# K100649: Soundbite Hearing System by Sonitus

- Pathway: 510(k) (Traditional)
- Applicant: Sonitus Medical, Inc.
- Decided: Jan 14, 2011 after 312 days
- Product code: LXB (Hearing Aid, Bone Conduction)
- Device class: 2
- Regulation: 21 CFR 874.3302
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K861971 (1986). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953872: Second Ear Bone Conduction Hearing Aid, Wordcomp International Communication Group (Wicg) (1996) Summary page 2.
- K021837: Branenmark Bone-Anchored-Hearing Aid (Baha), Entific Medical Systems, Inc. (2002) Summary page 2.
- K090720: Cochlear Baha BP100, Cochlear Bone Anchored Systems AB (2009) Summary page 2.
- K050653: Transear Bone Conduction Hearing Aid, United Hearing Systems, Inc. (2005) Summary page 2.
- K062404: Transear Bone Conduction Hearing Aid, Ear Technology Corp. (2006) Summary page 2.

## Most influential descendants
- K110831: Soundbite Hearing System by Sonitus Medical (2011), 0 descendants of its own

## Indications for use
The SoundBite prosthetic device is intended for the following patients and indications: *Patients who are 18 years or older and have 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. 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/K100649
Methodology: https://510kreport.com/methodology