'Miracle' Hearing Aid For In the Mouth Hits Washington Market

WASHINGTON, DC - Sonitus Medical of San Mateo, CA partnered this week with a Washington, DC team of physicians in the release of a virtually invisible, in-the-mouth and behind-the-ear hearing system,

Washington, WA (prHWY.com) November 9, 2011 - WASHINGTON, DC - Sonitus Medical of San Mateo, CA partnered this week with a Washington, DC team of physicians in the release of a virtually invisible, in-the-mouth and behind-the-ear hearing system, offering a non-surgical solution to single sided deafness.

The new solution, appropriately named SoundBite, fits like a retainer to the teeth and communicates through a controlled magnetic frequency with a corresponding behind-the-ear device, delivering clear sound to the inner ear. Even more impressive, the sound waves travel via bone-conduction; from the teeth, through the bone, to the cochlea of the inner ear. Furthermore, power emitted from the SoundBite is less than one ten-thousandth (1/10,000) that of a cell phone, is harmless to surrounding tissue, and is FDA approved.

Patients in the northeast and beyond may now rely on an advanced team of physicians from the George Washington University Hospital for access to the device. Ontolaryngologist, Ashkan Monfared, MD, and surgical dentist, Lawrence D. Singer, DMD were selected by Sonitus Medical. Monfared is the Director of Otology and Neurotology at The George Washington Medical Faculty Associates (MFA), while Singer holds the title of Assistant Clinical Professor of Surgery. Also involved from Monfared's team of Audiologists at the MFA are Rachel Lazaro, Au.D. and Christine Sleger, Au.D.

Until now, the recommended treatment for single sided deafness has been a surgically implanted titanium cylinder directly into the external skull behind the ear (similar to a dental implant in design) with screw-on abutment that looks like a transistor radio on the head (commonly known as the BAHA - bone anchored hearing device). The implant, approximately 10mm in length (1/2 inch) and 10 mm in diameter, is screwed into the skull under general anesthesia. Once the patient heals, the abutment (a plastic box housing an electronic transmitter about the size of a garage opener remote control) is screwed onto the abutment to capture sound. Many find the esthetic of the system obvious and objectionable. This bone-anchorage implant system involves pain, surgical risk, and a minimum of three months before it becomes usable. If great care is not taken, the area where it interfaces with the skin and the skull bone can become infected.

Sonitus Medical has currently hand-selected only twelve physician teams across the country in the SoundBite pre-pilot implementations. These groups, labeled alpha providers, will have exclusive prescribing authority throughout the pre-pilot launch, expected to last through December, 2011.

"We are excited to be one of the first teams in the nation to offer the SoundBite. This is welcomed news by our Washington, DC area patients," sayd Monfared. "We expect a noticeable volume of patients travelling to us from all over the country for access to the new device."

Included in the nine million people affected by SSD is Singer's 5-year-old son, Max. Born with both microtia and atresia (no external ear or ear canal), Max's treatment options thus far have been less than desirable; the aforementioned bone-anchorage implant, or a visible headband with a box attached.

"When Dr. Monfared and Sonitus approached me with the opportunity of a partnership, I couldn't believe how close to home this hit for me," said Singer. "I'm excited to be the one of the first dentists to work with a product that may not only change my son's life, but the lives of millions."

Monfared and Singer wasted no time treating their first SSD patient, Kristin Elmendorf, who learned of the SoundBite last year on an online forum. Elmendorf, a 30-year-old high school teacher in Brooklyn, NY, has been waiting patiently for her "miracle hearing aid" to hit the market. Previous methods, for her, remained undesirable.

"I considered the BAHA implant for years, but there's always a risk involved when you're drilling so close to the brain," cautioned Elmendorf, "I had too many fears. What about infection? What if I jumped in the pool with my abutment on? I just didn't trust myself or the process."

Elmandorf explained how SSD affects her every day. One of the biggest challenges comes when her students call out answers in class.

"I encourage my kids to be confident, yell out the answers to tough question, and not be afraid of participating in class. The problem with that, I can't tell where or who the answers are coming from," said Elmandorf. "I never tell my students about my SSD. I never want them to look at me differently, so my SoundBite can't arrive soon enough. Still not sure what I'll say when they notice a difference right away."

When choosing which of the few providers to visit, she started targeting geographically. After narrowing it down to Pittsburgh, PA and Washington, she chose Monfared and Singer based on a recommendation from an old college friend who had previously had excellent successes with the GWU doctors.

"The process was so quick and easy with Dr. Monfared and Dr. Singer," she urged. "Even though I had to travel from New York City to see my doctors, the excitement makes up for it ten times over."

SoundBite received FDA clearance in January and has been successful in investigative trials. Partner doctors like Monfared and his team will be responsible for identifying candidates, and the doctor-dentist teams for perfecting practical applications of the technology, and ensuring patient satisfaction. Best practices from this year's pre-pilot launch will be unveiled at the American Academy of Otolaryngology's annual meeting this fall. The device will tentatively become available to more doctors across the country in early 2012.

About Dr. Lawrence Singer, DMD, PC:
Dr. Lawrence D. Singer, DMD, PC is the owner of DC Smiles, a comprehensive dental, oral health practice of providing patient care from two locations; DC Smiles in Washington, DC and NOVA Smiles in Alexandria, VA. Patients visit DC Smiles for a wide range care; from general dentistry and routine care, to a full suite of oral reconstructive (dental implants, bone grafts) and cosmetic procedures. Dr. Singer earned his bachelor of science in human development from Vanderbilt University, and his doctor of medical dentistry (DMD) from the University of Pennsylvania, School of Dental Medicine. As the Assistant Clinical Professor of Surgery at the George Washington University Hospital, he is responsible for emergency facial trauma, and performs surgeries and procedures for special needs patients. For more information on Dr. Singer and DC Smiles, please contact Amanda Mitchell at dc.nova.smiles@gmail.com.

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Categories: Health

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Lawrence D. Singer
DC Smiles
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