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510(k) Data Aggregation
(189 days)
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.
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.
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.
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