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Phonak, 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

Country
US
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LinkedIn
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EUDAMED SRN
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FDA FEI Number
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Catalogue (3047)

Page 23 of 61
DeviceModel / ReferenceRegistriesClassStatus
Phonak 050-0178-P4
FDA UDI
Class IIActive
Phonak 050-0329-M8
FDA UDI
Class IIActive
Phonak 050-0163-Q2
FDA UDI
Class IIActive
Phonak 050-0192-Q1
FDA UDI
Class IIActive
Phonak 050-0193-P8
FDA UDI
Class IIActive
Phonak 050-0177-Q3
FDA UDI
Class IIActive
Phonak 050-0265-P6
FDA UDI
Class IIActive
Phonak 050-0266-P3
FDA UDI
Class IIActive
Phonak 050-0242-P4
FDA UDI
Class IIActive
Phonak 050-0140-P4
FDA UDI
Class IIActive
Phonak 050-0342-M8
FDA UDI
Class IIActive
Phonak 050-0349-P155
FDA UDI
Class IIActive
Phonak 050-0116-P656
FDA UDI
Class IIActive
Phonak 063-0422-01
FDA UDI
Class IActive
Phonak 050-0113-P8
FDA UDI
Class IIActive
Phonak 050-0124-38
FDA UDI
Class IIActive
Phonak 050-0191-P4
FDA UDI
Class IIActive
Phonak 050-0207-P8
FDA UDI
Class IIActive
Phonak 050-0267-P8
FDA UDI
Class IIActive
Phonak 050-0080-P456
FDA UDI
Class IIActive
Phonak 050-0166-P8
FDA UDI
Class IIActive
Phonak 050-0905-G2
FDA UDI
Class IIActive
Phonak 050-0296-P2
FDA UDI
Class IIActive
Phonak 050-0453-06
FDA UDI
Class IIActive
Phonak 050-0988-G3
FDA UDI
Class IActive
Phonak 052-3182-D02P96
FDA UDI
Class IActive
Phonak 050-0956-04
FDA UDI
Class IIActive
Phonak 050-0245-P4
FDA UDI
Class IIActive
Phonak 050-0165-01
FDA UDI
Class IIActive
Phonak 050-0113-P9
FDA UDI
Class IIActive
Phonak 050-0163-Q6
FDA UDI
Class IIActive
Phonak 050-0144-01
FDA UDI
Class IIActive
Phonak 050-0957-36
FDA UDI
Class IIActive
Phonak 050-0163-P1
FDA UDI
Class IIActive
Phonak 050-0138-Q1
FDA UDI
Class IIActive
Phonak 063-0156-01
FDA UDI
Class IActive
Phonak 050-0340-P3
FDA UDI
Class IIActive
Phonak 052-3116-D02Q3
FDA UDI
Class IActive
Phonak 050-0356-P6
FDA UDI
Class IIActive
Phonak 050-0143-P8
FDA UDI
Class IActive
Phonak 050-0282-P155
FDA UDI
Class IIActive
Phonak 063-0152-01
FDA UDI
Class IIActive
Phonak 050-0344-T3
FDA UDI
Class IIActive
Phonak 050-0291-P7
FDA UDI
Class IIActive
Phonak 050-0973-G4
FDA UDI
Class IIActive
Phonak 052-3189-D02P3
FDA UDI
Class IActive
Phonak 050-0093-P8
FDA UDI
Class IIActive
Phonak 063-0143-01
FDA UDI
Class IActive
Phonak 050-0079-3756
FDA UDI
Class IActive
Phonak 050-0453-G5
FDA UDI
Class IIActive

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Phonak AG CH