Q. Who should I consider a candidate for the Alpha1 (M)?
A. Adults and children above the age of 5 with bone condition thresholds better than or equal to 45 dB HL, for cases of conductive or mixed hearing loss. Patients with single sided deafness must have thresholds better than or equal to 20 dB HL on the good ear.
Q. Basically, how does the system work?
A. The Alpha 1 (M) requires no abutment or permanent opening of the skin. It is comprised of a surgically implanted internal plate that houses two magnets hermetically sealed in a titanium case. The external sound processor houses a bone oscillator and uses a metal disc and spacer shim to magnetically couple to the internal component and deliver auditory stimulation through the closed skin.
Q. Is there an attenuation of the vibration through the skin?
A. The same physics involved when using a softband are true when using the Alpha 1 with the magnetic implant. The patient receives the same vibrational amplitude through the skin with the magnetic implant as they do with the softband or headband.
Q. Is the magnet sufficient to secure the processor to the implant?
A. Sophono produces a number of external magnets with varying strengths to ensure firm contact and protection from skin irritation. The magnetic retention of the external processor is more than adequate for normal activity levels.
Q. Will the strength of the magnetic attraction be significant enough to cause discomfort and/or skin breakdown?
A. Patients followed over time were given the choices of magnet strength and on average preferred a magnet strength equivalent to, or less than, the pressure exerted in use of a soft band. Should skin irritation occur, the retention force can be reduced by use of a weaker external magnet, and skin irritation should subside.
Q. What clinical data is available on the Alpha 1 System?
A. Data collected on the first 84 implants (57 patients) implanted demonstrates significant improvement in sound field thresholds and word recognitions scores. BC thresholds were between 5 – 43dB and air bone gaps between 18 – 75 dB. Average gain was 38 +/-8db. Average word recognition scores were 2% pre-operatively and 77% post-operatively at 65dB SPL.†
†Siegert, R. (2010). Magnetic Coupling of Partially Implantable Bone Conduction Hearing Aids Without Open Implants, Laryngo-Rhino-Otol, 89, 1-6.
