INDICATIONS, SAFETY, AND WARNINGS BONE CONDUCTION HEARING THERAPY
The Alpha 2 MPO ePlus™ is intended for use for the following patients and indications:
Patients and/or patient guardians must be able to understand that Alpha 2 MPO ePlus™ 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 Alpha 2 MPO ePlus™ 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.
The Alpha 2 MPO ePlus™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 Alpha 2 MPO ePlus™ sound processor attached magnetically to a headband or softband (no age limitations). The second configuration is the Alpha 2 MPO ePlus™ 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 Alpha 2 MPO ePlus™ sound processor against the head, and vibration is transduced through direct contact with the patient’s skin and the bone below.
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.