Face Plate Hearing Aid
FDA product code LRB · Class I (low risk) · 21 CFR 874.3300 · Ear, Nose, Throat
24510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974219 | Faceplate AssemblyLRB · Traditional | Finetone Hearing Instruments | 02/20/1998SE |
| K961593 | Intrastar Pre-Wired Faceplate for In-The-Ear Hearing AidsLRB · Traditional | Segi Hearing Aid Co. | 11/07/1996SE |
| K942722 | Module ProgramLRB · Traditional | Electone, Inc. | 09/06/1994SE |
| K942236 | Audina Prewires (Faceplate Hearing Aid Series)LRB · Traditional | Audina Hearing Instrument | 06/17/1994SE |
| K935048 | Artisan Programmer & Hearing AidLRB · Traditional | Telex Communications, Inc. | 02/09/1994SE |
| K933046 | Silver L Module, IteLRB · Traditional | Electone, Inc. | 08/02/1993SE |
| K933045 | Silver Rechargeable Module, IteLRB · Traditional | Electone, Inc. | 08/02/1993SE |
| K933044 | Silver LD Module, IteLRB · Traditional | Electone, Inc. | 08/02/1993SE |
| K933043 | Silver PPP Module, IteLRB · Traditional | Electone, Inc. | 08/02/1993SE |
| K933040 | Gold CD Module, IteLRB · Traditional | Electone, Inc. | 08/02/1993SE |
| K933039 | Gold L Module, IteLRB · Traditional | Electone, Inc. | 08/02/1993SE |
| K933038 | Gold Af Module, IteLRB · Traditional | Electone, Inc. | 08/02/1993SE |
| K933037 | Gold K Amp, IteLRB · Traditional | Electone, Inc. | 08/02/1993SE |
| K910901 | Faceplate Ite Hearing Aid Model 28ALRB · Traditional | Telex Communications, Inc. | 05/30/1991SE |
| K910900 | Faceplate Ite Hearing Aid Model TcaLRB · Traditional | Telex Communications, Inc. | 05/30/1991SE |
| K897023 | Oversight Program for In-Office Assembly, HRNG AidLRB · Traditional | Audina Hearing Instrument | 03/16/1990SE |
| K896304 | Olympia Faceplate ModuleLRB · Traditional | Olympia Instruments, Inc. | 01/26/1990SE |
| K873031 | Starkey Model P1 ModuleLRB · Traditional | Starkey Laboratories, Inc. | 02/08/1988SE |
| K873300 | Service Master (Impulse)LRB · Traditional | Richards Medical Co., Inc. | 12/08/1987SE |
| K872645 | Air Conduction In-The-Ear Hearing Aid UA/115/SCRLRB · Traditional | Richards Medical Co., Inc. | 12/08/1987SE |
| K871884 | In the Ear & in the Canal Hearing Aid Face PlateLRB · Traditional | Hearing Services, Inc. | 10/27/1987SE |
| K862769 | Faceplate, Custom In-The-Ear Hearing Aid, FPRLRB · Traditional | Maico Hearing Instruments, Inc. | 08/13/1986SE |
| K862768 | Faceplate, Custom In-The-Ear Hearing Aid, MCA10LRB · Traditional | Maico Hearing Instruments, Inc. | 08/13/1986SE |
| K834479 | ReliableLRB · Traditional | Reliable Hearing Aide | 07/11/1984SE |