Hearing Aids Via Teeth Receives Second FDA Clearance


Hearing Aids

Hearing Aids

The SoundBite Hearing Aid system has received it’s second clearance by the USA Food and Drug Administration.  The device provides a unique and innovative alternative for the hearing impaired.  The new FDA clearance allows use of the SoundBite system for patients with conductive hearing loss.

SoundBite is a non surgical solution for the hearing impaired. It is a cost effective alternative to existing surgical procedures that yield similar results.  The device is a removable prosthetic that uses bone conduction through your teeth to amplify and transmit sound clearly to your inner ear.

“We are pleased that the uses of the SoundBite system continue to expand,” said Amir Abolfathi, CEO of Sonitus Medical. “As we begin the roll out of our product in partnership with Otologists, ENTs, and Audiologists, we remain committed to increasing the number of patients who may benefit from our non-surgical treatment option.”

No modifications to your teeth are needed to use the SoundBite system. The process is comprised of a custom made ITM(in the mouth) hearing device that is fitted on the patients upper left or right back teeth and a microphone  device that is worn behind the ear.

The new SoundBite system will be available through audiologist and physicians sometime this fall. It will only be available initially in a few select markets.  Currently it is cleared for conductive hearing loss and  single sided deafness. Future plans are to support solutions for mixed hearing loss as well.

For more information visit: http://www.soundbitehearing.com

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