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Tinearity G1 is intended to generate noise of sufficient intensity and bandwidth to mask ringing in the ears or internal head noise to provide relief for patients with normal hearing in the home healthcare environment. The device is for prescription use only. The target population is adult population over 18 years of age. Tinearity G1 is applied on intact skin at the mastoid bone and transfers sound through bone conduction to the cochlea. Hearing health care professional shall be consulted for diagnosis, fitting of devices, and follow-up care.

The Tinearity G1 device is designed to generate sounds to be used in a Tinnitus Management Program to relieve patients suffering from tinnitus. Tinearity G1 comprises of three components: a sound generator, an adapter and a charger. The sound generator is attached to the skin behind the ear by means of the adapter. The sound generator converts white noise into vibrations that are transmitted via the adapter through the skull to the inner ear. The device generates white noise within the frequency span of 700z-10Khz with a maximum output level of 48dB HL. The adapter is a disposable device that serves as a mechanical connector between the sound generator and the user. The adapter is made up of a plastic holder that is compatible with the sound generator and a medical grade tape to be attached to the user's skin behind the ear. The adapter is a single use device and is designed to be removed daily after each treatment. The sound generator uses a re-chargeable battery as power source which is charged with the charger. The Tinearity G1 sound generator and adapter can be used during all times of the day, during sleep as well as during work and spare time.