The device, Sound Options Timitus Treatment, version SO 2.0, is for the temporary relief of tinnitus symptoms. The device is a software application that embeds sounds and spectral content into music to relieve patients suffering from timitus and can be used as part of a timitus management program for adults 18 years and older. The device is for prescription use by a physician, audiologist or other healthcare professional.

Device Description

The device is a software application that embeds sounds and spectral content into music to relieve patients suffering from tinnitus and can be used as part of a tinnitus management program.

The Sound Options device software version is 2.0. The device comprises of tinnitus pitch match and audiogram submission software for health care professionals (Web Software) and Sound Options software application for sound therapy generation (manufacturer use only)

AI/ML Overview

Acceptance Criteria and Study for Sound Options Tinnitus Treatment

This document describes the acceptance criteria and the study performed for the Sound Options Tinnitus Treatment device, version SO 2.0.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria in a table format. However, the study aims to demonstrate clinical effectiveness, which implies that the acceptance criteria are met if the device shows a statistically significant and clinically meaningful improvement in tinnitus symptoms compared to a placebo.

Based on the study results, the reported device performance can be summarized as:

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
THI Total Score	Statistically significant and clinically meaningful reduction from baseline	Significantly lower at 3, 6, and 12-month follow-ups compared to baseline in the treatment group.
TFI Total Score	Statistically significant and clinically meaningful reduction from baseline	Significantly lower at 3, 6, and 12-month follow-ups compared to baseline in the treatment group.
Anxiety Symptoms (HADS)	Reduction from baseline	Reduced from baseline to follow-ups, with a significant change occurring at 6 months.
Depression Symptoms (HADS)	Reduction from baseline	No significant change.
Adverse Effects	No serious adverse effects	No adverse effects reported.

Implicit Acceptance Criteria: The device's performance must demonstrate a positive and statistically significant impact on tinnitus symptoms, as measured by validated questionnaires (THI, TFI), and be safe for use without adverse effects. The significant reduction in THI and TFI scores in the treatment group, compared to no significant changes in the placebo group, indicates that these implied criteria were met.

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

Test Set Sample Size:
- Baseline: 45 eligible participants were randomized (22 to treatment, 23 to placebo).
- Follow-up (3, 6, 12 months): 15 participants in the treatment group and 19 participants in the placebo group were assessed.
Data Provenance: Canada (indicated as "Location of Study"). The study was conducted as a prospective, randomized, multi-arm, "blinded" study with concurrent sham (placebo) control.

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

The document does not specify the number of experts or their qualifications used to establish the ground truth for the test set. The primary effectiveness endpoints (THI, TFI, HADS) are self-reported measures filled out by the study participants themselves, rather than evaluations by experts to establish ground truth for each case. The reliability and validity of these measures are cited from scientific literature.

4. Adjudication Method for the Test Set

No adjudication method is described for the test set. Given that the endpoints are self-reported questionnaires, an adjudication process by experts would not typically be applicable in the same way it would be for image interpretation or diagnosis.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The study compares the device's effectiveness against a placebo, focusing on patient-reported outcomes rather than human reader performance with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone study of the algorithm's effect was performed. The clinical study evaluated the direct impact of the "Sound Options customized music" (the device's output) on tinnitus symptoms in a controlled setting, effectively studying the algorithm's output without human intervention in the application of the therapy once customized music files are generated. Once the music is generated, patients listen to it on their personal music-playing devices.

7. Type of Ground Truth Used

The ground truth used for evaluating the device's effectiveness was based on patient-reported outcomes data derived from validated clinical questionnaires:

Tinnitus Handicap Inventory (THI): A 25-item self-report measure for overall tinnitus distress.
Tinnitus Functional Index (TFI): A 25-item self-reported clinical measure for chronic tinnitus, measuring overall severity and negative impact across eight domains.
Hospital Anxiety and Depression Scale (HADS): A 14-item self-report measure to assess anxiety and depression levels.

8. Sample Size for the Training Set

The document does not provide information about a "training set" in the context of an AI/machine learning model. The device description states that the software "modifies frequency-specific amplitudes within music tracks to a customized music based sound therapy for tinnitus patients" based on patient audiogram and tinnitus frequency/pitch match provided by healthcare professionals. This suggests a rule-based or algorithmic approach for customization rather than a machine learning model that would require a separate training set.

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

As there is no mention of a traditional machine learning "training set" or AI model that learns from data, the concept of establishing ground truth for a training set is not applicable here. The device's operation is based on established audiological principles and patient-specific data (audiogram, tinnitus type, pitch match) to generate customized sound therapy.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, stacked on top of each other.

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

September 28, 2016

Sound Options Tinnitus Treatments, Inc. Ms. Navneet Sekhon President AxSource Consulting, Inc. 336 Bronte Street South, Suite 224-225 Milton, Ontario L9T 7W6 CA

Re: K161562

Trade/Device Name: Sound Options Tinnitus Treatment Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: August 24, 2016 Received: August 25, 2016

Dear Ms. Sekhon:

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 and Part 809); medical device 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 and Part 809), please contact the Division of Industry and Consumer Education 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 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,

Eric A. Mann -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

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Indications for Use

510(k) Number (if known) K161562

Device Name

Sound Options Tinnitus Treatment

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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Image /page/3/Picture/0 description: The image is a logo for "Sound Options Tinnitus Treatments". The word "SOUND" is written vertically in blue letters, with a lightbulb replacing the "O". The word "OPTIONS" is written horizontally in blue letters, with the "O" in "OPTIONS" overlapping with the lightbulb. Above the word "OPTIONS" is the phrase "Tinnitus Treatments" in smaller letters.

SOUND OPTIONS 510(k) Number :K161562

7. 510(k) Summary - Submission No K161562

7.1 Owner Information

Name: Sound Options Tinnitus Treatments Inc. Device Trade name: Sound Options Tinnitus Treatment Device common name: Tinnitus Masker Address: 3841 Ridgepoint Way, Mississauga ON, L5N 7T7 Phone: 416-801-5356 Fax: N/A Contact: Michael Chrostowski President Title: michael@soundoptions.ca Email: Date of Preparation: 22 August 2016 510(k) Summary No: K161562

7.2 Regulatory Correspondent Information

Name:	AxSource Consulting Inc.
Address:	336 Bronte Street South, Suite 224-225 Milton, Ontario, L9T 7W6
Office Phone:	905-854-6059
Cell:	416-452-0100
Contact Person:	Ms. Navneet Sekhon, President
Contact Person:	Rama Joshi, Regulatory Affairs Consultant
Email:	nav.sekhon@axsource.ca
Email:	rama@axsource.ca

7.3 Device Information

Trade Name	Sound Options Tinnitus Treatment
Common Name	Tinnitus masker
Classification name	Tinnitus Masker
Model Number	SO 2.0
510(k) Submitter /Holder - K161562	Sound Options Tinnitus Treatments Inc.
Device Panel	Ear, Nose & Throat
Product Code	KLW
ClassificationRegulation	874.3400

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Image /page/4/Picture/0 description: The image is a logo for "Sound Options Tinnitus Treatments". The word "Sound" is written vertically on the left side of the image. The word "Options" is written horizontally on the right side of the image. There is a lightbulb in place of the "O" in "Sound".

7.4 Indications for Use

The device, Sound Options Tinnitus Treatment, version SO 2.0, is for the temporary relief of tinnitus symptoms. The device is a software application that embeds sounds and spectral content into music to relieve patients suffering from tinnitus and can be used as part of a tinnitus management program for adults 18 years and older. The device is for prescription use by a physician, audiologist or other healthcare professional.

7.5 Predicate(s) / Substantially Equivalent Device(s)

Generalinformation	510(k)	Predicate Device(s)[510(k) summaries attached]
Trade Name	SoundCure™Serenade™ TinnitusTreatment System	SoundCure Serenade TinnitusTreatment System
Model Number	unknown	unknown
510(k) Submitter /Holder	SoundCure Inc.	SoundCure Inc.
510(k) Number	K111293	K150065
Device Panel	Ear, Nose & Throat	Ear, Nose & Throat
Product Code	KLW	KLW

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Image /page/5/Picture/0 description: The image is a logo for "Sound Options Tinnitus Treatments". The word "SOUND" is written vertically in blue letters, with a lightbulb replacing the "O". The word "OPTIONS" is written horizontally in blue letters, with the lightbulb connecting the two words. Above the word "OPTIONS" are the words "Tinnitus Treatments" in a smaller font.

7.6 Device Description

The device is a software application that embeds sounds and spectral content into music to relieve patients suffering from tinnitus and can be used as part of a tinnitus management program.

Environment of Use

Patient assessment is done at the clinic by a qualified health care professional. Software programming is done at the manufacturer's office. Sound therapy music files produced may be listened to / used by patients at home or anywhere.

Principle of Operation

Patient hearing thresholds (from a standard audiometric assessment), tinnitus type (tonal, ringing or hissing) and pitch match are supplied by qualified health care professionals to Sound Options. Traceability is achieved via unique clinic and order identifiers. Using patient audiogram and tinnitus frequency / pitch match provided by health care professionals, the Sound Options software only device, SO 2.0, modifies frequency-specific amplitudes within music tracks to a customized music based sound therapy for tinnitus patients. OTS software is used to equalize the average volume of a collection of tracks (i.e. to make the average volume similar) prior to patient delivery. Customized music tracks are available to patients by download or on CD. Patients are to listen to the sound therapy at a comfortable volume level by adjusting the volume control on their personal music-playing device.

The Patient and Clinician User Manuals contain information on compatible MP3 players and headphones/earphones for use of the Sound Options sound therapy as well as how to set the volume to safe levels.

Safe levels were determined through bench testing for each of the recommended commercial device options described in the user manuals. Bench testing was conducted to ensure volume settings would not exceed 85 dBA.

7.7 Comparison of Technological Characteristics with Predicate Device(s)

Principles of operation and fundamental design and technology considerations are shared by Sound Options and its predicates.

Specifically, Sound Options and its predicate(s)

1. Are non-invasive devices and so do not deliver energy to patients
1. Do not pose any issues in terms of electrical, chemical, thermal or radiation safety

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Image /page/6/Picture/0 description: The image shows a logo for "Sound Options Tinnitus Treatments". The word "Sound" is written vertically on the left side of the image. There is a lightbulb in the middle of the word "Sound". The word "Options" is written horizontally on the right side of the image.

1. Are non-sterile devices
1. Stimuli can be amplitude modulated, placed in the background and ignored. Use broadband noise. Allow user volume control. (Principle of Operation)
1. Broadband frequency sound is prescribed by qualified HCP and is custom to patient (Design)
1. Include web software (Materials)

Sound Options is validated for system compatibility and performance.

The following technological differences exist between Sound Options and its predicates. However, the difference(s) raise no safety or effectiveness concerns for the Sound Options device in comparison to its predicates. Where possible, adequate control measures have been applied.

1. Sound Options device, SO 2.0, differs from its predicates by utilizing the patient's personal music playing device while the predicate devices include a handheld device component with earphones. An OTS software used with SO 2.0 to equalize average sound volume has been validated in a clinical study as safe for sound volume management. Device labeling additionally instructs patients to adjust to a suitable sound volume using their personal music playing device.
1. Sound Options device, SO 2.0, is a software only medical device while the predicates include hardware.
1. Sound Options device, SO 2.0, is a software only medical device and involves no patient contacting material(s) while the predicates include patient contacting silicone earphones.

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Image /page/7/Picture/0 description: The image is a logo for "Sound Options Tinnitus Treatments". The word "Sound" is written vertically on the left side of the image, with a lightbulb replacing the "O" in "Sound". The word "Options" is written horizontally on the right side of the image. The words "Tinnitus Treatments" are written in smaller font above the word "Options".

SOUND OPTIONS 510(k) Number :K161562

7.8 Performance Data

7.8.1 Performance Testing

SoundCureTM	SoundCureTM	Sound Options	Comparison to
SerenadeTM TinnitusTreatment SystemK111293	SerenadeTM TinnitusTreatment SystemK150065	Software device,SO 2.0K161562	Predicates
System OutputPerformanceTesting, HardwareVerification,SoftwareVerification &Validation, BatteryUseful Life In VitroBench Testing. MaxOutput fixed at92dB SPL, OutputFrequencyResponse: 1-14kHz	System OutputPerformanceTesting, SoftwareVerification &Validation, MaxOutput fixed at 92dBSPL, OutputFrequencyResponse: 1 - 14kHz	Sound Options hasa software onlydevice that hasbeen subjected toSoftwareVerification andValidation.Output Frequency:dependent onpatient headphones(commercial)	Sound Options has asoftware only devicethat utilizes the patient'spersonal music playingdevice while thepredicate devicesinclude a handhelddevice component withearphones. Devicelabeling instructspatients to adjust to asuitable sound volumeusing their personalmusic playing device.This difference raisesno safety oreffectiveness concernsfor the Sound Optionsdevice in comparison toits predicates.

7.8.2 Standards Conformance

The Sound Options device, SO 2.0, is a software only device of minor level of concern. In accordance with IEC 62304:2006 below, the device is deemed Class A: No injury or damage to health is possible. Sound Options has justified the minor level of concern for the software device.

In addition to the software device being of minor level of concern, partial device conformance to applicable sections of various FDA recognized standards and guidance documents have been used to support device safety and performance.

Sound Options software device, SO 2.0, complies with relevant sections of the following standards and FDA guidance documents through adequate risk management and maintenance processes, software verification and validation testing to user and functional requirement specifications and adequate labeling.

. IEC 60601-1
IEC 60601-1-11 Edition 2.0 2015-01 .
IEC 62304:2006
Guidance for the Content of Premarket Submissions for Software Contained in Medical ● Devices - Guidance for Industry and FDA Staff, May 2005

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Image /page/8/Picture/0 description: The image is a logo for "Sound Options Tinnitus Treatments". The logo is in blue and white. The word "Sound" is written vertically on the left side of the logo. There is a lightbulb in the middle of the word "Sound". The words "Tinnitus Treatments" are written in smaller font above the word "Options".

General Principles of Software Validation; Final Guidance for Industry and FDA Staff, ● January 2002
. Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices, September 9, 1999

The Sound Options software device and both predicate devices partially conform to the same standard IEC 60601-1.

7.8.3 Clinical Study

Objective

To determine how effective Sound Options customized music is at reducing or eliminating tinnitus symptoms over the span of several months to a year.

Location of Study

Canada

Level of Evidence

Randomized, multi-arm, "blinded" study with concurrent sham (placebo) control

Description of Subjects

Inclusion Criteria	Exclusion Criteria
Presence of mono- or bilateral tinnitus ≥12months	History of neurological/psychiatric disorders
Agree to ≥2 hrs of daily music listening over12 months	Medical illness that affects tinnitus therapy,severe hyperacusis, conductive orretrocochlear hearing loss, or Meniere'sDisease
≥18 years old	Taking ototoxic medication during the study
English language abilities to answerquestionnaires	Constant exposure to loud noise
Tinnitus Handicap Inventory (THI) score(calculated after phone interview) > 26	THI score <26
	Absolute hearing thresholds >70dB HL forfrequencies <8kHz

Primary Effectiveness Endpoint(s)

According to scientific literature cited in the clinical performance section of this 510(k), the following endpoints have high reliability and validity.

Tinnitus Handicap Inventory (THI) is a well-accepted measure of subjective tinnitus in tinnitus treatment studies. This 25-item self-report measure produces a global tinnitus distress score ranging from 0 to 100 points.

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Image /page/9/Picture/0 description: The image contains the words "SOUND OPTIONS" in a stylized format. The word "SOUND" is written vertically, and the "O" in "SOUND" is replaced with a lightbulb graphic. The word "OPTIONS" is written horizontally, and above it are the words "TINNITUS TREATMENTS" in a smaller font. The text is in a teal color.

Tinnitus Functional Index [TFI] is a 25-item, self-reported clinical measure for chronic tinnitus. The total TFI score is suggested to be a good measure of the overity of tinnitus. In addition to overall severity, TFI also measures the negative impact of tinnitus in eight important domains: intrusiveness, reduced sense of control, cognitive interference, sleep disturbance, auditory difficulties, relaxation issues, quality of life, and emotional distress.

The Hospital Anxiety and Depression Scale [HADS] was used to assess anxiety and depression levels in participants. This 14-item self-report measure has two subscales, including depression and anxiety, and is commonly used for assessing such symptoms among somatic patients.

Study Design Overview & Subject Accountability

To examine the change in the endpoint / outcome measures from baseline to follow-ups among the treatment and placebo groups, multilevel random-intercepts linear regressions were performed for the two groups separately. Three wave variables were included as independent variables, each being an indicator of a follow-up wave. Treatment adherence was included as a control variable.

Randomized, blinded, parallel-arm, placebo-controlled trial

Image /page/9/Figure/7 description: This image shows a flow diagram of a clinical trial. The trial starts with 50 eligible participants. 5 participants dropped out prior to the start of the trial, 22 participants were randomized to the treatment group, and 23 participants were randomized to the placebo group. At 3, 6, and 12 months, 15 participants in the treatment group were assessed, and 19 participants in the placebo group were assessed.

Study Results and Conclusions

In the placebo group, there were no significant changes in the endpoint / outcome measures from baseline to any of the follow-up sessions. In contrast, the treatment group reported THI and TFI total scores significantly lower at all 3 follow-up waves than at baseline. Anxiety symptoms also reduced from baseline to follow-ups, but such change was only significant at 6 months. There were no significant change in depression symptoms.

Treatment adherence level dropped significantly after 6 months of treatment. At this time point, subjects reported boredom with the music selection and repeated for new music. New music was not administered due to resource and budgetary constraints, which may have led to the participants choosing to stop listening to the music.

The results corroborate previous findings in suggesting that auditory stimuli have the potential to gradually reduce tinnitus with continued listening [Davis et al., 2008; Pantev et al., 2012, Tyler et al., 2014]. Specifically, the results indicated that significant benefits can be achieved by tailoring the auditory stimuli to the individual's hearing threshold and the tinnitus type and pitch. This is in agreement with findings reported for sound therapies using pitch match to treat tonal tinnitus [Pantev et al., 2012], as well as the observation that whether tinnitus sufferers experience an

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Image /page/10/Picture/0 description: The image is a logo for "Sound Options Tinnitus Treatments". The word "Sound" is written vertically on the left side of the image, with a lightbulb in place of the letter "O". The word "Options" is written horizontally on the right side of the image. The words "Tinnitus Treatments" are written in smaller font above the word "Options".

SOUND OPTIONS 510(k) Number :K161562

improvement in tinnitus using hearing aids is associated with the relationship between frequency of the tinnitus sound and the output frequency range of the hearing aid [Schaette et al., 2010]. The results demonstrated a statistically significant and clinically meaningful overall effect of the personalized music therapy.

Adverse Effects

No adverse effects were reported as expected by study subjects.

Literature References

Davis PB, Wilde RA, Steed LG, Hanley PJ: Treatment of tinnitus with a customized acoustic neural stimulus: a controlled clinical study. Ear Nose Throat J 2008;87:330-339.

Pantev C, Okamoto H, Teismann H: Tinnitus: The dark side of the auditory cortex plasticity, Ann N Y Acad Sci 2012;1252:253-258.

Schaette R., König O., Hornig D., Gross M., Kempter R. (2010). Acoustic stimulation treatments against tinnitus could be most effective when tinnitus pitch is within the stimulated frequency range. Hear. Res. 269, 95-101.

Tyler R. Stocking C. Secor C. Slattery III WH: Amplitude modulated S-tones can be superior to noise for tinnitus reduction. Am J Audiol. 2014;23:303-308.

7.9 Other Information

7.9.1 Compliance to FDA Quality System Requlation (QSR) 21 CFR 820

Sound Options has been implemented with appropriate change management controls per Sound Options quality system which is compliant with FDA's Quality System Requlation 21 CFR 820. Standard Operating Procedures relevant to this 510(k) have been referenced herein.

7.9.2 Labeling Controls

Sound Options is a prescription use device and various labeling precaution statements further serve as potential device hazard mitigation controls.

7.10 Substantial Equivalence Rationale

The Sound Options software only device, SO 2.0, shares the same intended use and fundamental principles of operation, design and technology considerations with both predicate devices. The technological differences that exist do not raise any safety or effectiveness concerns for the Sound Options device in comparison to its predicates.

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.