SoundBite Dental Hearing System Now an Option in Europe

SoundBite Dental Hearing System Now an Option in Europe

The SoundBite™ Hearing System in Detail

SoundBite Hearing System works by making innovative use of the well-established, natural principle of bone conduction – the transmission of imperceptible sound vibrations through the bones to the inner ears – to deliver clear, natural, high quality sound.

Nearly invisible when worn, the SoundBite system consists of two components: an easy to insert and remove ITM (in-the-mouth) hearing device and a small BTE (behind-the-ear) microphone unit worn on the impaired ear. No dental work or modifications to the teeth are required. Both components have rechargeable batteries and a system charger is also provided.

The BTE (Behind-The-Ear) Microphone Unit

SoundBite Behind-the-Ear Unit

BTE (Behind-The-Ear)

Microphone Unit

To take advantage of the natural acoustic benefits provided by the patient’s own ear, sound in the environment is picked up by a tiny microphone placed within an open fit dome worn in the canal of the impaired ear and connected to the BTE by a small translucent tube. The BTE uses a digital signal processor to process the sound and a wireless chip to transmit the signals to the ITM hearing device, which in turn sends imperceptible vibrations via the teeth near-simultaneously to both cochleae. In this way, sound is rerouted from the impaired ear directly to the good cochlea – bypassing the middle and outer ear entirely – to effectively restore the perception of hearing from the impaired ear. SoundBite Hearing System delivers sound across a broad frequency range of 500 Hz to more than 12 kHz.

The ITM (In-the-Mouth) Hearing Device

SoundBite Oral Device

ITM (In-The-Mouth)

Hearing Device

The ITM device is custom made to fit around either the upper left or right back teeth, does not require any alteration of the teeth, and is easily inserted and removed by the wearer. It contains electronics, a sealed, flat, rechargeable battery, wireless capability that picks up sound transmissions from the BTE, and a small actuator that converts those signals into vibratory energy. All of these miniaturized components are hermetically sealed inside a dental grade acrylic that has been safely used for making dental appliances for many years.

System Charger

SoundBite Charger

System Charger with

BTE and ITM

SoundBite does not require changing batteries. A system charger powers both the ITM Hearing Device and BTE microphone unit. The charge lasts 6 to 8 hours for the ITM and 15 to 18 hours for the BTE.

SAN MATEO, Calif., Sept. 5, 2012 /PRNewswire/ — Sonitus Medical, Inc., a medical device company that manufactures the world’s first non-surgical and removable hearing device to transmit sound via the teeth, today is announcing the global commercialization and a limited market launch in Europe of its SoundBite™ Hearing System. The first deployment of its prosthetic devices throughout Europe is a measured roll out to seven centers of excellence in key markets in order to conduct a multi-site evaluation of the SoundBite prosthetic device.

“This is a major milestone for our company as we begin to establish a commercial network for SoundBite in Europe,” said Amir Abolfathi, CEO of Sonitus Medical. “We are gratified to be working with esteemed hearing specialists in the EU medical community to undertake this post-market evaluation which will document long-term utilization and patient experience.”

The SoundBite Hearing System received CE Mark certification in The European Union for the treatment of single sided deafness, or patients who are essentially deaf in one ear, those with conductive hearing loss, and those with mixed hearing loss.

SoundBite uses bone conduction to deliver clear, high quality sound to the inner ear. Many familiar sounds are heard through bone conduction; for example chattering teeth, crunching on potato chips, or scratching the scalp. Nearly invisible when worn, the SoundBite system consists of an easy to insert and remove in-the-mouth hearing device and a small microphone unit worn behind the ear.

About the European Pilot Study

Currently underway with 20 patients at four leading academic medical centers, the pilot study will monitor patient experiences and qualitative results at one, six, and 12 months, and will grow to include five patients at each site for a total of 35 subjects.

The seven participating centers of excellence are: The University Hospital Southampton, United Kingdom; University Hospital Ramon y Cajal, Madrid, Spain; University Hospital, Maastricht, Netherlands; University Hospital of Geneva, Switzerland; University Medical Center of Mainz, Germany; Hanusch Hospital, Vienna, Austria; and ENT Practice of Dr. Waldemar Motzko, Bad Soden, Germany.

New Senior Management

With Sonitus’ European commercialization plans well underway, the company has deepened its management team with the recent appointment of two high level senior executives with decades of relevant experience.

Mike Favet, named Chief Operating Officer, has been in the medical device industry for more than 20 years, accumulating broad cross-functional experience in companies of various sizes with products in diverse therapeutic areas. Chief Financial Officer Jeff Mack brings more than 25 years of experience, including a strong background with fast-growing, technology-based companies. He has extensive experience in all areas of financial management, including capital events/IPOs, SEC reporting and compliance, M&A and investor relations.

“We are extremely pleased to welcome these two seasoned executives to the company,” said Abolfathi. “As we to continue to ramp up our European network, Mr. Favet and Mr. Mack will play integral roles in guiding Sonitus Medical forward in our efforts to offer a novel treatment solution for all patient who suffer from single sided deafness, conductive hearing loss, or mixed hearing loss.”

About Sonitus Medical

Sonitus Medical (www.sonitusmedical.com) is a privately held medical device company committed to providing advanced hearing solutions that hearing professionals such as otologists, ENTs, and audiologists can use to help their patients rejoin the conversation of life. Founded in June 2006, the company is headquartered in San Mateo, California. Its SoundBite Hearing System (www.soundbitehearing.com) is the world’s first non-surgical and removable hearing solution that relies on bone conduction to imperceptibly transmit sound via the teeth.

Currently FDA cleared for the treatment of both single sided deafness and conductive hearing loss, SoundBite Hearing System has intended future indications for hearing disorders such as tinnitus. The technology also has application in consumer and communications. Additionally, the company has received its CE Mark certification, which indicates full quality assurance system approval and that Sonitus Medical’s design and manufacturing processes for the SoundBite device comply with certain manufacturing and design standards under the European directive concerning medical devices.

Source : http://www.prnewswire.com/news-releases/sonitus-medical-announces-first-european-commercialization-with-shipment-of-soundbite-hearing-system-to-seven-centers-of-excellence-168601676.html

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