510(k) Report

FDA applicant

Sound Options Tinnitus Treatments, Inc.

Mississauga, CA1 decision2016–20160 recalls

FDA records 1 decision for Sound Options Tinnitus Treatments, Inc. (Mississauga, CA) in 2016: 1 510(k) clearance. All are in product code KLW (Masker, Tinnitus). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ear, nose and throat panel, where it files most

How often FDA has decided Sound Options Tinnitus Treatments, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2016: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Sound Options Tinnitus Treatments, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sound Options Tinnitus Treatments, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • KLWMasker, Tinnitus1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K161562Sound Options Tinnitus TreatmentSound Options Tinnitus Treatments, Inc. · 20161cites it

What has FDA decided for it lately?

  • K161562Sound Options Tinnitus TreatmentSound Options Tinnitus Treatments, Inc. · 2016

The one decision as Sound Options Tinnitus Treatments, Inc. →

Other applicant names beginning “Sound”

FDA records each applicant name separately; these may or may not be the same firm.

Sound Surgical Technologies, LLC 6Sound Health Systems, Inc. 2Sound 2000 Medical Systems, Inc. 1Sound Imaging, Inc. 1Sound Life Sciences, Inc. 1Sound Land Corp. 1Sound Acoustic Systems, Ltd. 1Sound Crafters Hearing Instruments 1Sound Technique System, LLC 1Sound Hearing Instruments, Inc. 1Sound Linked Data, Inc. 1