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SoundBite Hearing System

by Sonitus Medical, Inc.

510(k) K110831

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK110831 Date21 Jun 2011ClearedStatusActive

Recalls

5 recalls · FDA

  • 5 recalls, same reason

    • Terminated Z-1182-2012 FDA Not yet classified initiated 2 Feb 2012
    • Terminated Z-1180-2012 FDA Not yet classified initiated 2 Feb 2012
    • Terminated Z-1179-2012 FDA Not yet classified initiated 2 Feb 2012
    • Terminated Z-1183-2012 FDA Not yet classified initiated 2 Feb 2012
    • Terminated Z-1181-2012 FDA Not yet classified initiated 2 Feb 2012

    Sonitas received reports of stress cracking on the SoundBite Microphone Tube.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Soundbite Hearing System by Sonitus Medical
510(k) Number
FDA Product Code
LXB
Device Class
Class II
Regulation
21 CFR Part 874.3302
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The SoundBite Hearing System is a Bone Conduction Hearing Aid, designed to transmit sound vibrations through the bones of the skull to the inner ear, bypassing the outer and middle ear. It is classified as a Class II medical device and intended for patients aged 18 and older with sensorineural hearing loss ranging from moderately severe to profound. The system leverages bone conduction technology to provide auditory stimulation without relying on traditional ear canal placement.

This device is supplied as a reusable, non-sterile medical instrument and is regulated under FDA 510(k) clearance (K110831) as substantially equivalent to predicate devices. It is intended for use in clinical settings by audiologists or hearing healthcare professionals, with no specific MRI safety restrictions noted. The system is available in multiple configurations, as indicated by the registration numbers (e.g., 3007275459), and adheres to regulatory standards outlined in 874.3302. Storage and handling follow standard medical device protocols for reusable auditory aids.

Other devices from Sonitus Medical, Inc.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the SoundBite Hearing System designed for?

    The SoundBite Hearing System is a bone conduction hearing aid intended for adults aged 18 and older with sensorineural hearing loss ranging from moderately severe to profound. Unlike traditional hearing aids that rely on ear canal placement, this device transmits sound vibrations through the bones of the skull to the inner ear, bypassing the outer and middle ear.

  • How is the SoundBite Hearing System supplied and what does that mean for its use?

    The SoundBite Hearing System is supplied as a reusable, non-sterile medical instrument. This means it is intended for repeated use in clinical settings by audiologists or hearing healthcare professionals, and it does not require sterilization between patients. Standard medical device protocols for reusable auditory aids apply to its storage and handling.

  • What regulatory approval does the SoundBite Hearing System have?

    The SoundBite Hearing System holds FDA 510(k) clearance (K110831) and is classified as a Class II medical device. It is considered substantially equivalent to predicate devices, as determined by the FDA’s Ear, Nose, and Throat (ENT) advisory committee. This clearance confirms its compliance with regulatory standards outlined under 874.3302.

  • Are there different configurations or models available for the SoundBite Hearing System?

    Yes, the SoundBite Hearing System is available in multiple configurations, each identified by unique registration numbers such as 3007275459, 3013177549, and others. These variations may cater to different clinical needs or user preferences, though all adhere to the same core design principles for bone conduction hearing support.

  • Does the SoundBite Hearing System have any MRI safety restrictions?

    The SoundBite Hearing System does not have specific MRI safety restrictions noted in its documentation. However, as with any medical device, clinicians should always verify compatibility with MRI procedures on a case-by-case basis, particularly if the device contains metallic components or electronic circuitry.