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The Sophono® Sound Processor is intended for use with the Sophono® Headband (no age limitations), or with the Sophono® Magnetic Implant (patients 5 years of age and up) for the following patients and indications: - Patients with conductive or mixed hearing losses, who can still benefit from amplification of sound. The pure tone average (PTA) bone conduction (BC) threshold for the indicated ear should be better than 45 dB HL (measured at 0.5, 1, 2, and 3 kHz). - Bilateral fitting is applicable for most patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2, and 4 kHz, or less than 15 dB at individual frequencies. - Patients who have a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear, who for some reason will not or cannot use an AC CROS. The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should be better than 20 dB HL (measured at 0.5, 1, 2, and 3 kHz).

The Sophono® Bone Conduction Hearing Systems are a family of sound processors and accessories that operate on the principle of bone conduction of sound vibrations. The Sophono® (S) configurations are held directly against the head using either a soft band or a headband with the Sophono™ Sound Processor. The vibration from the Sound Processor is transduced through direct contact with the patient's skin and the bone below. The Sophono® (M) configuration is magnetically attracted to the Sophono® Sound Processor through a Magnetic Implant, and a Magnetic Spacer. The Magnetic Implant attracts a Magnetic Spacer that is held against the head through magnetic attraction forces to the Magnetic Implant, with the Sound Processor also held magnetically against the Magnetic Spacer. The vibration from the Sound Processor is transduced through direct contact with the patient's skin and the bone below to the inner ear. The Sophono® Systems are designed for use for those patients with conductive hearing loss, those patients who have sensorineural hearing loss up to 45 dB in combination with their conductive loss, and single sided deafness as defined in the indications for use. The prescriptive formula and adjustments available to the audiologist in the software allow for programming the Sophono® Systems for individual patient hearing loss.