Bte Hearing Aid Siemens Model 284PP-ASP
FDA 510(k) K884583 · Siemens Hearing Instruments, Inc.
510(k) numberK884583
Submission
- Device name
- Bte Hearing Aid Siemens Model 284PP-ASP
- Applicant
- Siemens Hearing Instruments, Inc.
Piscataway, NJ, US - Received
- November 2, 1988
- Decision date
- January 18, 1989
- 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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| K081136 | Lyric Hearing AidESD · Traditional | Insound Medical, Inc. | 05/08/2008SE |
| 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 |
|---|---|---|
| K071462 | Unity 2 Hia & Probe ( for Use with Unity 2)ETW · Traditional | 06/05/2007SE |
| K011364 | Custom Tci (Tinnitus Control Instrument)KLW · Traditional | 06/07/2001SE |
| K011366 | Custom Tci-Combi (Tinnitus Control Instrument Combination)KLW · Traditional | 06/01/2001SE |
| K003559 | Tci (Tinnitus Control Instrument)KLW · Traditional | 04/26/2001SE |
| K003558 | Tci Combi (Tinnitus Control Instrument Combination)ESD · Traditional | 04/24/2001SE |
| K972998 | PrismaESD · Traditional | 09/05/1997SE |
| K962170 | Siemens Vita 160 Series Pocket Hearing Instrument: Vita 162E,166M,168PPESD · Traditional | 07/25/1996SE |
| K952940 | Personal Programmer 2000ESD · Traditional | 07/26/1995SE |
| K951828 | Full Dynamic Range Compression Behind the Ear Hearing InstrumentESD · Traditional | 06/30/1995SE |
| K952263 | Programmable Two Memory, Single Band Behind the Ear Hearing InstrumentESD · Traditional | 06/05/1995SE |
Questions and answers
When was Bte Hearing Aid Siemens Model 284PP-ASP cleared by the FDA?
Bte Hearing Aid Siemens Model 284PP-ASP (K884583) received a 510(k) decision of Substantially Equivalent on January 18, 1989, 77 days after the submission was received.
What is the product code of K884583?
The FDA product code is ESD – Hearing Aid, Air-Conduction, Prescription, a Class I (low risk) device regulated under 21 CFR 874.3300.