Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on personalized sound therapy based on patient evaluation and customized audio stimulus generation, not on adaptive learning or AI-driven algorithms.

Therapeutic

Yes
The device is indicated for "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," indicating a therapeutic purpose.

Diagnostic

No

The device is described as a "personalized sound therapy system" that "generates customized sounds to relieve patients suffering from tinnitus." While it evaluates a patient's tinnitus to create customized audio, it does not diagnose medical conditions. It is a treatment tool, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components like the "Serenade Patient Device," "Earphones," "power supply," "power cord," and "USB cable," in addition to the software. The performance studies also include "Hardware Verification."

IVD (In Vitro Diagnostic)

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

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 one.
Device Description: The device is described as a "personalized sound therapy system" that generates "sound therapy/masking." This aligns with a treatment device, not a device used to diagnose a condition by examining samples outside the body.
Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (like blood, urine, tissue, etc.) to provide diagnostic information. The input is related to the patient's tinnitus characteristics (pitch matching), not biological markers.
Anatomical Site: The anatomical site is the ear, which is where the sound is delivered for therapeutic effect, not where a diagnostic sample would be collected or analyzed.

In summary, the Serenade System is a therapeutic medical device designed to manage the symptoms of tinnitus through sound therapy, not a diagnostic device used to identify or characterize a disease or condition by testing samples.

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 (comma separated list FDA assigned to the subject device)

KLW

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).

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

physician, audiologist or other hearing healthcare professional.

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)

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.

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.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K073636

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

0

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: (408) 938-5745 Fax: (408) 938-5746

B. Contact Person

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

Altemate Contact: Diana DeGregorio Lincé Consulting Regulatory Affairs Consultant (925) 980-8047 dianadegregorio@comcast.net

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™
Tinnitus Treatment System
510(k) Number	K073636	K111293
Indications for Use	The Tinnitus Sound Generator
Module is a tool to generate
sounds to be used in a tinnitus
management program to
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 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).
Manufacturer
Device Name	GN Resound A/S
TSG Module	SoundCure, Inc.
SoundCure™ Serenade™
Tinnitus Treatment System
510(k) Number	K073636	K111293
	The Tinnitus Sound Generator
module is targeted for
healthcare professionals,
which are treating patients
suffering from tinnitus, as well
as conventional hearing
disorders. The fitting of the
Tinnitus Sound generator
module must be done by
hearing professional
participating in a tinnitus
management program.	This is a medical device and
should only be used with the
advice of a physician,
audiologist or other hearing
healthcare professional.
	Mechanism of
Action	Uses noise that can be
configured from broad band to
narrow band customized to the
patient.	Uses noise that can be
configured from broad band to
narrow band, and pure tones
customized to the patient
		Stimulus can be amplitude
modulated	Stimulus can be amplitude
modulated
		Level of sound can be adjusted
by a user volume control	Level of sound can be
adjusted by a user volume
control
		Independent volume
parameters per ear (inherent
to ear specific device)	Independent volume
parameters per ear
	Stimulus designed to be
placed in the background and
ignored	Stimulus designed to be
placed in the background and
ignored
Maximum Output
Characteristics	Maximum output fixed at
93dB SPL
Output Frequency Response:
Cutoffs at 500-6000 Hz	Maximum output fixed at
92dB SPL
Output Frequency
Response: 1 kHz to 14 kHz
Target Anatomy	Ear	Ear
Design Features	Tinnitus Sound Generator with
frequency shaping

Environmental Steering™ | Patient Device Sound
Generator with frequency
shaped sounds

2

3

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.

4

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.

5

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.

6

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 (800) 638-2041 or (301) 796-7100 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

7

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