TinniLogic Mobile Tinnitus Management Device

K163094 · Jiangsu Betterlife Medical Co., Ltd. · KLW · May 17, 2017 · Ear, Nose, Throat

Device Facts

• Record ID: K163094
• Device Name: TinniLogic Mobile Tinnitus Management Device
• Applicant: Jiangsu Betterlife Medical Co., Ltd.
• Product Code: KLW · Ear, Nose, Throat
• Decision Date: May 17, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TinniLogic Mobile Tinnitus Management Device is indicated for use in the temporary relief of tinnitus symptoms. The device is a player to play customized sounds and display professional counseling or education 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

Device is a sound player system comprising a tablet, specialized headset, and charger; used by patients for tinnitus management. Healthcare professionals customize sound therapies and counseling/education content for the patient. Device delivers sound stimulation during sleeping or waking hours. Inputs include customized sound profiles; outputs include sinusoidal amplitude modulated (SAM) tinnitus pitch-matched sounds, narrow-band noise (centered at tinnitus frequency), broad-band noise, pure tones, white noise, natural sounds, and relax sounds. Device features individual volume control per ear and data logging of patient usage. Intended for use in clinical or home settings under professional supervision. Benefits include temporary relief of tinnitus symptoms through sound therapy and patient education.

Clinical Evidence

No clinical data. Bench testing only, including IEC 60601-1 (safety) and IEC 60601-1-2 (EMC) compliance, plus output performance testing (maximum output, harmonic distortion, frequency response).

Technological Characteristics

Sound player system; tablet-based with specialized headset. Energy source: rechargeable Li-Ion battery. Connectivity: USB and wireless. Output: 50Hz-15KHz, max 90 dB SPL. Standards: IEC 60601-1:2005+A1:2012, IEC 60601-1-2:2014. Software-based sound generation and data logging.

Indications for Use

Indicated for temporary relief of tinnitus symptoms in adults (18+). Must be used under the guidance of 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

• LEVO Tinnitus Masking Software Device (K140845)
• SoundCure™ Serenade™ Tinnitus Management System (K111293)

Submission Summary (Full Text)

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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 an abstract design featuring three stylized human profiles facing to the right, with flowing lines suggesting movement or connection.

Public Health Service

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

May 17, 2017

Jiangsu Betterlife Medical Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CN

Re: K163094

Trade/Device Name: TinniLogic Mobile Tinnitus Management Device Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: April 14, 2017 Received: April 17, 2017

Dear Diana Hong:

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 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 2017.05.17 13:21:17 -04'00'

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

510(k) Number (if known)

### Device Name

Mobile Tinnitus Management Device

## Models:BTG-A5/ BTG-A6/ BTG-B5/ BTG-B6/ BTG-C5/ BTG-C6

Indications for Use (Describe)

The TimiLogic Mobile Timitus Management Device is indicated for use in the temporary relice of timitus symptoms. The device is a plaver to play customized sounds and display professional counseling or education 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.

Type of Use (Select one or both, as applicable)

| <div></div> | <span>Form Designed to Meet ATBCB/ADA Guidelines</span> |
|-------------|---------------------------------------------------------|
| <div></div> | <span>Form Designed to Meet WCAG 2.0 Guidelines</span> |

X Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K163094

- 1. Date of Preparation: 4/14/2017
- 2. Sponsor Identification

# Jiangsu BetterLife Medical Co., Ltd.

No. 11 Si Hai Road, Changshu Economic and Technological Development Park, Jiangsu Province, 215513, China.

Establishment Registration Number: 3010197022

Contact Person: Mr. Hongwei Xu Position: Management Representative Tel: [phone] Fax: [phone] Email: jerry.xu(@goblm.com.cn

- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)

Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone], Fax: [phone] Email: [e-mail]

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#### 4. Identification of Subject Device

Trade Name: TinniLogic Mobile Tinnitus Management Device Common Name: Tinnitus Masker Models: BTG-A5, BTG-A6, BTG-B5, BTG-B6, BTG-C5 and BTG-C6

### Regulatory Information

Classification Name: Tinnitus Masker; Classification: II; Product Code: KLW; Regulation Number: 21CFR 874.3400 Review Panel: Ear Nose& Throat;

### Indications for Use

The TinniLogic Mobile Tinnitus Management Device is indicated for use in the temporary relief of tinnitus symptoms. The device is a player to play customized sounds and display professional counseling or education 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 Description

The TinniLogic Mobile Tinnitus Management Device is a sound player which is designed to assist the qualified healthcare professional in delivering customized sound therapies and professional counseling or education to the patient for treatment. The TinniLogic Mobile Tinnitus Management Device provides idiopathic timitus sound treatment based upon sound stimulation during sleeping or waking hours. The TinniLogic Mobile Tinnitus Management Device uses amplitude modulated (SAM) timitus pitch matched sounds, narrow-band noise centered at the tinnitus frequency. broad-band noise, pure tone, white noise, natural sounds, and combination of these sounds.

The subject device consists of a tablet, a specialized headset, a charger and a charger cable.

#### Identification of Predicate Devices ર .

Predicate Device 1 510(k) Number: K140845 Product Name: LEVO Tinnitus Masking Software Device

Predicate Device 2 510(k) Number: K111293 Product Name: SoundCure™ Serenade™ Tinnitus Management System

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Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subject device complies with the following standards:

- > IEC 60601-1-2: 2014 Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests
- A IEC 60601-1:2005+A1:2012 Medical electrical equipment- Part 1: General requirements for basic safety, and essential performance, including the US National Differences
- A Output performance testing including the testing of Maximum output, harmonic distortion and Output frequency; additionally, the output performance testing is conducted to demonstrate that the device calibration and the maximum output reamin valid in various settings of three possible volume controls.
- 6. Clinical Test Conclusion

No clinical study is included in this submission.

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#### 7. Substantially Equivalent (SE) Comparison

| Item | Subject Device | Predicate Device 1<br>K140845 | Predicate Device 2<br>K111293 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | KLW | KLW | KLW |
| Regulation Number | 21 CFR 874.3400 | 21CFR 874.3400 | 21 CFR 874.3400 |
| Indications for Use | The TinniLogic Mobile Tinnitus<br>Management Device is indicated<br>for use in the temporary relief of<br>tinnitus symptoms. The device is a<br>player to play customized sounds<br>and display professional<br>counseling or education 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). This is a medical device<br>and should only be used with the<br>advice of a physician, audiologist<br>or other hearing healthcare<br>professional. | The Levo System is<br>indicated for use in the<br>temporary relief of<br>tinnitus symptoms. The<br>device is a tool to<br>generate customized<br>sounds to relieve patients<br>suffering from tinnitus<br>and can be used in a<br>tinnitus management<br>program. The target<br>population is adults (18<br>years or older).<br>This is a medical device<br>and should only be used<br>with the advice of a<br>physician, audiologist or<br>other hearing healthcare<br>professional. | The SoundCure Serenade<br>Tinnitus Treatment System is<br>indicated for use in the<br>temporary relief of tinnitus<br>symptoms. The device is a tool<br>to generate customized sounds<br>to relieve patients suffering<br>from tinnitus and can be used<br>in a tinnitus management<br>program. The target<br>population is adults (18 years<br>or older). This is a medical<br>device and should only be<br>used with the advice of a<br>physician, audiologist or other<br>hearing healthcare<br>professional. |
| Components | TinniLogic Mobile Tinnitus<br>Management Device<br>with software pre-installed<br>Earphones<br>Accessories (adaptor, power cable,<br>USB cable) | Levo Manager software<br>supplied pre-installed on<br>iPad or iPad Air<br>Levo Patient software<br>supplied pre-installed on<br>iPod touch<br>Ear buds<br>Accessories (standard<br>Apple charger with<br>Apple device) | Serenade Treatment Software<br>(to be used with user's<br>commercially available<br>computer)<br>Serenade patient device with<br>software pre-installed<br>Earphones<br>Accessories (power supply,<br>power cord, USB cable) |
| Sounds | Sounds customized to the patient<br>by qualified healthcare<br>professional.<br>The subject device just only<br>displays the following sounds and | Sounds customized to the<br>patient by qualified<br>health care professional.<br>From 1 to ten (10)<br>combinations of the<br>following sounds: | Sounds customized to the<br>patient by qualified health care<br>professional. Individual<br>patient selectable from the<br>following sounds:<br>Sinusoidal amplitude |
| | | | |
| | the combination of them:<br>Sinusoidal amplitude modulated<br>(SAM) tinnitus pitch matched<br>sounds<br>Narrow-band noise centered at the<br>tinnitus frequency<br>Broad-band noises<br>Pure tone<br>White noises<br>Natural sounds<br>Relax sounds | Pure Tone<br>White Noises<br>Narrow Band Noises<br>(bandwidth selectable by<br>HCP)<br>Includes the ability to<br>create sinusoidal<br>amplitude modulated<br>(SAM) tones. | modulated (SAM) tones (S-<br>Tones) (choice of 2 predefined<br>by HCP)<br>White Noises<br>Band Noises |
| Data Logging | Data logging of patient use. | Data logging of patient<br>use. | Data logging of patient use. |
| Volume Control | Individual volume control per ear<br>of the application software;<br>Physical volume controls | Individual volume<br>control per ear of the<br>application software;<br>Physical volume controls | Individual volume control per<br>ear of the application software;<br>Physical volume controls |
| Maximum Sound<br>Loudness Output | 90 dB SPL | 85 dB SPL | 92 dB SPL |
| Sound<br>Output<br>Frequency | 50Hz~15KHz | 100Hz- 16KHz | 1 KHz to 14 KHz |
| Power | Rechargeable lithium-Ion (Li-Ion)<br>Battery, external power supply<br>with power cord for recharging | Rechargeable lithium-Ion<br>(Li-Ion) Battery, external<br>power supply with power<br>cord for recharging.<br>(Battery and charger<br>provided by Apple for<br>Apple devices) | Rechargeable lithium-Ion<br>(Li-Ion) Battery, external<br>power supply with power cord<br>for recharging. |
| Communication | USB cable and/or Wireless | Wireless | USB cable |
| Patient<br>contact<br>material | Earphones | Earphones | Earphones |
| Electrical Safety | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 |

# Table 1 Comparison of Technology Characteristics

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The subject device is as safe and effective as the two predicate devices. The subject device has the similar indications for use, technological characteristics as its predicate devices. The subject device and predicate devices have the same target population and audio player functions.

of the subject device are The Maximum sound loudness output and Output sound frequency of similar as those of the predicate devices. This minor difference on output performance will not raise new problem on the safety and effectiveness of the subject device. The output performance he subject device have been conducted to demonstrate that the device calibration and the um output reamin valid in various settings of three possible volume controls.

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#### 8. Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the subject device is determined to be Substantially Equivalent (SE) to the predicate devices.