RX12 Linear Full Shell and in the Canal
FDA 510(k) K953728 · Midwest City Hearing Aid Center
510(k) numberK953728
Submission
- Device name
- RX12 Linear Full Shell and in the Canal
- Applicant
- Midwest City Hearing Aid Center
Midwest City, OK, US - Received
- August 10, 1995
- Decision date
- September 12, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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.
Other 510(k)s with product code ESD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232999 | Lyric4 Hearing AidESD · Traditional | Sonova AG | 04/11/2024SE |
| K130790 | LYRIC2ESD · Traditional | Phonak, LLC | 06/27/2013SE |
| 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 |
|---|---|---|
| K970430 | Adaptive Compression - Class D/ Class D AgciESD · Traditional | 03/11/1997SE |
| K963604 | Dynamic Eq II - 2 Channel Wide Dynamic Range CompressionESD · Traditional | 09/27/1996SE |
| K963607 | Horizon 1 and 2 Programable Full Shell and in the CanalESD · Traditional | 09/20/1996SE |
| K953729 | K Amp Full Shell and in the EarESD · Traditional | 09/12/1995SE |
| K953631 | Snip Input Compression Class aESD · Traditional | 08/28/1995SE |
| K952986 | Spi-Secret Personal Instrument CicESD · Traditional | 08/07/1995SE |
| K953038 | Dynamic Eq/Class DESD · Traditional | 07/21/1995SE |
| K953036 | DB Push-Pull Hearing AidESD · Traditional | 07/21/1995SE |
| K952821 | Mwchac 95 FS 12345ESD · Traditional | 07/21/1995SE |
| K952820 | Mwchac 95 C 12345ESD · Traditional | 07/21/1995SE |
Questions and answers
When was RX12 Linear Full Shell and in the Canal cleared by the FDA?
RX12 Linear Full Shell and in the Canal (K953728) received a 510(k) decision of Substantially Equivalent on September 12, 1995, 33 days after the submission was received.
What is the product code of K953728?
The FDA product code is ESD – Hearing Aid, Air-Conduction, Prescription, a Class I (low risk) device regulated under 21 CFR 874.3300.