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510(k) Data Aggregation
(113 days)
The device is intended to be used for the temporary relief of tinnitus. The unit emits an ultrasonic signal that masks or inhibits the sound of timitus in many afflicted individuals. The tip of the device is placed firmly against the bone behind the ear and held in place until the device goes off (60-90 seconds).
This is a medical device and should only be used with the advice of a physician, audiologist or licensed hearing aid dispenser. Only adults 18 years of age and older should be dispensed an instrument.
The Inhibitor" is a hand-held device that emits a ultrasonic signal in the range of 20 – 60 kHz (depending on the resonant frequency of the Piezo element used). It is powered by a 3.6 V Lithium ion rechargeable battery. The transducer is a piezoelectric element. The acoustic output is <100 mW/cm2.
Here’s an analysis of the provided text regarding the acceptance criteria and supporting study for "The Inhibitor" tinnitus masking device:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not outline specific, quantified acceptance criteria in the traditional sense (e.g., a target percentage for reduction in tinnitus loudness, or a specific range for duration of relief). Instead, the primary "acceptance criterion" appears to be demonstrating substantial equivalence to predicate devices, particularly concerning safety and intended use (temporary relief of tinnitus).
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Safety: Acoustic output below levels causing thermal damage or other known bio-effects, satisfying IEC 61689. | Meets: University of Illinois Bioacoustics Research Laboratory study (9) on predicate HiSonic-TRD measured acoustic output <100 mW/cm², too low to produce thermal damage or other known damaging bio-effects. Satisfies safety limits of IEC 61689. The Inhibitor deemed substantially equivalent in output. |
| Effectiveness (Temporary Tinnitus Relief): Device provides temporary relief of tinnitus. | Meets (variably): Clinical trials (2,3,4,5,6,7) by Hearing & Balance Research Center observed: "Some individuals who used the device reported that their tinnitus went completely away, others found that the loudness of their tinnitus was reduced and some reported no effect." "Benefit of treatment varied considerably from one individual to another." "The benefit was temporary and their tinnitus eventually returned to the pre-treatment level." |
| Substantial Equivalence: To predicate devices regarding intended use and technological characteristics (ultrasonic signal for tinnitus masking/inhibition). | Meets: Explicitly stated that "The Inhibitor" is substantially equivalent to predicate devices (HiSonic TDR, Ultra Quiet, Starkey TM-3/TM-5, Siemens TCI) in intended use, technological characteristics (ultrasonic range 20-60 kHz, acoustic output <100 mW/cm²), and safety profile. |
| No New Issues of Safety or Effectiveness. | Meets: The document repeatedly states that "The Inhibitor raises no new issues of safety or effectiveness," based on its substantial equivalence to predicate devices which have been demonstrated safe and effective. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The clinical trials involved an unspecified number of "participants." However, a specific mention is made that "Hearing was evaluated on 14 ears after 16 (one minute) treatments." This refers to a safety evaluation, not directly an efficacy test set for tinnitus relief. For efficacy, the number of participants is not explicitly stated.
- Data Provenance: The studies were conducted by:
- The University of Illinois Bioacoustics Research Laboratory (for acoustic output measurements and safety).
- The Hearing & Balance Research Center in Hurst, Texas (for clinical trials on efficacy).
- Retrospective or Prospective: Not explicitly stated, but the description of "clinical trials over a three year period (2004 to 2006)" with "procedures" outlined (informed consent, audiological evaluation, rating tinnitus loudness before/after treatment) strongly suggests these were prospective studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable in the context of this device and study. The "ground truth" for tinnitus relief was based on patient-reported loudness ratings on a 1-10 scale, not an expert panel. For safety, the ground truth was based on physical measurements of acoustic intensity by a bioacoustics research laboratory, not expert consensus.
4. Adjudication Method for the Test Set
This is not applicable. The primary outcome for efficacy was patient self-reporting. There was no mention of an expert panel adjudicating patient responses.
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
This is not applicable. This device is a direct-to-patient hardware device (tinnitus masker), not an AI-powered diagnostic or assistive tool for human readers (e.g., radiologists). Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. This device is not an algorithm; it is a physical device used by patients, often under the guidance of a healthcare professional. Its performance is its direct effect on a patient's tinnitus.
7. The Type of Ground Truth Used
- For Safety: Instrumentational measurements by the University of Illinois Bioacoustics Research Laboratory, comparing acoustic output to known injury mechanisms and safety standards (IEC 61689).
- For Efficacy: Patient-reported outcome measures (PROMs), specifically a 1-10 scale for tinnitus loudness, before and after treatment.
8. The Sample Size for the Training Set
This is not applicable. This device is not an AI/machine learning model, and therefore, it does not have a "training set" in the computational sense. The clinical trials evaluated the device itself.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set for this type of device.
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