Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of WS AudiologyLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Siemens Hearing Instruments, Inc. with 42 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Jun 5, 2007: UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2).
| Jun 5, 2007 | UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)K071462 · ETW | 510(k) clearances |
| Jul 1, 2005 | Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pediatric patients.Class II · Siemens became aware of an issue where an infant or child could open the tamper resistant battery compartment of the Sie | Device recalls |
| Jun 7, 2001 | CUSTOM TCI (TINNITUS CONTROL INSTRUMENT)K011364 · KLW | 510(k) clearances |
| Jun 1, 2001 | CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)K011366 · KLW | 510(k) clearances |
| Apr 26, 2001 | TCI (TINNITUS CONTROL INSTRUMENT)K003559 · KLW | 510(k) clearances |
| Apr 24, 2001 | TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)K003558 · ESD | 510(k) clearances |
| Sep 5, 1997 | PRISMAK972998 · ESD | 510(k) clearances |
| Jul 25, 1996 | SIEMENS VITA 160 SERIES POCKET HEARING INSTRUMENT: VITA 162E,166M,168PPK962170 · ESD | 510(k) clearances |
| Jul 26, 1995 | PERSONAL PROGRAMMER 2000K952940 · ESD | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
