Amir Abolfathi, CEO and Founder of Sonitus Medical, talked about the SoundBite Hearing System, world’s first non-surgical and removable prosthetic hearing solution that relies on bone conduction to transmit sound, via teeth, at www.bio2devicegroup.org . Prior to Sonitus, Abolfathi served as VP of R&D at Align Technology, the makers of Invisalign, a unique, invisible, orthodontic product. And prior to that he served on senior management team at Embolic Protection Inc. and before that co-founded EndoTex, both of which were acquired by Boston Scientific.
Abolfathi began with a background on types of hearing loss and the size of the market. Hearing loss can be categorized by which part of the auditory system is damaged. There are three basic types of hearing loss: conductive hearing loss, sensorineural hearing loss, and mixed hearing loss. Sensorineural hearing loss (SNHL) occurs where there is damage to the inner ear (cochlea), or to the nerve pathways from the inner ear to the brain. This is the most common type of permanent hearing loss and can be caused due to illnesses, certain drugs, genetics, aging, head trauma, malformation of the inner ear, and exposure to loud noises. Conductive hearing loss occurs when the sound is not conducted through the outer ear canal to the eardrum and the bones or ossicles of the middle ear and causes include ear infection, allergies, fluid in the middle ear, peforated ear drum and so on. When there is a combination of both conductive hearing loss and sensorineural hearing loss, it is referred to as mixed haring loss.
Single Sided Deafness (SSD) refers to significant or total hearing loss in one ear and can be very debilitating, impacting safety, social comfort, professional performance and can lead to depression and loneliness. Although currently there is no cure, the treatment market is $130M and growing. Each year, there are approximately 200 new cases of SSD per million inhabitants in the world. Every year, there are 60,000 new cases of SSD, in the US alone.
One of the prominent treatment option for conductive hearing loss is BAHA (a bone anchored hearing device). BAHA works by transferring sound directly to the inner ear (cochlea), using bone conduction. Sound is picked up by the sound processor which transmits sound vibrations through the titanium implant to the skull bone. The sound waves then travel through the patient’s skull directly to the working inner ear. It is an invasive treatment option, requiring surgery and has low patient acceptance.
Sonitus SoundBite Hearing System is world’s first prosthetic device that is non-surgical, removable hearing solution based on the principle of bone conduction to transmit sound via the teeth, intended for those suffering from single sided deafness or Conductive Hearing Loss. Sonitus device is customized to be fitted over the upper back molar. Patients can even eat food, with the device on. It is a relatively low cost, non invasive device that does not require surgery, has minimal complications, and is more effective in transmitting sound. The battery is hermetically sealed, the patients are instructed to wear the device up to 15 hours a day, and the device is good for up to 2 years. Sound is picked up by small BTE (behind-the-Ear) microphone unit, worn on the impaired ear, and is wirelessly transmitted via the teeth, through bone, to the cochlea, thus it is re-routed from the impaired ear directly to the good cochlea, bypassing the middle and outer ear entirely. Safety and efficacy have been proven in various clinical trials and currently the focus is on commercialization and profitability, said Abolfathi. Sonitus is a core technology platform with multiple application in medical and non-medical market. In a total of 4 financing rounds, the company has raised $67M to date. The presentation was followed by Q&A.