Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA files no records under this name; these are its 6 companies' records, each linked to the record.
As of Nov 15, 2026, FDA's public records list WS Audiology and its 6 subsidiaries with 118 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Jun 10, 2026: Tinnitus Therapy.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, WS Audiology and its 6 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jun 10, 2026 | Tinnitus TherapyK260614 · KLW | 510(k) clearances |
| Jul 29, 2025 | SImmetry+ SystemK250647 · OUR | 510(k) clearances |
| May 5, 2011 | IE-ZEN (IN CLEAR SERIES HEARING AID)K110973 · KLW | 510(k) clearances |
| Jun 27, 2008 | ZEN PROGRAM (MIND 440 HEARING AID)K080955 · KLW | 510(k) clearances |
| 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 |
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
