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Sonitus Medical, Inc.

United StatesFDA applicant, unverified

Devices
2
FDA recalls
5

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Sonitus Medical, Inc. makes

Sonitus Medical, Inc. makes the SoundBite Hearing System, a bone conduction hearing device designed to transmit sound through the teeth to the inner ear for individuals with certain types of hearing loss.

The SoundBite Hearing System is classified as a Class II medical device and is listed in the FDA 510(k) registry; the company is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue2

Newest first, rows 1-2 of 2

FDA recalls5

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 5 recalls initiated by Sonitus Medical, Inc., initiated on 2012-02-02. By recorded status: 5 terminated. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2012

    • 2 Feb 2012 Z-1179-2012 Not yet classified Terminated Sonitas received reports of stress cracking on the SoundBite Microphone Tube. Distribution: Class III Recall - Nationwide Distribution, including the states of CA, AZ, PA, MI, UT, NC, NY, WI, TX, FL and DC. Submission number: K110831
    • 2 Feb 2012 Z-1180-2012 Not yet classified Terminated Sonitas received reports of stress cracking on the SoundBite Microphone Tube. Distribution: Class III Recall - Nationwide Distribution, including the states of CA, AZ, PA, MI, UT, NC, NY, WI, TX, FL and DC. Submission number: K110831
    • 2 Feb 2012 Z-1181-2012 Not yet classified Terminated Sonitas received reports of stress cracking on the SoundBite Microphone Tube. Distribution: Class III Recall - Nationwide Distribution, including the states of CA, AZ, PA, MI, UT, NC, NY, WI, TX, FL and DC. Submission number: K110831
    • 2 Feb 2012 Z-1182-2012 Not yet classified Terminated Sonitas received reports of stress cracking on the SoundBite Microphone Tube. Distribution: Class III Recall - Nationwide Distribution, including the states of CA, AZ, PA, MI, UT, NC, NY, WI, TX, FL and DC. Submission number: K110831
    • 2 Feb 2012 Z-1183-2012 Not yet classified Terminated Sonitas received reports of stress cracking on the SoundBite Microphone Tube. Distribution: Class III Recall - Nationwide Distribution, including the states of CA, AZ, PA, MI, UT, NC, NY, WI, TX, FL and DC. Submission number: K110831

Frequently asked questions

How many devices does Sonitus Medical, Inc. have in the registry?

The registry currently lists 2 devices for Sonitus Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Sonitus Medical, Inc.'s devices?

Among its 2 most recently registered devices, Sonitus Medical, Inc. has devices listed in FDA 510(k) (2 devices).

What risk classes do Sonitus Medical, Inc.'s devices fall under?

Among its 2 most recently registered devices, the classes recorded for Sonitus Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Sonitus Medical, Inc.?

FDA recall records list 5 recalls initiated by Sonitus Medical, Inc., the most recent initiated on 2 Feb 2012. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Sonitus Medical, Inc. in the registry?

The most recently registered devices listed for Sonitus Medical, Inc. include SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL and SOUNDBITE HEARING SYSTEM BY SONITUS.

Generated automatically from registry data and not verified by a human reviewer.