The HiSonic-TRD tinnitus masker is a wearable behindthe-ear style ultrasonic, bone conducted broadband noise and/or sweep frequency stimuli noise generator intended to generate noise of sufficient intensity and bandwidth to be used for tinnitus habituation therapy and is also suitable for tinnitus masking therapy. The HiSonic-TRD is intended to be used by those individuals who experience tinnitus, and do not need or desire amplification. The intended use of the HiSonic-TRD includes it's fitting by a qualified audiologist or other hearing healthcare professional familiar with the diagnosis of tinnitus and subsequent rehabilitation therapies. The target population is the adult population over 18 years of age. This product is not intended for use in children under the age of 18.

Device Description

The HiSonic-TRD generates ultrasound energy and couples the energy to the mastoid bone in order to activate the auditory nervous system, and produce auditory sensations that mask tinnitus. The device consists of a generator/amplifier unit, a piezoelectric transducer, and a headband to hold the transducer firmly against the mastoid bone. A 7.2V Lithium Ion battery powers the device. The tranducer is a piezoelectric ceramic that transmits ultrasonic energy in a typical operating frequency bandwidth of 19.5kHz-25.8kHz to the user. The generator/amplifier unit is worn on the body and houses the lithium ion battery. In addition, the body worn unit has an "on/off" switch, a noise/sweep selector switch and a volume control wheel for use by the patient. Both broadband noise and sweep frequency stimuli are incorporated in the device as masking stimuli. The HiSonic-TRD generates and amplifies electronic oscillations, and then converts them into ultrasound energy with a piezoelectric ceramic transducer. The ultrasound energy is emitted as a broadband noise or as a sweep frequency.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the HiSonic-TRD based on the provided text:

No specific quantitative acceptance criteria relating to device performance metrics (e.g., sensitivity, specificity, accuracy, or a threshold for masking effectiveness) are explicitly stated in the document. The document primarily focuses on safety and demonstrating that the device is "substantially similar in effectiveness" to predicate devices.

However, based on the performance data presented, we can infer some desired outcomes which function as de facto acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance
Safety:
1.1. Ultrasound energy output is too low to cause thermal damage or other known bio-effects.	The University of Illinois Bioacoustics Research Laboratory measured output intensity against a standard thermal model and found the ultrasound energy "too low to produce thermal damage and too low to produce any other known damaging bio-effects." The output satisfies IEC 61689 safety limits.
1.2. Acoustic intensity output is not possible to reach unsafe levels, even at maximum setting.	Calibration measurements by the University of Illinois Bioacoustics Research Laboratory demonstrated that "due to the low level of acoustic intensity (mw/cm²)*, output power, generated by the HiSonic-TRD device that it is not possible to reach unsafe acoustic intensity output levels with the device, even at the highest possible setting on the volume wheel."
1.3. No significant changes in auditory thresholds or speech intelligibility.	A safety study with human subjects demonstrated "no significant changes in threshold, there was no decrease in speech discrimination and no interference with speech understanding."
1.4. No serious adverse events.	The safety study reported "no adverse events as a result of patient use of the device" with the "exception of headaches reported in two subjects." The safety of the HiSonic-TRD is "comparable to the safety of the predicates."
Effectiveness:
2.1. Device is audible and produces effective masking in patients with clinically significant	An efficacy study found that "All subjects were easily able to hear the HiSonic-TRD masking sound (both sweep frequency tones and narrow band noise)." The data indicated "that the ultrasound emitted by the device is audible and produces effective masking in patients with clinically significant tinnitus."
tinnitus.	The "rate of masking achieved with the HiSonic-TRD device was similar to or slightly exceeded the rate of masking observed with FDA cleared tinnitus maskers." The study also demonstrated "a lack of interference with the patient's ability to hear ambient sounds during tinnitus masking." No adverse events were reported for the efficacy study itself.
2.2. Masking rate is similar to or exceeds that of existing FDA-cleared devices.	The "rate of masking achieved with the HiSonic-TRD device was similar to or slightly exceeded the rate of masking observed with FDA cleared tinnitus maskers."
2.3. No interference with hearing ambient sounds during masking.	The efficacy study demonstrated "a lack of interference with the patient's ability to hear ambient sounds during tinnitus masking."

Study Details:

2. Sample size used for the test set and data provenance:

Safety Study: 11 human subjects. Data provenance is prospective (study conducted specifically for this submission) in the USA (University at Buffalo Speech-Language and Hearing Clinic).
Efficacy Study: 20 human subjects. Data provenance is prospective (study conducted specifically for this submission) in the USA (Oregon Health Sciences University Tinnitus Clinic).
Bioacoustics Research Laboratory (Safety measurements): The text does not specify a "sample size" in terms of cases for these technical measurements, as it involves physical measurement of the device, not patient data in the same way. The provenance is the USA (University of Illinois Bioacoustics Research Laboratory).

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:

Safety Study: The text does not mention specific "experts" establishing ground truth in terms of diagnostic labels for a test set. The study observed changes in auditory thresholds, speech intelligibility, and adverse events. These were likely measured by qualified clinicians (e.g., audiologists) at the University at Buffalo Speech-Language and Hearing Clinic. The qualifications of these individuals are not specified beyond their affiliation with the clinic.
Efficacy Study: The text does not explicitly detail "experts" creating a ground truth label for the test set. Instead, researchers at the Oregon Health Sciences University Tinnitus Clinic (implied to be experts familiar with tinnitus assessment) conducted baseline measurements and assessed the device's ability to mask tinnitus based on a "threshold approach to audibility" and measuring "masking effects." The selection criteria required subjects with "clinically significant tinnitus," implying a prior diagnosis by a qualified professional, but not an independent "ground truth" establishment for the study itself by experts.

4. Adjudication method for the test set:

The text does not describe any formal adjudication method (e.g., 2+1, 3+1, none) for either the safety or efficacy studies. The measurements and observations appear to be direct outputs or assessments from the clinics.

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:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a treatment device, not an AI diagnostic tool that assists human readers. The efficacy study compared the device's masking rate to that of "FDA cleared tinnitus maskers," which is a comparative effectiveness claim, but not in the context of human reader improvement with AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This question is not applicable. The HiSonic-TRD is a medical device for treatment, not an algorithm. The "standalone" performance here would be the device functioning on its own, which is what the studies assessed (its ability to generate sound and mask tinnitus irrespective of operator skill in using it).

7. The type of ground truth used:

Safety Study: The ground truth was primarily based on objective measurements of audiological parameters (auditory thresholds, speech intelligibility) and self-reported adverse events. There isn't a "ground truth" label in the sense of a diagnosis being confirmed by an external gold standard.
Efficacy Study: The ground truth for efficacy was the subjective experience of tinnitus and its masking. The study selected subjects whose "tinnitus was present for at least twelve months and that the tinnitus showed little variability in loudness, localization or sound quality." Masking effectiveness was assessed by subjects reporting audibility of the device's sound and the effect on their tinnitus, as measured by a clinical "threshold approach to audibility." This relies on patient self-report and clinical assessment rather than an objective "pathology" or external "outcomes data" in the typical sense for diagnostic devices.

8. The sample size for the training set:

There is no mention of a "training set" as this device is not an AI/machine learning model. The studies described are for validation of the device itself.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this device.

Summary

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K 013 253/51

APR = 5 2002

510(k) SUMMARY

Hearing Innovations Incorporated HiSonic-TRD

Name and Address of Submitter

Arthur S. Przybyl President and CEO Hearing Innovations Incorporated 9040 S. Rita Road Suite 2250 Tucson, Arizona 85747

Phone: 520-663-0544 Facsimile: 520-663-0018

וגם מסוג מסוג בית ം പ്രവർശ്വ C

Date Prepared: March 11, 2002

Name of Device and Name/Address of Sponsor

HiSonic-TRD

Hearing Innovations Incorporated 9040 S. Rita Road Suite 2250 Tucson, Arizona 85747

Phone: 520-663-0544 Facsimile: 520-663-0018

Contact Person: Arthur S. Przybyl President and CEO

Common or Usual Name

Bone Conduction Tinnitus Relief Device

Classification Name

Tinnitus Masker

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Predicate Devices

K9638381 Starkey TM Air Conduction Tinnitus Masker, Starkey Labs K791790 Starkey TM-5 Behind Ear Tinnitus Masker, Starkey Labs K981704 Aurex-3 Tinnitus Masker, ADM-Tronics Unlimited, Inc. K951678 HiSonic Hearing Instrument, Hearing Innovations Incorporated

Intended Use

The HiSonic-TRD tinnitus masker is a wearable behind-the-ear style ultrasonic, bone conducted broadband noise and/or sweep frequency stimuli noise generator intended to generate noise of sufficient intensity and bandwidth to be used for tinnitus habituation therapy and is also suitable for tinnitus masking therapy. The HiSonic-TRD is intended to be used by those individuals who experience tinnitus, and do not need or desire amplification. The intended use of the HiSonic-TRD includes it's fitting by a qualified audiologist or other hearing healthcare professional familiar with the diagnosis of tinnitus and subsequent rehabilitation therapies. The target population is the adult population over 18 years of age. This product is not intended for use in children under the age of 18.

Technological Characteristics and Substantial Equivalence

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A 7.2V Lithium Ion battery powers the device. The tranducer is a piezoelectric ceramic that transmits ultrasonic energy in a typical operating frequency bandwidth of 19.5kHz-25.8kHz to the user. The generator/amplifier unit is worn on the body and houses the lithium ion battery. In addition, the body worn unit has an "on/off" switch, a noise/sweep selector switch and a volume control wheel for use by the patient. Both broadband noise and sweep frequency stimuli are incorporated in the device as masking stimuli.

The HiSonic-TRD generates and amplifies electronic oscillations, and then converts them into ultrasound energy with a piezoelectric ceramic transducer. The ultrasound energy is emitted as a broadband noise or as a sweep frequency.

The HiSonic-TRD is substantially equivalent to the other currently marketed tinnitus maskers that are referenced above. The HiSonic-TRD and three of the predicate devices are all tinnitus maskers. In addition, the Company's own 510(k) for an ultrasonic hearing instrument (K951678) supports equivalence of the HiSonic-TRD with regard to the piezoelectric ceramic transducer used to generate the ultrasound. Thus, the HiSonic-TRD raises no new issues of safety or effectiveness.

Performance Data

The company has conducted several safety and efficacy studies.

The University of Illinois Bioacoustics Research Laboratory measured the ultrasound energy emitted by the HiSonic-TRD at maximum output power levels against known injury mechanisms. The output intensity data were calculated against a standard thermal model supported by theoretical and experimental studies on blood and intact tissues. The ultrasound energy has been shown to be too low to produce thermal damage and too low to produce any other known damaging bio-effects. The output satisfies the safety limits of IEC 61689.

In a separate study, the University of Illinois Bioacoustics Research Laboratory, performed calibration measurements on the company's HiSonic-TRD device. The results of the calibration measurements demonstrated that

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the device is calibrated and that due to the low level of acoustic intensity (mw/cm²)*, output power, generated by the HiSonic-TRD device that it is not possible to reach unsafe acoustic intensity output levels with the device, even at the highest possible setting on the volume wheel.

*The measured output of acoustic devices intended for use in the audiology market is specified in dbSPL (decibels, sound pressure level) for air-borne devices and bone conducted auditory devices. If the available national or international measurement standards were applied to the HiSonic-TRD device, the output data would be misleading. The company provides exposure data in terms of fundamental physical principles. The output of the device is quantified in terms of the temporal-average acoustic power. The unit of measure is the watt. The acoustic power is then normalized to the area of the transducer element; the area is 1.27cm². The ratio of acoustic power to area is defined as acoustic intensity. Watts/cm2=Acoustic intensity. Due to the low level of output power generated by the HiSonic-TRD the acoustic intensity is reported in milliwatts per cm2 (mw/cm2).

A safety study was conducted using eleven human subjects at the University at Buffalo Speech-Language and Hearing Clinic. Subjects ranged in age from 22-70 years, six females and five males. Subjects had normal hearing, hearing loss, tinnitus and no tinnitus present. The study was conducted to examine any changes in auditory thresholds, speech intelligibility and any extra-auditory effects that might occur when using the HiSonic-TRD device. The results demonstrated that there were no significant changes in threshold, there was no decrease in speech discrimination and no interference with speech understanding. With the exception of headaches reported in two subjects the study reported no adverse events as a result of patient use of the device. The safety of the HiSonic-TRD is comparable to the safety of the predicates.

An efficacy study was conducted using twenty human subjects at the Oregon Health Sciences University Tinnitus Clinic. The study was conducted to evaluate the ability of HiSonic-TRD devices to produce clinically useful masking of tinnitus and to determine the effect of any aftereffects. The selection criteria required that each subject's tinnitus was present for at least twelve months and that the tinnitus showed little variability in loudness, localization or sound quality. Baseline air-conduction sound thresholds were measured across the audible range of hearing on all subjects prior to tinnitus

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assessment. The HiSonic-TRD device was evaluated using a threshold approach to audibility. The dynamic range (threshold to uncomfortable level) was measured and then the masking effects were assessed. The data obtained from this study indicate that the ultrasound emitted by the device is audible and produces effective masking in patients with clinically significant tinnitus. All subjects were easily able to hear the HiSonic-TRD masking sound (both sweep frequency tones and narrow band noise). The rate of masking achieved with the HiSonic-TRD device was similar to or slightly exceeded the rate of masking observed with FDA cleared tinnitus maskers. In addition, the study demonstrated a lack of interference with the patient's ability to hear ambient sounds during tinnitus masking. The study showed no adverse events as a result of patient use of the device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's services. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Hearing Innovations, Inc. c/o Arthur S. Przybyl President and CEO 9040 S. Rita Road, Suite 2250 Tucson, Arizona 85747

APR = 5 2002

Re: K013253/S001

Trade/Device Name: HiSonic-TRD Tinnitus Relief Device Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: March 6, 2002 Received: March 7, 2002

Dear Mr. Przybyl:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 801); 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address . http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use Form

510(k) Number (if known): K013253_____________________________________________________________________________________________________________________________________________

Device Name:

HiSonic®-TRD Tinnitus Masker

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 C.F.R. 801.109)

Over-The-Counter Use_

(Optional Format 1-2-96)

Jams K. Raugho

1 3 GM of Ophthalmic Ear, roat Devises

510(k) Number K01325

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.