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 Description

Multiflex Tinnitus TechnologyTM (Tinnitus Multiflex) is designed to generate noise that can optionally periodically fluctuate in amplitude and frequency to provide relief for patients suffering from tinnitus.

Tinnitus Multiflex is a firmware program code (algorithm) that is embedded as part of the integrated circuit (IC) in the Digital Signal Processing (DSP) stage of a hearing-aid. More specifically, Tinnitus Multiflex is an added branch of code that is separate from the normal existing hearing-aid firmware. As such, hearing-aid operating characteristics (besides tinnitus-stimulus functionalities) are not impacted by the Tinnitus Multiflex branch of code. Tinnitus Multiflex may be deployed across all Starkey hearing-aid models.

Tinnitus Multiflex functionalities and parameters are enabled and adjusted by a hearing-care professional utilizing the Starkey proprietary hearing-aid programming software, Inspire. The Tinnitus Multiflex can be manually adjusted to a patient's stimulus needs or automatically adjusted via the new audiogram shaping functionality.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a Tinnitus Masker device (Multiflex Tinnitus Technology) and does not contain detailed information about a clinical study involving experts, test sets, or ground truth establishment in the context of typical AI/ML device evaluations. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (K122876) based on technological characteristics and performance specifications for non-clinical testing.

Therefore, many of the requested items (2, 3, 4, 5, 6, 7, 8, 9) cannot be answered directly from the provided text as they pertain to clinical evaluations that were explicitly stated as not being performed for this submission.

Here is the information that can be extracted from the document:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Predicate Device)	Reported Device Performance (Subject Device)
Max overall output level - 87 dB SPL	Same (Acoustic measurements of output levels, utilizing previously defined limits, were used during verification to ensure that the maximum allowable stimulus level for the subject device was the same as the predicate device. All results passed.)
Max A-weighted overall output - 87 dB SPL	Same (Acoustic measurements of output levels... All results passed.)
Max 1/3 octave output level – 87 dB SPL	Same (Acoustic measurements of output levels... All results passed.)
Maximum output in a 2cc coupler limited to 87 dB SPL	Same (Acoustic measurements of output levels... All results passed.)
Tinnitus output levels are set to specified limits by the hearing-care professional. Patient volume/level controls can be enabled to provide adjustments that can decrease or increase output levels within set limits.	Same
Power Source: May use any 1.4V hearing-aid battery (size 13, 312 or 10) or be rechargeable.	Same
Risk analysis and verification testing to ensure safety and effectiveness.	Risk analyses and verification testing were performed for the addition of the audiogram-shaping functionality. Results demonstrated that Tinnitus Multiflex meets the device testing acceptance criteria described in the predicate submission (K122876) and is substantially equivalent.
Addition of audiogram-shaping functionality does not impact safety and effectiveness.	The addition of the audiogram-shaping functionality was assessed by appropriate risk management methodology and addressed with verification and validation testing. The results of the verification and validation testing support that the addition of the audiogram-shaping functionality does not impact safety and effectiveness.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No clinical test set data was reported. The device is a "firmware program code (algorithm)" embedded in a hearing aid, and the testing described is non-clinical (risk analysis, verification, and validation testing for the audiogram-shaping functionality).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No clinical expert review for ground truth was reported.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical adjudication method was reported.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. No MRMC study was reported. The device is a "Tinnitus Masker" technology, not an AI assistance tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable in the context of typical AI/ML algorithm-only performance studies. The Multiflex Tinnitus Technology is described as an algorithm embedded in a hearing aid, but its "performance" is primarily related to its ability to generate specific sound characteristics and adjust based on audiograms, rather than an AI-driven diagnostic or interpretative function. The evaluation focuses on meeting predefined acoustic output limits and maintaining safety and effectiveness.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For the non-clinical testing performed, the "ground truth" consisted of predetermined acoustic specifications and safety/effectiveness criteria for the device's functionality.

8. The sample size for the training set
Not applicable. This document is a 510(k) submission for a non-AI/ML device (firmware for a tinnitus masker) and does not describe a machine learning training process or training set.

9. How the ground truth for the training set was established
Not applicable, as there was no reported machine learning training set.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 ( Select one or both, as applicable )
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Number	K201370
Date Prepared	19 June 2020
Submitter Name &Address	Starkey Laboratories, Inc.6700 Washington Ave. SouthEden Prairie, MN 55344
Contact Person	Ka Zoua XiongSenior Regulatory Affairs SpecialistPhone: 952-915-6235 ext.6235Email: KaZoua_Xiong@starkey.com
Alternative ContactPerson	Yangjun XingSenior Regulatory Affairs ManagerPhone: 952-947-4635 ext.4635Email: Yangjun Xing@starkey.com
Proprietary/TradeName	Multiflex Tinnitus TechnologyTM
Common/Usual Name	Tinnitus Masker
Product ClassificationCode	KLW
Product RegulationNumber and Name	21 CFR § 874.3400 - Tinnitus Masker
Device Class	II
Predicate Device	Predicate: Multiflex Tinnitus TechnologyTM510(k) Number: K122876Clearance Date: 31 Oct 2012
Device Description	Multiflex Tinnitus TechnologyTM (Tinnitus Multiflex) is designed to generate noise thatcan optionally periodically fluctuate in amplitude and frequency to provide relief forpatients suffering from tinnitus.Tinnitus Multiflex is a firmware program code (algorithm) that is embedded as part ofthe integrated circuit (IC) in the Digital Signal Processing (DSP) stage of a hearing-aid.More specifically, Tinnitus Multiflex is an added branch of code that is separate fromthe normal existing hearing-aid firmware. As such, hearing-aid operating characteristics(besides tinnitus-stimulus functionalities) are not impacted by the Tinnitus Multiflexbranch of code. Tinnitus Multiflex may be deployed across all Starkey hearing-aidmodels.Tinnitus Multiflex functionalities and parameters are enabled and adjusted by a hearing-care professional utilizing the Starkey proprietary hearing-aid programming software,Inspire. The Tinnitus Multiflex can be manually adjusted to a patient's stimulus needsor automatically adjusted via the new audiogram shaping functionality.
Indications for Use/Intended Use	The Multiflex Tinnitus Technology is a tool to generate sounds to be used in a TinnitusManagement Program to relieve patients suffering from tinnitus. The target populationis primarily the adult population over 18 years of age.The Multiflex Tinnitus Technology is targeted for healthcare professionals, which aretreating patients suffering from tinnitus, as well as conventional hearing disorders. Thefitting of the Multiflex Tinnitus Technology must be done by a hearing professionalparticipating 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.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.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).
	PerformanceSpecifications	Same	Max overall output level - 87 dBSPL
		Same	Max A-weighted overall output - 87dB SPL
			Max 1/3 octave output level – 87 dBSPL
	MaximumSoundLoudnessOutput	Same	Maximum output in a 2cc couplerlimited to 87 dB SPL.
	VolumeControl	Same	Tinnitus output levels are set tospecified limits by the hearing-careprofessional. The patientvolume/level controls can be enabledto provide adjustments that candecrease or increase output levelswithin set limits.
	Power Source	Same	May use any 1.4V hearing-aidbattery (size 13, 312 or 10) or berechargeable.
Summary of Non-Clinical Testing	Risk analyses and verification testing were performed for the addition of the audiogram-shaping functionality. Results demonstrated that Tinnitus Multiflex meets the devicetesting acceptance criteria described in the predicate submission (K122876) and issubstantially equivalent to the predicate (Multiflex Tinnitus Technology™).
Summary of ClinicalTesting	No new clinical testing was completed, nor relied upon, in support of this Special510(k).
	Changes to the subject device, Tinnitus Multiflex, do not raise new questions of safetyor effectiveness. The addition of the audiogram-shaping functionality was assessed byappropriate risk management methodology and addressed with verification andvalidation testing.
Statement ofEquivalence	Acoustic measurements of output levels, utilizing previously defined limits, were usedduring verification to ensure that the maximum allowable stimulus level for the subjectdevice was the same as the predicate device. All results passed, and the results of theverification and validation testing support that the addition of the audiogram-shapingfunctionality does not impact safety and effectiveness.
	The subject and predicate devices are technologically identical and neither the subjectdevice safety and effectiveness, nor intended use is impacted. The results supportsubstantial equivalence of the subject device to the predicate device (K122876).

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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.