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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.

Intended to be used as a wearable sound amplifying device to compensate for mild to severe hearing loss.

Model WMR BTE is a dual-channel, wide-dynamic range input instrument which allows for loudness correction compression by changing compression ratios within the two bands. The WMR separates incoming signals into high and low frequency bands which can be independently compressed prior to recombination and amplification. The electronics for the hearing instrument are contained in a custom plastic case. The Model WMR BTE features three adjustable trimmers that can only be adjusted by the dispenser to meet individual patient requirements. The user may adjust the gain (loudness) of the hearing instrument by rotating the volume control dial to his/her most comfortable listening level. This hearing instrument does not require a special fitting system; however, the trimmer controls may only be adjusted by an authorized hearing aid dispenser, NOT by the consumer. Notes to this effect are included in the User Instruction Booklet included in this submission. - The crossover frequency between the low band and high band channels; 1) - 2) High band compression ratio; - 3) Low band compression ratio