General
Q. Is there a quick start guide for surgery or operation of the processor?
A. Yes. For surgeons and the OR, A Surgical Guide for the Alpha ImplantTM is available. For Audiologists, a Fitting and Software ManualTM is available as well as in-house training from a Sophono representative. Please contact your Sophono representative or call toll-free 1-877-604-9441 for more information.
Q. Is the product reimbursed through insurance?
A. Yes. The product is well reimbursed in most markets.
Q. Does the processor software support NOAH?
A. We are currently validating our software for NOAH compatibility. Sophono is aware of the importance of NOAH and how this software is utilized by clinics.
Audiology
Q. Why are there 0-5 magnetic strength baseplates?
A. A series of magnet strengths are provided to enable the Audiologist to find the best comfort and maximum security of the processor on the patient. A protocol is being developed for external magnet fitting and a Magnetic Retention ScaleTM is available from your Sophono representative.
Q. What strength baseplate is best to use for a patient?
A. We recommend the use of the weakest strength that keeps the processor properly attached. There is no “acoustic benefit” from using magnets stronger than required to keep the processor in place.
Q. What is “out of box” program for demo purposes?
A. The Sophono AlphaTM processor is set and shipped with a standard program. While the default program may be suitable for most demo purposes, it may be necessary to program the processor for specific patients based on their particular hearing loss.
Q. Is the Alpha 2TM headband system a good indication for the implant performance for a patient?
A. The Alpha 2 headband system performance is a very good indication on how the implanted device will perform. If patients like the headband system performance, they will certainly like the implant performance. This is why we recommend testing of all patients with headbands first, in particular those patients at the limits of the indication range. This also applies to the Alpha softband system.
Q. Are there any single sided deafness studies available?
A. Studies are constantly being presented and published. To ensure you receive the latest and most accurate information, please contact Sophono at information@sophono.com for the latest presentations and studies regarding the Alpha SystemTM.
Q. What if my patient is active in sports? Will the Alpha System work for these patients?
A. Increasing the external magnet strength of the baseplate during more strenuous activity provides added security as does the simultaneous wearing of the safety clip.
Q. Is the Alpha System moisture resistant?
A. Sophono is currently assessing nano-coating technology to include as part of the Alpha 2 System.
Q. Do you have an implant dummy? How can I buy them?
A. You can obtain an implant dummy from your Sophono Sales Rep or directly at www.sophono.com or order them by email, fax 720 407-5168 or telephone 720 407-5160.
Q. Can patients have an MRI with the implant?
A. On April 11, 2013, Sophono received clearance from the U.S. Food and Drug Administration for their patients with the Alpha 2 or Alpha 1 bone conduction hearing system to be able to have a magnetic resonance imaging (MRI) test. With the clearance, individuals in the United States who have the Sophono Alpha 2™ System can undergo MRI – in both 1.5 and 3-tesla magnetic fields – without removing the magnetic implant.
Outside the U.S., the Alpha 2 hearing device has earned clearance for use in an MRI field after passing rigorous tests from ASTM International, the globally recognized leader in the development and delivery of international voluntary consensus standards. The device underwent rigorous ASTM International tests for translation, torque, heating and signal loss artifacts produced in a magnetic resonance image by a passive implant. As a result, individuals in Europe, and other countries outside the United States, who have the Alpha implant can undergo MRI tests – in both 1.5 and 3-tesla magnetic fields – with the device intact.
Q. Does the software provide an initial fit?
A. Yes. We observe that in many cases the initial fit is very appropriate. Typically only small adjustments need to be done, i.e. gain and feedback related fine-tuning.
Q. How soon after implantation can the processor be fitted?
A. About 4 weeks after the implant surgery. It is important that the swelling has subsided and the skin is healed.
Surgical
Q. Can I implant the device in kids under 5 years of age?
A. Our Commercial Approval and respective registrations state that the minimum age for eligibility to be 5 years or older. We have been made of aware of some surgeons who decided to implant in younger than 5 year old kids. We can refer you to our Medical Director, Prof. Ralf Siegert, ralf.siegert@sophono.com, who is collecting such data and is properly qualified to respond to such medical indication questions. From Sophono’s perspective, patients must be 5 years of age or older to be eligible for implantation.
Q. Will a previous implant, like a Baha®, interfere with the magnet implant?
A. If the Baha implant is removed, there should be no issues with implanting an Alpha magnet device.
Q. Can the implant be placed closer to the patient’s ear?
A. Placement of the device should be as close as possible to the measurements stated in the Sophono Physician’s Manual.
Q. Should a patient have local anesthesia for this procedure?
A. This decision is up to the surgeon to utilize local or general anesthesia for the patient.
Q. Is tissue thinning beneficial?
A. Optimal tissue thickness is 4 mm to 6 mm. If the tissue is thicker, then thinning is beneficial.
Q. Could the “skin flap” for the implant be turned the other way, better concealing the scar behind ear?
A. If no reconstructive ear surgery is planned, the incision can be.
Q. Does the implant ship sterile?
A. Not yet. As of today implants are shipped non-sterile, however, as of second quarter of 2013, we expect to ship sterile implants in all markets.
Q. How should we sterilize the implant?
A. The sterilization procedure, which is standard in most clinics, is described in our Instructions for Use (IFU).
Q. Can I bend the arms of the implant?
A. Yes, to a certain degree. Care should be applied as frequent bending may weaken the titanium material. However, bending the implant’s arms to allow these to follow the contour of the skull surface is both permitted and desired.
Q. Can I implant the magnets facing out?
A. No. Sophono recommends that the implant magnets face down into a bone-bed of about 2 mm depth.
Q. What if I drill into the dura?
A. ENT surgeons routinely expose dura during their various surgical procedures. With the Alpha implantation, exposing dura may occur. This is not uncommon and without complications, as long as standard procedures are followed.
Q. Do I have to make a bone-bed?
A. Yes. We recommend that you implant the magnets face down into a bone-bed of about 2 mm depth. This needs to be flush under the skin.
Q. Does it matter what screw I put in first?
A. Yes. Sophono recommends placing the center screw first. This is to ensure the implant is as flush to the bone as possible.
Q. Can I put in only 3 or 4 screws?
A. We recommend all 5 screws are used to ensure the implant is stable and will not move. Using fewer screws may cause acoustic distortions that may be audible by the patient.
Q. What screws are approved for the Alpha implant?
A. Sophono did its testing with the Stryker Leibinger self-tapping and self-drilling screws, but does not approve a particular vendor over another. However, all screws must be made of titanium and need to be 1.7 mm in diameter and 4 mm in length or closely equivalent. Other commercially available cranio-maxillofacial screws may be used as long as the screw shaft diameter is less than 2.0 mm and the screw head size is greater than 2.45 mm.
Q. Will Sophono provide screws for the implant?
A. In some markets, Sophono offers screws for sale. Sophono continues to pursue validations and qualifications of high-quality screws for its product, in-line with the current approval language.
Q. Can we use other brands of screws?
A. Yes. Other brands may be used. Those other commercially available cranio-maxillofacial screws may be used as long as the screw shaft diameter is less than 2.0 mm and the screw head size is greater than 2.45 mm.
Q. What is better, self-drilling or self-tapping screws for the implant?
A. For the adult population, surgeons regularly use self-tapping 4 mm long screws. We have received reports that surgeons decided to use shorter screws for younger patients as well as self-drilling screws. We continue to pursue validations and qualifications of high-quality screws for our products, with specifications similar to the current approval language.
Q. Will the screws be delivered sterile?
A. Not yet. We are working on delivering sterile screws as of early second quarter of 2013. Typically the screws come in large OR trays, or if shipped by Sophono, in a package of 5 each.
Q. Should we have an emergency screw available?
A. Sophono suggests having extra emergency screws available and to have them already sterilized for surgery.
Q. Is there a phone number I can call if I have a question?
A. Please call toll-free 1-877-604-9441 with any questions at any time. We’ll be glad to help.
