The Problem: Main Drawbacks of current solutions

Bone anchored devices

• Exhibit skin traumas
• Insufficient gain in high frequencies.
• Requires lot of care of the abutment area
• Side to side cross talk
• Some large devices fit only certain skull size and exhibit complication risks
• Applicable for children only over 5 years old
• Esthetics

Middle Ear Implants

• Complicated surgery with some associated complications
• Ossicular coupling type must have normal ME function
• No sufficient gain at different frequencies.
• Gain may deteriorate over time
• Not applicable for children under 5 years old

The Challenge

There are several challenges in developing an efficient implantable Hearing Devices:

• They must be Powerful enough.
• They must have a good and long-term stable attachment.
• They must be effective and safe for the patient.
• They should have a solution that is safe for the patient, and preferably also safe for the Implant, if a magnetic resonance imaging (MRI) investigation is needed.
• It has been shown that the sensitivity increases for BC stimulation positions closer to the cochlea.
It was found that the acceleration, measured by laser Doppler vibrometer on the cochlear promontory of cadavers increased by 5–15 dB at frequencies between 600 Hz and 10 kHz by moving the stimulation position closer to the cochlea
Ref:
Håkansson B, Eeg-Olofsson M, Reinfeldt S, Stenfelt S, Granström G. Percutaneous vs transcutaneous bone conduction implant system: a feasibility study on a cadaver head. Otol Neurotol. 2008;29(8):1132–1139.
Håkansson B, Reinfeldt S, Eeg-Olofsson M, et al. A novel bone conduction implant (BCI):Engineering aspects and pre-clinical studies. Int J Audiol. 2010;49:203–215.
Eeg-Olofsson M, Stenfelt S, Tjellström A, Granström G. Transmission of bone-conducted sound in the human skull measured by cochlear vibrations. Int J Audiol. 2008;47:761–769.

The Solution: A novel patented implant technology

• Uses a miniature piezo based device.
• Attached to the cochlear structure on one side and anchored with a counter bone attachment unit to a bone in the opposite side, increasing overall response.
• Deformation of the piezo causes local deformation of the cochlear bone and a mixed air/bone conduction hearing.
• Very efficient cochlear stimulation (based on ABRs; LDV; Human trials)
• Direct bonny cochlear stimulation
• No physical damage to any ear structure
• No pre-requisite for middle ear status (active or non-active disease)
• Reversible surgery –the device can be taken out with no functional damage
• Simple surgery
• Large tested dynamic range in our animal studies > 48 dB
• Full and linear frequency range
• Less acoustic distortions
• No cross talk between ears
• MRI compatible
• Low power consumption
• Functional stability over time – not sensitive to infections or tissue growth