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
    Health
    Healthcare organizations are operating on slimmer profit margins than ever. One report in August showed that they are even lower than the beginning of the…
    Show More
    Top News
    photo of hands with blue veins
    8 Proven Tips on Finding Difficult Veins
    November 12, 2021
    tips for getting over the pandemic blues
    4 Proven Ways to Get Over the Pandemic Blues
    February 22, 2022
    medical industry innovations
    How is CNC Machining Transforming the Medical Industry?
    June 2, 2022
    Latest News
    Why Custom Telemedicine Apps Outperform Off‑the‑Shelf Solutions
    July 20, 2025
    How Probate Planning Shapes the Future of Your Estate and Family Care
    July 17, 2025
    Beyond Nutrition: Everyday Foods That Support Whole-Body Health
    June 15, 2025
    The Wide-Ranging Benefits of Magnesium Supplements
    June 11, 2025
  • Policy and Law
    • Global Healthcare
    • Medical Ethics
    Policy and Law
    Get the latest updates about Insurance policies and Laws in the Healthcare industry for different geographical locations.
    Show More
    Top News
    Good Riddance to Routine Pelvic Examinations
    August 26, 2014
    Image
    AMA Awards $11M to Medical Schools Poised to Transform #meded
    June 21, 2013
    HIPAA, content marketing
    Keeping Your Content Marketing HIPAA-Compliant
    October 7, 2014
    Latest News
    How IT and Marketing Teams Can Collaborate to Protect Patient Trust
    July 17, 2025
    How Health Choices and Legal Actions Intersect After an Injury
    July 17, 2025
    How communities and healthcare providers can address slip and fall injuries with legal awareness
    July 17, 2025
    Let Your Lawyer Handle the Work Before You Pay Medical Costs
    July 6, 2025
  • 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

Social Media and TEDMED
FDA Updates List of Recognized Standards, Confusion Ensues
Huddle for Excellence In Healthcare Delivery
Here’s How Technological Innovation Is Transforming Healthcare
Mirror, Mirror On the Wall, Am I Healthy After All: Device Connectivity

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

botox certification
Help Improve People’s Skin Health Via Botox Certification
Skin Specialties
July 22, 2025
Telemedicine Apps
Why Custom Telemedicine Apps Outperform Off‑the‑Shelf Solutions
Health
July 20, 2025
Grounded Healing: A Natural Ally for Sustainable Healthcare Systems
How IT and Marketing Teams Can Collaborate to Protect Patient Trust
Global Healthcare Policy & Law
July 17, 2025
paramedics in surgical gloves and masks
How Health Choices and Legal Actions Intersect After an Injury
Health care
July 16, 2025

You Might also Like

Image
Medical InnovationsMobile HealthTechnology

Mobile Health Around the Globe: KTH Develops the BioPatch Sensor

June 24, 2013

Medical Robotics Could Help Treat Arrhythmia, Keep Patients Mobile

October 25, 2013
How To Choose Medical Equipment Bags and Cases
Medical Innovations

How To Choose Medical Equipment Bags and Cases

June 13, 2022

Chancellor Hints at Regenerative Medicine #regenmed Anouncement

November 10, 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?