Multiflex Tinnitus Technology

K201370 · Starkey Laboratories, Inc. · KLW · Jun 19, 2020 · Ear, Nose, Throat

Device Facts

• Record ID: K201370
• Device Name: Multiflex Tinnitus Technology
• Applicant: Starkey Laboratories, Inc.
• Product Code: KLW · Ear, Nose, Throat
• Decision Date: Jun 19, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.3400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Multiflex Tinnitus Technology 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. The Multiflex Tinnitus Technology is targeted for healthcare professionals, which are treating patients suffering from tinnitus, as well as conventional hearing disorders. The fitting of the Multiflex Tinnitus Technology must be done by a hearing professional participating in a Tinnitus Management Program.

Device Story

Multiflex Tinnitus Technology is a firmware-based tinnitus masker embedded within the DSP stage of Starkey hearing aids. It generates broadband white noise that can fluctuate in amplitude and frequency. Hearing professionals use proprietary 'Inspire' software to enable and adjust stimulus parameters. The device offers two modes: manual adjustment to patient needs or automatic adjustment via audiogram shaping functionality. The output is delivered through the hearing aid to provide tinnitus relief. It is intended for use by patients under the guidance of a hearing professional in a clinical setting. The device does not impact standard hearing aid functions. Benefits include customizable sound therapy to assist in tinnitus management programs.

Clinical Evidence

No clinical testing was completed or relied upon. Substantial equivalence is supported by bench testing, risk analysis, and verification/validation of the new audiogram-shaping functionality against established performance specifications.

Technological Characteristics

Firmware-based algorithm embedded in hearing aid DSP integrated circuit. Powered by 1.4V batteries (size 13, 312, 10) or rechargeable. Maximum output limited to 87 dB SPL (2cc coupler). Connectivity via proprietary Inspire programming software. No specific material standards cited.

Indications for Use

Indicated for adults >18 years suffering from tinnitus; used by hearing professionals within a Tinnitus Management Program to provide sound-based relief.

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

• Multiflex Tinnitus Technology (K122876)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Starkey Laboratories, Inc. Ka Xiong Sr. Regulatory Affairs Specialist 6700 Washington Ave S Eden Prairie, Minnesota 55344

# Re: K201370

Trade/Device Name: Multiflex Tinnitus Technology Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: May 20, 2020 Received: May 22, 2020

# Dear Ka Xiong:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Michael J. Ryan Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K201370

Device Name Multiflex Tinnitus Technology

## Indications for Use (Describe)

The Multiflex Timitus Technology 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.

The Multiflex Tinnitus Technology is targeted for healthcare professionals, which are treating patients suffering from timitus, as well as conventional hearing disorders. The fitting of the Multiflex Timitus Technology must be done by a hearing professional participating in a Tinnitus Management Program.

| Type of Use ( <i>Select one or both, as applicable</i> ) | |
|---------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"> <span>☒</span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div style="display:flex; align-items:center;"> <span>☐</span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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| 510(k) Number | K201370 |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | 19 June 2020 |
| Submitter Name &<br>Address | Starkey Laboratories, Inc.<br>6700 Washington Ave. South<br>Eden Prairie, MN 55344 |
| Contact Person | Ka Zoua Xiong<br>Senior Regulatory Affairs Specialist<br>Phone: [phone] ext.6235<br>Email: [e-mail] |
| Alternative Contact<br>Person | Yangjun Xing<br>Senior Regulatory Affairs Manager<br>Phone: [phone] ext.4635<br>Email: Yangjun [e-mail] |
| Proprietary/Trade<br>Name | Multiflex Tinnitus TechnologyTM |
| Common/Usual Name | Tinnitus Masker |
| Product Classification<br>Code | KLW |
| Product Regulation<br>Number and Name | 21 CFR § 874.3400 - Tinnitus Masker |
| Device Class | II |
| Predicate Device | Predicate: Multiflex Tinnitus TechnologyTM<br>510(k) Number: K122876<br>Clearance Date: 31 Oct 2012 |
| Device Description | Multiflex Tinnitus TechnologyTM (Tinnitus Multiflex) is designed to generate noise that<br>can optionally periodically fluctuate in amplitude and frequency to provide relief for<br>patients suffering from tinnitus.<br><br>Tinnitus Multiflex is a firmware program code (algorithm) that is embedded as part of<br>the integrated circuit (IC) in the Digital Signal Processing (DSP) stage of a hearing-aid.<br>More specifically, Tinnitus Multiflex is an added branch of code that is separate from<br>the normal existing hearing-aid firmware. As such, hearing-aid operating characteristics<br>(besides tinnitus-stimulus functionalities) are not impacted by the Tinnitus Multiflex<br>branch of code. Tinnitus Multiflex may be deployed across all Starkey hearing-aid<br>models.<br><br>Tinnitus Multiflex functionalities and parameters are enabled and adjusted by a hearing-<br>care professional utilizing the Starkey proprietary hearing-aid programming software,<br>Inspire. The Tinnitus Multiflex can be manually adjusted to a patient's stimulus needs<br>or automatically adjusted via the new audiogram shaping functionality. |
| Indications for Use/<br>Intended Use | The Multiflex Tinnitus Technology is a tool to generate sounds to be used in a Tinnitus<br>Management Program to relieve patients suffering from tinnitus. The target population<br>is primarily the adult population over 18 years of age.<br><br>The Multiflex Tinnitus Technology is targeted for healthcare professionals, which are<br>treating patients suffering from tinnitus, as well as conventional hearing disorders. The<br>fitting of the Multiflex Tinnitus Technology must be done by a hearing professional<br>participating in a Tinnitus Management Program. |

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| Features | Multiflex Tinnitus TechnologyTM (Subject Device) | Multiflex Tinnitus TechnologyTM (Predicate Device - K122876) | |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use and Indications for Use | Same | The Multiflex Tinnitus Technology 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.<br><br>The Multiflex Tinnitus Technology is targeted for healthcare professionals, which are treating patients suffering from tinnitus, as well as conventional hearing disorders. The fitting of the Multiflex Tinnitus Technology must be done by a hearing professional participating in a Tinnitus Management Program. | |
| Schedule of Use | Same | This device is intended for use for a maximum of sixteen (16) hours a day when set at the maximum output level. | |
| Design Features | Same. | The Multiflex Tinnitus TechnologyTM is designed to generate broadband white noise that periodically fluctuates in amplitude and frequency to provide relief for patients suffering from tinnitus. | |
| Mechanism of Action | The Multiflex Tinnitus TechnologyTM provides a flat stimulus shape (irrespective of patient thresholds) that can be manually adjusted to a patient's stimulus needs.<br><br>The Multiflex Tinnitus TechnologyTM can also utilize the Tinnitus audiogram shaping functionality to automatically shape the tinnitus stimulus based on a patient's audiogram. | The Multiflex Tinnitus TechnologyTM provides a flat stimulus shape (irrespective of patient thresholds) that can be manually adjusted to a patient's stimulus needs. | |
| Technological Characteristics | Same | Firmware based, enabled with a hearing-aid programming software (Inspire). | |
| | Performance<br>Specifications | Same | Max overall output level - 87 dB<br>SPL |
| | | Same | Max A-weighted overall output - 87<br>dB SPL |
| | | | Max 1/3 octave output level – 87 dB<br>SPL |
| | Maximum<br>Sound<br>Loudness<br>Output | Same | Maximum output in a 2cc coupler<br>limited to 87 dB SPL. |
| | Volume<br>Control | Same | Tinnitus output levels are set to<br>specified limits by the hearing-care<br>professional. The patient<br>volume/level controls can be enabled<br>to provide adjustments that can<br>decrease or increase output levels<br>within set limits. |
| | Power Source | Same | May use any 1.4V hearing-aid<br>battery (size 13, 312 or 10) or be<br>rechargeable. |
| Summary of Non-<br>Clinical Testing | Risk analyses and verification testing were performed for the addition of the audiogram-<br>shaping functionality. Results demonstrated that Tinnitus Multiflex meets the device<br>testing acceptance criteria described in the predicate submission (K122876) and is<br>substantially equivalent to the predicate (Multiflex Tinnitus Technology™). | | |
| Summary of Clinical<br>Testing | No new clinical testing was completed, nor relied upon, in support of this Special<br>510(k). | | |
| | Changes to the subject device, Tinnitus Multiflex, do not raise new questions of safety<br>or effectiveness. The addition of the audiogram-shaping functionality was assessed by<br>appropriate risk management methodology and addressed with verification and<br>validation testing. | | |
| Statement of<br>Equivalence | Acoustic measurements of output levels, utilizing previously defined limits, were used<br>during verification to ensure that the maximum allowable stimulus level for the subject<br>device was the same as the predicate device. All results passed, and the results of the<br>verification and validation testing support that the addition of the audiogram-shaping<br>functionality does not impact safety and effectiveness. | | |
| | The subject and predicate devices are technologically identical and neither the subject<br>device safety and effectiveness, nor intended use is impacted. The results support<br>substantial equivalence of the subject device to the predicate device (K122876). | | |

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