SoundCure Serenade Tinnitus Treatment System

K150065 · Soundcure, Inc. · KLW · Apr 13, 2015 · Ear, Nose, Throat

Device Facts

• Record ID: K150065
• Device Name: SoundCure Serenade Tinnitus Treatment System
• Applicant: Soundcure, Inc.
• Product Code: KLW · Ear, Nose, Throat
• Decision Date: Apr 13, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3400
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

System provides personalized sound therapy for tinnitus relief; consists of handheld digital audio device, earphones, and treatment software. Device generates customized audio stimuli, including modulated tinnitus pitch-matched tones (S-Tones), narrow-band noise, and broad-band noise. Operated by patient; programmed by hearing healthcare professional (HHP) either in-office or remotely via PC/web-based software. HHP evaluates patient tinnitus to create customized audio profiles; device delivers sound to ears via earphones. Output is designed to be background-level and ignorable. Remote programming modification allows HHP to access patient device via home computer/web interface. System includes data logging of patient usage. Benefits include symptom relief through customized sound masking/therapy.

Clinical Evidence

Prospective, non-significant risk study comparing in-office vs. remote device programming. Evaluated whether remote programming via patient PC resulted in successfully programmed devices matching in-office parameters. Results showed remote programming successfully configured devices within acceptable test-retest variability, demonstrating equivalence to in-office methods without new safety concerns.

Technological Characteristics

Handheld digital sound generator; silicone earphones. Power: Rechargeable Li-Ion battery. Output: 1 kHz to 14 kHz frequency response; max 92 dB SPL. Connectivity: USB, web-based server, PC software for programming. Software: Embedded firmware, PC software, web software. Compliance: IEC 60601-1.

Indications for Use

Indicated for temporary relief of tinnitus symptoms in adults (18+) as part of a tinnitus management program. Requires professional guidance from physician, audiologist, or hearing healthcare professional.

Regulatory Classification

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.

Special Controls

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.

Predicate Devices

• SoundCure® Serenade® Tinnitus Treatment System (K111293)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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: [phone] Fax: [phone]

Contact Person: Diana DeGregorio Lincé Consulting Regulatory Affairs Consultant [phone] [e-mail]

Alternate Contact: Nancy Lincé, RAC Lincé Consulting Clinical and Regulatory Affairs Consultant [phone] [e-mail]

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<br>Device Name | SoundCure, Inc.<br>SoundCure® Serenade® Tinnitus<br>Treatment System | SoundCure, Inc.<br>SoundCure® Serenade® Tinnitus<br>Treatment System |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K111293 | Remote Programming Modification |
| Indications for Use | The SoundCure™ Serenade™<br>Tinnitus Treatment System is<br>indicated for use in the temporary<br>relief of tinnitus symptoms. The<br>device is a tool to generate<br>customized sounds to relieve<br>patients suffering from tinnitus and<br>can be used in a tinnitus<br>management program. The target<br>population is adults (18 years or<br>older).<br><br>This is a medical device and<br>should only be used with the<br>advice of a physician, audiologist<br>or other hearing healthcare<br>professional. | Same |
| Product Code | KLW<br>Tinnitus Masker,<br>21CFR874.3400 Class II | Same |
| Common Name | Tinnitus Masker | Same |
| Dispensing<br>Professional | Hearing Healthcare Professional | Same |
| Programming Location | In office | In office or Remotely |
| Target Population | Adults with Tinnitus | Same |
| Use Location | May be used anywhere | Same |
| Physical Description | Handheld device with sounds<br>delivered through earphones | Same |
| Mechanism of Action | Uses noise that can be configured<br>from broad band to narrow band,<br>and pure tones customized to the<br>patient<br><br>Stimulus can be amplitude<br>modulated<br><br>Level of sound can be adjusted by<br>a user volume control<br><br>Independent volume parameters<br>per ear<br><br>Stimulus designed to be placed in<br>the background and ignored | Same |
| Maximum Output<br>Characteristics | Maximum output fixed at 92dB<br>SPL<br>Output Frequency Response:1<br>kHz to 14 kHz | Same |
| Manufacturer<br>Device Name | SoundCure, Inc.<br>SoundCure® Serenade® Tinnitus<br>Treatment System | SoundCure, Inc.<br>SoundCure® Serenade® Tinnitus<br>Treatment System |
| 510(k) Number | K111293 | Remote Programming Modification |
| Target Anatomy | Ear | Same |
| Design Features | Patient Device Sound Generator<br>with frequency shaped sounds<br><br>Sleep Mode Timer (60 min timer to<br>shut-off when button is pressed)<br><br>Amplitude modulation<br><br>Sounds customized to the patient<br><br>Handheld device with earphones<br><br>4 sound programs / tracks<br>(memory for up to 8)<br><br>Data logging of patient use<br><br>Individual volume control per ear | Same |
| Software Architectural<br>Design | Serenade Patient Device<br>(Embedded Software), hearing<br>healthcare professional's computer<br>(PC Software), and SoundCure<br>Server (Web Software) | Serenade Patient Device (Embedded<br>Software), hearing healthcare<br>professional's computer (PC Software),<br>patient's home computer<br>(Communications Software),<br>SoundCure Server (Web Software) |
| Patient Contact<br>Materials | Silicone earphones | Same |
| Biocompatible for<br>Intended Use | Yes | Same |
| Training Course | Specific Training course for hearing<br>healthcare professionals<br><br>In office support | Specific Training course for hearing<br>healthcare professionals<br><br>Supplemental Training course (hearing<br>healthcare professionals) for remote<br>programming.<br><br>In office support |
| Power | Rechargeable Lithium-Ion (Li-Ion)<br>Battery<br><br>Serenade System also includes an<br>external power supply (100-<br>250VAC to 5V DC) with power<br>cord for recharging | Same |
| Meets Applicable<br>IEC60601-1 testing | Yes | Same |

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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.