(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
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 |
§ 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.