The Hansaton Tinnitus Maskers are air conduction broad band noise generators and hearing aids intended to output noise of sufficient intensity and bandwidth to be used for tinnitus habituation therapy and are suitable for tinnitus masking therapy. Optional, the Hansaton SOUL Tinnitus Maskers provide amplification, intended to be used by those individuals who experience tinnitus and desire amplification. Diagnosis and prescription of the tinnitus maskers must be performed by hearing health specialists (e.g., ENT specialists, audiologists, or hearing system professionals) who are experienced in tinnitus management.

The target population is primarily the adult population over 18 years of age. The instruments are not intended for pediatric use.

Device Description

The Hansaton Tinnitus Maskers are provided in two versions; the WAVE 2G, a noise generator intended to output noise for tinnitus habituation therapy and tinnitus masking therapy, and SOUL, a noise generator and hearing aid additionally providing amplification. Both, the WAVE 2G and the SOUL, systems are available as 'In The Ear' (ITE) and 'Behind The Ear' (BTE) versions.

AI/ML Overview

The provided document is a 510(k) Summary for Hansaton Tinnitus Maskers (WAVE 2G and SOUL). It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study specifically designed to establish performance against those criteria.

Therefore, the requested information elements related to specific acceptance criteria, a standalone study to prove performance against those criteria, sample sizes for test and training sets, expert consensus for ground truth, and MRMC studies are not explicitly present in this type of regulatory submission.

However, I can extract and infer the closest relevant information from the document as follows:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present a table of specific acceptance criteria (e.g., specific accuracy metrics, sensitivity, specificity, etc.) for the device's clinical performance. Instead, it relies on demonstrating substantial equivalence to existing legally marketed predicate devices. The "reported device performance" is primarily characterized by its electroacoustical characteristics and biocompatibility, as evaluated against established standards for hearing aids.

Category	Acceptance Criteria (Inferred from standards and predicate devices)	Reported Device Performance (as stated or implied)
Intended Use	Must be substantially equivalent to predicate devices for tinnitus habituation therapy, tinnitus masking therapy, and optional amplification.	- WAVE 2G: Noise generator for tinnitus habituation therapy and tinnitus masking therapy. - SOUL: Noise generator and hearing aid for tinnitus habituation therapy, tinnitus masking therapy, and amplification for those experiencing tinnitus and desiring amplification. - Target population: Adults over 18.
Technological Characteristics	Must be substantially equivalent to predicate devices (e.g., digital circuit type, programmability, multiple programs, available noises, volume control, physical description, RMS output characteristics).	WAVE 2G: Digital, Programmable (Yes), Multiple programs (Yes, except Cymba), Four available noises, Volume control (Yes), Eight channels, Available as standard BTE (X-Mini and Slim) and ITE (Mini Canal and Cymba), RMS output (Noiser): 70-90 dB (device dependent). SOUL: Digital, Programmable (Yes), Multiple programs (Yes, except Cymba), Four available noises, Volume control (Yes), 8/4 or 12/12 channels (Economy/Business), Available as standard BTE and ITE, RMS output (Noiser): 65-85 dB (device dependent), RMS output (Hearing aid amplifier) up to 116 dB HF-Average OSPL 90.
Safety	Must comply with biocompatibility standards (ISO 10993). Must not introduce new potential hazards or safety risks compared to predicates.	All patient contacting materials evaluated in terms of biocompatibility in accordance with the ISO 10993 standard series.
Electoacoustical Performance	Must comply with IEC 60118 series standards for hearing aids.	Developed and tested in accordance with IEC 60118-0, -1, -2, -6, -13. (Specific values are listed under "RMS output characteristics" in the comparison table with predicate devices, suggesting compliance with performance envelopes of predicates and standards).
Speech Test	Implied compliance with "Nordic Requirements 7th edition appendix A."	A speech test performed in accordance with the Nordic Requirements 7th edition appendix A. (No specific outcomes reported, only that it was performed.)

2. Sample size used for the test set and the data provenance

Not applicable. This is not a study involving patient data for a test set. The performance testing refers to engineering and quality assurance tests on the devices themselves against established standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No "ground truth" for clinical performance on a test set is established by experts in this type of submission.

4. Adjudication method for the test set

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is not an AI-powered diagnostic tool. It is a tinnitus masker and hearing aid.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an algorithm. Its performance is evaluated intrinsically (electroacoustical characteristics) and for safety (biocompatibility).

7. The type of ground truth used

The "ground truth" in this context refers to established engineering standards (IEC 60118 series) for electroacoustical performance and biocompatibility standards (ISO 10993) for patient-contacting materials. The comparison is also made against the specifications and performance of legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This device is not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

{0}------------------------------------------------

ﺮ

510(k) Summary of Safety and Effectiveness

In accordance with the requirements of the Safe Medical Device Act, Hansaton Akustik GmbH herewith submits a Summary of Safety and Effectiveness.

Submitter Information:	Hansaton Akustik GmbHSachsenkamp 520097 HamburgGermanyRegistration Number: 3004597869Owner/Operator Number: 9042953
Official Correspondent:	Mrs. Kathrin HesebeckHansaton Akustik GmbHSachsenkamp 520097 HamburgPhone: +49 40 298 011-146
US Agent (Contact):	Jane A. Flynn209 Johnson RoadMorris Plains, NJ 07950 USAPhone: +1 973 290 9866E-mail: jflynnmpi@aol.com
Date Prepared:	January 03, 2014
Device(s) Identification:Device Trade Name:Common Name:	WAVE 2G,SOULTinnitus Maskers
Classification of the device:Device Classification Name:Product Code:Device Classification No.:Panel:Regulatory Status:	Masker, TinnitusKLWPart 874.3400Ear Nose & ThroatClass 2

{1}------------------------------------------------

Device Description:

Intended Use:

The Hansaton Tinnitus Maskers are air conduction broad band noise generators and hearing aids intended to output noise of sufficient intensity and bandwidth to be used for tinnitus habituation therapy and are suitable for tinnitus masking therapy. Optional, the Hansaton SOUL Tinnitus Maskers provide amplification, intended to be used by those individuals who experience tinnitus and desire amplification. Diagnosis and prescription of the tinnitus maskers must be performed by health specialists (e.g., ENT specialists, audiologists, or hearing system professionals) who are experienced in tinnitus management.

The target population is primarily the adult population over 18 years of age. The instruments are not intended for pediatric use.

Predicate devices:

1.Device Trade Name:Applicant:510(k) No.:	TCI CombiSiemens Hearing InstrumentsK003558		HansatonWAVE 2G	Hansaton SOUL	TCI CombiK003558	TCIK003559	Custom TCI CombiK011366	Widexlink inclear serieshearing aidsK101699
2.Device Trade Name:Applicant:510(k) No.:	TCISiemens Hearing InstrumentsK003559	Intended Use	The HansatonTinnitusMaskers are airconductionbroad bandnoise generatorsand hearing aidsintended tooutput noise ofsufficientintensity andbandwidth to beused for tinnitushabituationtherapy and aresuitable fortinnitus maskingtherapy.Diagnosis andprescription ofthe tinnitusmaskers mustbe performed byhearing healthspecialists (e.g.,ENT specialists,audiologists, orhearing systemprofessionals)who areexperienced intinnitusmanagement.The targetpopulation isprimarily theadult populationover 18 years ofage. Theinstruments arenot intended forpediatric use.	The HansatonTinnitus Maskersare airconduction broadband noisegenerators andhearing aidsintended tooutput noise ofsufficientintensity andbandwidth to beused for tinnitushabituationtherapy and aresuitable fortinnitus maskingtherapy.Optional, theHansaton SOULTinnitus Maskersprovideamplification,intended to beused by thoseindividuals whoexperiencetinnitus anddesireamplification.Diagnosis andprescription ofthe tinnitusmaskers must beperformed byhearing healthspecialists (e.g.,ENT specialists,audiologists, orhearing systemprofessionals)who areexperienced intinnitusmanagement.The targetpopulation isprimarily theadult populationover 18 years ofage. Theinstruments arenot intended forpediatric use.	Mask tinnitus aspart of tinnitusmanagementprogramProvideamplification forcompensation ofhearing loss	Mask tinnitusas part oftinnitusmanagementprogram	Mask tinnitus as partof tinnitusmanagementprogramProvide amplificationfor compensation ofhearing loss	Mask tinnitus aspart of tinnitusmanagementprogram
3.Device Trade Name:Applicant:510(k) No.:	Custom TCI CombiSiemens Hearing InstrumentsK011366	Targetpopulation	Individuals whoexperiencetinnitus. Thetarget populationis primarily theadult populationover 18 years of	Individuals whoexperiencetinnitus anddesireamplification.The targetpopulation isprimarily the	Adults and children(≥ 5 years) withtinnitus andhearing loss thatare participating ina tinnitusmanagement	Adults andchildren (≥ 5years) withtinnitus that areparticipating ina tinnitusmanagement	Adults and children(≥ 5 years) withtinnitus that areparticipating in atinnitus managementprogram	Individuals with afull range ofhearing lossseverity (fromslight (16 to 25 dBHL) to profound(90+ dB HL)) and

য :

WIDEXLINK IN CLEAR SERIES HEARING AIDS Device Trade Name: Applicant: Office Research in Clinical Amplification 510(k) No.: K101699

{2}------------------------------------------------

{3}------------------------------------------------

	HansatonWAVE 2G	Hansaton SOUL	TCI CombiK003558	TCIK003559	Custom TCI CombiK011366	Widexlink inclear serieshearing aidsK101699
	instruments arenot intended forpediatric use.	adult populationover 18 years ofage. Theinstruments arenot intended forpediatric use.				configurations.
Circuit type	Digital	Digital	Digital	Digital	Digital	Digital
Programmable	Yes	Yes	Yes	Yes	Yes	Yes
Multipleprograms/memories	Yes(except Cymba)	Yes(except Cymba)	Yes	No	Yes	Yes
Available noises	Four	Four	One	Four	One	n/a
Volume control	Yes	Yes	Yes	Yes	Yes	Yes
Number ofchannels	Eight	(G/AGC)Business: 12/12Economy:8/4	Four	n/a	n/a	n/a
Physicaldescription	Available asstandard behind-the-ear (X-Miniand Slim) andin-the-earsolutions (MiniCanal andCymba):Mini Canal iscustom made	Available asstandard behind-the-ear (X-Miniand Slim) and in-the-ear solutions(Mini Canal andCymba);Mini Canal iscustom made	Standard behind-the-ear instrumenthousing	Standardbehind-the-earinstrumenthousing	Custom product,available as in-the-ear, half shell, andin-the-canal shellstyles	n/a
RMS outputcharacteristics(Noiser)	Mini Canal80 dBSlim80/90 dBX-Mini(S-receiver)70 dBX- Mini(M-receiver)80 dB	Mini Canal: 75dBSlim:75/85 dB(Mini tube/earhook)X-Mini(S-receiver):65 dBX-Mini(M-receiver):75 dBX-Mini(P-receiver)85 dB	102 dB Broadbandnoise	White noise71 dB SPLPink noise69 dB SPLSpeech noise69 dB SPLHigh-tonenoise76 dB SPL	ITE:89 dBBroadband noiseIn-the-canal and halfshell:84 dB Broadbandnoise	n/a
RMS outputcharacteristics(Hearing aidamplifier)	n/a	(ANSI S3.22-2003)HF-AverageOSPL 90Mini Canal:	105 dB HF-Average OSPL 90(ANSI S3.22-1996)	n/a	ITE:105 dBHF-Average OSPL90 (ANSI S3.22-1996) (110/40/03matrix)	n/a
	Hansaton WAVE 2G	Hansaton SOUL	TCI CombiK003558	TCIK003559	Custom TCI CombiK011366	Widexlink in clear serieshearing aidsK101699
		Slim:116 dBX-Mini(S-receiver):101 dBX-Mini(M-receiver):114 dBX-Mini(P-receiver)116 dB			In-the-canal and halfshell:107 dBHF-Average OSPL90 (ANSI S3.22-1996) (110/35/03matrix)
Volume controlrange	Programmable:OFF, 8 dB,16 dB, 32 dB	Programmable:OFF, 8 dB,16 dB, 32 dB	Programmable:OFF, 8 dB, 16 dB,32 dB	Programmable:OFF, 8 dB,16 dB, 32 dB	Programmable:OFF, 8 dB, 16 dB,32 dB	n/a
Wirelesscommunicationof pair ofhearing aids ordeviceaccessories	No	Yes	No	No	No	Yes

{4}------------------------------------------------

The Hansaton WAVE 2G and SOUL Tinnitus Maskers are considered substantial equivalent to the Siemens TCI Combi (K003558), Siemens TCI (K003559), Siemens Custom TCI Combi (K011366), and Office Research in Clinical Amplification's WIDEXLINK (K101699). There is no significant difference in intended use or technology.

Summary of performance testing:

The Hansaton WAVE 2G and SOUL tinnitus maskers have been developed and tested in accordance with hearing aids specific standard IEC 60118 series.

IEC 60118-0: Hearing aids Measurement of electroacoustical characteristics .
IEC 60118-1: Hearing aids Hearing aids with induction pick-up coil input .
IEC 60118-2: Hearing aids -Hearing aids with automatic gain control circuits .
IEC 60118-6: Hearing aids -Characteristics of electrical input circuits for hearing aids .
IEC 60118-13: Hearing aids -- Electromagnetic compatibility .

All patient contacting materials have been evaluated in terms of biocompatibility in accordance with the ISO 10993 standard series.

Additionally a speech test was performed in accordance with the Nordic Requirements 7th edition appendix A.

{5}------------------------------------------------

Conclusion:

Hansaton Akustik GmbH believes that the Hansaton Tinnitus Maskers WAVE 2G and SOUL are substantially equivalent to the currently legally marketed devices. They do not introduce new indications for use, have the same technological characteristics and do not introduce new potential hazards or safety risks.

{6}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

DEPARTMENT OF HEALTH & HUMAN SER

January 3, 2014

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Hansaton Akustik GmbH c/o Mr. Nick Burmester Regulatory Affairs & Project Manager, Prosystem AG Beim Strohhause 17 Hamburg, Germany 20097

Re: K130937

Trade/Device Name: WAVE 2G, SOUL Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: November 18, 2013 Received: December 2, 2013

Dear Mr. Burmester:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

{7}------------------------------------------------

Page 2 - Mr. Nick Burmester

You must comply with all the Act's requirements, including, but not limited to: Registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Bradley S. Cunningham -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{8}------------------------------------------------

Indications for Use

510(k) number (if known): K130937

Device Name:

WAVE 2G, SOUL Tinnitus Masker

Indications for Use:

The target population is primarily the adult population over 18 years of age. The instruments are not intended for pediatric use.

Prescription Use x (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Srinivas Nandkumar -S

Page 1 of 1

Regulation Number and Section

§ 874.3400 Tinnitus masker.

(a)
Identification. A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to mask ringing in the ears or internal head noises. Because the device is able to mask internal noises, it is also used as an aid in hearing external noises and speech.(b)
Classification. Class II. The special control for this device is patient labeling regarding:(1) Hearing health care professional diagnosis, fitting of the device, and followup care,
(2) Risks,
(3) Benefits,
(4) Warnings for safe use, and
(5) Specifications.