REVE134

K151719 · Kw Ear Lab, Inc. · KLW · Oct 9, 2015 · Ear, Nose, Throat

Device Facts

• Record ID: K151719
• Device Name: REVE134
• Applicant: Kw Ear Lab, Inc.
• Product Code: KLW · Ear, Nose, Throat
• Decision Date: Oct 9, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3400
• Device Class: Class 2
• Attributes: Software as a Medical Device, Therapeutic, Pediatric

Intended Use

REVE134 is a sound generating software used in a Tinnitus Management Program designed to provide temporary relief for people experiencing tinnitus symptoms. It is intended primarily for adults over 18 years of age, but may also be used for children 5 years of age or older. REVE134 is for use by hearing healthcare professionals who are familiar with the evaluation and treatment of tinnitus and hearing losses. A hearing healthcare professional should recommend that a patient listen to the REVE134 signal for 30 minutes twice a day at the barely audible level (minimally detectable level).

Device Story

REVE134 is sound-generating software for tinnitus management; installed on PC; fitted by hearing healthcare professionals. Device generates modulated white noise (233–12912 Hz), modulated narrow-band noises, or tones. Professional adjusts output to patient's barely audible level; patient listens for 30 minutes twice daily. Provides temporary relief from tinnitus symptoms; intended for use in clinical settings by audiologists or hearing specialists. Benefits include symptom management through sound therapy.

Clinical Evidence

Bench testing only. Software verified and validated according to IEC 62304 and ISO 14971:2007 standards. No clinical data provided.

Technological Characteristics

Software-based sound generator installed on PC. Generates modulated white noise (233–12912 Hz) or modulated narrow-band noises/tones. Frequency range for narrow-band noise is approximately 1/3 octave. Software life-cycle processes per IEC 62304; risk management per ISO 14971:2007.

Indications for Use

Indicated for adults >18 years and children ≥5 years experiencing tinnitus symptoms as part of a Tinnitus Management Program.

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

• Tinnitus SoundSupport, Oticon (K133308)
• Tinnitus Sound Generator, GN Resound (K110932)

Submission Summary (Full Text)

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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 stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are black and have a flowing, abstract design. Encircling the profiles is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

October 8, 2015

KW Ear Lab, Inc. Mr. Sungwoo Cho Vice President/General Counsel 18655 South Bishop Ave Carson, CA 90746

Re: K151719

Trade/Device Name: Reve134 Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: June 25, 2015 Received: July 1, 2015

Dear Mr. Cho:

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); medical device reporting (reporting of medical devicerelated 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.

# 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

Enclosure

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## Exhibit 5 Indications for Use Statement

K151719 510(k) number (if known):

Device Name: REVE134

Indications for Use:

REVE134 is a sound generating software used in a Tinnitus Management Program designed to provide temporary relief for people experiencing timitus symptoms. It is intended primarily for adults over 18 years of age, but may also be used for children 5 years of age or older. REVE134 is for use by hearing healthcare professionals who are familiar with the evaluation and treatment of tinnitus and hearing losses. A hearing healthcare professional should recommend that a patient listen to the REVE134 signal for 30 minutes twice a day at the barely audible level (minimally detectable level).

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart C)

(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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# Exhibit 6 510(k) Summary

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# 510(k) Summary (REVE134)

| Submitter: | KW EAR LAB, INC.<br>18655 South Bishop Ave, Carson, CA 90746<br>Phone: [phone] |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Sungwoo Cho<br>KW EAR LAB, INC.<br>18655 South Bishop Ave, Carson, CA 90746<br>Phone: [phone] |
| Date Prepared: | May 30, 2015 |
| Device Name: | REVE134 |
| Device Class: | Class II |
| Classification Name: | Tinnitus Masker |
| Classification Regulation: | 21 C.F.R. 874.3400 |
| Product Code | KLW |
| Predicate Devices: | K133308 Tinnitus SoundSupport, Oticon<br>K110932 Tinnitus Sound Generator, GN Resound |
| Intended Use / Indication for Use: | REVE134 is a sound generating software used in a Tinnitus<br>Management Program designed to provide temporary relief for<br>people experiencing tinnitus symptoms. It is intended<br>primarily for adults over 18 years of age, but may also be used<br>for children 5 years of age or older. REVE134 is for use by<br>hearing healthcare professionals who are familiar with the<br>evaluation and treatment of tinnitus and hearing losses. A<br>hearing healthcare professional should recommend that a<br>patient listen to the REVE134 signal for 30 minutes twice a<br>day at the barely audible level (minimally detectable level). |
| Technological Characteristics: | KW EAR LAB'S REVE134 consists of software installed in PC<br>(desktop or laptop computer). REVE134 is fitted to the patient by<br>the hearing healthcare professional. The software enables qualified<br>professional to create customized sounds with specific frequency<br>range for sound therapy/masking. REVE134 software can generate<br>either modulated white noise (233~12912 Hz) or modulated narrow |

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band noises or tones with specific frequency range. One narrow band noise has a frequency range of approximately 1/3 octave.

## Performance Data:

KW EAR LAB's REVE134 software installed and embedded in PC has been verified and validated according to relevant standards for medical device software and risk management procedure (Fig. 1). In all verification and validation process, KW Ear lab's REVE134 functioned properly as intended and the performance observed was as expected.

#### Fig. 1

| Standard No. | Standard Title |
|---------------|-----------------------------------------------------------------------|
| IEC 62304 | Medical device software – Software life-cycle<br>processes |
| ISO14971:2007 | Medical devices- Application of risk<br>management to medical devices |

## Substantial Equivalence:

KW EAR LAB REVE134 is as safe and effective as Oticon's Tinnitus SoundSupport (K133308) and GN Resound's Tinntius Sound Generator (K110932). As shown in the table below, KW Ear lab's REVE134, Oticon's Tinnitus SoundSupport (K133308), and GN Resound's Tinntius Sound Generator (K110932) have the same intended use and similar indications, technological characteristics, and principles of operation. Minor technological differences do not present any new issues of safety or effectiveness. Thus, KW Ear lab's REVE134 is substantially equivalent to Oticon's Tinnitus SoundSupport (K133308), and GN Resound's Tinntius Sound Generator (K110932).

#### Comparison Table:

# KW Ear lab Inc. REVE134

## Substantial Equivalent Chart

| Device | New | Predicate | Predicate |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | KW Ear lab | Oticon | GN Resound |
| Name | REVE134 | Tinnitus SoundSupport | Tinnitus Sound Generator |
| 510(K) No. | | K133308 | K110932 |
| Indication<br>for Use | REVE134 is a tool to<br>generate sounds to be used<br>in a Tinnitus Management<br>Program to relieve patients<br>suffering from tinnitus. | Tinnitus SoundSupport is a<br>tool intended to generate<br>sounds to provide temporary<br>relief to patients suffering<br>from tinnitus as part of a | The Tinnitus Sound<br>Generator is a tool to<br>generate sounds to be used<br>in a Tinnitus Management<br>Program to relieve patients |
| | The target population is<br>primarily the adult<br>population over 18 years of<br>age. This product may also<br>be used with children 5 years<br>of age or older.<br>REVE134 is targeted for<br>healthcare professionals who are<br>familiar with the evaluation<br>and treatment of tinnitus and<br>hearing losses. A hearing<br>healthcare professional<br>should recommend for a<br>patient to listen to the<br>REVE134 signal for 30<br>minutes twice a day at the<br>barely audible level<br>(minimally detectable level).<br>A default starting level of<br>REVE134 is 54 dBr. A<br>hearing healthcare<br>professional needs to adjust<br>this default value of '54 dBr'<br>into patient's barely audible<br>level. | tinnitus management<br>program.<br>The target population is the<br>adult population (>18yrs).<br>Tinnitus SoundSupport is<br>targeted for licensed hearingprofessionals<br>(audiologists, hearing aid<br>specialists, or<br>otolaryngologists) who are<br>familiar with the evaluation<br>and treatment of tinnitus and<br>hearing losses.<br>The fitting of Tinnitus<br>SoundSupport must be done<br>by a hearing care professional<br>participating in a tinnitus<br>management program. | suffering from tinnitus.<br>The target population is<br>primarily the adult<br>population over 18 years of<br>age. This product may also<br>be used with children 5<br>years of age or older.<br>The Tinnitus Sound<br>Generator Module is<br>targeted for healthcare<br>professionals, which are<br>treating patients suffering<br>from tinnitus, as well as<br>conventional disorders. |
| User<br>Population | Primarily adult population<br>(>18yrs), can be used for<br>patients >5yrs | Adult population (>18yrs) | Primarily adult population<br>(>18yrs), can be used for<br>patients >5yrs |
| Schedule of Use | All day | All day | All day in all environments |
| Mechanism | Volume is set by HCP and<br>can be adjusted by patients,<br>when in use. Default level<br>fixed.<br>Amplitude modulation noise<br>and frequency modulation<br>pure tone | Volume is set by HCP and can<br>be adjusted by patients, when<br>in use. Default level fixed.<br>Amplitude modulation and<br>steady noise. | Volume is set by HCP and<br>can be adjusted by patients,<br>when in use. Default level<br>fixed.<br>Amplitude modulation and<br>steady noise. |
| Technological<br>Characteristics | Software module embedded<br>into a digital hearing<br>instrument platform. Sound<br>files generated by the<br>REVE134 can be used only<br>in a digital hearing<br>instrument platform which<br>provides MP3 codec (e.g., | Software module embedded<br>into a digital hearing<br>instrument platform | Software module embedded<br>into a digital hearing<br>instrument platform |

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