California-based Sonitus Medical, Inc, the manufacturer of the world’s first and only non-surgical and removable hearing device to transmit sound through the teeth, has announced that the American Academy of Otolaryngology- Head and Neck Surgery has approved a policy statement on implantable hearing devices that includes placement of a bone conduction oral applicance as an acceptable procedure for the relief of appropriate indications, such as Single Sided Deafness or Conductive Hearing loss when performed by a qualified professional.
This means that patients suffering from these conditions will be able to take advantage of intra oral prosthetic hearing devices, which will offer them non-surgical and cost-effective treatment option.
“We are delighted that the AAO-HNS Board of Directors has acknowledged the clinical safety and efficacy of an oral appliance for treatment of single-sided deafness and conductive hearing loss in its policy statement library," said Amir Abolfathi, CEO of Sonitus Medical. "This positive action by such a prestigious professional organization is an important product milestone and promises to be very beneficial as we actively pursue securing a broad-based reimbursement for SoundBite Hearing System.”
An innovation in hearing loss technology, SoundBite transmits sound using the well-established principle of bone conduction. Unlike predecessor prosthetic devices that reroute sound through skull bones, SoundBite places a custom fabricated transducer on the tooth, thereby eliminating the need to surgically implant a post in the skull. In this way, SoundBite eliminates the surgical costs and potential complications of the implant by using the tooth as a "naturally osseointegrated" post.
The SoundBite system comprises two parts. The first component is a removable in-the-mouth (ITM) appliance, which is custom made for each patient to fit on either the upper left or right back teeth. The ITM transducer produces vibrations that allow sound to reach the cochleae via bone conduction. The second component is a small digital signal processor unit worn behind the ear (BTE) which picks up the sound and wirelessly transmits the signal to the ITM. The ITM does not require modification to the teeth, and an oral exam is conducted by a medical professional prior to use of SoundBite. SoundBite is removable, with normal daily functions such as talking and eating attainable with the device in place.
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