Q: How do I know if I’m a good candidate for the Alpha SystemTM?
A: The Alpha System works well for patients with conductive, mixed and single sided hearing loss. To ensure that you are a good candidate, please contact your hearing clinic or Audiologist for a trial and evaluation with the Alpha Sound Processor.
Q: Can I speak with someone who has undergone the surgery?
A: At this time we do not have a direct patient connection, but please feel free to post on our Sophono facebook page or the Sophono Bone Conductive Hearing Aid facebook page to connect with other patients and families.
Q: How long have you been in operation?
A: Sophono was incorporated in October 2009, following five years of research and development, with a vision and dedication to improving the bone anchored hearing device experience.
Q: Are you FDA approved and since when?
A: Sophono received FDA clearance in June 2011, however the initial product has actually been available in Europe since 2006.
Q. Is there a standard warranty for the Alpha System in the U.S.?
A. Sophono’s standard warranty is two years for the Alpha System. An extended warranty program is now available. Contact Sophono for information.
Alpha Sound Processor
Q: Can I try the Alpha System before I get the implant?
A: Absolutely! Contact your area hearing clinic or Audiologist to schedule a demo with an Alpha 2TM softband or headband system.
Q. Is it easy to place the Alpha sound processor and baseplate on the magnet site?
A. The Alpha processor is easy for patients to place. It is easier to first place the baseplate over the implanted magnet site and then fit the Alpha processor into place over the baseplate. Since the two implanted magnets are at opposite poles, the baseplate and Alpha self-locate to the correct position.
Q: Can I sleep with my processor on?
A: The processor is designed to be worn comfortably for most of the day. Sophono suggests taking the Alpha processor off when sleeping. Wearing your processor while sleeping could cause pressure in the implant area and possibly damage to the sound processor.
Q: How can I adjust the volume on the Alpha 2?
A: Your Audiologist can program the volume control to allow you to adjust up to 8 times as loud as the basic setting.
Q. How long does the battery last?
A. The battery typically lasts a few weeks, but it does depend on the hours of daily use and the volume programmed.
Q. Can all Alphas connect to my cellphone or FM Systems like my mp3 player?
A. The just-released Alpha 2 has an integral DAI connection. All future sound processors will have the integral DAI connection. In order to use an FM system for the Alpha 1TM, it is necessary to have the processor with the DAI input.
Q: What is the benefit to having direct auditory input or DAI?
A: The DAI allows for direct input of sound from an external source such as an assistive listening device (FM system or direct connect system).
Q: Is the Alpha 2 Bluetooth compatible?
A: No. Bluetooth systems consume a lot of energy. Due to the drain on the battery, we have decided not to add Bluetooth availability at this time.
Q. What colors are available for the Alpha processor?
A. Anthracite, Silver, Brown and Champagne. Colorful SkinitTM decals are also available for the Alpha 2. For more information, go to www.skinit.com/sophono.
Q. How many programs does the Alpha processor have?
A. There are 4 memory programs. The Audiologist may activate fewer than 4 programs after consultation with the patient or guardian. The 4 programs allow the Audiologist to set individual programs for specific listening situations as well as interfacing with assistive listening devices.
Q. Is the Alpha 2 headband system a good indication for the implant performance?
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: How wet can I get my processor?
A: We recommend that you treat your processor as you would any sensitive electronic device such as your cellphone. The processor is meant to withstand a very low amount of moisture, but cannot be submerged in water or subjected to rain, snow or humid conditions.
Q: What is the difference between your product and the Baha® and Ponto?
A: These are bone anchored hearing aids (“baha” for short). The Baha and Ponto devices utilize a metal post, also called an abutment, which protrudes through the skin. The Alpha System uses an FDA-cleared implantable magnet that is completely underneath the skin, which eliminates the need for daily post-surgical care of the abutment site and reduces your chance of infections or complications. The two small magnets are encased in titanium.
Q: How does the Alpha System performance compare to other popular hearing devices?
A: The performance of the Sophono Alpha System is comparable to other bone conduction products on the market. However, Sophono offers significant cosmetic improvements and post-surgical complications are dramatically lower than with abutment-based devices.
Q: What are the complication rates associated with these products?
A: Because the Alpha System does not protrude through the skin, patients do not experience the same complication rates as abutment-based devices. Potential complications should be discussed with your Implant Surgeon prior to surgery.
Q: How much does the product cost?
A: This will be determined by your audiologist or health care insurance provider in your country.
Q: Is there anyone in my area performing this surgery or who offers your product?
A: We have more than 150 clinics in the U.S. and Canada and we are represented in 36 countries internationally. Please contact Sophono at 877-604-9441 (toll-free) or email us for more information.
Q: Is there a safety clip option?
A: The Alpha System does have a safety clip accessory available.
Q. Can I engage in active sports while wearing my Alpha device?
A. Sure. Just make sure you use a magnetic baseplate strong enough to hold the device during activity.
Q. Can I wear a baseball cap with my Alpha processor in place?
A. Since the Alpha is positioned just behind the ear for the optimum bone conduction level, a baseball cap should fit comfortably just above the site. Some cyclists can even wear their cycle helmets.
Q. Does the Alpha Sound Processor support directional microphone technology?
A. The Alpha 2 Processor has directional or dual microphone technology. This improves hearing in environments where background noise is an issue. The technology automatically detects and reduces amplification of unwanted noise from behind, while preserving frontal amplification of people or sound for clearer conversations and communication. The Alpha 1 has omnidirectional microphone technology, which means the microphone has equal sensitivity in all directions.
Q. What do I do if it hurts to put the processor on? What should I do if the device is not comfortable?
A. Use a weaker baseplate and reduce the daily use until the pain goes away. Having some light pressure and skin sensitivity is normal with the initial use of the processor. These sensations will pass quickly with the daily use of the device.
Q. What if the processor falls on the floor?
A. For any sensitive electrical device like a sound processor, dropping it on a hard floor may damage the device. It is up to the patient to decide when to use the safety clip for the Alpha processor.
Q: If my processor needs repair, who do I contact?
A: Please contact your Audiologist and they will work with Sophono or a local Distributor to have your processor repaired.
Q: Why are different magnetic baseplates available?
A: By having different baseplates with varying magnetic strengths, your Audiologist can choose which strength baseplate is best for your and most comfortable.
Q: Are the baseplate magnets available in different colors?
A: Right now, the baseplates are only available in black. Sophono will have a blonde colored baseplate available in the second quarter 2013.
Q: Could the baseplate be thinner, making the device lower in profile?
A: We are constantly working on improving all of our products. A thinner plate is under development.
Magnetic Implant and Surgery
Q: How old do you have to be to get the implant?
A: Anyone age five or older can have the implant procedure. We have an Alpha Sound Processor softband and a headband system for children under five years of age or for anyone not choosing to have an implant.
Q. Do I have to stay in the hospital overnight?
A. No. Typically the surgical procedure is done following outpatient procedures.
Q: Will my head be shaved for the implant surgery?
A: Just the incision site will be shaved before the surgery. Surgical technique differs, but, many surgeons consult with the patient prior to surgery to minimize the area to be shaved. However, follicle removal is not part of the surgical procedure as is the case with abutment-based devices. Your hair can grow back normally as the site heals.
Q. Will I have to keep the hair shaved around the healed incision area? Will I have a bald spot?
A. No. You can grow your hair back as normal. Sometimes, the longer hair you have the better the magnet sticks. It’s easier to fold over the hair than push against it. The hair can provide an extra cushion.
Q. How long does the surgical procedure take?
A. Typically the surgical procedure takes about 30 minutes.
Q: How long will I be in the hospital after surgery and how long will it take for me to heal after the surgery?
A: The post-surgical timeframe may vary from hospital to hospital and doctor to doctor, but generally you can expect to leave the hospital the same day. Your Alpha processor can be activated approximately four weeks after surgery.
Q. What special care must I give to my incision site?
A. Because there is no abutment, there are no daily routines for cleaning the skin once the incision line from surgery is healed.
Q. My surgeon said I have to wait a week or so to shampoo my hair after I’ve had the implant. What can I do to keep my hair clean and not put water on my head?
A. Many Alpha patients have used a dry shampoo on their hair to stay comfortable during the first week after surgery. Talk with your surgeon’s office about what they recommend.
Q: Can I go through a metal detector?
A: Yes. If an alarm goes off as you walk through a metal detector, just show your implant patient card to the screening agent.
Q: Can I have an MRI procedure with an Alpha magnetic 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 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: Will having a magnet in my head hurt me?
A: No. There is no historical evidence of problems or any side effects with magnetic implants. The brain and the body are not affected by magnets, especially not in these low strengths.
Q: How many people have been implanted in the U.S. and abroad?
A: To date, there are approximately 2,500 patients with the Alpha implant and the processor system.
Q: Will my insurance company cover the Alpha System?
A: All major U.S. insurance carriers have covered the product and in most countries where we currently do business through distributors. However as with any medical device, Sophono suggests you submit for pre-authorization to avoid any surprises and to confirm if there are out- of-pocket costs.