#1 Bone Conduction of Sound For Single-Sided Deafness

Overview

Imagine for a moment that you had single sided deafness (SSD) and were only able to hear out of your right ear: You might start your day sleeping through your bedside alarm and arrive late for work. No longer able to pinpoint the exact source of sound, you almost get hit by a car while crossing the street. In a noisy conference room, you can barely hear a close conversation your boss is having with you because he is speaking towards your left (deaf) ear and because of the meaningless cacophony of noise in the background. Sound seems to be coming from all directions. You soon get tired and frustrated trying to concentrate on what is being said to you.

Single sided deafness, which affects 9 million people in the United States, refers to significant and typically permanent hearing loss in one ear and normal hearing in the other. When someone speaks, sounds cannot properly reach the working inner ear (cochlea) or when sounds do reach the inner ear, they cannot be turned into neural impulses that are sent to the brain.

As you can imagine, an impaired ability to detect the direction of sounds and to separate background noise to make sense of speech can make work and social situations nearly impossible and painfully embarrassing. Feelings of social isolation and exclusion are common.

SSD, which can be caused by trauma, viral infections, and an acoustic neuroma, a slow-growing benign tumor of the auditory nerve, cannot be cured but can be rehabilitated. Two treatments have been available for several years, but both have their distinct disadvantages.

However, there is now a non-surgical, removable hearing and communication device that is designed to imperceptibly transmit sound via the teeth to help people with single sided deafness regain their hearing.

 “This innovative device is different from conventional hearing aids, which employ air conduction to simply turn up the volume of sound traveling into the ear,” says Michael Benninger, M.D., Chairman of the Head and Neck Institute at the Cleveland Clinic. “This is a bone conduction device, and it doesn’t require a functional middle or outer ear to deliver sound. Instead, the hearing system is designed to let sound travel via the teeth, through the bones, to both cochleae, bypassing the middle and outer ear entirely.”

As a nearly invisible digital audio device, the system consists of a small microphone unit worn behind the ear and an easy-to-insert and remove dental retainer-like device that contains electronics, a sealed, flat, rechargeable battery, wireless capability that picks up sound transmissions from the ear unit, and a small actuator that converts those signals into vibratory energy.

FDA approval of the device is expected in 2010 for SSD, and intended future indications include addressing the needs of patients with conductive or mixed hearing loss and tinnitus.

 

Where Are They Now

Single sided deafness (SSD) affects 9 million people in the U.S. The newly developed non-surgical, non-invasive, removable hearing device bypasses this requirement by transmitting sound via the teeth and bones, to both cochleae. This digital audio device is nearly invisible and consists of a small microphone unit worn behind the ear on the deaf side and an easy-to-remove dental retainer-like processor for the conversion of audio signals into vibratory energy.

The world's first non-surgical, non-invasive bone-conduction hearing device received FDA 510(k) clearance in 2011. Unfortunately, the startup that created this device has been shut down after CMS failed to provide coverage for the bone conduction sound system, even after multiple appeals. This is a surprising outcome for the technology which had a 2014 revenue of $4.8 million, and an expected 2015 revenue of $10 million, on top of an $80 million initial investment from top investors.  The first direct-to-device wireless technology for bone conduction hearing has been engineered by the medical device company at the forefront of this technology and was approved by the FDA in March of 2016. The device became commercially available in the United States in late summer of 2016.

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