audifon Tinnitus-Module is a tool intended to generate sound as part of a Tinnitus Retraining Therapy (TRT) protocol designed to provide temporary relief for people experiencing tinnitus symptoms. The module in a hearing aid.

audifon Tinnitus-Module is intended for adults over 18 years of age.

audifon Tinnitus-Module is targeted for licensed hearing care professionals who are familiar with the evaluation and treatment of tinnitus and hearing losses. The fitting of audifon Timitus-Module must be done by a hearing care professional participating in a tinnitus management program.

Device Description

The above mentioned audifon Tinnitus module is a digital noise generator which was developed to be used in a tinnitus retraining therapy. This product has up to four different programs, which can be programmed in shape and level to fit the individual user's needs. The programming can be done with a standard HI-PRO and the audifon audifit software. Within the software the amplification of the device can be fitted to the individual needs. The noise can be adjusted in shape with low- and high-cut filters and in the output level. It can be housed in a standard In-the-ear instrument housing, in a standard behind-the-ear instrument housing as well as in standard receiver-in-the ear housing.

AI/ML Overview

The audifon Tinnitus-Module is a digital noise generator intended to provide temporary relief for tinnitus symptoms as part of a Tinnitus Retraining Therapy (TRT) protocol. The device is designed to be embedded in a hearing aid and is targeted for adults over 18 years of age, with fitting to be done by licensed hearing care professionals.

The study presented to establish substantial equivalence for the audifon Tinnitus-Module primarily relies on non-clinical performance data and a comparison to a legally marketed predicate device, the audifon vico TRT devices (K130514).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating equivalence to the predicate device's performance based on official standards (ANSI S3.22-2014) and functional comparisons.

Criterion	Acceptance Criteria (Predicate Device K130514)	Reported Device Performance (audifon Tinnitus-Module)
Indications for Use	The combined devices are intended for persons suffering from a chronic persistent ringing in the ears (Tinnitus) in combination with a mild to moderate hearing loss that is indicated for a hearing aid fitting. The products may be used for masking Tinnitus as part of a Tinnitus Retraining Therapy (TRT) protocol and should be utilized only in consultation with a qualified hearing healthcare professional. The devices provide hearing aid amplification to compensate for the hearing loss as well as broadband noise for immediate distraction or masking of Tinnitus or long term habituation of Tinnitus.	A tool intended to generate sound as part of a Tinnitus Retraining Therapy (TRT) protocol designed to provide temporary relief for people experiencing tinnitus symptoms. The module can be embedded in a hearing aid. Intended for adults over 18 years of age. Targeted for licensed hearing care professionals familiar with evaluation and treatment of tinnitus and hearing losses. Fitting must be done by a hearing care professional participating in a tinnitus management program.
Operation / Mechanism	Uses broadband noise; Manages tinnitus through masking and distraction. Digital circuit, programmable (Yes), four available noises, volume control, adjustable white-noise, programmable noise level, adjustable Low Battery Indicator, programmable Program Switch Tones.	Uses broadband noise; Manages tinnitus through masking and distraction. Digital circuit, programmable (Yes), four available noises, volume control, adjustable white-noise, programmable noise level, adjustable Low Battery Indicator, programmable Program Switch Tones.
Where Used	May be used anywhere.	May be used anywhere.
Physical Description	Standard In-the-ear instrument housing, Standard behind-the-ear instrument housing.	Standard In-the-ear instrument housing, Standard behind-the-ear instrument housing, Standard receiver-in-the-ear instrument housing. (Note: The new device offers an additional housing type, which is considered an expansion rather than a deviation from safety/effectiveness).
Maximum Output Characteristics	White noise: 107 - 116 dB SPL; frequency range: 100 - 8000 Hz.	White noise: 100 - 112 dB SPL; frequency range: 100 - 8000 Hz. (Note: The rationale states that for TRT, sound levels below 80 dB SPL are typically used and the output level should not exceed 85 dB A per OSHA. A warning in the software occurs for higher levels. Therefore, the slightly lower maximum output has "no influence on the effectiveness of the devices").
Power Source	Standard 10, 312, 13 zinc air 1.4V hearing aid battery.	Standard 10, 312, 13 zinc air 1.4V hearing aid battery.
Quality Assurance Standard	ANSI S3.22-2014 to ensure proper functioning of HA.	ANSI S3.22-2014 to ensure proper functioning of HA.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a specific sample size for a test set for clinical performance evaluations. The supporting data is described as "non-clinical performance data" measured according to official standards (ANSI S3.22-2014). This implies laboratory testing rather than human subject testing.

The data provenance is Germany, where audifon GmbH & Co. KG, the manufacturer, is located. The study is retrospective in the sense that it relies on existing standards and predicate device data, rather than a new prospective clinical trial.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable, as the evaluation is based on non-clinical performance data and comparison to a predicate device, not on ground truth established by experts for a test set of clinical cases.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document describes a comparison between devices, but not a multi-reader multi-case (MRMC) study involving human readers with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

Yes, in the sense that the "non-clinical performance data" assessed the device's technical specifications (like sound output and frequency range) in isolation, demonstrating its inherent functional capabilities according to industry standards (ANSI S3.22-2014). This is considered a standalone technical performance assessment.

7. The Type of Ground Truth Used

The "ground truth" used is defined by adherence to established industry standards (ANSI S3.22-2014) for hearing aid performance and the functional characteristics of the legally marketed predicate device (audifon vico TRT devices, K130514). This is a technical and regulatory ground truth.

8. The Sample Size for the Training Set

Not applicable. The device is a digital noise generator, not an AI/ML algorithm that requires a training set in the conventional sense. Its functionality is based on programmed parameters and physical acoustic properties.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI/ML algorithm. The device's "ground truth" (i.e., its intended and verified performance) is established through its design specifications and compliance with non-clinical performance standards.

Summary

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October 19, 2017

audiofon USA, Inc. Jane E. Perrone V.P. of U.S. Operations 403 Chairman CT., Suite 1 Debary, FL 32713

Re: K171243

Trade/Device Name: audifon Tinnitus-Module Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: September 13, 2017 Received: September 18, 2017

Dear Jane E. Perrone:

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.

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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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education (DICE) 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education (DICE) 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,

Srinivas Nandkumar -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

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Indications for Use

510(k) Number (if known) K171243

Device Name audifon Tinnitus-Module

Indications for Use (Describe)

audifon Tinnitus-Module is intended for adults over 18 years of age.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/2 description: The image shows the logo for Audifon hearing systems. The word "audifon" is written in gray letters, except for the "o" which is red. Below the word "audifon" is the phrase "hearing systems" in a smaller, gray font.

l. Introduction

1.	Applicant's Name and Address:	audifon USA Inc.403 Chairman Ct., Suite 1Debary, Florida 32713PO BOX 531700USA
2.	Contact Person:	Jane E PerronePhone: 386-6688812
3.	Trade or Proprietary Name:	audifon Tinnitus-Module
4.	Device Common Name /Classification Name:	Tinnitus Masker(Regulation Number: 21 CFR 874.3400)
5.	Product Code:	KLW
6.	Classification of Device:	Class II
7.	Type of 510(k) submission	Abbreviated 510(k)
8.	Establishment RegistrationNumber:	3005384855
9.	Address of Manufacturing Site:	audifon GmbH& Co. KGWerner-von-Siemens-Str. 2D-99625 KölledaGermany
10.	Predicate Device Identification:	K130514audifon vico TRT devices
11.	Date of Preparation	April 02, 2017

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Image /page/4/Picture/2 description: The image shows the logo for Audifon hearing systems. The word "audifon" is written in gray letters, with the "o" in "audifon" being red. Below the word "audifon" is the phrase "hearing systems" in a smaller, gray font.

Indications for Use .

audifon Tinnitus-Module is intended for adults over 18 years of age.

audifon Tinnitus-Module is targeted for licensed hearing care professionals who are familiar with the evaluation and treatment of tinnitus and hearing losses. The fitting of audifon Tinnitus-Module must be done by a hearing care professional participating in a tinnitus management program.

. Description of Device

IV. Comparison Information to Predicate Device

The mentioned devices are substantially equivalent to the audifon vico TRT devices (K130514). The mentioned devices and the audifon vico TRT devices are fully digital masker, with programmable noises. Within the program the level and the shape of the noise can be adjusted. Also the mentioned devices and the audifon vico TRT devices provide an additional amplification and can be programmed with the fitting software and a standard HI-PRO programming box.

The non-clinical performance data which were measured according to official standards (ANSI S3.22-2014) verify that the devices have a similar effectiveness as the predicate device. For TRT therapy sound level below 80 dB SPL are needed. Level above 80 dB SPL usually not used. Furthermore. as described within the OSHA (29CFR 1910.95) the output level should not exceed 85 dB A. Therefore a warning in the software will occur that higher level should not be used or only in case of a hearing loss. So the lower maximum output has no influence on the effectiveness of the devices.

The frequency range provides an equivalent white noise with the same sound quality.

In conclusion, the non-clinical tests demonstrate that the submitted devices are as safe as effective the predicate device and the performance are as well as the predicate device.

The submission for tinnitus masker relies on a special control that is defined in section 874.3400. The special controls are identical applied as with the predicate device and supports the substantial equivalence.

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The following tables compare the submitted devices and the audifon vico TRT devices.

	audifon device with active audifonTinnitus-Module	audifon vicoTRT family
Indications ForUse	audifon Tinnitus- Module is a toolintended to generate sound as part ofa Tinnitus Retraining Therapy (TRT)protocol designed to providetemporary relief for peopleexperiencing tinnitus symptoms. Themodule can be embedded in a hearingaid.audifon Tinnitus- Module is intendedfor adults over 18 years of age.audifon Tinnitus- Module is targetedfor licensed hearing care professionalswho are familiar with the evaluationand treatment of tinnitus and hearinglosses. The fitting of audifon Tinnitus-Module must be done by a hearingcare professional participating in atinnitus management program.	The combined devices are intendedfor persons suffering from a chronicpersistent ringing in the ears (Tinnitus)in combination with a mild to moderatehearing loss that is indicated for ahearing aid fitting. The products maybe used for masking Tinnitus as partof a Tinnitus Retraining Therapy (TRT)protocol and should be utilized only inconsultation with a qualified hearinghealthcare professional. The devicesprovide hearing aid amplification tocompensate for the hearing loss aswell as broadband noise for immediatedistraction or masking of Tinnitus orlong term habituation of Tinnitus.
Operation /Mechanism	Uses broadband noise; Managestinnitus through masking anddistractionDigitalCircuit type:Programmable:YesAvailable noises:FourVolume control:Yeswhite-noise is adjustablenoise level is programmableadjustable Low Battery Indicatorprogrammable Program Switch Tones	Uses broadband noise; Managestinnitus through masking anddistractionDigitalCircuit type:Programmable:YesAvailable noises:FourVolume control:Yeswhite-noise is adjustablenoise level is programmableadjustable Low Battery Indicatorprogrammable Program Switch Tones
Where Used	May be used anywhere	May be used anywhere
PhysicalDescription	Standard In-the-ear instrumenthousingStandard behind-the-ear instrumenthousingStandard receiver-in-the-earinstrument housing	Standard In-the-ear instrumenthousingStandard behind-the-ear instrumenthousing
	audifon device with active audifonTinnitus-Module	audifon vicoTRT family
MaximumOutputCharacteristics	White noise: 100 - 112 dB SPLfrequency range:100 - 8000 Hz	White noise: 107 - 116 dB SPLfrequency range: 100 - 8000 Hz
Power Source	standard 10 zinc air 1,4V hearing aidbatterystandard 312 zinc air 1,4V hearing aidbatterystandard 13 zinc air 1,4V hearing aidbattery	standard 10 zinc air 1,4V hearing aidbatterystandard 312 zinc air 1,4V hearing aidbatterystandard 13 zinc air 1,4V hearing aidbattery
QualityAssuranceStandard	ANSIS3.22-2014 to ensure properfunctioning of HA	ANSIS3.22-2014 to ensure properfunctioning of HA

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Image /page/6/Picture/2 description: The image shows the Audifon hearing systems logo. The word "audifon" is written in gray letters, except for the "o" which is red. Below the word "audifon" is the phrase "hearing systems" in smaller gray letters.

Conclusion V.

The devices have similar operating mechanisms as the predicate device. ●
. The devices have similar acoustic characteristics as the predicate device.
The devices are similar in style as the predicate device. .
The devices are similar in intended use as the predicate device .
The devices have the same targeted population as the predicate device

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.