Programmable Two Memory, Single Band Behind the Ear Hearing Instrument
FDA 510(k) K952263 · Siemens Hearing Instruments, Inc.
510(k) numberK952263
Submission
- Device name
- Programmable Two Memory, Single Band Behind the Ear Hearing Instrument
- Applicant
- Siemens Hearing Instruments, Inc.
Piscataway, NJ, US - Received
- May 15, 1995
- Decision date
- June 5, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| 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 |
| K951896 | Intelivenience Programmable Full Dynamic Range Compression Behind the Ear Hearing…ESD · Traditional | 05/30/1995SE |
Questions and answers
When was Programmable Two Memory, Single Band Behind the Ear Hearing Instrument cleared by the FDA?
Programmable Two Memory, Single Band Behind the Ear Hearing Instrument (K952263) received a 510(k) decision of Substantially Equivalent on June 5, 1995, 21 days after the submission was received.
What is the product code of K952263?
The FDA product code is ESD – Hearing Aid, Air-Conduction, Prescription, a Class I (low risk) device regulated under 21 CFR 874.3300.