Predicate Devices

Reference Devices

No reference devices were used in this submission.

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on customized sound generation based on patient evaluation and does not mention AI/ML algorithms for this customization or any other function.

Therapeutic

Yes
The device is indicated for use in the "temporary relief of tinnitus symptoms" and is described as a "personalized sound therapy system designed specifically to evaluate a patient's tinnitus, to create customized audio stimulus, and to deliver and monitor/data log the audio stimulus." The goal is "to provide relief from the debilitating effects of tinnitus." This directly aligns with the definition of a therapeutic device, which aims to treat or provide relief from a medical condition.

Diagnostic

No

The device is described as a "Tinnitus Treatment System" that generates customized sounds for relief. While it's designed to "evaluate a patient's tinnitus" to create the customized audio stimulus, its primary stated purpose is treatment ("temporary relief of tinnitus symptoms") by delivering sound therapy/masking, rather than providing a diagnosis of tinnitus itself.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components such as the "Serenade Patient Device," "Earphones," "power supply," "power cord," and "USB cable," in addition to the software.

IVD (In Vitro Diagnostic)

Based on the provided information, the SoundCure® Serenade® Tinnitus Treatment System is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is for the "temporary relief of tinnitus symptoms" by generating customized sounds. This is a therapeutic or management function, not a diagnostic function performed on samples taken from the human body.
Device Description: The device is described as a "personalized sound therapy system" that generates and delivers audio stimulus. It does not involve analyzing biological samples (blood, urine, tissue, etc.) to diagnose a condition.
Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVD devices, such as reagents, assays, or analysis of biological specimens.

In summary, the SoundCure® Serenade® Tinnitus Treatment System is a medical device used for the management and relief of tinnitus symptoms through sound therapy, not for diagnosing a condition using in vitro methods.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The SoundCure® Serenade® Tinnitus Treatment System is indicated for use in the temporary relief of tinnitus symptoms. The device is a tool to generate customized sounds to relieve patients suffering from tinnitus and can be used in a tinnitus management program. The target population is adults (18 years or older).

This is a medical device and should only be used with the advice of a physician, audiologist or other hearing healthcare professional.

Product codes

KLW

Device Description

The SoundCure® Serenade® Tinnitus Treatment System (Serenade System) is a personalized sound therapy system designed specifically to evaluate a patient's tinnitus, to create customized audio stimulus, and to deliver and monitor/data log the audio stimulus. The Serenade System is intended to provide relief from the debilitating effects of tinnitus through the use of a hand-held customized digital audio device (Serenade Patient Device) that generates sound therapy/masking. The Serenade System uses modulated tinnitus pitch matched tones (S-Tones) and narrow-band noise centered at the tinnitus frequency and provides broad-band noise. The Serenade System consists of the following components: Serenade Treatment Software, Earphones, Serenade Patient Device as well as the following Accessories: power supply, power cord and USB cable.

The Serenade System with Remote Programming modification is limited to changes to components of the Serenade Treatment Software (Web, PC & addition of Communications Software Component on patient's home computer), modifications to user interface and updates to labeling (Professional, Patient and Patient Remote Connection Quick Start Guide). The Serenade Patient Device and accessories are unchanged.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Ear

Indicated Patient Age Range

Adults (18 years or older)

Intended User / Care Setting

This is a medical device and should only be used with the advice of a physician, audiologist or other hearing healthcare professional.
Programming Location: In office or Remotely
Use Location: May be used anywhere

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance Testing was performed in accordance to Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Tinnitus Masker Devices dated November 8, 2005. The following performance testing was conducted on the Serenade System to support a determination of substantial equivalence to the predicate device.

System Output Performance Testing
Electrical Safety & Electromagnetic Compatibility Testing
Packaging Validation Testing
Software Verification and Validation

Results of the non-clinical testing demonstrate that the materials chosen, the manufacturing process, and design of the Serenade System meet the established specifications necessary for consistent performance during its intended use. In addition, the testing demonstrates the Serenade System is substantially equivalent to the named predicate.

Clinical Performance Testing
A clinical study was conducted to demonstrate that the SoundCure Serenade Tinnitus Treatment System using the remote programming model is substantially equivalent to the Serenade Device using the current programming model (in-office). The study was a non-significant risk, prospective site study involving patients with confirmed tinnitus who did not have any previous experience with the Serenade System. Each patient underwent in-office and remote device programming. The purpose of the study was to determine if the patient labeling and remote HHP instructions and process using the patient's PC as an access port for HHP performed matching and device programming, resulted in a successfully programmed device. Differences between parameters obtained from in-person (local) evaluation or remote evaluation should not differ from the known test-retest variability with in-person (local) testing. The results from this study demonstrated that the SoundCure Serenade Tinnitus Treatment System can be successfully programmed remotely without introducing new safety concerns.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K111293

Reference Device(s)

No reference devices were used in this submission.

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

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

April 13. 2015

Ms. Diana DeGregorio Regulatory Affairs Consultant SoundCure, Inc. 560 S. Winchester Blvd, Suite 500 San Jose, CA 95128

Re: K150065

Trade/Device Name: SoundCure Serenade Tinnitus Treatment System Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: January 12, 2015 Received: January 13, 2015

Dear Ms. DeGregorio:

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. You must comply

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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); 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 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,

Kesia Y. Alexander -A

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 Statement

150065 510(k) Number (if known): K_

Device Name: SoundCure® Serenade®Tinnitus Treatment System

Indications for Use:

The SoundCure® Serenade® Tinnitus Treatment System is indicated for use in the temporary relief of tinnitus symptoms. The device is a tool to generate customized sounds to relieve patients suffering from tinnitus and can be used in a tinnitus management program. The target population is adults (18 years or older).

This is a medical device and should only be used with the advice of a physician, audiologist or other hearing healthcare professional.

Prescription Use	X
Or	Over-The-Counter Use

(per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

l. SUBMITTER

SoundCure, Inc. 560 S. Winchester Blvd Suite 500 San Jose, CA 95128 Phone: (408) 938-5745 Fax: (408) 938-5746

Contact Person: Diana DeGregorio Lincé Consulting Regulatory Affairs Consultant (925) 980-8047 ddegregorio@linceconsulting.com

Alternate Contact: Nancy Lincé, RAC Lincé Consulting Clinical and Regulatory Affairs Consultant (650) 759-6186 nlince@linceconsulting.com

Date Prepared January 9, 2015

II. DEVICE

Trade Name: Common Name: Classification Name: Classification: Product Code: Device Class:

SoundCure® Serenade® Tinnitus Treatment System Tinnitus Masker Tinnitus Masker 21 CFR §874.3400 KLW Class II

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lll. PREDICATE

SoundCure, Inc. SoundCure® Serenade® Tinnitus Treatment System (K111293) This predicate has not been subject to a design-related recall. No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

The SoundCure® Serenade® Tinnitus Treatment System (Serenade System) is a personalized sound therapy system designed specifically to evaluate a patient's tinnitus, to create customized audio stimulus, and to deliver and monitor/data log the audio stimulus. The Serenade System is intended to provide relief from the debilitating effects of tinnitus through the use of a hand-held customized digital audio device (Serenade Patient Device) that generates sound therapy/masking. The Serenade System uses modulated tinnitus pitch matched tones (S-Tones) and narrow-band noise centered at the tinnitus frequency and provides broad-band noise. The Serenade System consists of the following components: Serenade Treatment Software, Earphones, Serenade Patient Device as well as the following Accessories: power supply, power cord and USB cable.

The Serenade System with Remote Programming modification is limited to changes to components of the Serenade Treatment Software (Web, PC & addition of Communications Software Component on patient's home computer), modifications to user interface and updates to labeling (Professional, Patient and Patient Remote Connection Quick Start Guide). The Serenade Patient Device and accessories are unchanged.

V. INDICATIONS FOR USE

The Serenade System is indicated for use in the temporary relief of tinnitus symptoms. The device is a tool to generate customized sounds to relieve patients suffering from tinnitus and can be used in a tinnitus management program. The target population is adults (18 years or older).

This is a medical device and should only be used with the advice of a physician, audiologist or other hearing healthcare professional.

OF TECHNOLOGICAL CHARACTERISTICS VI. COMPARISON WITH THE PREDICATE DEVICE

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The Serenade System has similar features as compared to the predicate devices in the table below.

| Manufacturer
Device Name | SoundCure, Inc.
SoundCure® Serenade® Tinnitus
Treatment System | SoundCure, Inc.
SoundCure® Serenade® Tinnitus
Treatment System |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K111293 | Remote Programming Modification |
| Indications for Use | The SoundCure™ Serenade™
Tinnitus Treatment System is
indicated for use in the temporary
relief of tinnitus symptoms. The
device is a tool to generate
customized sounds to relieve
patients suffering from tinnitus and
can be used in a tinnitus
management program. The target
population is adults (18 years or
older).

Stimulus can be amplitude
modulated

Level of sound can be adjusted by
a user volume control

Independent volume parameters
per ear

Sleep Mode Timer (60 min timer to
shut-off when button is pressed)

Amplitude modulation

Sounds customized to the patient

Handheld device with earphones

4 sound programs / tracks
(memory for up to 8)

Data logging of patient use

Individual volume control per ear | Same |
| Software Architectural
Design | Serenade Patient Device
(Embedded Software), hearing
healthcare professional's computer
(PC Software), and SoundCure
Server (Web Software) | Serenade Patient Device (Embedded
Software), hearing healthcare
professional's computer (PC Software),
patient's home computer
(Communications Software),
SoundCure Server (Web Software) |
| Patient Contact
Materials | Silicone earphones | Same |
| Biocompatible for
Intended Use | Yes | Same |
| Training Course | Specific Training course for hearing
healthcare professionals

In office support | Specific Training course for hearing
healthcare professionals

Supplemental Training course (hearing
healthcare professionals) for remote
programming.

In office support |
| Power | Rechargeable Lithium-Ion (Li-Ion)
Battery

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The technological characteristics and principals of operation of the Serenade System are substantially equivalent to the named predicate device.

VII. PERFORMANCE DATA

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Performance Testing was performed in accordance to Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Tinnitus Masker Devices dated November 8, 2005. The following performance testing was conducted on the Serenade System to support a determination of substantial equivalence to the predicate device.

· System Output Performance Testing • Electrical Safety & Electromagnetic
Compatibility Testing • Packaging Validation Testing
- Software Verification and Validation

Results of the non-clinical testing demonstrate that the materials chosen, the manufacturing process, and design of the Serenade System meet the established specifications necessary for consistent performance during its intended use. In addition, the testing demonstrates the Serenade System is substantially equivalent to the named predicate.

Clinical Performance Testing

A clinical study was conducted to demonstrate that the SoundCure Serenade Tinnitus Treatment System using the remote programming model is substantially equivalent to the Serenade Device using the current programming model (in-office). The study was a non-significant risk, prospective site study involving patients with confirmed tinnitus who did not have any previous experience with the Serenade System. Each patient underwent in-office and remote device programming. The purpose of the study was to determine if the patient labeling and remote HHP instructions and process using the patient's PC as an access port for HHP performed matching and device programming, resulted in a successfully programmed device. Differences between parameters obtained from in-person (local) evaluation or remote evaluation should not differ from the known test-retest variability with inperson (local) testing. The results from this study demonstrated that the SoundCure Serenade Tinnitus Treatment System can be successfully programmed remotely without introducing new safety concerns.

VIII. CONCLUSIONS

The Serenade System has been carefully compared to a legally marketed predicate device with respect to intended use/indications for use, technological characteristics, anatomical sites, performance, safety characteristics, and labeling. In addition, nonclinical and clinical testing was conducted to verify and validate the performance of the device and ensure the Serenade System performs as intended and meets the design specifications. The comparison, non-clinical and clinical performance testing

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results demonstrate that the device is substantially equivalent to the predicate device for its intended use and does not raise new issues of safety or effectiveness.