The Tinnitus Sound Generator Module is a tool to generate sounds to be used in a Tinnitus Management Program to temporarily 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 healthcare professionals, which are treating patients suffering from Tinnitus, as well as conventional hearing disorders. The Tinnitus Sound Generator Module must be done during an in-office visit by a hearing professional participating in a Tinnitus Management Program. If deemed feasible by the hearing professional, subsequent fittings of the Tinnitus Sound Generator Module may be performed remotely and in real time while having live communication via live audio, video and chat on the user's dedicated app.

Device Description

The Tinnitus Sound Generator (TSG) Module is software that provides a means for healthcare professionals to create a hearing instrument solution that provides temporary relief for Tinnitus patients. This software solution is embedded into a digital hearing instrument platform, so that the end-user (EU) can wear this device in all environments. The fitting of the digital device, which contains the TSG Module, is performed by a healthcare professional, in order to meet the exact needs of the Tinnitus patient.

A mobile medical application (app) is available as an optional device to use with the TSG. The mobile medical app allows the user to adjust the hearing aid within the limits set by the healthcare professional during fitting of the hearing aid. The app is known as the TSG Tinnitus Manager app and is part of the Smart3D app. The Smart3D app also enables a Health Care Professional (HCP) to remotely adjust the TSG settings using a Remote Fine Tuning Feature (RFT). The Support for the RFT feature for the TSG Module can be enabled by the doctor, audiologist or other hearing healthcare professional, at the time of first fitting. Afterwards, the doctor, audiologist or other hearing healthcare professional is able to remotely make adjustments to TSG Module settings. RFT is only enabled when the doctor, audiologist or other hearing healthcare professional finds it feasible, based on an initial in-office assessment of the user and communication with the user, and the parent or legal guardian in cases where the user is a minor. Subsequent to the in-office assessment, the user, or the parent or legal guardian in cases where the user is a minor, is required to accept to receive the adjustments via the TSG portion of the Smart3D app, called the Tinnitus Manager.

Compared to the Remote Fine Tuning, available in the predicate device, the subject TSG Module additionally supports Remote Fitting, being used for real time, online adjustments, with live communication with the end user. Support for Remote Fitting is a process where the end user (EU) has a scheduled appointment with the hearing Health Care Professional (HCP) while the EU is at a remote location, like at home. HCP and EU meet via an HCP initiated live audio, live video and chat on the user's Smart3D app, and adjustments can be made to the Hearing Aids per agreement and prescription of the HCP. During this process, the HCP can make multiple adjustments in real time to the Hearing Aids, including TSG, while having live communication with the EU as if they were in the same room. The session is similar to an adjustment session done at the HCP office, but with the EU at a remote location. When the final settings are decided, a fitting data package is generated by the HCP, and the Hearing Aids are updated remotely while having the live session with the EU. Subsequent to the in-office assessment, the user, or the parent or legal guardian in cases where the user is a minor, is required to accept the adjustments. The Remote Fitting is only made available and technically working for follow-up sessions when found feasible by the HCP, and not available for the initial first-time fitting of the Hearing Aids, that has to take place at the HCP office.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a Tinnitus Sound Generator Module. However, it does not include information about acceptance criteria or a study that proves the device meets those criteria in the context of typical AI/ML medical device submissions.

The document states that the Tinnitus Sound Generator Module is software embedded into a digital hearing instrument. The 510(k) is specifically for a Special 510(k), indicating a modification to an already cleared device (the predicate device K180495).

The primary focus of this 510(k) is the addition of "Support for Remote Fitting" to the existing TSG Module. The document explicitly states:

"The TSG software is unchanged, but now claims support for the added Remote Fitting feature." (Page 6)
"The acceptance criteria were not altered, and no additional types of evaluation was needed." (Page 6)

Therefore, the study design elements you've requested (e.g., sample size for test/training sets, expert ground truth establishment, MRMC studies, standalone performance) are typically associated with performance studies for novel devices or significant algorithmic changes in AI/ML products. This submission is for a feature addition to existing software that, according to the manufacturer, uses "already implemented services" and does not change the "basic operating principle of the TSG module" or raise "new or different questions of safety or effectiveness."

Instead of a clinical performance study with acceptance criteria around diagnostic accuracy or efficacy, the document describes verification and validation activities focused on the software and system functionality related to the new remote fitting feature.

Here's a breakdown of what is reported, in the context of your questions, and what is not:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: The document states: "The acceptance criteria were not altered, and no additional types of evaluation was needed." This implies that the original acceptance criteria for the TSG Module itself still apply, but these are not detailed in the document. For the new remote fitting feature, the acceptance criteria appear to be an implicit set of functional and usability requirements focused on the safe and effective operation of the remote fitting process.
Reported Device Performance:
- "The result of the system verification show that tests has passed with no defects critical for function, form, intended use, or pose any user risks." (Page 7)
- "The successful validation activities related to the Support for Remote Fitting feature were conducted to show that human factors and usability are safe and effective as the predicate device." (Page 7)

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

Test Set Sample Size: Does not apply in the context of a typical clinical performance study for an AI/ML diagnostic. The "testing" described is system verification and validation. There's no mention of a "test set" of patient data in the sense of clinical images or physiological signals.
Data Provenance: Not applicable. The "software design model" and "verification and validation method" used are "well-established" and the "same as used in the previously cleared 510(k)." (Page 6)

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

Not applicable. There is no "ground truth" establishment described in the sense of expert annotation of patient data, as this is a software update for a sound generator, not a diagnostic AI.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No expert adjudication process is described.

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

No. An MRMC study was not done. The device is a "Tinnitus Sound Generator Module" creating sounds for temporary relief, not a diagnostic aid that would assist human readers in interpreting medical images or data. The human interaction described is with healthcare professionals for fitting adjustments, not "readers" of medical cases.

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

No. This is software within a hearing aid system, designed to be used by healthcare professionals and patients. Standalone performance as an algorithm without human interaction or device integration is not relevant for this type of device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The ground truth for a Tinnitus Sound Generator is its ability to generate specific sounds and for the new feature, to allow remote fitting of those sounds safely and effectively. This is assessed through system functional tests, rather than clinical ground truth from patient data.

8. The sample size for the training set

Not applicable. This is not a machine learning device that requires a "training set" of data in the typical sense. It is software that generates sounds and facilitates remote adjustments.

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

Not applicable.

Summary of Device Performance and Evidence Provided:

The evidence provided for this 510(k) consists primarily of engineering verification and validation efforts designed to demonstrate that the new remote fitting feature works as intended and does not negatively impact the safety and effectiveness of the existing Tinnitus Sound Generator Module.

Risk Analysis: Performed to demonstrate that all risks are mitigated to an acceptable level.
Verification & Validation: "Necessary verification and validation activities" performed to show that "design outputs... meet the design input requirements" for the remote fitting feature.
System Verification: Included "end-to-end testing and interoperability performance testing" of the integrated system (Hearing Instrument hardware, TSG Module, App, Fitting Software).
Validation for Remote Fitting: Focused on "human factors and usability" to show they are "safe and effective as the predicate device."

In essence, for this specific 510(k) submission, the "study" proving the device met "acceptance criteria" was a comprehensive software and system verification and validation process demonstrating that the updated software behaves functionally as expected and does not introduce new safety concerns for the remote fitting functionality, relying on the already cleared predicate for the core TSG module's performance.

Summary

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February 20, 2020

GN Hearing A/S Lars Hagander Vice President Corporate Quality Lautrupbjerg 7 DK 2750 Ballerup Denmark

Re: K193303

Trade/Device Name: Tinnitus Sound Generator Module Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus masker Regulatory Class: Class II Product Code: KLW Dated: January 17, 2020 Received: January 21, 2020

Dear Lars Hagander:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for Michael Ryan Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193303

Device Name Tinnitus Sound Generator Module

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

I) SUBMITTER

Submission Type:	Special 510(k)
Submitter:	GN Hearing A/SLautrupbjerg 7DK-2750 Ballerup DenmarkPhone: +45 45 75 11 11

Contact Person:	Lars Hagander
Date Prepared:	February 13, 2020

II) DEVICE

Trade or Proprietary Name: Tinnitus Sound Generator Module

Common or Usual Name:	Tinnitus Masker
Classification Name:	21 CFR 874.3400 Tinnitus masker
Regulatory Class:	Class II
Classification Panel:	Ear, Nose, and Throat
Product Code:	KLW

III)PREDICATE DEVICE

Predicate Device: K180495

IV)DEVICE DESCRIPTION

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Health Care Professional (HCP) to remotely adjust the TSG settings using a Remote Fine Tuning Feature (RFT). The Support for the RFT feature for the TSG Module can be enabled by the doctor, audiologist or other hearing healthcare professional, at the time of first fitting. Afterwards, the doctor, audiologist or other hearing healthcare professional is able to remotely make adjustments to TSG Module settings. RFT is only enabled when the doctor, audiologist or other hearing healthcare professional finds it feasible, based on an initial in-office assessment of the user and communication with the user, and the parent or legal guardian in cases where the user is a minor. Subsequent to the in-office assessment, the user, or the parent or legal guardian in cases where the user is a minor, is required to accept to receive the adjustments via the TSG portion of the Smart3D app, called the Tinnitus Manager.

V) INDICATIONS FOR USE / INTENDED USE

The Tinnitus Sound Generator Module is a tool to generate sounds to be used in a Tinnitus Management Program to temporarily relieve patients suffering from Timitus. 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 healthcare professionals, which are treating patients suffering from Tinnitus, as well as conventional hearing disorders. The initial fitting of the Tinnitus Sound Generator module must be done during an inoffice visit by a hearing professional participating in a Tinnitus Management Program. If deemed feasible by the hearing professional, subsequent fittings of the Timitus Sound Generator Module may be performed remotely and in real time while having live communication via live audio, video and chat on the user's dedicated app.

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The Indications for Use are not identical to those of the predicate device. However, the differences do not alter the intended therapeutic use of the device, nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices have the same intended use, i.e., to generate sounds to be used in a Tinnitus Management Program to temporarily relieve patients suffering from Timitus.

VI) COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

All of the new device's technological characteristics are identical to those of the predicate device except for one modification: the addition of Support for Remote Fitting, which is technically supported by the TSG software in the predicate device. This means that the TSG software is unchanged, but now claims support for the added Remote Fitting feature. The Remote Fitting feature is implemented in the Fitting Software used by the HCP, at the HCP office, and the App used by the EU. The unchanged TSG software supports the Remote Fitting using already implemented services.

The Remote Fitting is only available and technically working for follow-up adjustment sessions, and not available for the initial first-time fitting of the Hearing Aids, that still has to take place at the HCP office. The Remote Fitting is only used when found feasible by the HCP, based on a clinical judgement. The EU, or the parent or legal guardian in cases where the user is a minor, is required to accept the changes.

This modification to the technological characteristics of the subject device, has minimal risk to the patient and based on the risk analysis, all risks are mitigated to an acceptable level. The minor modification in relation to the predicate device does not change the basic operating principle of the TSG module.

VII) PERFORMANCE DATA

GN Hearing has conducted a risk analysis and has performed the necessary verification and validation activities to demonstrate that the design outputs of the modified device meet the design input requirements in relation to supporting the Remote Fitting feature. Changes are verified and validated using the same well-established software design model, with same verification and validation method as used in the previously cleared 510(k). The acceptance criteria were not altered, and no additional types of evaluation was needed.

The TSG Module is verified in an integrated system verification test. The integrated system consists of:

Different Hearing Instrument hardware with embedded software, including the ● TSG Module.
App (iOS & Android)
Fitting Software (FSW) ●

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The system verification includes system end-to-end testing and interoperability performance testing. The result of the system verification show that tests has passed with no defects critical for function, form, intended use, or pose any user risks.

The successful validation activities conducted for the subject device are based on experience with similar validation method and activities for the predicate device. The successful validation activities related to the Support for Remote Fitting feature were conducted to show that human factors and usability are safe and effective as the predicate device.

VIII) CONCLUSIONS

The modification to the technological characteristics of the new device, i.e., support for the added Remote Fitting feature, does not raise new or different questions of safety or effectiveness as compared to the predicate device. The results of risk analysis and design verification and validation activities provide evidence that the new device is as safe and effective as its predicate and therefore, demonstrate that the TSG Module is substantially equivalent to 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.