Indication for Use
The Sophono Sound Processor is intended for use 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 Air Conduction Contralateral Routing of Signal (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).
Patients and/or patient guardians must be able to understand that the Sophono System will not restore hearing to normal and will not prevent additional hearing impairment resulting from conditions such as disease, old age hearing loss, genetic hearing loss, ototoxic drugs or noise induced hearing loss. The prospective patient should have a successful trial assessment with the Sophono system before receiving this hearing therapy. In addition to risks related to surgery, complications can include discomfort, pain, numbness or tingling at the implant site.
Important Risk Information About the Sophono® Hearing Therapy: The Sophono Magnetic Bone Conduction Hearing System includes a family of Sound Processors and accessories that operate on the principle of bone conduction of sound vibrations. The Hearing System is supplied in either of two configurations. The first configuration is the Sophono Sound Processor attached magnetically to a Headband or Softband (no age limitations). The second configuration is the Sophono Sound Processor and Attract® Magnetic Spacer attached magnetically to a Magnetic Implant which is surgically implanted behind the patient’s ear (indicated for patients 5 years of age and up). The Headband, Softband, or Magnetic Implant (with the magnetic spacer) holds the Sophono Sound Processor against the head, and vibration is transduced through direct contact with the patient’s skin and the bone below.
Warnings: This therapy is not for everyone. Please consult your physician. A prescription is required. For further information, please contact Medtronic at 800-510-6735, or refer to www.medtronic.com. Nota Bene: The technique description herein and the use of instructions for the related procedures are made available by Medtronic ENT to the healthcare professional to illustrate the author’s suggested treatment for the uncomplicated patient. In the final analysis, the preferred treatment is that which, in the healthcare professional’s judgment, addresses the needs of the individual patient. Rx only. Refer to product instruction manual/package insert for instructions, warnings, precautions, and contraindications. For further information, please call Medtronic ENT at 800.874.5797 or 904.296.9600. You may also consult our website at www.MedtronicENT.com.