510(k) · Cleared

Cleared

Tinnitus Sound Generator Module

K110932510(k) SpecialCleared May 3, 201129-day reviewClass II21 CFR 874.3400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cleared on May 3, 2011 as substantially equivalent to K073636 (Gn Resound A/S, 2008) after a 29-day review. Its family tree reaches back 4 generations to 1998. 13 later devices descend from it.

Decided: May 3, 2011
Review: 29 days
Class: Class II
Product code: KLW
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K974501 (1998). 6 ancestors in all. 13 later devices descend from it, 7 citing it directly.

By dateBy generation

Root · 4 generations backK974501 Digital Tinnitus Masking SystemPetroff Audio Technologies · 1998
3 generations backK030791 Anmp (Acoustic Neuro Modulation Protocol)Tinnitech, Ltd. · 2003
2 generations backK040330 QuiescenceSpectral Visualization & Development, Inc. · 2004
1 generation backK073636 Tinnitus Sound Generator ModuleGn Resound A/S · 2008
This deviceK110932 Tinnitus Sound Generator ModuleGn Resound A/S · 2011
Descendant · cites it directly · 3 of its ownK150171 Tinnitus Sound Generator ModuleGn Resound A/S · 2015
Descendant · cites it directly · 3 of its ownK123450 Phonak Tinnitus BalancePhonak, LLC · 2013
Descendant · 2 generations on · 2 of its ownK181586 Tinnitus Sound Generator ModuleGN Hearing A/S · 2018
Descendant · cites it directly · 2 of its ownK133308 Tinnitus SoundsupportOticon A/S · 2014
Descendant · 3 generations on · 1 of its ownK180495 Tinnitus Sound Generator ModuleGN Hearing A/S · 2018

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2012high 3 (2015) · low 0 (2017)2026

Most influential descendants

Showing 5 of 13 · See all

K150171Tinnitus Sound Generator ModuleGn Resound A/S · 2015 · cites it directly3descendants
K123450Phonak Tinnitus BalancePhonak, LLC · 2013 · cites it directly3descendants
K181586Tinnitus Sound Generator ModuleGN Hearing A/S · 2018 · 2 generations on2descendants
K133308Tinnitus SoundsupportOticon A/S · 2014 · cites it directly2descendants
K180495Tinnitus Sound Generator ModuleGN Hearing A/S · 2018 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K974501	Digital Tinnitus Masking System	Petroff Audio Technologies	1998	—
−3	K030791	Anmp (Acoustic Neuro Modulation Protocol)	Tinnitech, Ltd.	2003	—
−2	K040330	Quiescence	Spectral Visualization & Development, Inc.	2004	—
−1	K073636	Tinnitus Sound Generator Module	Gn Resound A/S	2008	—
0 (this device)	K110932	Tinnitus Sound Generator Module	Gn Resound A/S	2011	—
+1	K150171	Tinnitus Sound Generator Module	Gn Resound A/S	2015	—
+1	K123450	Phonak Tinnitus Balance	Phonak, LLC	2013	—
+2	K181586	Tinnitus Sound Generator Module	GN Hearing A/S	2018	—
+1	K133308	Tinnitus Soundsupport	Oticon A/S	2014	—
+3	K180495	Tinnitus Sound Generator Module	GN Hearing A/S	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2013	2	0
2014	1	0
2015	3	0
2016	1	0
2018	2	0
2020	2	0
2023	1	0

FIG. 1 — Lineage of K110932, 1998–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KLW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KLW device

#1 K260413 Levo Gen 2 Tinnitus Therapy Systemscore 11.8 · 1 generation · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K073636	Tinnitus Sound Generator Module Summary page 1 …R 874.3400 Tinnitus masker Classification Panel: Ophthalmic and Ear, Nose, and Throat Division Product Code: KLW Predicate Device: K073636 Device Description 'lhe Tinnitus Sound Generator provides a means for healthcare professionals to create a hearing instrument s…	Gn Resound A/S	2008	—

Also cleared against K073636: 3 other devices →

What descends from it? (13)

See all 13

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K150171	Tinnitus Sound Generator Module	Gn Resound A/S	2015	3
K123450	Phonak Tinnitus Balance	Phonak, LLC	2013	3
K133308	Tinnitus Soundsupport	Oticon A/S	2014	2
K151719	REVE134	Kw Ear Lab, Inc.	2015	1
K130494	Unitron Tinnitus Masker Feature	Unitron Hearing	2013	1
K122876	Multiflex Tinnitus Technology	Starkey Laboratories	2012	1
K161331	HyperSound Tinnitus Module	Turtle Beach Corporation	2016	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
None of the 6 ancestors has a recall.
Of its descendants, K150171 (Gn Resound A/S, 2015) has gone furthest, with 3 descendants of its own.
3 other devices also cite its predicate K073636.

How does its category compare?

All KLW devices

KLW Masker, Tinnitus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · KLW

1in 2024

2007high 4 (2011) · low 0 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KLW

261in 2023

2007high 261 (2023) · low 58 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KLW

No recall names KLW since 2007.

Adverse event reports per year · KLW

4in 2015

2007high 4 (2015) · low 0 (2008)2025

MAUDE reports naming product code KLW, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	2	—	1
2008	2	—	0
2009	2	—	1
2010	1	—	1
2011	4	58	1
2012	1	—	1
2013	4	150	0
2014	4	164	0
2015	4	107	4
2016	3	114	0
2017	2	—	0
2018	2	—	0
2019	0	—	0
2020	2	—	0
2021	0	—	0
2022	0	—	0
2023	3	261	0
2024	1	—	0
2025	0	—	0
2026	2	—	—

What is it indicated for?

The Tinnitus Sound Generator Module is a tool to generate sounds to be used in a Tinnitus Management Program to relieve patients suffering from tinnitus. The target population is primarily the adult population over 18 years of age. This product may also be used with children 5 years of age or older.

The Tinnitus Sound Generator Module is targeted for hcalthcare professionals, which are treating patients suffering from tinniitus, as well as conventional hearing disorders. The fitting of the Tinhitus Sound Generator Module must be done by a hearing professional participating. in a Tinnitus Management Program.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K110932 · printed Nov 5, 2026

Cite this page

510(k) Report. “K110932: Tinnitus Sound Generator Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110932

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026