A Single Spark of Ingenuity Can Ignite the Inferno of Invention

Contributed by: Stephani Gonzales, SDSU Audiology




Sophono, Inc. have produced the Alpha 1 system, a bone-anchored hearing device, since 2010.

How It Works

• The Alpha 1 (M), made of an implanted internal plate with two magnets hermetically sealed in a titanium case, requires no abutment or permanent opening of the skin.
• The Alpha 1 (S) external sound processor contains a bone oscillator and uses a metal disc and spacer to magnetically attach to the internal plate.
• Auditory stimulation is delivered through the closed skin.
• Conductive loss or mixed hearing loss: bone conduction thresholds < 45 dB.
• Single-sided deafness: bone conduction thresholds < 20 dB in the hearing ear.

The Alpha 1 (M) Implant

Clinical Data

• 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.

Additional information

 ========================================================================

The SoundBite Hearing System, developed by San Mateo, CA-based Sonitus Medical, Inc., is world's first non-surgical and removable hearing solution to use bone conduction to transmit sound via the teeth.

How It Works

• An in-the-mouth (ITM) hearing device, custom made to fit around the upper, left or right, back teeth.
• A small behind-the-ear (BTE) receiver unit.

Who Is It For?

• SoundBite™ Hearing System is an FDA 510(k) cleared device for single-sided deafness and conductive hearing loss.
• For patients 18 years and older with the following indications:
• Single sided deafness classified as moderately severe to profound sensorineural hearing loss in one ear and normal hearing in the other ear. Normal hearing is defined as a pure tone average (PTA) air-conduction (AC) hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 25 dB HL.
• Patients with conductive hearing loss with bone conduction threshold PTA at 0.5, 1, 2, and 3 kHz < to 25 dB HL.

Benefits

• Removable and totally non-invasive.
• Takes advantage of the pinna and outer ear resonance with ear canal microphone placement: this can help with localization and speech in noise.
• Broad frequency response range 500- 12,000 Hz.

Additional information