Siemens Hearing Instruments, Inc.

Medical device manufacturer in Piscataway, NJ.

42510(k) clearances
0PMA approvals
1recalls

Device types

510(k) clearances

510(k)DeviceDecision
K071462Unity 2 Hia & Probe ( for Use with Unity 2)ETW · Traditional 06/05/2007SE
K011364Custom Tci (Tinnitus Control Instrument)KLW · Traditional 06/07/2001SE
K011366Custom Tci-Combi (Tinnitus Control Instrument Combination)KLW · Traditional 06/01/2001SE
K003559Tci (Tinnitus Control Instrument)KLW · Traditional 04/26/2001SE
K003558Tci Combi (Tinnitus Control Instrument Combination)ESD · Traditional 04/24/2001SE
K972998PrismaESD · Traditional 09/05/1997SE
K962170Siemens Vita 160 Series Pocket Hearing Instrument: Vita 162E,166M,168PPESD · Traditional 07/25/1996SE
K952940Personal Programmer 2000ESD · Traditional 07/26/1995SE
K951828Full Dynamic Range Compression Behind the Ear Hearing InstrumentESD · Traditional 06/30/1995SE
K952263Programmable Two Memory, Single Band Behind the Ear Hearing InstrumentESD · Traditional 06/05/1995SE
K951896Intelivenience Programmable Full Dynamic Range Compression Behind the Ear Hearing…ESD · Traditional 05/30/1995SE
K952098Siemens PC Auidiometer Model SD 100 & PC Probe Mic System Model SD 110/SD with Unity…ETW · Traditional 05/25/1995SE
K943380Siemens 10A Faceplate with Cic InstrumentsESD · Traditional 01/05/1995SE
K944645Siemens Frontier Serice, Models S-1,S-2 and S-3 Multiple Situation, Single Channel…ESD · Traditional 12/27/1994SE
K944174Lifesound Multiple Situation, Single Channel Programmable InstrumentsESD · Traditional 12/27/1994SE
K935019Infinity 252ESD · Traditional 09/07/1994SE
K934752Siemens Model 584 P-2ESD · Traditional 09/07/1994SE
K942857Siemens Bte Hearing AidsESD · Traditional 08/22/1994SE
K931000Siemens Model 584-P-AI-DESD · Traditional 04/12/1993SE
K930999Siemens Model 584-P-AIESD · Traditional 04/12/1993SE
K930998Siemens Model 584-P-GCESD · Traditional 04/12/1993SE
K923380Siemens Model Triton 3004 BESD · Traditional 08/18/1992SE
K923379Siemens Model Infiniti 1001 BESD · Traditional 08/18/1992SE
K921656Lifesound Ite (Lsi-I)W/ Triton 3004I ProgrammableESD · Traditional 05/08/1992SE
K914333Siemens Model Ls-I W/Infiniti Programmable OptionESD · Traditional 10/11/1991SE
K911811Siemens Model 604 Pp-L, Behind-The-Ear Hearing AidESD · Traditional 06/26/1991SE
K911810Siemens Model 604 PP, Behind-The-Ear Hearing AidESD · Traditional 06/26/1991SE
K903760Model Triton 3000 Bte Hearing Aid and PMC SystemESD · Traditional 10/05/1990SE
K893576Siemens Model 284 PPESD · Traditional 05/21/1990SE
K893575Siemens Model 283 AspESD · Traditional 05/21/1990SE
K893574Siemens Model 284 Pp-AgcESD · Traditional 05/21/1990SE
K893573Siemens Model 284 Pp-LESD · Traditional 05/21/1990SE
K891251Behind-The-Ear Hearing Aid Model 408 W-HESD · Traditional 03/31/1989SE
K891250Behind-The-Ear Hearing Aid Model 264 D-Pp-PcESD · Traditional 03/29/1989SE
K891249Behind-The-Ear Hearing Aid Model 303 AspESD · Traditional 03/29/1989SE
K891248Behind-The-Ear Hearing Aid Model 304 Pp-Agc-IESD · Traditional 03/29/1989SE
K891247Behind-The-Ear Hearing Aid Model 404 Pp-PcESF · Traditional 03/29/1989SE
K884583Bte Hearing Aid Siemens Model 284PP-ASPESD · Traditional 01/18/1989SE
K882678Ite Hearing Aid, Siemens Model 007, with TelosESD · Traditional 09/22/1988SE
K872152Siemens Silicone Impression MaterialESD · Traditional 08/11/1987SE
K840893Conferette C2ESD · Traditional 08/02/1984SE
K833773Canal Hearing AidESD · Traditional 03/30/1984SE

Recalls

RecallProductInitiated
Z-0988-2014 Class IISiemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid…Siemens became aware of an issue where an infant or child could open the tamper resistant battery… 07/01/2005Terminated