SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM

K111293 · Soundcure, Inc. · KLW · Aug 24, 2011 · Ear, Nose, Throat

Device Facts

• Record ID: K111293
• Device Name: SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM
• Applicant: Soundcure, Inc.
• Product Code: KLW · Ear, Nose, Throat
• Decision Date: Aug 24, 2011
• 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

Serenade Tinnitus Treatment System provides sound therapy for tinnitus relief. System inputs include patient tinnitus characteristics evaluated by healthcare professionals. Device transforms inputs into customized audio stimuli, including modulated tinnitus pitch-matched tones (S-Tones), narrow-band noise, and broad-band noise. Output is delivered via handheld patient device with earphones. Used in clinical or home settings under professional guidance. Healthcare providers use Serenade Treatment Software to evaluate tinnitus and program device parameters. Features include amplitude modulation, independent volume control per ear, and sleep mode timer. Data logging tracks patient usage. Benefits include personalized sound masking to reduce debilitating tinnitus effects.

Clinical Evidence

Bench testing only. Studies included system output performance, operational/storage environmental testing, electrical safety, electromagnetic compatibility, hardware verification, software verification and validation, packaging validation, and battery useful life.

Technological Characteristics

Handheld device with earphones; rechargeable Lithium-Ion battery; external power supply (100-250VAC to 5V DC). Generates broad-band noise, narrow-band noise, and pure tones (1 kHz to 14 kHz). Features amplitude modulation, independent volume control per ear, and data logging. Software-driven programming. Meets IEC60601-1 standards.

Indications for Use

Indicated for temporary relief of tinnitus symptoms in adults (18 years or older) as part of a tinnitus management program. Requires professional oversight by a 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

• GN Resound A/S Tinnitus Sound Generator Module (K073636)

Submission Summary (Full Text)

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SoundCure, Inc.

# 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.

# Name, Address, Phone and Fax Number of Applicant A.

SoundCure, Inc. 560 S. Winchester Blvd Suite 500 San Jose, CA 95128 Phone: [phone] Fax: [phone]

# B. Contact Person

Nancy Lincé, RAC Clinical and Regulatory Affairs Consultant [phone] [e-mail]

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

- C. Date Prepared
May 5, 2011

# D. Device Name

| Trade Name: | SoundCure™ Serenade™ Tinnitus Treatment System |
|----------------------|------------------------------------------------------|
| Common Name: | Tinnitus Masker |
| Classification Name: | Tinnitus Masker (21 CFR §874.3400, Product Code KLW) |

## E. Predicate Devices

The SoundCure™ Serenade™ Tinnitus Treatment System is substantially equivalent to the GN Resound A/S Tinnitus Sound Generator Module cleared under K073636.

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#### F. Device Description

The 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 (provided separately).

#### Indications For Use G.

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.

#### Technological Comparison H.

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

| Manufacturer | GN Resound A/S | SoundCure, Inc. | |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Device Name | TSG Module | SoundCure™ Serenade™<br>Tinnitus Treatment System | |
| 510(k) Number | K073636 | K111293 | |
| Indications for Use | The Tinnitus Sound Generator<br>Module is a tool to generate<br>sounds to be used in a tinnitus<br>management program to<br>relieve patients suffering from<br>tinnitus. The target population<br>is primarily the adult population<br>over 18 years of age. This<br>product may also be used with<br>children 5 years of age or<br>older. | The SoundCure™<br>Serenade™ Tinnitus<br>Treatment System is indicated<br>for use in the temporary relief<br>of tinnitus symptoms. The<br>device is a tool to generate<br>customized sounds to relieve<br>patients suffering from tinnitus<br>and can be used in a tinnitus<br>management program. The<br>target population is adults (18<br>years or older). | |
| Manufacturer<br>Device Name | GN Resound A/S<br>TSG Module | SoundCure, Inc.<br>SoundCure™ Serenade™<br>Tinnitus Treatment System | |
| 510(k) Number | K073636 | K111293 | |
| | The Tinnitus Sound Generator<br>module is targeted for<br>healthcare professionals,<br>which are treating patients<br>suffering from tinnitus, as well<br>as conventional hearing<br>disorders. The fitting of the<br>Tinnitus Sound generator<br>module must be done by<br>hearing professional<br>participating in a tinnitus<br>management program. | This is a medical device and<br>should only be used with the<br>advice of a physician,<br>audiologist or other hearing<br>healthcare professional. | |
| | Mechanism of<br>Action | Uses noise that can be<br>configured from broad band to<br>narrow band customized to the<br>patient. | Uses noise that can be<br>configured from broad band to<br>narrow band, and pure tones<br>customized to the patient |
| | | Stimulus can be amplitude<br>modulated | Stimulus can be amplitude<br>modulated |
| | | Level of sound can be adjusted<br>by a user volume control | Level of sound can be<br>adjusted by a user volume<br>control |
| | | Independent volume<br>parameters per ear (inherent<br>to ear specific device) | Independent volume<br>parameters per ear |
| | Stimulus designed to be<br>placed in the background and<br>ignored | Stimulus designed to be<br>placed in the background and<br>ignored | |
| Maximum Output<br>Characteristics | Maximum output fixed at<br>93dB SPL<br>Output Frequency Response:<br>Cutoffs at 500-6000 Hz | Maximum output fixed at<br>92dB SPL<br>Output Frequency<br>Response: 1 kHz to 14 kHz | |
| Target Anatomy | Ear | Ear | |
| Design Features | Tinnitus Sound Generator with<br>frequency shaping<br><br>Environmental Steering™ | Patient Device Sound<br>Generator with frequency<br>shaped sounds<br><br>Sleep Mode Timer (60 min<br>timer to shut-off when button<br>is pressed) | |
| | Amplitude modulation | Amplitude modulation | |
| Manufacturer | GN Resound A/S | SoundCure, Inc. | |
| Device Name | TSG Module | SoundCure™ Serenade™<br>Tinnitus Treatment System | |
| 510(k) Number | K073636 | K111293 | |
| | Sounds customized to the<br>patient | Sounds customized to the<br>patient | |
| | Behind the Ear | Handheld device with<br>earphones | |
| | 4 sound programs/tracks | 4 sound programs / tracks<br>(memory for up to 8) | |
| | Data logging of patient use | Data logging of patient use | |
| | Independent volume control<br>per ear (inherent with<br>individual devices per ear) | Individual volume control per<br>ear | |
| Patient Contact<br>Materials | Silicone domes in open<br>configuration | Silicone earphones | |
| Power | Battery, Hearing Aid Battery<br>Size 13 | Rechargeable Lithium-Ion (Li-<br>Ion) Battery | |
| | | Serenade System also | |
| | | includes an external power | |
| | | supply (100-250VAC to 5V | |
| | | DC) with power cord for | |
| | | recharging | |
| Meets Applicable<br>IEC60601-1 testing | Yes | Yes | |

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Traditional 510(k) SoundCure™ Serenade™ Tinnitus Treatment System

SoundCure, Inc.

The subject Serenade Patient Device and predicate device are both battery-powered devices worn in the patient's ear. The Serenade Patient Device is equipped with a power supply to recharge the battery and replacement batteries are used with the predicate device. The subject Serenade Patient Device is a hand-held device with earphones while the predicate device is a behind the ear hearing aid style device. Both the subject and predicate device produce individually customizable sounds designed to provide relief to patients suffering from tinnitus. Both the subject and predicate device use software driven applications to allow the healthcare professional to perform the hearing evaluations and to program the devices to produce the customizable sounds.

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

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### l. Summary of Non-Clinical Data

The Serenade System performance characteristics were evaluated in the following in-vitro bench studies:

- · System Output Performance Testing
- · Operational and Storage Temperature and Humidity Testing
- Electrical Safety & Electromagnetic Compatibility Packaging Testing
- Hardware Verification
- · Software Verification and Validation
- · Packaging Validation Testing · Battery Useful Life

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.

#### J. Summary of Data

The Serenade System has been carefully compared to a legally marketed device with respect to intended use and technological characteristics. In addition, nonclinical testing was conducted to validate the performance of the device and ensure the Serenade System performs as intended and meets the design specifications. The non-clinical performance testing and comparison to the predicate device demonstrate that the Serenade System is substantially equivalent to the predicate device and does not raise new issues of safety or effectiveness.

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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings, depicted in a minimalist, abstract design.

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

SoundCure, Inc. c/o Ms. Nancy Lince Clinical and Regulatory Affairs Consultant 560 S. Winchester Blvd. Suite 500 San Jose, CA 95128

AUG 2 4 2011

Re: K111293

Trade/Device Name: Serenade Tinnitus Treatment System Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: July 13, 2011 Received: July 14, 2011

Dear Ms. Lince:

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.

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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (600 acon). Existing major regulations affecting your device can be may be subject to additions, Title 21, Parts 800 to 898. In addition, FDA may found in the Oous of incements 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 that I Dri has Intact a and regulations administered by other Federal agencies. You must or any I edelul statutes and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CI K Fall 607); abonnig (21 CFR 803); good manufacturing practice requirements as set de nece relation adverse orients (2) CFR Part 820); and if applicable, the electronic forth in the quality by seller (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 11 you desire specific advice to: your conters offices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please the Concertor Devices and "Misbranding by reference to premarket notification" (21CFR Part note the regulations 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 r ou may oouall only generers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

E. Feldman, M.D.

Malvina B. Eydelman, Mr Director Division of Opthalmic, Neurological, Ears, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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SoundCure, Inc.

# Indications for Use Statement

510(k) Number (if known): K_111293

SoundCure™ Serenade™ Tinnitus Treatment System Device Name:

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)

Kim Mathews

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K111293

Appendix J, Page 1 of 1