Hearing Instr | K924913 | FDA 510(k) | Class I | Active |
| Phonak Phonica Model 312-Sc Ite Hearing Instrument | K912571 | FDA 510(k) | Class I | Active |
| Phonak Pico-Forte Pp-Sc-2 Bte Hearing Instrument | K924911 | FDA 510(k) | Class I | Active |
| Phonak Audinet Pp-C-P Bte Hearing Instrument | K913502 | FDA 510(k) | Class I | Active |
| Post Auricular Hearing Aid Model Pico Sc-H | K910028 | FDA 510(k) | Class I | Active |
| Phonak 9100 Sc-Af Ite Hearing Instrument | K911211 | FDA 510(k) | Class I | Active |
| Lyric2 | K130790 | FDA 510(k) | Class I | Active |
| Phonak 9800 Sc-Af Ite Hearing Instrument | K911210 | FDA 510(k) | Class I | Active |
| Dyna 231x | K950758 | FDA 510(k) | Class I | Active |
| Phonak Model Pico C-S-H-T, Bte Hearing Aid | K910012 | FDA 510(k) | Class I | Active |
| Bte With Accessory Attached | K923743 | FDA 510(k) | Class I | Active |
| Post Auricular Hearing Aid Model Pico-Forte Pp-Sc | K910018 | FDA 510(k) | Class I | Active |
| Phonak Pico-Forte Ppc-P-2 Bte Hearing Instrument | K924914 | FDA 510(k) | Class I | Active |
| Phonak Epica | K972105 | FDA 510(k) | Class I | Active |
| Phonak 9300 Sc-Af Ite Hearing Instrument | K911209 | FDA 510(k) | Class I | Active |
| Bte Super-Front Ppscl, Super-Front Ppsc | K900829 | FDA 510(k) | Class I | Active |
| Phonak Ite 8000, 7000, 6000 Ite Hearing Aid | K900675 | FDA 510(k) | Class I | Active |
| Phonak Piconet 232x-Az Bte Hearing Instrument | K935791 | FDA 510(k) | Class I | Active |
| Phonak Lexa 231x Ite Series Hearing Sinstrument | K932175 | FDA 510(k) | Class I | Active |
| Bte Super-Front Ppcl4, Super-Front Ppc4 | K900830 | FDA 510(k) | Class I | Active |
| Phonak Sono-Forte 331x Bte Hearing Instruments | K941734 | FDA 510(k) | Class I | Active |
| Phonak Microlink, Personal Fm Receiver | K964035 | FDA 510(k) | Class I | Active |
| Phonak Piconet 232x-Az Hearing Instrument | K945439 | FDA 510(k) | Class I | Active |
| Phonak Pico-Forte Sc-2 | K932734 | FDA 510(k) | Class I | Active |
| Phonak 9000-Af Ite Hearing Instrument Series | K915461 | FDA 510(k) | Class I | Active |
| Phonak Sona P2 | K961653 | FDA 510(k) | Class I | Active |
| Phonak Tinnitus Balance | K123450 | FDA 510(k) | Class II | Active |
| Phonak Piconet 231-X | K930145 | FDA 510(k) | Class I | Active |
| Phonak Sono-Forte 332x-Az | K946294 | FDA 510(k) | Class I | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Phonak AG CH