# K110831: Soundbite Hearing System by Sonitus Medical

- Pathway: 510(k) (Traditional)
- Applicant: Sonitus Medical, Inc.
- Decided: Jun 21, 2011 after 88 days
- Product code: LXB (Hearing Aid, Bone Conduction)
- Device class: 2
- Regulation: 21 CFR 874.3302
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K861971 (1986). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100649: Soundbite Hearing System by Sonitus, Sonitus Medical, Inc. (2011) Summary page 2.
- K090720: Cochlear Baha BP100, Cochlear Bone Anchored Systems AB (2009) Summary page 2.

## Recalls of this device
- Feb 2, 2012 · Not classified · Z-1182-2012: Sonitas received reports of stress cracking on the SoundBite Microphone Tube.
- Feb 2, 2012 · Not classified · Z-1179-2012: Sonitas received reports of stress cracking on the SoundBite Microphone Tube.
- Feb 2, 2012 · Not classified · Z-1181-2012: Sonitas received reports of stress cracking on the SoundBite Microphone Tube.
- Feb 2, 2012 · Not classified · Z-1183-2012: Sonitas received reports of stress cracking on the SoundBite Microphone Tube.
- Feb 2, 2012 · Not classified · Z-1180-2012: Sonitas received reports of stress cracking on the SoundBite Microphone Tube.

## Indications for use
The SoundBite Hearing System is intended for patients 18 years and older with the following indications: * Patients with moderately severe, severe, or profound sensorineural hearing loss in one ear and normal hearing in the other ear (i.e. single sided deafness or 'SSD"). Normal hearing is defined as a pure tone average (PTA) air-conduction (AC) hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 25 dB HL. " Patients with conductive hearing loss where the pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) is better than or equal to 25 dB HL. Additionally, use of SoundBite is intended for patients with: * At least two contiguous molar or premolar teeth with no untreated tooth decay. Patients with tooth decay present are to first have restorations before being fitted for SoundBite; * Healthy attachment to those teeth with tooth pockets limited to no more than 5mm; * No mobile teeth; " Bone loss no greater than a 34% average on the mesial and distal sides of the tooth as measured on X-ray on the teeth on which the device will be worn.

Source page: https://510kreport.com/device/K110831
Methodology: https://510kreport.com/methodology