Post-Auricular Hearing Aid Model Pe 600 PPC
FDA 510(k) K844859 · Phonic Ear, Inc.
510(k) numberK844859
Submission
- Device name
- Post-Auricular Hearing Aid Model Pe 600 PPC
- Applicant
- Phonic Ear, Inc.
Mill Valley, CA, US - Received
- December 14, 1984
- Decision date
- March 28, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ESD – Hearing Aid, Air-Conduction, Prescription
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.3300
- Specialty
- Ear, Nose, Throat
An air-conduction hearing aid is a wearable sound amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. This is a prescription hearing aid.
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| K021867 | Insound XT Series Hearing AidESD · Traditional | Insound Medical, Inc. | 11/19/2002SE |
| K003558 | Tci Combi (Tinnitus Control Instrument Combination)ESD · Traditional | Siemens Hearing Instruments, Inc. | 04/24/2001SE |
| K984518 | Sonic Innovations Completely-In-The-Canal DSP Hearing Aid with Soft ShellESD · Traditional | Sonic Innovations, Inc. | 03/12/1999SE |
| K974751 | Tranquil Tri-Oe, Tranquil Tri-Coe, Tranquil Tri-CicESD · Traditional | General Hearing Instruments, Inc. | 03/06/1998SE |
| K974242 | Argosy Programmable OnqueESD · Traditional | Argosy Electronics | 01/20/1998SE |
| K973880 | Sonix Hearing Aid Fitting and Programming SystemESD · Traditional | Sonix Technologies, Inc. | 01/12/1998SE |
| K974211 | Opus 2 - Full Concha Series - IteESD · Traditional | Bernafon-Maico, Inc. | 12/15/1997SE |
More from Bernafon-Maico, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K043090 | Easylistener 2 FM, Radium FM and Vocalight Infrared Sound Field SystemsLZI · Traditional | 12/23/2004SE |
| K974658 | Infrared Group Amplification System, Infrared Emitter, Infrared Body Worn Receiver…EPF · Traditional | 02/25/1998SE |
| K974287 | FM Receiver - Auditory TrainerEPF · Traditional | 02/10/1998SE |
| K950730 | Group Auditory Trainer (Group Amplification System)EPF · Traditional | 06/30/1995SE |
| K940313 | Phonic EarEPF · Traditional | 03/22/1994SE |
| K923234 | Pe 400IR, Pe 400T, Pe 400EEPF · Traditional | 09/29/1992SE |
| K922720 | Group Auditory Training SystemEPF · Traditional | 08/24/1992SE |
| K912356 | Group Auditory Trainer,Fm ReceiverEPF · Traditional | 08/15/1991SE |
| K893431 | Auditory Trainer PE150R FM ReceiverEPF · Traditional | 08/21/1989SE |
| K882409 | PE100R FM Receiver Used W/PE100T FM TransmitterEPF · Traditional | 07/05/1988SE |
Questions and answers
When was Post-Auricular Hearing Aid Model Pe 600 PPC cleared by the FDA?
Post-Auricular Hearing Aid Model Pe 600 PPC (K844859) received a 510(k) decision of Substantially Equivalent on March 28, 1985, 104 days after the submission was received.
What is the product code of K844859?
The FDA product code is ESD – Hearing Aid, Air-Conduction, Prescription, a Class I (low risk) device regulated under 21 CFR 874.3300.