By using this site, you agree to the Privacy Policy and Terms of Use.
Accept
Health Works CollectiveHealth Works CollectiveHealth Works Collective
  • Health
    • Mental Health
  • Policy and Law
    • Global Healthcare
    • Medical Ethics
  • Medical Innovations
  • News
  • Wellness
  • Tech
Search
© 2023 HealthWorks Collective. All Rights Reserved.
Reading: FDA Approves SoundBite Hearing System That Attaches to Your Teeth
Share
Notification Show More
Font ResizerAa
Health Works CollectiveHealth Works Collective
Font ResizerAa
Search
Follow US
  • About
  • Contact
  • Privacy
© 2023 HealthWorks Collective. All Rights Reserved.
Health Works Collective > Technology > Medical Innovations > FDA Approves SoundBite Hearing System That Attaches to Your Teeth
Medical Innovations

FDA Approves SoundBite Hearing System That Attaches to Your Teeth

BarbaraDuck
BarbaraDuck
Share
4 Min Read
SHARE

A couple years ago I remember when I first posted about the development of the product and it sounded a bit out there but here it is with FDA approval and the sound system will be going on sale this fall in the US. In March of this year the product received the CE Mark of Approval.  There is a piece you wear behind your ear as well and it is small so the part on the teeth communicates with the part behind the ear. 

A couple years ago I remember when I first posted about the development of the product and it sounded a bit out there but here it is with FDA approval and the sound system will be going on sale this fall in the US. In March of this year the product received the CE Mark of Approval.  There is a piece you wear behind your ear as well and it is small so the part on the teeth communicates with the part behind the ear. 

SoundBite™ Hearing System Gets European CE Mark–Wireless Hearing Aid That Attaches to Your Teeth

image

In addition to the doctor, this also requires a visit to the dentist as the device is custom made to fit inside your mouth.  For reimbursement the website states that the device is a DME and they seek reimbursement directly from the patient’s insurance company.  The device is programmed via software with a regular PC with the device attached via a cable and settings are stored on the BTE microphone unit..  BD   

More Read

5 Reasons Why Doctors Are Considering Artificial Disc Replacement Over Cervical Fusions
Scanadu Rocks Indiegogo For $1.1M … And Counting
Genetically Informed Therapy and Technical Innovations in Cardiology
Cutting the Cord in Ultrasound Systems
What Do Patients Really Want? Part I

SAN MATEO, Calif., July 1, 2011 /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 announced that it has received an additional FDA clearance for its SoundBite Hearing System. The FDA 510(k) clearance for Conductive hearing loss is the second for the SoundBite prosthetic device and marks another significant milestone for the company.

“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.”

Expanding upon the FDA clearance for the treatment of Single Sided Deafness attained by the company earlier this year, this second indication for use in treating patients with Conductive hearing loss further establishes SoundBite as a non-surgical and cost-effective alternative to bone anchored surgical implants. The SoundBite hearing system will be available starting early this fall through physicians and audiologists in a few select markets in the US (see where at www.soundbitehearing.com/find/), with expansion to additional markets nationwide over the following several months.

Sonitus Medical Receives Second FDA Clearance for SoundBite™ Hearing System — SAN MATEO, Calif., July 1, 2011 /PRNewswire/ —

TAGGED:FDAhearing systemmedical innovationsSoundBite
Share This Article
Facebook Copy Link Print
Share

Stay Connected

1.5kFollowersLike
4.5kFollowersFollow
2.8kFollowersPin
136kSubscribersSubscribe

Latest News

a woman walking on the hallway
6 Easy Healthcare Ways to Sit Less and Move More Every Day
Health
September 9, 2025
Clinical Expertise
Healthcare at a Crossroads: Why Leadership Matters More Than Ever
Global Healthcare
September 9, 2025
travel nurse in north carolina
Balancing Speed and Scope: Choosing the Nursing Degree That Fits Your Goals
Nursing
September 1, 2025
intimacy
How to Keep Intimacy Comfortable as You Age
Relationship and Lifestyle Senior Care
September 1, 2025

You Might also Like

HIMSS 2014
Medical InnovationsTechnology

HIMSS14: Population Health Management and the CareXcell™ Solution

February 26, 2014

How Physician Offices Can Improve Patient Health Care

March 31, 2016

Engaging Patients in Palliative Care

December 2, 2012

The Top 10 Healthcare Innovations of 2012. How Well Did They Do?

December 4, 2012
Subscribe
Subscribe to our newsletter to get our newest articles instantly!
Follow US
© 2008-2025 HealthWorks Collective. All Rights Reserved.
  • About
  • Contact
  • Privacy
Welcome Back!

Sign in to your account

Username or Email Address
Password

Lost your password?